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CDC's MMWR: ACIP Recommendations for 21-22 Flu Season

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CDC's MMWR: ACIP Recommendations for 21-22 Flu Season

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MMWR - ACIP 21-22 Flu Season Recommendations

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'Flu Facts You Should Know' Patient Handout

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'Flu Facts You Should Know' Patient Handout

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Families Fighting Flu's 'Flu Facts You Show Know' flashcards for patients. 2 pages and is a moderate low to moderate health literacy level.

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How much influenza vaccine is projected to be available for the 2021-2022 influenza season?

Are there delays in the distribution of influenza vaccine?

Currently, influenza vaccine manufacturers are not reporting any expected delays in national flu vaccine supply or distribution this season.

Influenza vaccine production and distribution in the U.S. are primarily private sector endeavors. CDC encourages manufacturers and distributors to use a distribution strategy in which providers receive smaller shipments to allow as many providers as possible to begin vaccination activities early in the vaccination season. Ideally, the intervals between shipments are short so that each provider has a continuous supply and can continue vaccinating patients without interruption. While no important delays have been reported, in some places, robust demand for vaccine and supplies required to support flu vaccination efforts, like needles or syringes, may mean that some providers run out of vaccine or other supplies before their next shipment has arrived. An allocation system can initially limit the size of individual orders. However, as supplies become available in increasing numbers, supply is expected to catch up with demand. Additionally, because vaccine manufacturing has been extended to support the production of a record number of flu vaccine doses this year, providers are likely to receive more shipments throughout the season.

To make sure your provider has flu vaccine available, call ahead to confirm availability. There also may be other locations in your area that have vaccine available.

CDC will continue to provide weekly updates on total flu vaccine doses distributed throughout the 2021-2022 flu season.

How much thimerosal-free influenza vaccine is expected to be available for the 2021-2022 season?

For the 2021-2022 season, manufacturers will produce influenza vaccines that do not contain thimerosal and some vaccines that do contain thimerosal. For the 2021-2022 season, only multidose vial formulations of influenza vaccines will contain thimerosal.

Approximately 87% of projected vaccine supply produced for the 2021-2022 flu season will be thimerosal-free or thimerosal-reduced (i.e., preservative-free).

How much quadrivalent (four-component) vaccine is expected to be available for the 2021-2022 season?

For the 2021-2022 season, 100% of the projected vaccine supply produced will be quadrivalent (4-component) vaccines. There will not be any trivalent flu vaccine available.

How much of the U.S. flu vaccine supply for 2021-2022 will be produced using egg-based manufacturing?

Approximately 82% of the projected vaccine supply produced for the 2021-2022 flu season will be produced using egg-based manufacturing technology. The remaining vaccine will be produced using cell-based and recombinant technology.

Can I still buy influenza vaccine for the 2021-2022 season?

Influenza vaccine pre-booking typically occurs between January and March. Some formulations of vaccine should still be available for purchase. Providers should contact distributors and local vendors about remaining supply. In addition, beginning in early October each year, information about manufacturers and distributors who still have influenza vaccine available for sale can be found at http://www.preventinfluenza.org/ivats/external icon .

Updates on the distribution of influenza vaccine doses for the 2021-2022 season will be provided as the season progresses.

What can we anticipate in terms of the timing of vaccine availability for the 2021-2022 season?

The timing of vaccine availability depends on when production is completed. Influenza vaccine distribution generally begins in August and continues through September, October, and November until all of the vaccines are distributed.

Are all influenza vaccines the same?

While all influenza vaccines will protect against the same 4 flu viruses, different influenza vaccines are manufactured differently and different preparations have different indications as licensed by the FDA. In particular, each vaccine is licensed for a specific age range. All recipients should receive a vaccine that is appropriate for their age. In addition, LAIV (the nasal spray flu vaccine) is not recommended for use in some populations.

People with egg allergies can receive any licensed, recommended age-appropriate influenza vaccine (IIV, RIV4, or LAIV4) that is otherwise appropriate. People who have a history of severe egg allergy (those who have had any symptom other than hives after exposure to egg) should be vaccinated in a medical setting, supervised by a health care provider who is able to recognize and manage severe allergic reactions. Two completely egg-free (ovalbumin-free) flu vaccine options are available: quadrivalent recombinant vaccine and quadrivalent cell-based vaccine.

Where can I find information about vaccine supply?

Information about vaccine supply is available here.

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Seasonal Influenza Vaccine Supply for the U.S. 2021-2022 Influenza Season

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Currently, influenza vaccine manufacturers are not reporting any expected delays in national flu vaccine supply or distribution this season. Influenza vaccine production and distribution in the U.S. are primarily private sector endeavors. CDC encourages manufacturers and distributors to use a distribution strategy in which providers receive smaller shipments to allow as many providers as possible to begin vaccination activities early in the vaccination season.

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DRIVE Sustainable Flu Vaccine Equity Initiative Information.

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DRIVE Sustainable Flu Vaccine Equity Initiative Information.

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Information about free tools and resources and upcoming events related to flu vaccine equity.

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DRIVE sustainable flu vaccine equity (1)

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A low to moderate infographic created by Families Fighting Flu to encourage patients to get the flu shot.

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1-Page Communication Guidance for FAQ from Patients

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1-Page Communication Guidance for FAQ from Patients

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Guidance on how to respond to frequently asked questions about the flu vaccine from patients. This 1-page document was created by the nonprofit, Families Fighting Flu.

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A compilation of checklists, worksheets, and planning recommendations for a flu clinic for the 2021-22 season. Created by Sanofi Pasteur.

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AVS Clinic Planning Tools, Rep Contact (1)

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Developed for providers by Sanofi Pasteur.

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AVS -Adaptive Vaccination Solutions- Vaccination Timing and Avoiding Fatigue (1)

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This 2-page handout was created by Sanofi Pasteur for the 2021-22 flu season and address COVID-19 and the flu. It is a low - moderate health literacy level.

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AVS - Adaptive Vaccination Solutions Flu Shot Importance Flashcard (1)

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Poster template from Families Fighting Flu.

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Pneumococcal Vaccine Recommendations - Can be administered with Flu Vaccine

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Pneumococcal Vaccine Recommendations - Can be administered with Flu Vaccine

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The Pneumococcal vaccine can be administered at the same time as the flu vaccine.

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CDC Interim Guidance on Routine & Flu Vaccines During Pandemic

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CDC Interim Guidance on Routine & Flu Vaccines During Pandemic

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Updated for 2021-2022 flu season.

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The COVID-19 pandemic has caused healthcare providers to change how they operate to continue to provide essential services to patients. Ensuring immunization services are maintained or reinitiated is essential for protecting individuals and communities from vaccine-preventable diseases and outbreaks and reducing the burden of respiratory illness during the upcoming influenza season.

The following are a collection of federal resources designed to guide vaccine planning during the COVID-19 pandemic:

To receive email updates about this page, enter your email address:

Interim Guidance for Immunization Services During the COVID-19 Pandemic

Vaccination Recommendations during the COVID-19 Pandemic

COVID-19 Operational Guidance

Administration of vaccines is an essential medical service.

Assess the vaccination status of all patients across the life span at every health care visit.

Administer routinely recommended vaccines to children, adolescents, and adults (including pregnant women).

Delay vaccination for persons with suspected or confirmed COVID-19.

Follow guidance to prevent the spread of COVID-19 in health care settings.

Encourage vaccination at the patient's medical home.

Implement effective strategies for catch-up vaccination.

Communicate with patients/families about how they can be safely vaccinated during the pandemic.

Page last reviewed:

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The COVID-19 pandemic has caused healthcare providers to change how they operate to continue to provide essential services to patients. Ensuring immunization services are maintained or reinitiated is essential for protecting individuals and communities from vaccine-preventable diseases and outbreaks and reducing the burden of respiratory illness during the upcoming influenza season.

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CDC Interim Clinical Considerations for Use of approved COVID vaccines

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CDC Interim Clinical Considerations for Use of approved COVID vaccines

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Updated to include recommendations for COMIRNATY

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Background

COVID-19 vaccination is recommended for all people 12 years and older for the prevention of coronavirus disease 2019 (COVID-19) in the United States under the U.S. Food and Drug Administration's (FDA) Emergency Use Authorization (EUA). The Advisory Committee on Immunization Practices (ACIP) has issued interim recommendations for the use of:

On April 23, 2021, ACIP reaffirmed its interim recommendation for use of the Janssen COVID-19 vaccine in all persons ages ≥18 years; ACIP's updated recommendation followed a review of cases of thrombosis with thrombocytopenia syndrome (TTS) among Janssen COVID-19 vaccine recipients and consideration of the risks and benefits of resuming vaccination. FDA has added a warning to the Janssen COVID-19 vaccine EUAexternal icon fact sheets and prescribing information that rare clotting events might occur after vaccination, primarily among women ages 18-49 years.

The Pfizer-BioNTech and Moderna vaccines are lipid nanoparticle-formulated, nucleoside-modified mRNA vaccines encoding the prefusion spike glycoprotein of SARS-CoV-2, the virus that causes COVID-19. The Janssen vaccine is a recombinant replication-incompetent adenovirus type 26 (Ad26) vector encoding the stabilized prefusion spike glycoprotein of SARS-CoV-2. None of the currently authorized COVID-19 vaccines are live virus vaccines.

These interim CDC clinical considerations are informed by data submitted to the FDA for EUA of the vaccines, other data sources, general best practice guidelines for immunization, and expert opinion. These considerations apply only to the vaccine products currently authorized in the United States (i.e., Pfizer-BioNTech, Moderna, and Janssen COVID-19 vaccines). Considerations will be updated when additional information becomes available or if additional vaccine products are authorized.

In addition to the following considerations, the EUA conditions of use and storage, handling, and administration procedures described in the prescribing information should be referenced when using the Pfizer-BioNTechexternal icon , Modernaexternal icon , and Janssenexternal icon COVID-19 vaccines.

Authorized age groups

COVID-19 vaccination is recommended for all people 12 years and older. Under the EUAs, the following age groups are authorized to receive vaccination:

Pfizer-BioNTech: ages ≥12 years

Moderna: ages ≥18 years

Janssen: ages ≥18 years

Children outside these authorized age groups should not receive COVID-19 vaccination at this time.

Vaccine administration

COVID-19 vaccines are administered intramuscularly as either a two-dose series or single dose.

A single, valid vaccination series (i.e., either a two-dose mRNA COVID-19 vaccine series or a single dose of Janssen COVID-19 vaccine) should be administered. People are not recommended to receive more than one complete COVID-19 vaccination series.

A person is considered fully vaccinated against COVID-19 ≥2 weeks after receipt of the second dose in a 2-dose series (Pfizer-BioNTech and Moderna) or ≥2 weeks after receipt of the single dose of the Janssen vaccine. CDC has developed public health recommendations for fully vaccinated people. People who have a contraindication to vaccination or who otherwise cannot complete a vaccination series are not considered fully vaccinated.
Interval between mRNA doses
The second dose of Pfizer-BioNTech and Moderna vaccines should be administered as close to the recommended interval as possible, but not earlier than recommended (i.e., 3 weeks [Pfizer-BioNTech] or 1 month [Moderna]). However, second doses administered within a grace period of 4 days earlier than the recommended date for the second dose are still considered valid. If it is not feasible to adhere to the recommended interval and a delay in vaccination is unavoidable, the second dose of Pfizer-BioNTech and Moderna COVID-19 vaccines may be administered up to 6 weeks (42 days) after the first dose. Currently, only limited data are available on efficacy of mRNA COVID-19 vaccines administered beyond this window.
Vaccine administration errors and deviations
Information on preventing, reporting, and managing COVID-19 vaccine administration errors is found in Appendix A. Vaccine administration errors should be reported to the Vaccine Adverse Event Reporting System (VAERS)external icon .

Interchangeability of COVID-19 vaccine products

Any currently FDA-authorized COVID-19 vaccine can be used when indicated; ACIP does not state a product preference. However, COVID-19 vaccines are not interchangeable.
mRNA COVID-19 vaccines (Pfizer-BioNTech and Moderna)
The safety and efficacy of a mixed-product series have not been evaluated. Both doses of the series should be completed with the same product.

Strategies to ensure that patients receive the second dose with the appropriate product and interval between doses include:

Providing COVID-19 vaccination record cards to vaccine recipients, asking recipients to bring their card to their appointment for the second dose, and encouraging recipients to make a backup copy (e.g., by taking a picture of the card with their phone)

Encouraging vaccine recipients to enroll in v-safe, a free smartphone-based tool that uses text messaging and web surveys to provide personalized health check-ins as well as second-dose reminders

Encouraging vaccine recipients to enroll in VaxText SM, a free text-message-based platform that provides COVID-19 vaccination second-dose reminders

Recording each recipient's vaccination in the immunization information system (IIS)

Recording vaccine administration information in the patient's medical record

Making an appointment for the second dose before the vaccine recipient leaves, to increase the likelihood that patients will present at the same vaccination site for the second dose

Using the above strategies, every effort should be made to determine which vaccine product was received as the first dose to ensure completion of the vaccine series with the same product. In exceptional situations in which the mRNA vaccine product given for the first dose cannot be determined or is no longer available, any available mRNA COVID-19 vaccine may be administered at a minimum interval of 28 days between doses to complete the mRNA COVID-19 vaccination series. In situations where the same mRNA vaccine product is temporarily unavailable, it is preferable to delay the second dose (up to 6 weeks) to receive the same product than to receive a mixed series using a different product. If two doses of different mRNA COVID-19 vaccine products are administered in these situations (or inadvertently), no additional doses of either product are recommended at this time. Such persons are considered fully vaccinated against COVID-19 ≥2 weeks after receipt of the second dose of an mRNA vaccine.

The safety and efficacy of Janssen COVID-19 vaccine administered after an mRNA COVID-19 vaccine has not been established. However, in limited, exceptional situations where a patient received the first dose of an mRNA COVID-19 vaccine but is unable to complete the series with either the same or different mRNA COVID-19 vaccine (e.g., due to contraindication), a single dose of Janssen COVID-19 vaccine may be considered at a minimum interval of 28 days from the mRNA COVID-19 vaccine dose. See Contraindications and Precautions section for additional information on use of Janssen COVID-19 vaccine and additional precautions in people with a contraindication to mRNA COVID-19 vaccines. Patients who receive Janssen COVID-19 vaccine after a dose of an mRNA COVID-19 vaccine should be considered to have received a valid, single-dose Janssen vaccination-not a mixed vaccination series-and are considered fully vaccinated against COVID-19 ≥2 weeks after receipt of the single dose of the Janssen vaccine.

People vaccinated outside the United States

People who were vaccinated outside the United States with an FDA-authorized COVID-19 vaccine and have received all the recommended doses do not need any additional doses. People who received the first dose of an FDA-authorized COVID-19 vaccine that requires two doses do not need to restart the vaccine series in the United States but should receive the second dose as close to the recommended time as possible.

Some people may have received a COVID-19 vaccine that is not currently authorized in the United States. No data are available on the safety or efficacy of receiving a COVID-19 vaccine currently authorized in the United States after receipt of a non-FDA-authorized COVID-19 vaccine. However, in some circumstances people who received a COVID-19 vaccine not currently authorized in the United States may be offered revaccination with an FDA-authorized vaccine:

COVID-19 vaccines not authorized by FDA but listed for emergency use by the World Health Organization (WHO)

People who have received all recommended doses of a COVID-19 vaccine that is listed for emergency use by WHO do not need any additional doses with an FDA-authorized COVID-19 vaccine.

People who have not received all the recommended doses of a COVID-19 vaccine listed for emergency use by WHO may be offered a complete FDA-authorized COVID-19 vaccine series.

COVID-19 vaccines neither authorized by FDA nor listed for emergency use by WHO
People who received all or some of the recommended doses of a COVID-19 vaccine that is neither authorized by FDA nor listed for emergency use by WHO may be offered a complete FDA-authorized COVID-19 vaccine series.

The minimum interval between the last dose of a non-FDA authorized vaccine or a WHO-listed vaccine and an FDA-authorized COVID-19 vaccine is 28 days. Only people who have received all recommended doses of an FDA-authorized or WHO-listed COVID-19 vaccine are considered fully vaccinated for the purpose of public health guidance.

Coadministration with other vaccines

COVID-19 vaccines were previously recommended to be administered alone, with a minimum interval of 14 days before or after administration of any other vaccines. This was out of an abundance of caution and not due to any known safety or immunogenicity concerns. However, substantial data have now been collected regarding the safety of COVID-19 vaccine currently authorized by FDA for use under EUA. Although data are not available for COVID-19 vaccines administered simultaneously with other vaccines, extensive experience with non-COVID-19 vaccines has demonstrated that immunogenicity and adverse event profiles are generally similar when vaccines are administered simultaneously as when they are administered alone.

COVID-19 vaccines and other vaccines may now be administered without regard to timing. This includes simultaneous administration of COVID-19 vaccine and other vaccines on the same day, as well as coadministration within 14 days. It is unknown whether reactogenicity of COVID-19 vaccine is increased with coadministration, including with other vaccines known to be more reactogenic, such as adjuvanted vaccines or live vaccines. When deciding whether to coadminister another vaccine(s) with COVID-19 vaccine, providers should consider whether the patient is behind or at risk of becoming behind on recommended vaccines, their risk of vaccine-preventable disease (e.g., during an outbreak or occupational exposures), and the reactogenicity profile of the vaccines.

If multiple vaccines are administered at a single visit, administer each injection in a different injection site. For adolescents and adults, the deltoid muscle can be used for more than one intramuscular injection.

Best practices for multiple injections include:

Label each syringe with the name and the dosage (amount) of the vaccine, lot number, the initials of the preparer, and the exact beyond-use time, if applicable.

Separate injection sites by 1 inch or more, if possible.

Administer the COVID-19 vaccines and vaccines that may be more likely to cause a local reaction (e.g., tetanus-toxoid-containing and adjuvanted vaccines) in different limbs, if possible.

Booster doses

The need for and timing for COVID-19 booster doses have not been established. No additional doses are recommended at this time.

COVID-19 vaccination and SARS-CoV-2 infection
People with prior or current SARS-CoV-2 infection
People should be offered vaccination regardless of their history of symptomatic or asymptomatic SARS-CoV-2 infection; this includes people with prolonged post-COVID-19 symptoms. Data from clinical trials indicate that the currently authorized COVID-19 vaccines can be given safely to people with evidence of a prior SARS-CoV-2 infection. Viral testing to assess for acute SARS-CoV-2 infection or serologic testing to assess for prior infection is not recommended for the purposes of vaccine decision-making.

Vaccination of people with known current SARS-CoV-2 infection should be deferred until the person has recovered from the acute illness (if the person had symptoms) and they have met criteria to discontinue isolation. This recommendation applies to people who experience SARS-CoV-2 infection before receiving any vaccine dose and those who experience SARS-CoV-2 infection after the first dose of an mRNA vaccine but before receipt of the second dose.

While there is no recommended minimum interval between infection and vaccination, current evidence suggests that the risk of SARS-CoV-2 reinfection is low in the months after initial infection but may increase with time due to waning immunity.
People with a history of multisystem inflammatory syndrome in children (MIS-C) or adults (MIS-A)
People with a history of MIS-C or MIS-A may choose to be vaccinated. Considerations for vaccination may include:

Clinical recovery from MIS-C or MIS-A, including return to normal cardiac function

Personal risk of severe acute COVID-19 (e.g., age, underlying conditions)

Level of COVID-19 community transmission and personal risk of reinfection

Lack of safety data of COVID-19 vaccines following these illnesses

Timing of any immunomodulatory therapies (ACIP's general best practice guidelines for immunization can be consulted for more information)

A conversation between the patient, their guardian(s), and their clinical team or a specialist may assist with decisions about the use of a COVID-19 vaccine, though a conversation with a healthcare provider is not required before vaccination.

Current evidence suggests that the risk of SARS-CoV-2 reinfection is low in the months after initial infection but may increase with time due to waning immunity. Thus, people with a history of MIS-C or MIS-A should consider delaying vaccination until they have recovered from their illness and for 90 days after the date of diagnosis of MIS-C or MIS-A, recognizing that the risk of reinfection and, therefore, the benefit from vaccination, might increase with time following initial infection.

For people who develop MIS-C or MIS-A that is associated with a confirmed SARS-CoV-2 infection but occurs after receipt of a COVID-19 vaccine, referral to a specialist in infectious diseases, rheumatology, or cardiology should be considered. Healthcare providers and health departments may also request a consultation from the Clinical Immunization Safety Assessment COVIDvax. In addition, information about these cases should be reported to VAERSexternal icon .
People who previously received passive antibody therapy
Currently, there are no data on the safety and efficacy of COVID-19 vaccines in people who received monoclonal antibodies or convalescent plasma as part of COVID-19 treatment. Based on the estimated half-life of such therapies and evidence suggesting that reinfection is uncommon in the 90 days after initial infection, vaccination should be deferred for at least 90 days. This is a precautionary measure until additional information becomes available, to avoid potential interference of the antibody therapy with vaccine-induced immune responses. This recommendation applies to people who receive passive antibody therapy before receiving any vaccine dose and to those who receive passive antibody therapy after the first dose of an mRNA vaccine but before the second dose, in which case the second dose should be deferred for at least 90 days following receipt of the antibody therapy. Receipt of passive antibody therapy in the past 90 days is not a contraindication to receipt of COVID-19 vaccine. COVID-19 vaccine doses received within 90 days after receipt of passive antibody therapy do not need to be repeated.

For people receiving antibody therapies not specific to COVID-19 treatment (e.g., intravenous immunoglobulin, RhoGAM), administration of COVID-19 vaccines either simultaneously with or at any interval before or after receipt of an antibody-containing product is unlikely to substantially impair development of a protective antibody response. Thus, there is no recommended minimum interval between antibody therapies not specific to COVID-19 treatment and COVID-19 vaccination.
Vaccinated people who subsequently develop COVID-19
For people who have received one or more doses of COVID-19 vaccine and subsequently experience COVID-19, prior receipt of a COVID-19 vaccine should not affect treatment decisions (including use of monoclonal antibodies, convalescent plasma, antiviral treatment, or corticosteroid administration) or timing of such treatments.

If a person who has SARS-CoV-2 RNA or antigen detected on a respiratory specimen collected ≥14 days after they complete all recommended doses of an FDA-authorized COVID-19 vaccine (defined as a COVID-19 vaccine breakthrough case), CDC encourages local health departments, healthcare providers, and clinical laboratories to:

Request the respiratory specimen be held for further testing

Report the case to the state health department where the individual resides for further investigation and reporting to the national system

Antiviral therapy and COVID-19 vaccination

Administration of an antiviral drug at any interval before or after vaccination with any of the currently FDA-authorized COVID-19 vaccines, including the adenovirus vector Janssen COVID-19 vaccine, is unlikely to impair development of a protective antibody response.

Vaccinating people with a known COVID-19 exposure or during COVID-19 outbreaks

COVID-19 vaccines are not currently recommended for outbreak management or for post-exposure prophylaxis to prevent SARS-CoV-2 infection in a person with a known exposure. Because the median incubation period of COVID-19 is 4-5 days, it is unlikely that a dose of COVID-19 vaccine would provide an adequate immune response within the incubation period for effective post-exposure prophylaxis.

People in the community or in outpatient settings who have had a known COVID-19 exposure should not seek vaccination until their quarantine period has ended to avoid potentially exposing healthcare personnel and others during the vaccination visit. This recommendation also applies to people with a known COVID-19 exposure before receipt of the second mRNA vaccine dose.

Residents or patients with a known COVID-19 exposure in congregate healthcare settings (e.g., long-term care facilities) or congregate non-healthcare settings (e.g., correctional and detention facilities, homeless shelters) may be vaccinated. In these settings, exposure to and transmission of SARS-CoV-2 can occur repeatedly for long periods of time, and healthcare personnel and other staff are already in close contact with residents. People residing in congregate settings (healthcare and non-healthcare) who have had an exposure and are awaiting SARS-CoV-2 testing results may be vaccinated if they do not have symptoms consistent with COVID-19. Vaccinators should employ appropriate infection prevention and control procedures.

Considerations for vaccination of people with certain underlying medical conditions

Any currently FDA-authorized COVID-19 vaccine can be administered to people with underlying medical conditions who have no contraindications to vaccination; ACIP does not state a product preference. Clinical trials demonstrated similar safety and efficacy profiles in people with some underlying medical conditions, including those that place them at increased risk for severe COVID-19, compared to people without comorbidities. Additional information for people with specific underlying medical conditions is included below. Healthcare providers or health departments in the United States can request a consultation from the Clinical Immunization Safety Assessment COVIDvax project if they have complex COVID-19 vaccine safety questions not readily addressed by CDC guidance.
Immunocompromised people
People with HIV infection or other immunocompromising conditions or people who take immunosuppressive medications or therapies might be at increased risk for severe COVID-19. No data are available to establish COVID-19 vaccine safety and efficacy in these groups. However, the currently FDA-authorized COVID-19 vaccines are not live vaccines and therefore can be safely administered to immunocompromised people. People with stable HIV infection were included in the COVID-19 vaccine clinical trials, though data remain limited.

Immunocompromised people can receive COVID-19 vaccination. Data are currently insufficient to inform optimal timing of COVID-19 vaccination among people who are planning to receive immunosuppressive therapies. However, based on general best practices for vaccination of immunocompromised people, ideally COVID-19 vaccination should be completed at least two weeks before initiation of immunosuppressive therapies. When it is not possible to administer a complete COVID-19 vaccination series (i.e., two doses of an mRNA vaccine or a single dose of Janssen COVID-19 vaccine) in advance, people on immunosuppressive therapy can still receive COVID-19 vaccination. Decisions to delay immunosuppressive therapy to complete COVID-19 vaccination should consider the person's risks related to their underlying condition. Consistent with general best practices for immunization for non-live vaccines, COVID-19 vaccines may be administered without regard to timing of corticosteroid treatment, including topical or intraarticular, bursal, or tendon injection.

Antibody testing is not recommended to assess for immunity to SARS-CoV-2 following COVID-19 vaccination. At this time, revaccination is not recommended after people who received COVID-19 vaccines during chemotherapy or treatment with other immunosuppressive drugs regain immune competence. Recommendations on re-vaccination or additional doses of COVID-19 vaccines may be updated when additional information is available.

People should be counseled about the unknown vaccine safety profile and effectiveness in immunocompromised populations, the potential for reduced immune responses, and the need to continue to follow current guidance to protect themselves against COVID-19.
People with autoimmune conditions
People with autoimmune conditions were eligible for enrollment in COVID-19 vaccine clinical trials. No imbalances were observed in the occurrence of symptoms consistent with autoimmune conditions or inflammatory disorders in clinical trial participants who received COVID-19 vaccine compared to placebo. People with autoimmune conditions may receive any FDA-authorized COVID-19 vaccine.
People with a history of Guillain-Barré syndrome
No cases of Guillain-Barré syndrome (GBS) were reported following vaccination among participants in the mRNA COVID-19 vaccine clinical trials. One case of GBS was reported in a participant in the vaccine group in the Janssen COVID-19 vaccine clinical trial, compared to one GBS case among those who received placebo. With few exceptions, ACIP's general best practice guidelines for immunization do not include history of GBS as a contraindication or precaution to vaccination. People with a history of GBS may receive any FDA-authorized COVID-19 vaccine. Any occurrence of GBS following COVID-19 vaccination should be reported to VAERSexternal icon .
People with a history of Bell's palsy People with a history of dermal filler use
Infrequently, people who have received dermal fillers might experience swelling at or near the site of filler injection (usually face or lips) following administration of a dose of an mRNA COVID-19 vaccine (no similar occurrences were observed in the Janssen COVID-19 vaccine clinical trials). The swelling appears to be temporary and resolves with medical treatment, including corticosteroid therapy. FDA-authorized COVID-19 vaccines can be administered to people who have received injectable dermal fillers who have no contraindications or precautions for vaccination. However, these people should be advised to contact their healthcare provider for evaluation if they experience swelling at or near a dermal filler site following vaccination.

Considerations for use of the Janssen COVID-19 vaccine in certain populations

TTS is a rare syndrome that involves acute venous or arterial thrombosis and new onset thrombocytopenia in patients with no recent known exposure to heparin. In the United States, the majority of persons with TTS that occurred after Janssen COVID-19 vaccination had clots located in cerebral venous sinuses; clots also occurred in other unusual locations including in the portal vein and splenic vein, and included a combination of venous and arterial thromboses. FDA has added a warning to the Janssen COVID-19 vaccine EUA and fact sheets and prescribing information regarding rare clotting events that have been reported among vaccine recipients. The EUA fact sheet should be provided to all vaccine recipients and their caregivers (as relevant) before vaccination with any authorized COVID-19 vaccine.
Woman aged <50 years
Women aged <50 years can receive any FDA-authorized COVID-19 vaccine. However, they should be aware of the rare risk of TTS after receipt of the Janssen COVID-19 vaccine and the availability of other FDA-authorized COVID-19 vaccines (i.e., mRNA vaccines). The highest rates of TTS per vaccine doses administered were identified in women <50 years of age. At the time of ACIP's review, TTS reporting rates to VAERS were 7.0 cases per million Janssen COVID-19 vaccine doses administered to women ages 18−49 years and 0.9 per million to women ages ≥50 years.
People with a history of thrombosis or risk factors for thrombosis
Although the etiology of TTS associated with the Janssen COVID-19 vaccine is unclear, it appears to be similar to another rare immune-mediated syndrome, heparin-induced thrombocytopenia (HIT). Until more information becomes available, experts advise that persons with a history of an episode of an immune-mediated syndrome characterized by thrombosis and thrombocytopenia, such as HIT, should be offered another FDA-authorized COVID-19 vaccine (i.e., mRNA vaccine) if it has been ≤90 days since their illness resolved. After 90 days, patients may be vaccinated with any FDA-authorized COVID-19 vaccine.

Venous thromboembolism (VTE), defined as deep vein thrombosis, pulmonary embolism, or both, are common. The biologic mechanisms for VTE (as well as arterial thrombi) differ from the underlying immune-mediated mechanism for HIT. Based on current knowledge, experts believe that people with risk factors for VTE (e.g., inherited or acquired thrombophilia including Factor V Leiden; prothrombin gene 20210A mutation; antiphospholipid syndrome; protein C, protein S or antithrombin deficiency), or a prior history of other types of thromboses (including cerebral venous sinus thrombosis [CVST]) not associated with thrombocytopenia are unlikely to be at increased risk for TTS. Likewise, although the risk of thrombosis is increased during pregnancy and the postpartum period, and with certain hormonal contraceptives (e.g., combined oral contraceptives, patch, and ring), experts believe that these factors do not make people more susceptible to TTS after receipt of the Janssen COVID-19 vaccine. These people can receive any FDA-authorized vaccine, including the Janssen COVID-19 vaccine.
Use of aspirin or anticoagulants
It is not recommended that people take aspirin or an anticoagulant before vaccination with the Janssen COVID-19 vaccine or any other FDA-authorized COVID-19 vaccine (i.e., mRNA vaccine) unless they take these medications as part of their routine medications.

Vaccination of pregnant or lactating people

Any of the currently authorized COVID-19 vaccines can be administered to pregnant or lactating people; ACIP does not state a product preference. However, pregnant, lactating, and post-partum people aged <50 years should be aware of the rare risk of TTS after receipt of the Janssen COVID-19 vaccine and the availability of other FDA-authorized COVID-19 vaccines (i.e., mRNA vaccines). See also People with a history of thrombosis or risk factors for thrombosis.
Pregnant people
Observational data demonstrate that pregnant people with COVID-19 have an increased risk of severe illness, including illness resulting in intensive care admission, mechanical ventilation, extracorporeal membrane oxygenation, or death, though the absolute risk for these outcomes is low. Additionally, they are at increased risk of preterm birth and might be at an increased risk of adverse pregnancy complications and outcomes, such as preeclampsia, coagulopathy, and stillbirth.

Data on the safety of COVID-19 vaccines in pregnant people are limited. No female reproduction or fetal, embryonal, or postnatal development safety concerns were demonstrated in animals that received Pfizer-BioNTech, Moderna, or Janssen COVID-19 vaccines before or during gestation. In addition, the adenovirus vector platform used in the Janssen COVID-19 vaccine has also been used for other Janssen vaccine development programs that have included pregnant people vaccinated during any trimester, including in a large-scale Ebola vaccination trial. No adverse pregnancy-related outcomes-including infant outcomes-were determined to be related to the vaccine in these trials.

Based on current knowledge, experts believe that COVID-19 vaccines are unlikely to pose a risk to the pregnant person or fetus. The FDA-authorized COVID-19 vaccines (i.e., mRNA vaccines and a non-replicating viral vector vaccine) cannot cause infection in either the mother or the fetus. No evidence exists of risk to the fetus from vaccinating pregnant women with non-replicating vaccines in general. However, the potential risks of COVID-19 vaccines to the pregnant person and the fetus are unknown because these vaccines have not been studied in pregnant people. Clinical trials to evaluate the safety and efficacy of COVID-19 vaccines in pregnant people are underway or planned. Vaccine manufacturers are also following outcomes in people in the clinical trials who became pregnant.

Pregnant persons are eligible for and can receive a COVID-19 vaccine. A conversation between the patient and their clinical team may assist with decisions about the use of a COVID-19 vaccine, though a conversation with a healthcare provider is not required before vaccination. When making a decision, pregnant people and their healthcare providers should consider the level of COVID-19 community transmission, the patient's personal risk of contracting COVID-19, the increased risks of severe COVID-19 to the patient and potential risks to the fetus, the known and potential benefits of vaccination, efficacy of the vaccine, side effects of the vaccine, and the limited but growing data about the safety of the vaccine during pregnancy. COVID-19 vaccines and other vaccines may now be administered without regard to timing; for additional information on coadministration of COVID-19 vaccines and other recommended vaccines see Coadministration with other vaccines. Pregnant people who choose to receive COVID-19 vaccine are encouraged to enroll in v-safe.

Side effects can occur with COVID-19 vaccine use in pregnant people, similar to those expected among non-pregnant people. Acetaminophen can be offered as an option for pregnant people experiencing fever (which has been associated with adverse pregnancy outcomes) or other post-vaccination symptoms.

There is no recommendation for routine pregnancy testing before receipt of a COVID-19 vaccine. Those who are trying to become pregnant do not need to avoid pregnancy after COVID-19 vaccination. There is no evidence that any of the COVID-19 vaccines affect future fertility.
Lactating people
There are no data on the safety of COVID-19 vaccines in lactating people or the effects of COVID-19 vaccines on the breastfed infant or milk production or excretion. However, the FDA-authorized COVID-19 vaccines (i.e., mRNA vaccines and a non-replicating viral vector vaccine) cannot cause infection in either the mother or the infant. Therefore, lactating people can receive a COVID-19 vaccine.

Vaccination of children and adolescents

Adolescents ages 12-17 years are eligible to receive the Pfizer-BioNTech COVID-19 vaccine and may be vaccinated with appropriate assent. Sites administering COVID-19 vaccines should follow current state/jurisdictional policies and practices in place for other routine immunizations in this age group.

Available safety, immunogenicity, and reactogenicity data are similar to those seen in young adults ages 16-25 years. Syncope (fainting) may occur in association with any injectable vaccines, especially among adolescents. Procedures should be in place to prevent falling injuries and manage syncopal reactions. All people are recommended to be observed for 15 minutes after vaccination (including COVID-19 vaccination); patients should be seated or lying down during the observation period to decrease the risk for injury should they faint. If syncope develops, patients should be observed until symptoms resolve.

Children younger than age 12 years are not authorized to receive the Pfizer-BioNTech COVID-19 vaccine at this time. Children and adolescents younger than age 18 years are not authorized to receive the Moderna or Janssen COVID-19 vaccines at this time.

Patient counseling
mRNA COVID-19 vaccines (Pfizer-BioNTech and Moderna)
Preliminary data suggest high vaccine efficacy in preventing COVID-19 following receipt of two doses of mRNA COVID-19 vaccine (Pfizer-BioNTech: 95.0% [95% CI: 90.3%, 97.6%] for people ages ≥16 years and 100% [95% CI: 75.3%, 100%] for adolescents ages 12-15 years; Moderna: 94.1% [95% CI: 89.3%, 96.8%]). Patients should be counseled on the importance of completing the two-dose series with the same vaccine product to optimize protection.

Before vaccination, providers should counsel mRNA COVID-19 vaccine recipients about expected local (e.g., pain, swelling, erythema at the injection site, localized axillary lymphadenopathy on the same side as the vaccinated arm) and systemic (e.g., fever, fatigue, headache, chills, myalgia, arthralgia) post-vaccination symptoms. Depending on vaccine product ( Pfizer-BioNTech vs. Moderna), age group, and vaccine dose, approximately 80%-91% of vaccinated people experience at least one local symptom and 48%-91% experience at least one systemic symptom following vaccination.

Most systemic post-vaccination symptoms are mild to moderate in severity, occur within the first three days of vaccination, and resolve within 1-2 days of onset. Overall, symptoms are more frequent and severe following the second dose and among younger people compared with older people (i.e., ages >55 or ≥65 years [for Pfizer-BioNTech or Moderna vaccines, respectively]). People with prior SARS-CoV-2 infection may be more likely to experience symptoms such as fever, chills, and myalgia after the first mRNA COVID-19 vaccine dose. Unless people have a contraindication to vaccination, they should be encouraged to complete the series to optimize protection against COVID-19 even if they experience local or systemic symptoms following the first dose.
Viral vector COVID-19 vaccine (Janssen)
Preliminary data suggest an overall efficacy of 66.3% (95% CI: 59.9%, 71.8%) against symptomatic, laboratory-confirmed COVID-19 from ≥14 days after vaccination with Janssen COVID-19 vaccine. Vaccine efficacy for the prevention of COVID-19-associated hospitalization was high; vaccine efficacy against hospitalization ≥14 days after vaccination was 93.1% (95% CI: 71.1%, 98.4%). No COVID-19-associated hospitalizations occurred ≥28 days after vaccination in the vaccine group, and 16 occurred in the placebo group (vaccine efficacy = 100%; 95% CI = 74.3%, 100.0%). Vaccine efficacy against all-cause death was 75.0% (95% CI: 33.4%, 90.6%).

Before vaccination, providers should counsel Janssen COVID-19 vaccine recipients about expected local (e.g., pain, swelling, erythema at the injection site) and systemic (e.g., fever, fatigue, headache, chills, myalgia, arthralgia) post-vaccination symptoms. Fifty percent of vaccinated people experience at least one local symptom, with pain at the injection site most common, and approximately 55% experience at least one systemic symptom following vaccination. Most systemic post-vaccination symptoms are mild to moderate in severity and resolve within 1-2 days after vaccination. Overall, symptoms were more frequent in younger people than older people (ages ≥60 years).

In view of reports of TTS after receipt of the Janssen COVID-19 vaccine, FDA has added a warning to the EUA fact sheets and prescribing informationexternal icon . It notes that blood clots involving blood vessels in the brain, abdomen, and legs along with low levels of platelets have occurred in some people who received the Janssen COVID-19 vaccine and that these symptoms began approximately 1-2 weeks following vaccination. Most people who developed these blood clots were women ages 18-49 years. Although the chance of having this occur is remote, people should seek medical attention right away if they have any of the following symptoms after receiving Janssen COVID-19 vaccine:

Shortness of breath

Chest pain

Leg swelling

Persistent abdominal pain

Severe or persistent headaches or blurred vision

Easy bruising or tiny blood spots under the skin beyond the site of the injection.

ACIP reviewed a risk-benefit assessment of TTS events after vaccination with the Janssen COVID-19 vaccine. Based on this risk-benefit analysis, ACIP reaffirmed its interim recommendation for the use of the Janssen COVID-19 vaccine in all persons ages ≥18 years, while still acknowledging the increased risk for TTS in women aged <50 years. These women should be aware of the increased risk for TTS and the availability of other FDA-authorized COVID-19 vaccines (i.e., mRNA vaccines). Clinicians should consult the HAN notification and guidanceexternal icon from the American Society of Hematology for information on the diagnosis and treatment of suspected cases of TTS.
Management of post-COVID-19-vaccination symptoms
For all currently authorized COVID-19 vaccines, antipyretic or analgesic medications (e.g., acetaminophen, non-steroidal anti-inflammatory drugs) can be taken for the treatment of post-vaccination local or systemic symptoms, if medically appropriate. However, routine prophylactic administration of these medications for the purpose of preventing post-vaccination symptoms is not currently recommended, because information on the impact of such use on COVID-19 vaccine-induced antibody responses is not yet available.

Anaphylactic reactions have been rarely reported following receipt of COVID-19 vaccines. Administration of antihistamines to COVID-19 vaccine recipients before vaccination to prevent allergic reactions is not recommended. Antihistamines do not prevent anaphylaxis, and their use might mask cutaneous symptoms, which could lead to a delay in the diagnosis and management of anaphylaxis. See section on contraindications and precautions to vaccination and interim considerations for anaphylaxis management for more information on management of anaphylaxis.

Infection prevention and control considerations are available for healthcare personnel and long-term care facility residents with systemic signs and symptoms following COVID-19 vaccination.

Contraindications and precautions

Contraindications and precautions to COVID-19 vaccines are described below and summarized in Appendix B. For the purposes of this guidance, an immediate allergic reaction to a vaccine or medication is defined as any hypersensitivity-related signs or symptoms such as urticaria, angioedema, respiratory distress (e.g., wheezing, stridor), or anaphylaxis that occur within four hours following administration.

Healthcare providers or health departments in the United States can request a consultation from the Clinical Immunization Safety Assessment COVIDvax project about an individual patient residing in the United States for a complex COVID-19 vaccine safety question not readily addressed by CDC guidance.
Contraindications
CDC considers a history of the following to be a contraindication to vaccination with COVID-19 vaccines:

Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a component of the COVID-19 vaccine

Immediate allergic reaction of any severity to a previous dose or known (diagnosed) allergy to a component of the vaccine

See Appendix C for a list of ingredients in COVID-19 vaccines. Polyethylene glycol (PEG) is an ingredient in both mRNA COVID-19 vaccines, and polysorbate 80 is an ingredient in Janssen COVID-19 vaccine. PEG and polysorbate are structurally related, and cross-reactive hypersensitivity between these compounds may occur. People with a contraindication to one of the mRNA COVID-19 vaccines should not receive doses of either of the mRNA vaccines (Pfizer-BioNTech or Moderna). However, people with a contraindication to mRNA COVID-19 vaccines may be able to receive Janssen COVID-19 vaccine, and vice versa, provided certain measures are taken (see "precautions" below). Known polysorbate allergy is no longer a contraindication to mRNA vaccination; however, known polysorbate allergy is a contraindication to Janssen COVID-19 vaccine and thus, a precaution to mRNA COVID-19 vaccination.

Providers should attempt to determine whether reactions reported following vaccination are consistent with immediate allergic reactions versus other types of reactions commonly observed following vaccination, such as a vasovagal reaction or post-vaccination side effects ( Appendix D). This will help determine which patients have a contraindication to vaccination, including to the second dose of an mRNA COVID-19 vaccine.
Precautions
Most people deemed to have a precaution to a COVID-19 vaccine at the time of their vaccination appointment can and should be administered vaccine. CDC considers a history of an immediate allergic reaction to any other vaccine or injectable therapy (i.e., intramuscular, intravenous, or subcutaneous vaccines or therapies [excluding subcutaneous immunotherapy for allergies, i.e., "allergy shots"]) as a precaution but not a contraindication to vaccination. People with a history of an immediate allergic reaction to a vaccine or injectable therapy that contains multiple components, one or more of which is a component of a COVID-19 vaccine, have a precaution to vaccination with that COVID-19 vaccine, even if it is unknown which component elicited the allergic reaction.

People with a contraindication to one type of the currently authorized COVID-19 vaccines (e.g., mRNA) have a precaution to the other (e.g., Janssen viral vector). However, because of potential cross-reactive hypersensitivity between ingredients in mRNA and Janssen COVID-19 vaccines, consultation with an allergist-immunologist should be considered to help determine if the patient can safely receive vaccination. Healthcare providers and health departments may also request a consultation from the Clinical Immunization Safety Assessment COVIDvax project. Vaccination of these individuals should only be undertaken in an appropriate setting under the supervision of a health care provider experienced in the management of severe allergic reactions.

People with a contraindication to mRNA COVID-19 vaccines (including due to a known PEG allergy): Consideration may be given to vaccination with Janssen COVID-19 vaccine. People who have received one mRNA COVID-19 vaccine dose but for whom the second dose is contraindicated should wait at least 28 days after the mRNA vaccine dose to receive Janssen COVID-19 vaccine.

People with a contraindication to Janssen COVID-19 vaccine (including due to a known polysorbate allergy): Consideration may be given to mRNA COVID-19 vaccination. Of note, polysorbate allergy is no longer a contraindication to mRNA COVID-19 vaccination, it is a precaution.

The following considerations can be used to help the provider conduct a risk assessment for vaccination in individuals with a precaution to vaccination:

Risk of exposure to SARS-CoV-2 (e.g., because of residence in a congregate setting such as a long-term care facility, occupation)

Risk of severe disease or death due to COVID-19 (e.g., because of age, underlying medical conditions)

The unknown risk of anaphylaxis (including fatal anaphylaxis) following COVID-19 vaccination in a person with a history of an immediate allergic reaction to other vaccines or injectable therapies

Ability of the patient to be vaccinated in a setting where appropriate medical care is immediately available for anaphylaxis. Note, for people with a contraindication to another type of COVID-19 vaccines (e.g., mRNA vaccines), vaccination with another type (e.g., Janssen viral vector vaccine) should only be undertaken in an appropriate setting under the supervision of a health care provider experienced in the management of severe allergic reactions.

Neither contraindications nor precautions to COVID-19 vaccination
Allergic reactions (including severe allergic reactions) not related to vaccines (COVID-19 or other vaccines) or injectable therapies, such as allergic reactions related to food, pet, venom, or environmental allergies, or allergies to oral medications (including the oral equivalents of injectable medications), are not a contraindication or precaution to COVID-19 vaccination. The vial stoppers of COVID-19 vaccines are not made with natural rubber latex, and there is no contraindication or precaution to vaccination for people with a latex allergy. In addition, because the COVID-19 vaccines do not contain eggs or gelatin, people with allergies to these substances do not have a contraindication or precaution to vaccination.

Delayed-onset local reactions have been reported after mRNA vaccination in some individuals beginning a few days through the second week after the first dose and are sometimes quite large. People with only a delayed-onset local reaction (e.g., erythema, induration, pruritus) around the injection site area after the first vaccine dose do not have a contraindication or precaution to the second dose. These individuals should receive the second dose using the same vaccine product as the first dose at the recommended interval, preferably in the opposite arm.
Observation periods following vaccination
CDC recommends the following observation periods after COVID-19 vaccination:

30 minutes:

History of an immediate allergic reaction of any severity to a vaccine or injectable therapy

People with a contraindication to a different type of COVID-19 vaccine (for example, people with a contraindication to mRNA COVID-19 vaccines who receive Janssen viral vector vaccine should be observed for 30 minutes following Janssen vaccination).

History of anaphylaxis due to any cause

15 minutes: All other people

Management of anaphylaxis after COVID-19 vaccination
Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of COVID-19 vaccine. Further information on anaphylaxis management can be found in the interim considerations for the management of anaphylaxis following COVID-19 vaccination and laboratory evaluation of people who experience anaphylaxis after vaccination.

Reporting of vaccine adverse events

Adverse events that occur in a recipient following COVID-19 vaccination should be reported to VAERS. Vaccination providers are required by the FDA to report the following that occur after COVID-19 vaccination under EUA:

Vaccine administration errors

Serious adverse events

Cases of Multisystem Inflammatory Syndrome

Cases of COVID-19 that result in hospitalization or death

In addition, CDC has developed a new voluntary, smartphone-based tool, v-safe. This tool uses text messaging and web surveys to provide near real-time health check-ins after patients receive COVID-19 vaccination. Reports to v-safe indicating a medically significant health impact, including pregnancy, are followed up by the CDC/ v-safe call center to collect additional information to complete a VAERS report, if appropriate.

Laboratory testing
Interpretation of SARS-CoV-2 test results in vaccinated people Use of immune-based tests for tuberculosis infection, such as the tuberculin skin test and interferon-gamma release assay
COVID-19 vaccination should not be delayed because of testing for TB infection. Testing for TB infection with one of the immune-based methods, either the tuberculin skin test (TST) or an interferon release assay (IGRA), can be done before or during the same encounter as COVID-19 vaccination. When testing with TST or IGRA cannot be done at the same time as COVID-19 vaccination, these tests should be delayed ≥4 weeks after the completion of COVID-19 vaccination but generally should not be cancelled.

Patients who have active TB disease or an illness that is being evaluated as active TB disease can receive a COVID-19 vaccine (note: the presence of a moderate or severe acute illness is a precaution to administration of all vaccines). Whereas a TST or IGRA test is part of a comprehensive evaluation for TB disease, positive TST or IGRA results are not required to diagnoseexternal icon active TB disease.
When considering a tuberculin skin test or interferon-gamma release assay:

The TST is not expected to have an effect on the safety or the effectiveness of COVID-19 vaccine. IGRAs are blood tests and, thus, do not affect vaccine safety or effectiveness.

The reliability of a positive TST or IGRA result after COVID-19 vaccination is expected to be the same as without the vaccination. COVID-19 vaccination is not expected to cause false positive results from a TB test that is done at the same encounter as or after COVID-19 vaccination.

The reliability of a negative TST or IGRA result after COVID-19 vaccination has not been studied.

The TST is not a vaccine. The guidance for separating other vaccines from COVID-19 vaccination by at least 2 weeks in time does not apply to the TST because the TST is not a vaccine.

When a tuberculin skin test or interferon gamma release assay is required by policy:

A TST or IGRA to meet administrative requirements (for example, for healthcare employment or for admission to long-term care) can be done prior to COVID-19 vaccination or at the same encounter. COVID-19 vaccination should not be delayed because of testing for TB infection.

A TST or IGRA should be deferred until ≥4 weeks after the completion of COVID-19 vaccination. If testing requirements or policies cannot be modified for the COVID-19 pandemic to accept this delay in TST or IGRA testing, it should be understood that a false negative TST or IGRA cannot be excluded, and consideration should be given to repeating negative TST or IGRA tests at least 4 weeks after the completion of COVID-19 vaccination. If TST was the initial test, boosting could be a factor if the result of the repeat test is positive.

When a tuberculin skin test or interferon gamma release assay is indicated for medical care:

The decision whether a TST or IGRA that is being done for medical diagnosisexternal icon of latent TB infection (for example, during a contact investigation after exposure to contagious TB disease) should be delayed for 4 weeks after completion of COVID-19 vaccination is at the discretion of the responsible medical provider and local tuberculosis program overseeing the contact investigation. Medical providers and local tuberculosis programs may not wish to delay testing for people at high risk for progression to TB disease. However, patients who have a negative result in this context should be considered for retesting >4 weeks after the completion of COVID-19 vaccination.

Patients who have symptoms or diagnostic findingsexternal icon consistent with active TB disease should receive further medical evaluation-for example with chest radiography and sputum bacteriology for Mycobacterium tuberculosis-regardless of TST or IGRA results.

Footnotes

The timing of the evaluation of vaccine efficacy (VE) against COVID-19 in trial participants varied by manufacturer's protocol design: Pfizer-BioNTech's protocol evaluated VE at >7 days after dose 2; Moderna's evaluated VE at >14 days after dose 2; and Janssen's evaluated VE >14 days and >28 days after the single dose. For consistency in public health post-vaccination guidance, a single time interval (i.e., >2 weeks) is used for the definition of fully vaccinated.

As of May 13, 2021, WHO has listed the following COVID-19 vaccines for emergency use:

Pfizer-BioNTech COVID-19 vaccines (e.g., COMIRNATY, Tozinameran)

AstraZeneca-Oxford COVID-19 vaccines (e.g., Covishield, Vaxzevria)

Janssen (Johnson & Johnson) COVID-19 vaccine

Moderna COVID-19 vaccine

Sinopharm COVID-19 vaccine

Sinovac COVID-19 vaccine

This list will be updated as additional COVID-19 vaccines receive an emergency use listing from WHO.

For consistency in public health post-vaccination guidance, a single time interval (i.e., >2 weeks after receipt of all recommended doses) is used for the definition of fully vaccinated.

The Society of Breast Imaging has developed "Recommendations for the Management of Axillary Adenopathy in Patients with Recent COVID-19 Vaccinationexternal icon " which includes considerations for patients and providers in scheduling screening exams in relation to the administration of a COVID-19 vaccine.

At the time of publication of ACIP's updated recommendations, all cases of TTS after FDA-authorization of the Janssen COVID-19 vaccine occurred in females. One case of CVST with thrombocytopenia occurred in a male, ages 18-49 years, during the Janssen COVID-19 vaccine Phase III clinical trial.

Appendix A. Vaccine administration errors and deviations

A vaccine administration error is any preventable event that may cause or lead to inappropriate use of vaccine or patient harm. This appendix provides resources for preventing and reporting COVID-19 vaccine administration errors, as well as actions to take after an error has occurred. For completeness, this includes additional scenarios that deviate from CDC recommendations for vaccine intervals but are not considered administration errors. This document is intended to assist providers with handling exceptional situations in which a vaccination error or deviation has already occurred and may be updated when additional information becomes available.

For all vaccine administration errors:

Table. Interim recommendations for COVID-19 vaccine administration errors and deviations

Vaccines

Type

Administration error/deviation

Interim recommendation

All currently authorized vaccines

(Pfizer-BioNTech Moderna, and Janssen COVID-19 vaccines)

Site/route

Incorrect site (i.e., site other than the deltoid muscle [preferred site] or anterolateral thigh [alternate site])

Do not repeat dose.* Inform the recipient of the potential for local and systemic adverse events.

Incorrect route (e.g., subcutaneous)

Do not repeat dose.* Inform the recipient of the potential for local and systemic adverse events.

Age

If received dose at age less than 12 years, do not give any additional dose at this time.∞

If age 12 to 17 years and a vaccine other than Pfizer-BioNTech was inadvertently administered:

If Moderna vaccine administered as the first dose, may administer Moderna vaccine as the second dose (as off-label use, because Moderna vaccine is not authorized in this age group).

If Janssen vaccine administered, do not repeat dose with Pfizer-BioNTech vaccine.

Dosage

Higher-than-authorized dose volume administered

Lower-than-authorized dose volume administered (e.g., leaked out, equipment failure, recipient pulled away)

If more than half of the dose was administered, do not repeat dose.*

If less than half of the dose was administered or the proportion of the dose cannot be estimated, administer the authorized dose immediately (no minimum interval) in the opposite arm.#

Storage and handling

Dose administered after improper storage and handling (e.g., temperature excursion, more than allowed time after first vial puncture)

Contact the manufacturer for guidance. If the manufacturer provides information supporting that the dose should be repeated, the repeated dose may be given immediately (no minimum interval) in the opposite arm.

Dose administered past the expiration/beyond-use date

Contact the manufacturer for guidance. If the manufacturer provides information supporting that the dose should be repeated, the repeated dose may be given immediately (no minimum interval) in the opposite arm.

Administration

Dose administered within 90 days of monoclonal antibodies or convalescent plasma for COVID-19 treatment

Do not repeat COVID-19 vaccine dose. If person has already received one mRNA COVID-19 vaccine dose, defer administration of second dose for 90 days following receipt of antibody therapy. This deviation from CDC guidance does not require VAERS reporting.

(Pfizer-BioNTech and Moderna)

Intervals

Second dose administered fewer than 17 days (Pfizer-BioNTech) or fewer than 24 days (Moderna) after the first dose (i.e., administered earlier than the 4-day grace period)

Second dose administered more than 42 days after the first dose

Do not repeat dose. This deviation from CDC guidance does not require VAERS reporting.

Mixed series

Incorrect mRNA COVID-19 vaccine product administered for second dose in 2-dose series

Pfizer-BioNTech only

Diluent

ONLY diluent administered (i.e., sterile 0.9% sodium chloride)

Inform the recipient that no vaccine was administered. Administer the authorized dose immediately (no minimum interval) in the opposite arm.#

No diluent, resulting in higher than authorized dose (i.e., 0.3 ml of undiluted vaccine administered)

Do not repeat dose*† Inform the recipient of the potential for local and systemic adverse events.

Incorrect diluent type (e.g., sterile water, bacteriostatic 0.9% NS)

Contact the manufacturer for guidance. If the manufacturer provides information supporting that the dose should be repeated, the repeated dose may be given immediately (no minimum interval) in the opposite arm.

Incorrect diluent volume (i.e., the vial contents were diluted with a diluent volume other than 1.8 ml, but a 0.3 ml dose was still administered)

For doses administered with diluent volume less than 1.8 ml, inform the recipient of the potential for local and systemic adverse events.* †

For doses administered with diluent volume greater than 1.8 ml, do not repeat dose. * (Note: Dilution with a volume up to 4.0 ml [which exceeds vial capacity] results in more-than-half of the authorized dose administered.)

Pfizer-BioNTech and Moderna vaccines only:
*If the dose given in error is the first dose, a second dose should be administered at the recommended interval (21 days [Pfizer-BioNTech] or 28 days [Moderna]). If this dose is the second dose, the series is complete, and no additional doses are needed.
∞Do not administer the second dose until the person becomes eligible to receive vaccination (either by reaching the authorized age or if the authorization is extended to include additional age groups), even if this results in the second dose being administered after the recommended interval between doses.
#If the dose given in error is the first dose, the second dose should be administered at the recommended interval (21 days [Pfizer-BioNTech] or 28 days [Moderna]) from the date of receipt of the valid dose (not the date of receipt of the erroneous dose).
†If the administration error resulted in a higher-than-authorized vaccine dose, in general the second dose may still be administered at the recommended interval. However, if local or systemic side effects following vaccination are clinically concerning (outside of the expected side effect profile), lead to serious adverse reactions, or are ongoing at the time of the second dose, the decision to administer the second dose may be assessed on a case-by-case basis.
§Although CDC provides considerations for a mixed series in exceptional circumstances, this is still considered an administration error that requires VAERS reporting (as a mixed series is not authorized under the vaccine Emergency Use Authorizationsexternal icon ).

Appendix B: Triage of people presenting for COVID-19 vaccination

† See Appendix C for a list of ingredients. People with a contraindication to one of the mRNA COVID-19 vaccines should not receive doses of either of the mRNA vaccines (Pfizer-BioNTech or Moderna).
* Immediate allergic reaction to a vaccine or medication is defined as any hypersensitivity-related signs or symptoms consistent with urticaria, angioedema, respiratory distress (e.g., wheezing, stridor), or anaphylaxis that occur within four hours following administration.
‡People with a history of an immediate allergic reaction to a vaccine or injectable therapy that contains multiple components, one or more of which is a component of a COVID-19 vaccine, have a precaution to vaccination with that COVID-19 vaccine, even if it is unknown which component elicited the allergic reaction.
#Polyethylene glycol (PEG) is an ingredient in both mRNA COVID-19 vaccines, and polysorbate 80 is an ingredient in Janssen COVID-19 vaccine. PEG and polysorbate are structurally related, and cross-reactive hypersensitivity between these compounds may occur. People with a contraindication to mRNA COVID-19 vaccines (including due to a known allergy to PEG) have a precaution to Janssen COVID-19 vaccine. Among people who received one mRNA COVID-19 dose but for whom the second dose is contraindicated, consideration may be given to vaccination with Janssen COVID-19 vaccine (administered at least 28 days after the mRNA COVID-19 dose). People with a contraindication to Janssen COVID-19 vaccine (including due to a known allergy to polysorbate) have a precaution to mRNA COVID-19 vaccines. For people with these precautions, referral to an allergist-immunologist should be considered. Healthcare providers and health departments may also request a consultation from the Clinical Immunization Safety Assessment COVIDvax project. In patients with these precautions, vaccination should only be undertaken in an appropriate setting under the supervision of a health care provider experienced in the management of severe allergic reactions.

Appendix C: Ingredients included in COVID-19 vaccines

The following is a list of ingredients for the Pfizer-BioNTechexternal icon , Modernaexternal icon , and Janssenexternal icon COVID-19 vaccines reported in the prescribing information for each vaccine.*

* None of the vaccines contain eggs, gelatin, latex, or preservatives. All COVID-19 vaccines are free from metals such as iron, nickel, cobalt, lithium, rare earth alloys or any manufactured products such as microelectronics, electrodes, carbon nanotubes, or nanowire semiconductors.
Note: Both the Pfizer-BioNTech and Moderna COVID-19 vaccines contain polyethylene glycol (PEG). PEG is a primary ingredient in osmotic laxatives and oral bowel preparations for colonoscopy procedures, an inactive ingredient or excipient in many medications, and is used in a process called "pegylation" to improve the therapeutic activity of some medications (including certain chemotherapeutics). Additionally, cross-reactive hypersensitivity between PEG and polysorbates (included as an excipient in some vaccines and other therapeutic agents) can occur. Information on active or inactive ingredients for vaccines and medications can be found in the package insert. CDC's vaccine excipient summary and the National Institutes of Health DailyMed databaseexternal icon can also be used as a resource.

Appendix D: Potential characteristics of allergic reactions, vasovagal reactions, and vaccine side effects following COVID-19 vaccination

In patients who experience post-vaccination symptoms, determining the etiology (including allergic reaction, vasovagal reaction, or vaccine side effects) is important to determine whether a person can receive additional doses of the vaccine (including the second dose of an mRNA COVID-19 vaccine). The following table of signs and symptoms is meant to serve as a resource but might not be exhaustive, and patients might not have all signs or symptoms. Providers should use their clinical judgement when assessing patients to determine the diagnosis and management.

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Interim Clinical Considerations for Use of COVID-19 Vaccines | CDC

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COVID-19 vaccination is recommended for all people 12 years and older for the prevention of coronavirus disease 2019 (COVID-19) in the United States under the U.S. Food and Drug Administration's (FDA) Emergency Use Authorization (EUA).

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NIH Influenza and SARS-COV2 Recommendations

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NIH Influenza and SARS-COV2 Recommendations

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Summary Recommendations

Influenza Vaccination

Although data are lacking on influenza vaccination for persons with COVID-19, on the basis of practice for other acute respiratory infections, the Panel recommends that persons with COVID-19 should receive an inactivated influenza vaccine (BIII). The Centers for Disease Control and Prevention (CDC) has provided guidance on the timing of influenza vaccination for inpatients and outpatients with COVID-19 (see Interim Guidance for Routine and Influenza Immunization Services During the COVID-19 Pandemic).

Diagnosis of Influenza and COVID-19 When Influenza Viruses and SARS-CoV-2 Are Cocirculating

Only testing can distinguish between severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and influenza virus infections and identify SARS-CoV-2 and influenza virus coinfection.

When SARS-CoV-2 and influenza viruses are cocirculating, the Panel recommends testing for both viruses in all hospitalized patients with acute respiratory illness (AIII).

When SARS-CoV-2 and influenza viruses are cocirculating, the Panel recommends influenza testing in outpatients with acute respiratory illness if the results will change clinical management of the patient (BIII).

Testing for other pathogens should be considered depending on clinical circumstances, especially in patients with influenza in whom bacterial superinfection is a well-recognized complication.

See the CDC Information for Clinicians on Influenza Virus Testing and the Infectious Diseases Society of America (IDSA) Clinical Practice Guidelines for more information.

Antiviral Treatment of Influenza When Influenza Viruses and SARS-CoV-2 Are Cocirculating

The treatment of influenza is the same in all patients regardless of SARS-CoV-2 coinfection (AIII).

The Panel recommends that hospitalized patients be started on empiric treatment for influenza with oseltamivir as soon as possible without waiting for influenza testing results (AIIb).
Antiviral treatment of influenza can be stopped when influenza has been ruled out by nucleic acid detection assay in upper respiratory tract specimens for nonintubated patients and in both upper and lower respiratory tract specimens for intubated patients.

For influenza treatment in hospitalized and non-hospitalized patients, see the CDC and IDSA recommendations on antiviral treatment of influenza.

Rating of Recommendations: A = Strong; B = Moderate; C = Optional
Rating of Evidence: I = One or more randomized trials without major limitations; IIa = Other randomized trials or subgroup analyses of randomized trials; IIb = Nonrandomized trials or observational cohort studies; III = Expert opinion

Introduction

Influenza activity in the United States during the 2020-2021 influenza season is difficult to predict and could vary geographically and by the extent of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) community mitigation measures. During early 2020, sharp declines in influenza activity coincided with implementation of SARS-CoV-2 control measures in the United States and several Asian countries. 1-4 Very low influenza virus circulation was observed in Australia, Chile, and South Africa during the typical Southern Hemisphere influenza season in 2020. 5 Clinicians should monitor local influenza and SARS-CoV-2 activity (e.g., by tracking local and state public health surveillance data and testing performed at health care facilities) to inform evaluation and management of patients with acute respiratory illness.

Influenza Vaccination

There are no data on the safety, immunogenicity, or effectiveness of influenza vaccines in patients with mild COVID-19 or those who are recovering from COVID-19. Therefore, the optimal timing for influenza vaccination in these patients is unknown. The safety and efficacy of vaccinating persons who have mild illnesses from other etiologies have been documented. 6 On the basis of practice following other acute respiratory infections, the Panel recommends that persons with COVID-19 should receive an inactivated influenza vaccine (BIII). The Centers for Disease Control and Prevention (CDC) has provided guidance on the timing of influenza vaccination for inpatients and outpatients with COVID-19 (see Interim Guidance for Routine and Influenza Immunization Services During the COVID-19 Pandemic). It is not known whether dexamethasone or other immunomodulatory therapies for COVID-19 will affect the immune response to influenza vaccine. However, despite this uncertainty, as long as influenza viruses are circulating, an unvaccinated person with COVID-19 should receive the influenza vaccine once they have substantially improved or recovered from COVID-19. See influenza vaccine recommendations from CDC and the Advisory Committee on Immunization Practices.

Clinical Presentation of Influenza Versus COVID-19

The signs and symptoms of uncomplicated, clinically mild influenza overlap with those of mild COVID-19. Ageusia and anosmia can occur with both diseases, but these symptoms are more common with COVID-19 than with influenza. Fever is not always present in patients with either disease, particularly in patients who are immunosuppressed or elderly. Complications of influenza and COVID-19 can be similar, but the onset of influenza complications and severe disease typically occurs within a week of illness onset whereas the onset of severe COVID-19 usually occurs in the second week of illness. Because of the overlap in signs and symptoms, when SARS-CoV-2 and influenza viruses are cocirculating, diagnostic testing for both viruses in people with an acute respiratory illness is needed to distinguish between SARS-CoV-2 and influenza virus, and to identify SARS-CoV-2 and influenza virus coinfection. Coinfection with influenza A or B viruses and SARS-CoV-2 has been described in case reports and case series, 7-11 but the frequency, severity, and risk factors for coinfection with these viruses versus for infection with either virus alone are unknown.

Which Patients Should be Tested for SARS-CoV-2 and influenza?

When influenza viruses and SARS-CoV-2 are cocirculating in the community, SARS-CoV-2 testing and influenza testing should be performed in all patients hospitalized with suspected COVID-19 or influenza (see Testing for SARS-CoV-2 Infection) (AIII). When influenza viruses and SARS-CoV-2 are cocirculating in the community, SARS-CoV-2 testing should be performed in outpatients with suspected COVID-19, and influenza testing can be considered in outpatients with suspected influenza if the results will change clinical management of the illness (BIII). Several multiplex assays that detect SARS-CoV-2 and influenza A and B viruses have received Food and Drug Administration Emergency Use Authorization and can provide results in 15 minutes to 8 hours on a single respiratory specimen. 12,13 For information on available influenza tests, including clinical algorithms for testing of patients when SARS-CoV-2 and influenza viruses are cocirculating, see the CDC Information for Clinicians on Influenza Virus Testing and recommendations of the Infectious Diseases Society of America (IDSA) on the use of influenza tests and interpretation of testing results. 14

Which Patients Should Receive Antiviral Treatment of Influenza?

When SARS-CoV-2 and influenza viruses are cocirculating in the community, patients who require hospitalization and are suspected of having either or both viral infections should receive influenza antiviral treatment with oseltamivir as soon as possible without waiting for influenza testing results (AIIb). 14 Treatment for influenza is the same for all patients regardless of SARS-CoV-2 coinfection (AIII). See the CDC Influenza Antiviral Medications: Summary for Clinicians, including clinical algorithms for antiviral treatment of patients with suspected or confirmed influenza when SARS-CoV-2 and influenza viruses are cocirculating, and the IDSA Clinical Practice Guidelines recommendations on antiviral treatment of influenza.

If a diagnosis of COVID-19 or another etiology is confirmed and if the result of an influenza nucleic acid detection assay from an upper respiratory tract specimen is negative:

In a Patient Who is Not Intubated: Antiviral treatment for influenza can be stopped.

In a Patient Who is Intubated: Antiviral treatment for influenza should be continued and if a lower respiratory tract specimen (e.g., endotracheal aspirate) can be safely obtained, it should be tested by influenza nucleic acid detection. If the lower respiratory tract specimen is also negative, influenza antiviral treatment can be stopped.

Treatment Considerations for Hospitalized Patients With Suspected or Confirmed SARS-CoV-2 and Influenza Virus Coinfection

Corticosteroids, which may be used for the treatment of COVID-19, may prolong influenza viral replication and viral RNA detection and may be associated with poor outcomes.14,15

Oseltamivir has no activity against SARS-CoV-2.16 Oseltamivir does not have any known interactions with remdesivir.

Standard-dose oseltamivir is well absorbed even in critically ill patients. For patients who cannot tolerate oral or enterically administered oseltamivir (e.g., because of gastric stasis, malabsorption, or gastrointestinal bleeding), intravenous peramivir is an option.14 There are no data on peramivir activity against SARS-CoV-2.

CDC does not recommend inhaled zanamivir and oral baloxavir for the treatment of influenza in hospitalized patients because of insufficient safety and efficacy data (see the CDC Influenza Antiviral Medications: Summary for Clinicians). There are no data on zanamivir activity against SARS-CoV-2. Baloxavir has no activity against SARS-CoV-2.16

Based upon limited data, the co-occurrence of community-acquired secondary bacterial pneumonia with COVID-19 appears to be infrequent and may be more common with influenza.17,18 Typical bacterial causes of community-acquired pneumonia with severe influenza are Staphylococcus aureus (methicillin-resistant S. aureus [MRSA] and methicillin-susceptible S. aureus [MSSA]), Streptococcus pneumoniae, and group A Streptococcus.14

Patients with COVID-19 who develop new respiratory symptoms with or without fever or respiratory distress, and without a clear diagnosis, should be evaluated for the possibility of nosocomial influenza.

References

Kuo SC, Shih SM, Chien LH, Hsiung CA. Collateral benefit of COVID-19 control measures on influenza activity, Taiwan. Emerg Infect Dis. 2020;26(8):1928-1930. Available at: https://www.ncbi.nlm.nih.gov/pubmed/32339091.

Soo RJJ, Chiew CJ, Ma S, Pung R, Lee V. Decreased influenza incidence under COVID-19 control measures, Singapore. Emerg Infect Dis. 2020;26(8):1933-1935. Available at: https://www.ncbi.nlm.nih.gov/pubmed/32339092.

Suntronwong N, Thongpan I, Chuchaona W, et al. Impact of COVID-19 public health interventions on influenza incidence in Thailand. Pathog Glob Health. 2020;114(5):225-227. Available at: https://www.ncbi.nlm.nih.gov/pubmed/32521210.

Lei H, Xu M, Wang X, et al. Non-pharmaceutical interventions used to control COVID-19 reduced seasonal influenza transmission in China. J Infect Dis. 2020; Published online ahead of print. Available at: https://www.ncbi.nlm.nih.gov/pubmed/32898256.

Olsen SJ, Azziz-Baumgartner E, Budd AP, et al. Decreased influenza activity during the COVID-19 pandemic-United States, Australia, Chile, and South Africa, 2020. MMWR Morb Mortal Wkly Rep. 2020;69(37):1305-1309. Available at: https://www.ncbi.nlm.nih.gov/pubmed/32941415.

Centers for Disease Control and Prevention. Contraindications and precautions. General best practice guidelines for immunization: best practices guidance of the advisory committee on immunization practices (ACIP). 2020. Available at: https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/contraindications.html. Accessed October 16, 2020.

Hashemi SA, Safamanesh S, Ghasemzadeh-Moghaddam H, Ghafouri M, Azimian A. High prevalence of SARS-CoV-2 and influenza A virus (H1N1) coinfection in dead patients in Northeastern Iran. J Med Virol. 2020; Published online ahead of print. Available at: https://www.ncbi.nlm.nih.gov/pubmed/32720703.

Huang BR, Lin YL, Wan CK, et al. Co-infection of influenza B virus and SARS-CoV-2: A case report from Taiwan. J Microbiol Immunol Infect. 2020; Published online ahead of print. Available at: https://www.ncbi.nlm.nih.gov/pubmed/32646801.

Yue H, Zhang M, Xing L, et al. The epidemiology and clinical characteristics of co-infection of SARS-CoV-2 and influenza viruses in patients during COVID-19 outbreak. J Med Virol. 2020; Published online ahead of print. Available at: https://www.ncbi.nlm.nih.gov/pubmed/32530499.

Cuadrado-Payan E, Montagud-Marrahi E, Torres-Elorza M, et al. SARS-CoV-2 and influenza virus co-infection. Lancet. 2020. Available at: https://www.ncbi.nlm.nih.gov/pubmed/32423586.

Wu X, Cai Y, Huang X, et al. Co-infection with SARS-CoV-2 and influenza A virus in patient with pneumonia, China. Emerg Infect Dis. 2020;26(6):1324-1326. Available at: https://www.ncbi.nlm.nih.gov/pubmed/32160148.

Food and Drug Administration. Coronavirus disease 2019 (COVID-19) emergency use authorizations for medical devices. Individual EUAs for molecular diagnostic tests for SARS-CoV-2. 2020. Available at: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/vitro-diagnostics-euas#individual-molecular. Accessed October 16, 2020.

Centers for Disease Control and Prevention. Table 4. Multiplex assays authorized for simultaneous detection of influenza viruses and SARS-CoV-2 by FDA. 2020. Available at: https://www.cdc.gov/flu/professionals/diagnosis/table-flu-covid19-detection.html. Accessed October 16, 2020.

Uyeki TM, Bernstein HH, Bradley JS, et al. Clinical practice guidelines by the Infectious Diseases Society of America: 2018 update on diagnosis, treatment, chemoprophylaxis, and institutional outbreak management of seasonal influenza. Clin Infect Dis. 2019;68(6):e1-e47. Available at: https://www.ncbi.nlm.nih.gov/pubmed/30566567.

Zhou Y, Fu X, Liu X, et al. Use of corticosteroids in influenza-associated acute respiratory distress syndrome and severe pneumonia: a systemic review and meta-analysis. Sci Rep. 2020;10(1):3044. Available at: https://www.ncbi.nlm.nih.gov/pubmed/32080223.

Choy KT, Wong AY, Kaewpreedee P, et al. Remdesivir, lopinavir, emetine, and homoharringtonine inhibit SARS-CoV-2 replication in vitro. Antiviral Res. 2020. Available at: https://www.ncbi.nlm.nih.gov/pubmed/32251767.

Vaughn VM, Gandhi T, Petty LA, et al. Empiric antibacterial therapy and community-onset bacterial co-infection in patients hospitalized with COVID-19: a multi-hospital cohort study. Clin Infect Dis. 2020; published online ahead of print. Available at: https://www.ncbi.nlm.nih.gov/pubmed/32820807.

Adler H, Ball R, Fisher M, Mortimer K, Vardhan MS. Low rate of bacterial co-infection in patients with COVID-19. Lancet Microbe. 2020. Available at: https://www.ncbi.nlm.nih.gov/pubmed/32835331.

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Influenza | COVID-19 Treatment Guidelines

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Summary Recommendations Although data are lacking on influenza vaccination for persons with COVID-19, on the basis of practice for other acute respiratory infections, the Panel recommends that persons with COVID-19 should receive an inactivated influenza vaccine (BIII).

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Final_EUA Fact sheet for Recipients - Pfizer-BioNTECH COVID-19 Vaccine

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Compiled materials related to statements from HHS and CDC regarding plans for booster shots.

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MMWR Article - New COVID Cases & Hospitalizations Among Adults by Vax Status

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MMWR Article - New COVID Cases & Hospitalizations Among Adults by Vax Status

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Published in CDC's MMWR on Aug 18, 2021

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MMWR Weekly - Effectives of Pfizer or Moderna Vax in Prevent COVID-19 Infection Among Nursing Home Residents... Before & After Delta Variant

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MMWR Weekly - Effectives of Pfizer or Moderna Vax in Prevent COVID-19 Infection Among Nursing Home Residents... Before & After Delta Variant

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Published Aug 18, 2021

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MMWR Weekly Article - Sustained Effectiveness of Pfizer and Moderna Vax... Associated Hospitalizations Among Adults'

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MMWR Weekly Article - Sustained Effectiveness of Pfizer and Moderna Vax... Associated Hospitalizations Among Adults'

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Published in the CDC's MMWR on Aug 18 2021

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Español
The U.S. Food and Drug Administration (FDA) is the regulatory authority that has oversight of the safety, effectiveness and quality of vaccines that are used in the United States.

Vaccines to prevent infectious diseases are given to millions of babies, children, adolescents and adults and it is critical that they are demonstrated to be safe and effective. Vaccines have prevented countless cases of disease and disability and have saved millions of lives. Ensuring the safety and effectiveness of vaccines is one of FDA's top priorities.

FDA's Center for Biologics Evaluation and Research (CBER) ensures that FDA's rigorous scientific and regulatory processes are followed by those who pursue the development of vaccines. Vaccine development is a complex science. FDA's scientific and regulatory advice to vaccine developers, as well as FDA's evaluation to determine the safety and effectiveness of vaccines, are among the most robust in the world.

How Vaccines Work

Vaccines work by mimicking the infectious bacteria or viruses that cause disease. Vaccination stimulates the body's immune system to build up defenses against the infectious bacteria or virus (organism) without causing the disease. The parts of the infectious organism that the immune system recognizes are foreign to the body and are called antigens. Vaccination exposes the body to these antigens.

Some vaccines contain weakened versions of a bacteria or virus, other vaccines contain only part of the bacteria or virus. Some vaccines contain only the genetic material for a specific protein and direct the body to produce a small amount of that protein. The body's immune system reacts defensively once it detects this protein.

After vaccination, the immune system is prepared to respond quickly and forcefully when the body encounters the real disease-causing organism.
Below is the typical process that FDA expects vaccine developers to follow to generate the information it needs to assess the safety and effectiveness of a vaccine to prevent an infectious disease:

Research and Discovery Stage Scientists develop a rationale for a vaccine based on how the infectious organism causes disease. The scientists then conduct laboratory research to test their idea for a vaccine candidate; sometimes this testing occurs in animals. This is considered the Research and Discovery Stage. Once a scientific finding is thought to have practical applications, in that it may be feasible to develop a vaccine candidate based on that finding, the research moves forward.

Before a vaccine can be tested in people, a company or researcher performs additional laboratory research and testing in animals to obtain information about how the vaccine works and whether it's likely to be safe and work well in humans. These tests are known as the Pre-clinical phase.

When the company/researcher is ready to begin studies in humans, they compile the results of their laboratory and other preclinical testing, as well as information pertaining to the manufacturing technology and the quality of the vaccine and submit these to FDA in the form of an Investigational New Drug application (IND). FDA evaluation includes an assessment of the preclinical data and a determination whether these tests were conducted according to Good Laboratory Practices. FDA also conducts an assessment of the product, its quality and safety, and the technology to manufacture it, to determine whether it is reasonably safe for testing of the vaccine to move forward in people. Studies conducted in people are known as the Clinical Development stage and typically cover three phases under the oversight of FDA.

Clinical trials are conducted according to plans that reflect FDA's considerable expertise in clinical trial design - these plans are called "protocols." Vaccines intended for children are generally tested first in adults, with a step-down clinical development program to children and infants.

The phases of the studies may progress sequentially, but it is also not uncommon for the phases of development to overlap.

Phase 1- Emphasis during this phase is on safety and generally includes 20-100 volunteers who haven't been exposed to the disease being studied and who are generally otherwise healthy. These studies are used to determine whether there are adverse reactions with increasing doses and, if possible, to gain early information about how well the vaccine works to induce an immune response in people.

Phase 2- In the absence of safety concerns from phase 1 studies, phase 2 studies include more people, where various dosages are tested on 100's of people with typically varying health statuses and from different demographic groups, in randomized-controlled studies. These studies provide additional safety information on common short-term side effects and risks, examine the relationship between the dose administered and the immune response, and provide initial information regarding the effectiveness of the vaccine in its ability to generate an immune response. Standardized and validated tests are used to evaluate the immune responses. These vaccine studies typically also include a control group consisting of people who may receive an FDA-approved vaccine, a placebo or another substance. People receiving the vaccine under study are compared to people in the control group.

Phase 3- The vaccine is generally administered to thousands of people and the study generates critical information on effectiveness and additional important safety data. This phase includes additional information about immune response and compares those who receive the vaccine to those who receive a control, such as a placebo. For example, the number of cases of disease in the vaccinated group is compared to the number in the control group to see whether the vaccine reduces the incidence of disease. These studies also provide information about the vaccine's safety including the identification of less common side effects.

In public health emergencies, such as a pandemic, the development process may be atypical or expedited. For example, as demonstrated by the response to the COVID-19 pandemic, the U.S. government may coalesce government agencies, international counterparts, academia, nonprofit organizations and pharmaceutical companies to develop a coordinated strategy for prioritizing and speeding development of the most promising treatments and vaccines. In addition, the federal government may make investments in the necessary manufacturing capacity at its own risk, giving companies confidence that they can invest aggressively in development and allowing faster distribution of an eventual vaccine.
Recognizing the urgent need for safe and effective vaccines FDA utilizes its various authorities and expertise to facilitate the expeditious development and availability of safe and effective vaccines. Early in a public health crisis, FDA provides clear communication to the pharmaceutical industry pertaining to the scientific data and information needed for safe and effective vaccines and works quickly to provide advice on their proposed development plans and assessment of the data that are generated. During a public health emergency, if certain criteria are met, manufacturers may submit a request forEmergency Use Authorization (EUA) to FDA to facilitate the availability and use of their vaccine during this time.

When evaluating the need for pre-clinical studies for a vaccine, FDA considers all data relevant to that vaccine and closely related vaccines, as well as the design of the specific clinical study for the vaccine in question. If FDA's evaluation of these data support initiating human studies of a candidate vaccine intended to prevent an infectious disease without first completing additional toxicology studies, then FDA would consider allowing such human studies to proceed.

There is no predetermined timeline for vaccine development. Typically, the better the scientific understanding of a pathogen and the disease it causes, the more efficient vaccine development.

Adaptive Trial Designs: These are clinical study designs which aim to expedite clinical trial decisions based on preliminary results derived from earlier trials and, in some cases, from the same trial. Using this approach can facilitate efficient clinical development. The goal of these designs is to reduce the size and duration of the trial and demonstrate an effect if one exists. These adaptations are performed with close attention to statistical rigor.

While the vaccine is being tested in people, FDA is also assessing information pertaining to the manufacturing of the vaccine and the facility where it will be made. Vaccine manufacturing is complex. The process of making the candidate vaccine for the phase 3 studies in batches called "lots" helps the manufacturer ramp up for commercial-scale manufacturing. FDA requires vaccine manufacturers to submit data to support manufacturing processes, facilities, product characterization, and demonstration of lot-to-lot consistency. FDA works with the manufacturer to develop a lot release protocol - a template of tests to be conducted on the vaccine- that will be used for each lot of vaccine post-approval. Experienced FDA-investigators carefully examine and evaluate the facility and operation for compliance with FDA regulations.

Once a manufacturing process is developed that ensures that the vaccine can be produced reliably and consistently, and the preclinical and clinical development programs have been successfully completed, companies submit a Biologics License Application (BLA) to the FDA. A BLA is a comprehensive submission that is submitted to the Agency. It includes preclinical and clinical data and information, as well as details of the manufacturing process and facility(ies).

By submitting a BLA to the FDA, a company is seeking permission to distribute and market a vaccine for use in the United States. FDA evaluates the data to determine whether the safety and effectiveness of the vaccine has been demonstrated and whether the manufacturing and facility information assure product quality and consistency. After its evaluation, FDA decides whether to approve (also known as to license) the vaccine for use in the United States. If FDA approves the vaccine, the company is permitted to market it in the United States for use in the population for which it is approved.

FDA makes its decisions based on its analysis of the benefits and risks for the intended population who will receive the vaccine, as well as the disease(s) to be prevented. FDA's scientific team works collaboratively to evaluate all of the scientific data and information included in the BLA and makes the determination whether to approve a vaccine. A typical FDA team is comprised of: physicians, chemists, statisticians, pharmacologists/toxicologists, microbiologists, experts in postmarketing safety, clinical study site inspectors, manufacturing and facility inspectors, and labeling and communications experts.

In some cases, FDA seeks the input of its Vaccines and Related Biological Products Advisory Committee (VRBPAC). This committee is comprised of a panel of outside, independent, technical experts from various scientific and public health disciplines that provide input on scientific data and its public health significance in a public forum. The FDA will consider, but is not bound by, the input received from the VRBPAC when determining whether to approve a vaccine.

Prescribing information for a vaccine is based on scientific data that are submitted by the manufacturer in the BLA and determined by the FDA to be satisfactory to support the approved indication(s), usage, dosing, and administration. The prescribing information is updated as needed to include the most current information about the vaccine that is available to and reviewed by FDA. The prescribing information does not necessarily address all aspects of vaccine use, such as recommendations that are specific to disease outbreaks, vaccine shortages, and all subpopulations with underlying medical conditions.

Monitoring of Safety and Effectiveness
It is important to note that a vaccine is a drug. Like any drug, vaccines have benefits and risks, and even when highly effective, no vaccine is 100 percent effective in preventing disease or 100 percent safe in all individuals. Most side effects of vaccines are usually minor and short-lived. For example, a person may feel soreness at the injection site or experience a mild fever. Serious vaccine reactions are extremely rare, but they can happen.

Although the vaccine development process and FDA's evaluation are rigorous and comprehensive, there is still a need for ongoing surveillance of vaccines after FDA-approval to identify uncommon adverse events or long-term complications that may occur, and sometimes to monitor effectiveness. In certain cases, the FDA may require the manufacturer to conduct post-marketing studies to further assess known or potential serious risks. (These studies are sometimes called Phase 4 of development).

Vaccines are closely monitored using various surveillance systems, such as the Vaccine Adverse Event Reporting System (VAERS), the FDA BEST (Biologics Effectiveness and Safety) program and the FDA Sentinel Program, the FDA and Centers for Medicare & Medicaid Services (CMS) partnership, and the Centers for Disease Control and Prevention's (CDC) Vaccine Safety Datalink.
Lot Release
Lot release is a mechanism that provides FDA with a real-time system to continuously monitor product quality. As previously noted, vaccines are generally made in batches called lots. FDA requires vaccine manufacturers to submit data to support the demonstration of lot-to-lot consistency. After approval, the manufacturer must submit the following materials relating to that vaccine lot (or "batch")

Protocols: contain the agreed-upon tests.

Results: the results of the testing performed by the manufacturer. Testing typically includes assessment of purity, potency, identity and sterility.

Samples: generally, the manufacturer must submit samples of the vaccine from the lot in question to permit FDA to perform confirmatory testing.

Manufacturers are not permitted to distribute a specific lot of vaccine until the FDA releases it.

Research is fundamental to FDA's ability to provide effective scientific and regulatory evaluation of vaccines. FDA conducts its research activities in conjunction with its regulatory activities, which provides the Agency a unique perspective on both fronts. A wide variety of rapidly evolving technical and scientific issues concerning the safety, potency, and effectiveness of vaccines requires knowledge of new developments in basic research in the relevant biological disciplines. For this reason, FDA scientists conduct a variety of research that contributes to policy, risk assessments, new methods and standards, and changes to product labeling, including promoting new techniques for assessing vaccine safety and potency, as well as strategies for vaccine development.

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Español The U.S. Food and Drug Administration (FDA) is the regulatory authority that has oversight of the safety, effectiveness and quality of vaccines that are used in the United States. Vaccines to prevent infectious diseases are given to millions of babies, children, adolescents and adults and it is critical that they are demonstrated to be safe and effective.

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CDC's 'How mRNA COVID-19 Vaccines Work' Handout

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CDC's 'How mRNA COVID-19 Vaccines Work' Handout

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AAP Resources on the COVID-19 Vaccine for Children

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AAP Resources on the COVID-19 Vaccine for Children

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Includes FAQ, implementation resources, and guidance on what pediatricians can do to start preparing now.

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Resources on Vaccines for Teenagers

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The Vaccinations 4 Teens customizable resources can help you, your care teams and office staff educate parents/guardians and teen patients on the four recommended immunizations for adolescents: meningococcal disease (MenACWY), human papillomavirus (HPV), tetanus, diphtheria, and pertussis (Tdap), and flu.

These materials include educational videos, question and answer examples for patient and parent conversations, a fact sheet, reminder emails, letters, texts, and postcards, schedule reminders, and website and social media content.

Materials for Office Staff

These materials are intended to help remind office staff about the need to discuss vaccination during teen visits and provides suggestions on how to respond to questions from parents/guardians and patients.

Materials for Patients and Parents/Guardians

These materials are to be used to remind parents/guardians and teen patients through various channels about scheduling immunization appointments and to educate them on the importance of vaccination.

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The Vaccinations 4 Teens resources are an easy-to-use collection of materials that AAFP members, care teams, and office staff can customize and use to help educate parents/guardians and teen patients about four AAFP- and Centers for Disease Control and Prevention (CDC)-recommended immunizations for adolescents: meningococcal disease (MenACWY); human papillomavirus (HPV); tetanus, diphtheria, and pertussis (Tdap); and flu.

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Mayo Clinic's answers to FAQs on COVID-19 Vaccine

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COVID-19 vaccines: Get the facts

Looking to get the facts about COVID-19 vaccines? Here's what you need to know about the different vaccines and the benefits of getting vaccinated.

As the coronavirus disease 2019 (COVID-19) pandemic continues, you might have questions about COVID-19 vaccines. Find out about the different types of COVID-19 vaccines, how they work, the possible side effects, and the benefits for you and your family.

COVID-19 vaccine benefits

What are the benefits of getting a COVID-19 vaccine?

A COVID-19 vaccine might:

Protect you from getting COVID-19

Prevent you from becoming seriously ill, becoming hospitalized or dying due to COVID-19

Limit the spread of COVID-19

Should I get the COVID-19 vaccine even if I've already had COVID-19?

If you were treated for COVID-19 with monoclonal antibodies or convalescent plasma, there is no need to delay getting a COVID-19 vaccine.

Safety and side effects of COVID-19 vaccines

What COVID-19 vaccines have been authorized or approved?

Because there is an urgent need for COVID-19 vaccines and the Food and Drug Administration's (FDA's) vaccine approval process can take years, the FDA first gave emergency use authorization to COVID-19 vaccines based on less data than is typically required. The data must show that the vaccines are safe and effective before the FDA can give emergency use authorization or approval. Vaccines with FDA emergency use authorization or approval include:

Pfizer-BioNTech COVID-19 vaccine. The FDA has approved the Pfizer-BioNTech COVID-19 vaccine, now called Comirnaty, to prevent COVID-19 in people age 12 and older. The FDA approved Comirnaty after data found the vaccine is safe and effective. The Pfizer-BioNTech COVID-19 vaccine is 91% effective in preventing severe illness with COVID-19 in people age 16 and older. The vaccine is 100% effective in preventing COVID-19 in children ages 12 through 15. For people age 12 and older, the Pfizer-BioNTech COVID-19 vaccine involves two shots. The second dose can be given three to eight weeks after the first dose.

The vaccine is available under an emergency use authorization for children ages 5 through 11. This vaccine is about 91% effective in preventing COVID-19 in children ages 5 through 11. It requires two shots, given three weeks apart. It also contains a lower amount of mRNA than the Pfizer-BioNTech COVID-19 vaccine used for people age 12 and older.

The vaccine is now also available under an emergency use authorization for children ages 6 months through 4 years old. It requires three shots. The first two shots are given three to eight weeks apart. The third shot is given at least eight weeks after the second shot.

Moderna COVID-19 vaccine. The FDA has approved the Moderna COVID-19 vaccine, now called Spikevax, to prevent COVID-19 in people age 18 and older. The Moderna COVID-19 vaccine is 94% effective in preventing COVID-19 with symptoms. It requires two shots. The second dose can be given four to eight weeks after the first dose.

The vaccine is now also available under an emergency use authorization for children ages 6 months through 17 years old. It requires two shots, given four to eight weeks apart.

Janssen/Johnson & Johnson COVID-19 vaccine. This vaccine is available under an emergency use authorization. In clinical trials, this vaccine was 66% effective in preventing the COVID-19 virus with symptoms - as of 14 days after vaccination. The vaccine also was 85% effective at preventing severe disease with COVID-19 - at least 28 days after vaccination. It requires one shot. Due to the risk of a potentially life-threatening blood-clotting problem, the FDA is restricting use of the Janssen/Johnson & Johnson vaccine to certain people age 18 and older. Examples include people who had a severe allergic reaction after getting an mRNA COVID-19 vaccine and people who can't get an mRNA COVID-19 vaccine due to limited access or personal or religious concerns. If you get this vaccine, be sure to understand the risks and symptoms of the blood-clotting problem.

Novavax COVID-19 vaccine, adjuvanted. This vaccine is available under an emergency use authorization for people age 12 and older. It requires two shots, given three to eight weeks apart. Research done before the spread of the delta and omicron variants has shown that the vaccine is 90% effective at preventing mild, moderate and severe disease with COVID-19. For people age 65 and older, the vaccine is 79% effective.

How do the COVID-19 vaccines work?

Viral vector COVID-19 vaccines can't cause you to become infected with the COVID-19 virus or the viral vector virus. Also, the genetic material that's delivered doesn't become part of your DNA.

Protein subunit COVID-19 vaccines don't use any live virus and can't cause you to become infected with the COVID-19 virus. The protein pieces also don't enter the nucleus of your cells, where your DNA is kept.

Can a COVID-19 vaccine give you COVID-19?

It can take a few weeks for your body to build immunity after getting a COVID-19 vaccination. As a result, it's possible that you could become infected with the virus that causes COVID-19 just before or after being vaccinated.

What are the possible general side effects of a COVID-19 vaccine?

A COVID-19 vaccine can cause mild side effects after the first or second dose, including:

Pain, redness or swelling where the shot was given

Fever

Fatigue

Headache

Muscle pain

Chills

Joint pain

Nausea and vomiting

Feeling unwell

Swollen lymph nodes

Babies ages 6 months through 3 years old also might cry, feel sleepy or lose their appetite after vaccination.

You'll be monitored for 15 minutes after getting a COVID-19 vaccine to see if you have an allergic reaction.

Most side effects go away in a few days. Side effects after the second dose might be more intense. Many people have no side effects. Side effects of booster shots appear to be similar to side effects experienced after the two-dose or single-dose primary shots.

If the redness or tenderness where the shot was given gets worse after 24 hours or you are concerned about any side effects, contact your doctor.

What are the long-term side effects of the COVID-19 vaccines?

Because COVID-19 vaccines clinical trials only started in the summer of 2020, it's not yet clear if these vaccines will have long-term side effects. However, vaccines rarely cause long-term side effects.

If you have additional questions or concerns about your symptoms, talk to your doctor.

Can COVID-19 vaccines affect the heart?

In the U.S., there has been an increase in reported cases of myocarditis and pericarditis after mRNA COVID-19 vaccination, particularly in males ages 12 to 29. Myocarditis is the inflammation of the heart muscle, while pericarditis is the inflammation of the lining outside the heart. These reports are rare.

Symptoms to watch for include:

Chest pain

Shortness of breath

Feelings of having a fast-beating, fluttering or pounding heart

If you or your child has any of these symptoms within a week of getting a COVID-19 vaccine, seek medical care.

What is the connection between the Janssen/Johnson & Johnson COVID-19 vaccine and Guillain-Barre syndrome?

Some people who received the Janssen/Johnson & Johnson COVID-19 vaccine have developed Guillain-Barre syndrome. This is a rare disorder in which your body's immune system attacks your nerves. The chances of this happening are very low.

This disorder is most often reported in men ages 50 to 64. Symptoms most often appeared within 42 days of vaccination. Seek immediate medical care after getting the Janssen/Johnson & Johnson COVID-19 vaccine if you have:

Weakness or tingling sensations, especially in the legs or arms, that worsen and spread to other body parts

Difficulty walking

Difficulty with facial movements, including speaking, chewing or swallowing

Double vision or inability to move eyes

Difficulty with bladder control or bowel function

What are the symptoms of a blood-clotting reaction to the Janssen/Johnson & Johnson COVID-19 vaccine?

The Janssen/Johnson & Johnson COVID-19 vaccine can cause thrombosis with thrombocytopenia syndrome. This is a blood-clotting problem that can be life-threatening.

As a result, the FDA is restricting use of the Janssen/Johnson & Johnson vaccine to certain people age 18 and older. Examples include people who had a severe allergic reaction after getting an mRNA COVID-19 vaccine and people who can't get an mRNA COVID-19 vaccine due to limited access or personal or religious concerns. Research suggests there isn't an increased risk of this blood-clotting problem after mRNA COVID-19 vaccination.

Serious side effects of the Janssen/Johnson & Johnson COVID-19 vaccine typically happen within two weeks of vaccination and require emergency care. Possible symptoms include:

Shortness of breath

Persistent stomach pain

Severe or persistent headaches or blurred vision

Chest pain

Leg swelling

Easy bruising or tiny red spots on the skin beyond the injection site

This vaccine shouldn't be given to anyone who develops thrombosis with thrombocytopenia after getting the Janssen/Johnson & Johnson COVID-19 vaccine or any other adenovirus vector COVID-19 vaccine.

Variants and COVID-19 vaccines

Do the COVID-19 vaccines protect against the COVID-19 variants?

Currently, the CDC has identified one variant of the virus (SARS-CoV-2) that causes coronavirus disease 2019 (COVID-19) as a variant of concern:

Omicron. Omicron spreads more easily than the original virus that causes COVID-19 and the delta variant. However, omicron appears to cause less severe disease. People who are fully vaccinated can get breakthrough infections and spread the virus to others. But the COVID-19 vaccines are effective at preventing severe illness. This variant also reduces the effectiveness of some monoclonal antibody treatments. Omicron has a few major offshoots (sublineages), including BA.5 and BA.2.12.1. BA.5 made up about 88% of COVID-19 infections that had genetic sequencing in the U.S. during a recent week in August 2022, according to the CDC.

In April, the CDC downgraded the delta variant from a variant of concern to a variant being monitored. This means that the delta variant isn't currently considered a major public health threat in the U.S.

Things to know before a COVID-19 vaccine

Are COVID-19 vaccines free?

In the U.S., the federal government is providing COVID-19 vaccines free of charge to all residents, regardless of immigration status or health insurance coverage. The COVID-19 vaccines are free whether offered by a clinic, retail pharmacy or other location.

Can I get a COVID-19 vaccine if I have an existing health condition?

Yes, COVID-19 vaccines are safe for people who have existing health conditions, including conditions that increase the risk of severe illness with COVID-19.

People who have a moderately or severely weakened immune system should get an additional primary shot and a booster shot.

Is it OK to take an over-the-counter pain medication before or after getting a COVID-19 vaccine?

Don't take medication before getting a COVID-19 vaccine to prevent possible discomfort. It's not clear how these medications might impact the effectiveness of the vaccines. However, it's OK to take this kind of medication after getting a COVID-19 vaccine, as long as you have no other medical reason that would prevent you from taking it.

Allergic reactions and COVID-19 vaccines

What are the signs of an allergic reaction to a COVID-19 vaccine?

You might be having an immediate allergic reaction to a COVID-19 vaccine if you experience these symptoms within four hours of getting vaccinated:

Hives

Swelling of the lips, eyes or tongue

Wheezing

If you have any signs of an allergic reaction, get help right away. Tell your doctor about your reaction, even if it went away on its own or you didn't get emergency care. This reaction might mean you are allergic to the vaccine. You might not be able to get a second dose of the same vaccine. However, you might be able to get a different vaccine for your second dose.

Can I get a COVID-19 vaccine if I have a history of allergic reactions?

If you have a history of severe allergic reactions not related to vaccines or injectable medications, you may still get a COVID-19 vaccine. You're typically monitored for 30 minutes after getting the vaccine.

If you have an immediate or severe allergic reaction after getting the first dose of a COVID-19 vaccine, don't get the second dose. However, you might be able to get a different vaccine for your second dose.

Pregnancy, breastfeeding and fertility with COVID-19 vaccines

Can pregnant or breastfeeding women get the COVID-19 vaccine?

If you are pregnant or breastfeeding, it's recommended that you get a COVID-19 vaccine.

Getting a COVID-19 vaccine can protect you from severe illness due to COVID-19. Vaccination can also help pregnant women build antibodies that might protect their babies. Research shows that infants born to mothers who receive two doses of an mRNA COVID-19 vaccine - such as the Pfizer-BioNTech or Moderna COVID-19 vaccine - might have a lower risk of hospitalization due to COVID-19 infection in their first six months of life.

COVID-19 vaccines don't cause infection with the virus that causes COVID-19, including in pregnant women or their babies. None of the COVID-19 vaccines contain the live virus that causes COVID-19. Also, keep in mind that mRNA COVID-19 vaccines don't alter your DNA.

Can a COVID-19 vaccine affect fertility or menstruation?

If you are trying to get pregnant or might become pregnant in the near future, it's recommended that you get a COVID-19 vaccine. There is no evidence that any vaccines, including COVID-19 vaccines, cause fertility problems in men or women.

Keep in mind that many things can affect menstrual cycles, including infections, stress, sleep problems, and changes in diet or exercise.

Children and COVID-19 vaccines

What COVID-19 vaccines have been authorized or approved for kids?

In the U.S., COVID-19 vaccines are available to children by age group:

Ages 6 months through 4 or 5 years old. The FDA has given emergency use authorization to a Pfizer-BioNTech COVID-19 vaccine for children ages 6 months through 4 years old. This vaccine requires three shots. The first two shots are given three to eight weeks apart. The third shot is given at least eight weeks after the second shot. Research shows that the three shots have produced antibody levels similar to those in young adults after getting the Pfizer-BioNTech vaccine.

The FDA has also given emergency use authorization to a Moderna COVID-19 vaccine for children ages 6 months through 5 years old. This vaccine requires two shots, given four to eight weeks apart. It's estimated that this vaccine is about 51% effective in preventing COVID-19 in babies ages 6 months through 23 months. For kids ages 2 through 5 years old, the vaccine is estimated to be 37% effective in preventing COVID-19.

Both vaccines contain lower amounts of mRNA than the mRNA COVID-19 vaccines for older children and adults.

Ages 5 or 6 through 11. The FDA has given emergency use authorization to a Pfizer-BioNTech COVID-19 vaccine for children ages 5 through 11. This vaccine involves two shots, given three weeks apart. Research shows that this vaccine is about 91% effective in preventing COVID-19 in this age group.

The FDA has also given emergency use authorization to a Moderna COVID-19 vaccine for children ages 6 through 11. This vaccine requires two shots, given four to eight weeks apart. For kids in this age group, the Moderna vaccine causes an immune response similar to that seen in adults.

Both vaccines contain lower amounts of mRNA than the mRNA COVID-19 vaccines for people age 12 and older.

Ages 12 through 17. The FDA has approved the Pfizer-BioNTech COVID-19 vaccine, now called Comirnaty, for people age 12 through 17. This vaccine involves three shots. The first two are given three to eight weeks apart. The third shot, a booster, is given at least two months after the second shot. It contains the same amount of mRNA as the Pfizer-BioNTech COVID-19 vaccine for people age 16 and older. Research has shown that this vaccine is 100% effective in preventing COVID-19 in children ages 12 through 15.

The FDA has also given emergency use authorization to a Moderna COVID-19 vaccine for children ages 12 through 17. This vaccine requires two shots, given four to eight weeks apart. It contains the same amount of mRNA as the Moderna COVID-19 vaccine for people age 18 and older. For kids ages 12 through 17, the Moderna vaccine causes an immune response similar to that seen in adults.

The FDA has also given emergency use authorization to a Novavax COVID-19 vaccine for people age 12 and older. This vaccine requires two shots, given three to eight weeks apart. Based on research submitted to the FDA, in children age 12 through 17, this vaccine is about 78% effective in preventing symptomatic COVID-19 illness.

An eight-week interval between the first and second doses might be best for some people, especially males ages 12 to 39. A longer interval might increase protection against COVID-19 and reduce the risk of rare heart problems, such as myocarditis and pericarditis.

Is there any difference in the COVID-19 vaccines for children and adults?

Smaller needles are also used to deliver the vaccine to the younger children.

If children don't frequently experience severe illness with COVID-19, why do they need a COVID-19 vaccine?

A COVID-19 vaccine can prevent your child from getting COVID-19 and spreading it at home and in school.

If your child gets COVID-19, a COVID-19 vaccine could prevent severe illness.

Getting a COVID-19 vaccine can also help keep your child in school and more safely have play dates and participate in sports and other group activities.

How did the FDA determine the safety and effectiveness of the COVID-19 vaccines for use in kids?

For kids ages 5 through 11, the FDA reviewed a vaccine study of more than 4,600 children in this age range. Of this group, about 3,100 were given the Pfizer-BioNTech COVID-19 vaccine. The other children were given an inactive (placebo) shot. Children who were given the vaccine were monitored for side effects for at least two months after the second dose. Side effects were generally mild to moderate.

The FDA also took an early look at cases of COVID-19 that occurred one week after children were given a second dose of the vaccine. None of the children in this analysis had been previously diagnosed with COVID-19. Among 1,305 children given the vaccine, there were three cases of COVID-19. Among 663 children given the placebo, there were 16 cases of COVID-19. The results suggest that the vaccine is about 91% effective in preventing COVID-19 in this age group.

For kids ages 12 through 15, the FDA reviewed a vaccine study of more than 2,200 U.S. children in this age range. Of this group, about half were given the Pfizer-BioNTech COVID-19 vaccine. The other children were given a placebo shot.

Also, a portion of the children in each age group were monitored for safety for at least two months after being given the second dose of the COVID-19 vaccine.

As with the other vaccines, side effects were recorded and a portion of the children were monitored for safety for at least two months after being fully vaccinated.

After a COVID-19 vaccine

Can I stop taking safety precautions after getting a COVID-19 vaccine?

The CDC recommends that you wear a mask on planes, buses, trains and other public transportation traveling to, within or out of the U.S., as well as in places such as airports and train stations.

If you are traveling in the U.S., you don't need to get tested before or after your trip or quarantine after you return. If you are traveling outside of the U.S., you don't need to get tested before you leave the U.S. unless your destination requires it. You no longer need to show a negative test result or proof that you've recovered from COVID-19 in the past three months before boarding an international flight to the U.S.

If you've gotten all recommended vaccine doses, including boosters and additional primary shots, and you've had close contact with someone who has the COVID-19 virus, get tested at least five days after the contact happens.

Can I still get COVID-19 after I'm vaccinated?

People with vaccine breakthrough infections can spread COVID-19 to others. However, fully vaccinated people with a breakthrough infection are less likely to have serious illness with COVID-19 than those who are unvaccinated. Even when vaccinated people develop symptoms, they tend to be less severe than those experienced by unvaccinated people.

Are COVID-19 vaccine additional primary shots or boosters recommended?

An additional primary shot of a COVID-19 vaccine is recommended for people who are vaccinated and might not have had a strong enough immune response.

In contrast, a booster dose is recommended for people who are vaccinated and whose immune response weakened over time. Immune response fades naturally over time. It can also happen when the virus that causes COVID-19 changes so the immune system doesn't recognize it as well. Research suggests that getting a booster dose can decrease your risk of infection and severe illness with COVID-19.

The CDC recommends additional primary shots and booster doses of COVID-19 vaccines in specific instances:

Additional primary shot. The CDC recommends an additional primary shot of an mRNA COVID-19 vaccine for some people with weakened immune systems, such as those who have had an organ transplant. People with weakened immune systems might not develop enough immunity after vaccination with two doses of an mRNA COVID-19 vaccine or one dose of the Janssen/Johnson & Johnson COVID-19 vaccine. An additional shot using an mRNA COVID-19 vaccine might improve their protection against COVID-19. This recommendation is for people age 5 and older.

The additional primary shot should be given at least four weeks after a second dose of an mRNA COVID-19 vaccine or one dose of the Janssen/Johnson & Johnson COVID-19 vaccine. The additional primary shot should be the same brand as the other two mRNA COVID-19 vaccine doses that were given. If the brand given isn't known, either brand of mRNA COVID-19 vaccine can be given as a third dose.

Booster dose. These recommendations differ by age, what vaccines you have been given and the state of your immune system.

People age 5 and older who had all recommended doses of the Moderna, Pfizer-BioNTech or Novavax COVID-19 vaccines can get the Pfizer-BioNTech COVID-19 updated, or bivalent booster. This booster is based on the original virus strain and two Omicron strains. Kids age 6 and older can choose between the Pfizer-BioNTech and the Moderna COVID-19 bivalent vaccine booster. People can get the booster shot at least two months after their last shot. People who recently had a positive COVID-19 test may consider waiting three months from when their symptoms started to get the booster.

If you are age 18 or older, and got the Janssen COVID-19 vaccine, you can get either of the mRNA vaccine bivalent boosters at least two months after your shot. People 18 and older may also get a Novavax booster based on the original virus strain as a first booster at least six months after their last shot.

Pregnant people can also get a COVID-19 booster dose.

Booster doses for people with weakened immune systems. People age 5 and older who have a weakened immune system and have had all recommended doses of the Moderna, Pfizer-BioNTech or Novavax COVID-19 vaccines can get an updated, or bivalent, booster dose of the Pfizer-BioNTech COVID-19 vaccine. The bivalent booster can be given at least two months after the last shot.

Are the new COVID-19 vaccines safe?

Andrew Badley, M.D., COVID-19 Research Task Force Chair, Mayo Clinic: The safety of these vaccines has been studied extensively. They've been tested now in about 75,000 patients in total, and the incidence of adverse effects is very, very low.

These vaccines were fast-tracked, but the parts that were fast-tracked were the paperwork; so the administrative approvals, the time to get the funding - those were all fast-tracked. Because these vaccines have such great interest, the time it took to enroll patients was very, very fast. The follow up was as thorough as it is for any vaccine, and we now have months of data on patients who received the vaccine or placebo, and we've compared the incidence of side effects between patients who received the vaccine and placebo, and that incidence of side effects, other than injection site reaction, is no different.

The side effects to the vaccines are very mild. Some of them are quite common. Those include injection site reactions, fevers, chills, and aches and pains. In a very, very small subset of patients - those patients who've had prior allergic reactions - some patients can experience allergic reaction to the vaccine. Right now we believe that number is exceedingly low.

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Coronavirus (COVID-19) update: FDA authorizes Moderna and Pfizer-BioNTech COVID-19 vaccines for children down to 6 months of age. Centers for Disease Control and Prevention. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-moderna-and-pfizer-biontech-covid-19-vaccines-children. Accessed June 21, 2022.

Fact sheet for healthcare providers administering vaccine. U.S. Food and Drug Administration. https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/comirnaty-and-pfizer-biontech-covid-19-vaccine. Accessed June 20, 2022.

International travel. Centers for Disease Control and Prevention. https://www.cdc.gov/coronavirus/2019-ncov/travelers/international-travel/index.html. Accessed June 21, 2022.

SARS-CoV-2 variant classifications and definitions. Centers for Disease Control and Prevention. https://www.cdc.gov/coronavirus/2019-ncov/variants/variant-classifications.html. Accessed July 7, 2022.

FDA roundup. U.S. Food and Drug Administration. https://www.fda.gov/news-events/press-announcements/fda-roundup-july-8-2022. Accessed July 15, 2022.

Coronavirus (COVID-19) update: FDA authorizes emergency use of Novavax COVID-19 vaccine, adjuvanted. U.S. Food and Drug Administration. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-emergency-use-novavax-covid-19-vaccine-adjuvanted. Accessed July 15, 2022.

Novavax COVID-19, adjuvanted vaccine: Overview and safety. Centers for Disease Control and Prevention. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/novavax.html. Accessed July 20, 2022.

Understanding protein subunit COVID-19 vaccines. Centers for Disease Control and Prevention. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/proteinsubunit.html. Accessed July 20, 2022.

Lee KMN, et al. Investigating trends in those who experience menstrual bleeding changes after SARS-CoV-2 vaccination. Science Advances. doi:10.1126/sciadv.abm720.

Reinfections and COVID-19. Centers for Disease Control and Prevention. https://www.cdc.gov/coronavirus/2019-ncov/your-health/reinfection.html. Accessed July 21, 2022.

Novavax COVID-19 vaccine, adjuvanted. Food and Drug Administration. https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/novavax-covid-19-vaccine-adjuvanted. Accessed Oct. 17, 2022.

Variants and genomic surveillance. Centers for Disease Control and Prevention. https://covid.cdc.gov/covid-data-tracker/#variant-proportions. Accessed Aug. 23, 2022.

COVID-19 bivalent vaccine boosters. U.S. Food and Drug Administration. https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-bivalent-vaccine-boosters. Accessed Sept. 9, 2022.

See more In-depth

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Looking to get the facts about COVID-19 vaccines? Here's what you need to know about the different vaccines and the benefits of getting vaccinated. As the coronavirus disease 2019 (COVID-19) pandemic continues, you might have questions about COVID-19 vaccines.

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Kaiser Family Foundation: In-depth research on parents' attitudes on vaccinating their children

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The KFF COVID-19 Vaccine Monitor is an ongoing research project tracking the public's attitudes and experiences with COVID-19 vaccinations. Using a combination of surveys and qualitative research, this project tracks the dynamic nature of public opinion as vaccine development and distribution unfold, including vaccine confidence and acceptance, information needs, trusted messengers and messages, as well as the public's experiences with vaccination.
Key Findings

As children around the country head back to school, nearly half of parents of children ages 12-17, the age group currently eligible to receive a COVID-19 vaccine, say their child has already been vaccinated (41%) or they will get the vaccine right away (6%). The vaccination status of children closely mirrors that of parents, with larger shares of older parents, Democrats, those with higher incomes and college degrees (all demographic groups with higher vaccine rates among adults), saying their child is vaccinated compared with their counterparts. Nearly four in ten Republican parents (37%) and half of parents who are unvaccinated themselves say they will "definitely not" get their 12-17 year-old vaccinated.

Parents of younger children who are not yet eligible to be vaccinated continue to take a cautious approach to COVID-19 vaccines, with four in ten parents of children under 12 saying that once a vaccine is authorized for their child's age group they will "wait a while to see how it is working" before getting their child vaccinated. About half of parents, regardless of their child's age, say they are very or somewhat worried about their child getting seriously sick from coronavirus.

For parents of unvaccinated teens, their top concerns about the COVID-19 vaccine center around the potential for long-term or serious side effects in children. However, we also find that as surveys of adults have identified, Hispanic and Black parents are more likely than White parents to cite concerns that reflect access barriers to vaccination, including not being able to get the vaccine from a trusted place, believing they may have to pay an out-of-pocket cost, or difficulty traveling to a vaccination site. A larger share of Hispanic parents than White parents also reports being concerned about needing to take time off work to get their child vaccinated.

Few working parents - particularly those with lower incomes - say their employer offers them paid time off to get their children vaccinated or care for them if they experience vaccine side effects. One quarter of working parents of unvaccinated 12-17 year-olds say they would be more likely to get their child vaccinated if their employer offered them paid time off to do so.

Four in ten parents of children ages 12-17 say their teen's school provided information about COVID-19 vaccines for children or encouraged parents to get their children vaccinated. Those who say their school did either one of these things are more likely to say their child has received a COVID-19 vaccine than parents who say their school did not do these things, even after controlling for other demographic factors associated with higher vaccination rates, suggesting that schools could play a role in increasing vaccine uptake among 12-17 year-olds.

A majority (58%) of parents of 12-17 year-olds say their child's school should not require students to be vaccinated for COVID-19, and a similar share (54%) of parents of all school-age children say schools should not require vaccination even once the FDA has fully approved the use of a COVID-19 vaccine in children. Majorities of Democrats and parents of children who are already vaccinated support schools requiring vaccinations in both scenarios, while majorities of Republican parents and those whose children are unvaccinated are opposed.

More than six in ten (63%) of all parents of children who attend school think their child's school should require unvaccinated students and staff to wear masks at school, although most Republican parents (69%) oppose such a requirement and parents of unvaccinated children are evenly divided.

Pediatricians continue to be a top trusted source of information on COVID-19 and kids, though most parents have not yet talked to their child's pediatrician about the vaccine. Among parents of teens who discussed the vaccine with their pediatrician, most say the doctor recommended their child get vaccinated, and three-quarters of those whose pediatrician recommended vaccination say their child has received at least one shot.

A majority of parents say they have talked about the COVID-19 vaccines with their 12-17 year-olds, including almost half who say they have discussed the vaccines "a lot." Among parents of unvaccinated teens, four in ten say their child has expressed concerns about getting a COVID-19 vaccine and 12% say their child has said that they want to be vaccinated.

Parents and COVID-19 Vaccines

COVID-19 Vaccination Status of Parents

One way for parents to protect their children from the risk of COVID-19 is to get vaccinated themselves. The latest KFF COVID-19 Vaccine Monitor finds 61% of parents say they have personally received at least one dose of a COVID-19 vaccine, which is somewhat lower than the 71% among adults without children (largely due to the fact that parents are younger on average than non-parents).

Among parents, some groups stand out as having lower vaccination rates than others, largely reflecting differences seen among the general population. For example, about half of those without health insurance (56%), Republican parents (54%), those with incomes under $40,000 per year (53%), parents ages 18-39 (50%), those without a college degree (49%), and Black parents (46%) say they have not received a COVID-19 vaccine.

Vaccination Intentions Among Parents Of Children Currently Eligible For COVID-19 Vaccination

Among parents of children ages 12-17, for whom the Pfizer COVID-19 vaccine is currently authorized, 41% now say their child has received at least one dose of a vaccine, up from 34% in June. An additional 6% of parents of 12-17 year-olds say they intend to get their child vaccinated "right away." Nearly one quarter of parents (23%) say they want to "wait and see" how the vaccine is working before getting their adolescent child vaccinated, while one in ten (9%) say they will only get their child vaccinated "if their school requires it," and one in five say they will "definitely not" vaccinate their child.

Not surprisingly, parents' vaccination intentions for their children are largely correlated with their own vaccination status. Six in ten parents who have received the vaccine themselves say their 12-17 year-old is vaccinated, compared to just 4% of unvaccinated parents. Among parents who have not been vaccinated themselves, half say they will "definitely not" vaccinate their child.

Besides vaccination status, parents' vaccination intentions for their children differ along similar lines as adults overall. Parents who identify as Democrats, older parents, and those with higher levels of income and education are more likely to say their child is already vaccinated or they will get them vaccinated right away. Notably, nearly four in ten (37%) Republican parents say they will "definitely not" get their 12-17 year-old vaccinated.

While there have been gaps in COVID-19 vaccine uptake among adults by race and ethnicity, the current survey does not find a statistically significant difference in child vaccination uptake between Hispanic, Black, and White parents. However, White parents of children ages 12-17 are twice as likely as Hispanic parents to say they will "definitely not" get their child vaccinated (24% vs. 12%).

Parents' intentions towards the COVID-19 vaccine for 12-17 year-olds are not necessarily a reflection of their behaviors with regards to other childhood vaccines. The vast majority of parents (90%) say they normally keep their children up-to-date with recommended vaccines such as the measles, mumps, and rubella (MMR) vaccine, while just 9% say they have delayed or skipped some childhood vaccines for their children. Yet even among parents of 12-17 year-olds who say their children are up-to-date on other childhood vaccines, fewer than half (43%) say their child has received a COVID-19 vaccine. (The sample of parents of 12-17 year-olds who have skipped or delayed other vaccines is too small for analysis.)

Just over half of parents (54%) say their child normally gets a flu vaccine each year. Among parents of 12-17 year-olds who say their child normally gets a flu shot, 57% say their adolescent has received a COVID-19 vaccine, which is twice the share of parents who say their child does not normally get a flu vaccine who have gotten the COVID-19 vaccine (25%).

Vaccination Intentions Among Parents Of Younger Children

While uptake of COVID-19 vaccines among 12-17 year-olds has increased over time, parents continue to report a more cautious attitude when it comes to vaccinations for children younger than 12. About a quarter (26%) of parents of children between the ages of 5-11 say they will vaccinate their child "right away" once a vaccine is authorized for their age group, as do one in five parents with children under 5. Four in ten parents in each age group say they will "wait and see" how the vaccine is working before having their younger child vaccinated. One-quarter say they will "definitely not" get their 5-11 year-old vaccinated and three in ten parents say the same about their children under age 5.

Parents' Concerns and Reasons For Holding Off On Child COVID-19 Vaccinations

Parents of unvaccinated children ages 12-17 cite a range of concerns when it comes to vaccinating their children for COVID-19, with safety and side effects at the top of the list. A large majority (88%) of these parents say they are "very" or "somewhat" concerned that not enough is known about the long-term effects of the COVID-19 vaccine in children, and nearly as many (79%) say they are concerned their child might experience serious side effects from the COVID-19 vaccine. Nearly three-quarters of parents of unvaccinated adolescents (73%) report being concerned that the vaccine may negatively impact their child's fertility in the future, even though the CDC states there is "no evidence that any vaccines, including COVID-19 vaccines, cause female or male fertility problems." Two-thirds of parents of unvaccinated adolescents (65%) say they are concerned that their child might be required to get the COVID-19 vaccine even if they don't want them to.

Notably, parents whose teens are unvaccinated but who have received a COVID-19 vaccine themselves are somewhat less likely than unvaccinated parents to express concern that their child will experience serious vaccine side effects (70% vs. 86%), that the vaccine might impact their child's future fertility (58% vs. 85%), and that they will be required to get the vaccine even if the parent doesn't want them to (50% vs. 78%).

A smaller share of parents overall cite concerns that may reflect access barriers to getting a COVID-19 vaccine for their child, though many of these concerns are more prevalent among Hispanic and Black parents than they are among White parents. For example, half (49%) of Hispanic parents of unvaccinated adolescents are concerned they might need to take time off work to get their child vaccinated or care for them if they experience side effects, twice the share of White parents (24%) who express the same concern. Similarly, among parents of unvaccinated 12-17 year-olds, larger shares of Hispanic and Black parents compared to White parents are concerned that they won't be able to get their child the vaccine at a place they trust, they might have to pay an out-of-pocket cost to get their child vaccinated, or they will have difficulty traveling to a vaccine site for their child.

In addition to these concerns, many parents of unvaccinated 12-17 year-olds view the vaccine as a bigger risk to their child's health than getting sick from COVID-19. Overall, six in ten (62%) parents of 12-17 year-olds say becoming infected with coronavirus is a bigger risk to their child's health than getting the COVID-19 vaccine, while about half as many (34%) say getting the vaccine is a bigger risk. The share saying the vaccine is a bigger risk rises to 55% among Republican parents and 73% among parents who are unvaccinated themselves. Among parents of unvaccinated 12-17 year-olds, 55% say the vaccine is a bigger risk, including 91% of those who say they will "definitely not" get their child vaccinated.

When parents of adolescent children who have not yet been vaccinated are asked to name in their own words the main reason why their child has not received a COVID-19 vaccine, the top reasons include that not enough is known about the vaccines or wanting more research on the vaccines in children (19%), they are concerned about side effects (13%), their child does not want the vaccine (13%), they do not believe a vaccine is necessary (7%), and they don't trust the vaccines (5%).
Side effects/reactions (13%) Don't trust the vaccine (5%)
Potential Role Of Employers In Facilitating COVID-19 Vaccinations For Children

Seven in ten parents of children under age 18 say they are employed, including six in ten who are employed full-time. More than a third of employed parents say their employer offers them paid time off to get a COVID-19 vaccine (39%) or to recover from side effects themselves (35%). However, most say their employer does not provide paid time off for them to get their children vaccinated (36%) or they are not sure if their employer offers this (42%). Similar shares say the same about paid time off to care for a child experiencing vaccine side effects.

Notably, parents with lower household incomes are even less likely than those earning higher incomes to say their employer provides paid time off for either their own vaccination and side effects or that of a child.

Among employed parents of unvaccinated 12-17 year-olds, one-quarter say they'd be more likely to get their child vaccinated if their employer gave them paid time off, while somewhat smaller shares of this group say they'd be more likely to vaccinate their child if their employer arranged for a medical provider to come to their workplace to vaccinate children and families (19%), or provided free transportation to a vaccine site (14%).

With lower rates of reported COVID-19 vaccination among parents with lower incomes, employer policies have the potential to reduce these income gaps somewhat. For example, just 29% of employed (non self-employed) parents with household incomes under $90,000 say their 12-17 year-old has been vaccinated for COVID-19 compared to over half (54%) of employed parents with higher incomes. Among employed parents with incomes under $90,000, an additional one in five say they'd be more likely to get their child vaccinated if their employer offered them paid time off, and some say they'd be more likely to vaccinate their child if their employer arranged for a medical provider to vaccinate children and families at their workplace (14%) or provided free transportation to a vaccination site (12%).

Parents' Worries About Kids and COVID-19

While research has shown that children are less likely than adults to become seriously ill from coronavirus infection, parents may nevertheless worry about their children being exposed or passing an infection on to other family members, particularly when it comes to children under the ages of 12 who are not eligible for COVID-19 vaccination. The latest KFF COVID-19 Vaccine Monitor reports that about half of parents of children ages 12-17 (48%) and under age 12 (52%) say they are worried about their child getting seriously ill from coronavirus. Similarly, about half of parents across child age groups say they are worried about their child being exposed to coronavirus and passing it on to family members or that they may personally be exposed to coronavirus and pass it on to their child.

Across child age groups, Black and Hispanic parents are much more likely than White parents to say they are worried about personally getting sick, about their child getting sick, about their child infecting someone else in the family, and about personally passing an infection on to their child. For example, among parents of children ages 12-17, 71% of Hispanic parents and 64% of Black parents are worried about their child getting seriously sick from coronavirus compared to 38% of White parents.

The July KFF COVID-19 Vaccine Monitor found that despite being at higher risk for contracting the disease, unvaccinated adults are less likely than vaccinated adults to worry about getting sick from COVID-19. A similar pattern holds among parents. Parents of vaccinated children ages 12-17 are more likely than parents of unvaccinated children in this age range to worry about their child getting seriously sick from coronavirus (56% vs. 42%) and about their child becoming infected and passing the virus on to someone else in their family (60% vs. 44%).

Schools and COVID-19 Vaccines

With some schools around the country already open for the 2021-2022 school year and many others set to open later this month, this Vaccine Monitor report examines parents' views on vaccines and other protective measures in their children's schools. We find that while most parents of school-age kids say their children attended school at least partially online during the previous school year, a large majority expect school to happen all or mostly in person during the upcoming school year (87% of parents of 12-17 year-olds and 89% of parents of 5-11 year-olds).

Among parents of children ages 12-17 who are enrolled in school for the upcoming school year, about four in ten (42%) say the school has provided them with information about how to get a COVID-19 vaccine for their child and a similar share (40%) say the school has encouraged parents to get their children vaccinated. Higher-income parents are more likely than those with lower incomes to say their child's school did either of these things; about half of parents with household incomes of $90,000 or more say their child's school provided vaccine information or encouraged vaccination compared to between one-third and four in ten among parents with lower incomes.

Fewer parents of 12-17 year-olds say their child's school asked about their child's COVID-19 vaccination status (11%) or said that they will require students to be vaccinated in order to return to school in-person (7%).

Parents of 12-17 year-olds who say their child's school provided information about COVID-19 vaccination are more likely than those whose school did not provide information to say their child has received a COVID-19 vaccine (58% vs. 32%). Similarly, about twice as many parents whose school encouraged vaccination report that their child is vaccinated compared to those whose schools did not (62% vs. 30%).

These differences may be at least partially due to differences in other demographic characteristics of parents whose schools provided information or encouraged vaccination compared to those who did not. However, using a statistical technique called multiple logistic regression, we find that parents whose children's schools provided information or encouraged vaccination are more likely to say their child is vaccinated, even after controlling for demographic characteristics associated with child vaccination, including parents' own vaccination status, age, race, ethnicity, education, income, party identification, urbanicity, and region. This suggests that more schools providing information and encouraging COVID-19 vaccination could contribute to higher vaccination rates among students.

Overall, most parents of children in the 12-17 age group currently eligible for vaccination say they do not think their child's school should require students to get a COVID-19 vaccine (58%) while four in ten parents (42%) say their school should require this. Views on this question diverge along partisan lines, with two-thirds of parents who identify as Democrats (66%) saying their child's school should require students to be vaccinated and nearly nine in ten Republican parents (87%) saying it should not. Majorities of White parents and Black parents say their school should not require students to be vaccinated, while Hispanic parents are more evenly divided on this question (51% should, 47% should not).

Not surprisingly, there is a huge divide in opinion of school vaccine mandates among parents by their child's vaccination status: 75% of parents of children ages 12-17 who have received a COVID-19 vaccine say their child's school should require vaccination while 83% of parents of unvaccinated children ages 12-17 say they should not.

Parents' views on schools requiring COVID-19 vaccinations remain divided even when asked how they would feel if the FDA were to grant full approval for the use of a vaccine in children. Among all parents of school-age children (ages 5-17), just under half (45%) say that once a COVID-19 vaccine receives full FDA approval, "schools should require students to be vaccinated for COVID-19 as they do for most other diseases like measles and tuberculosis" while just over half (54%) say schools should not require COVID-19 vaccinations in this scenario.

Similar to the question about their own child's school, majorities of Democrats, Hispanic parents, and parents of children who have already received a COVID-19 vaccine say schools should require students to receive a COVID-19 vaccine once one is approved by the FDA, while majorities of Republicans, Black parents, White parents, and parents of unvaccinated 12-17 year-olds say they should not.

In general, parents are more supportive of mask mandates in schools than they are of vaccine mandates. Over six in ten parents of children enrolled in school (63%) say their child's school should require unvaccinated students and staff to wear masks while they're in school while 36% say they should not. Previous Vaccine Monitor reports have shown that mask-wearing among adults divides largely along partisan lines and the same is true when it comes to opinions about mask mandates in schools. Large majorities of parents who identify as Democrats (88%) and independents (66%) say their child's school should require masks while most Republican parents (69%) say they should not. In addition, larger shares of Black parents (83%) and Hispanic parents (76%) compared to White parents (54%) support a mask requirement at their child's school. Among parents of 12-17 year-olds, a large majority (85%) of those whose child has received a COVID-19 vaccine say their school should require unvaccinated students and staff to wear masks while those whose child is unvaccinated are evenly split.

While some parents may be concerned about their child's risk of exposure to coronavirus at school or in social settings, about four in ten parents of children ages 12-17 (41%) say they don't know what share of their child's close friends have been vaccinated for COVID-19 and about half (48%) say the same about their child's schoolmates. Parents of vaccinated children are much more likely than parents of unvaccinated children to say all or most of their child's friends (32% vs. 2%) and schoolmates (14% vs. 1%) are vaccinated, while parents of unvaccinated 12-17 year-olds are more likely to say they don't know the vaccination status of their child's friends (45% vs. 34%) and schoolmates (55% vs. 38%).

Sources of Information and Information Needs

Throughout efforts to vaccinate adults for COVID-19, the Vaccine Monitor has documented gaps in information about COVID-19 vaccines, including that Black and Hispanic adults and those with lower incomes have been more likely to say they don't have enough information about vaccine side effects and access.

The latest survey finds that the same is true when it comes to parents' feelings about information on COVID-19 vaccines for children. While about four in ten parents say they have enough information, over half say they don't have enough information about the effectiveness (57%) or the potential side effects (60%) of the COVID-19 vaccines in children.

Larger shares of mothers, younger parents, Black and Hispanic parents, those with lower incomes, and parents without a college degree say they don't have enough information about effectiveness and side effects of vaccines in kids compared to fathers, older parents, White parents, and those with higher incomes and college degrees.

Parents' Trusted Sources Of Information On COVID-19 Vaccines For Kids

Overall, pediatricians are a top source for trusted information when it comes to COVID-19 vaccines and children. About eight in ten parents overall (78%) say they trust their child's pediatrician "a great deal" or "a fair amount" to provide reliable information about COVID-19 vaccines for kids. Over six in ten also say they trust the CDC (66%) and their local public health department (62%) at least a fair amount, while a majority of insured parents trust their health insurance company (58%) and over half of working parents trust their employer (53%). Schools and other parents are lower on parents' list of trusted information sources, with 44% saying they trust their child's school or daycare for vaccine information and 38% saying the same about other parents they know.

Reflecting partisan divisions in trusted information sources among all adults in previous Vaccine Monitor reports, parents who identify as Republicans are far less likely than those who identify as Democrats to trust most sources of information, with the exception of pediatricians (who are highly trusted by parents across the political spectrum) and other parents (who rank lower as a trusted resource regardless of partisanship).

A key target group for information is parents of unvaccinated children ages 12-17, who are currently eligible to receive a COVID-19 vaccine. Among these parents, nearly two-thirds (64%) trust their child's pediatrician at least a fair amount to provide reliable information about COVID-19 vaccines and children, but fewer than half trust any of the other information sources tested. Notably, among those who say they will "definitely not" vaccinate their child, four in ten (39%) say they trust their child's pediatrician and fewer than one-third put at least a fair amount of trust in any of the other information sources included in the survey.

Parents' Vaccine Conversations with Pediatricians And With Their Children

While pediatricians are a top trusted source of information, most parents have not yet discussed COVID-19 vaccinations with their child's pediatrician. Three in ten parents of children under age 18 say they have talked to their children's pediatrician about the COVID-19 vaccine, including a somewhat higher share of parents who have children between the ages of 12-17 (35%). Among parents of children in this age range who discussed the vaccine with their child's pediatrician, 72% (one quarter of all parents of 12-17 year-olds) say the pediatrician recommended that their child get vaccinated for COVID-19.

Parents who say their child's pediatrician recommended vaccination are about two and half times as likely to say their child has received a COVID-19 vaccine compared to parents who did not talk to a pediatrician or say the pediatrician did not recommend vaccination (75% vs. 31%). However, the extent to which a pediatrician's recommendation was a deciding factor for these parents is unclear, since parents who are more inclined towards getting their children vaccinated for COVID-19 may have been more likely to initiate these conversations with pediatricians in the first place.

Parents more commonly report discussing the COVID-19 vaccine with their children than with their pediatrician. Among parents of 12-17 year-olds, nearly half (46%) say they have talked with their child about the vaccine "a lot" and another third (32%) say they have discussed it "some." Parents with college degrees and those who have received the COVID-19 vaccine themselves are more likely to report discussing the vaccine with their adolescent children. In addition, more than six in ten parents of children who have received at least one dose of the vaccine say they have talked with their child "a lot" about the vaccine compared with about a third (35%) of parents of unvaccinated 12-17 year-olds.

About one-third of parents of children ages 12-17 say their child has expressed any concerns to them about getting a COVID-19 vaccine, including one quarter (24%) of parents of vaccinated children and four in ten (41%) parents of unvaccinated children.

Among parents of unvaccinated children ages 12-17, one in eight (12%) say their child has told them that they want to get the vaccine.

When asked to say in their own words the main concern their child has expressed, side effects are at the top of the list, with 29% of parents of children who expressed a concern saying this was their main concern (38% of parents of vaccinated children and 26% of unvaccinated). The second- and third-ranked concerns among parents of unvaccinated children who expressed concerns are not wanting to get the vaccine (16%) and concerns about long-term effects (14%). Among parents of vaccinated children who expressed concerns, 9% say their child was concerned about long-term effects and 8% expressed concerns about the safety of the vaccine.

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KFF COVID-19 Vaccine Monitor: Parents and the Pandemic

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This report examines attitudes and views of parents as children head back to school amidst the rise in COVID-19 cases due to the delta variant. Nearly half of parents of children ages 12-17, who are currently eligible to receive a COVID-19 vaccine, say their child has already been vaccinated or will get the vaccine right away.

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AAP Survey on Talking to Parents about COVID-19 Vaccine

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When deciding whether their child should get the COVID-19 vaccine, parents said a recommendation from their child's doctor will be influential, according to a new national poll.

However, 70% of parents of children ages 3-11 years said they have not discussed the COVID-19 vaccine with their child's doctor. Half of parents of children ages 12-18 have not had the discussion.

The University of Michigan Health C.S. Mott Children's Hospital National Poll on Children's Health sought to assess parents' stance on vaccinating children and gain insight on decision-making factors before the start of the 2021-'22 school year. The report was based on a nationally representative survey of 2,019 parents in June. The response rate was 56%.

Parents typically rely on their child's pediatrician for information and guidance on vaccines. A lack of discussion with pediatricians about COVID-19 vaccination leaves parents at a disadvantage when making an informed decision, according to the Mott Poll Report.

Among parents of children ages 12-18, 39% said their child had received a COVID-19 vaccine, 21% said their child likely would get it and 40% said it was unlikely their child would get the vaccine.

Parents of unvaccinated children ages 12-18 reported that a doctor's office would be the preferred location for vaccination.

When parents of children ages 3-11 were asked whether they would get the COVID-19 vaccine when it becomes available, answers were nearly evenly split (49% yes; 51% no).

Other factors besides a recommendation from their child's health care provider that would influence parents' decision to have their child age 3-18 vaccinated included:

vaccine side effects (70%),

testing in the child's age group (63%),

how well the vaccine works in children (62%) and

their own research (56%).

Authors of the report said talking with parents can ensure they have accurate information and a professional recommendation. It also provides an opportunity to differentiate between common side effects of vaccination and potentially more serious adverse events and explain the vaccine authorization process.

"Discussion with their child's health care provider can be the key for parents to get help sorting through the various data sources so they can make an informed choice that is right for their child and their family," according to the report.

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Survey: Communication with parents can boost COVID-19 vaccinations in children

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When deciding whether their child should get the COVID-19 vaccine, parents said a recommendation from their child's doctor will be influential, according to a new national poll. However, 70% of parents of children ages 3-11 years said they have not discussed the COVID-19 vaccine with their child's doctor.

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CDC's 'Talking with Patients Who Are Immunocompromised'

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CDC's 'Talking with Patients Who Are Immunocompromised'

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CDC guide: talking to immunocompromised patients about the COVID-19 booster shot

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About an additional dose of an mRNA COVID-19 vaccine

Effective August 13, 2021, CDC recommends that people who are moderately to severely immunocompromised receive an additional dose of an mRNA COVID-19 Vaccine (Pfizer-BioNTech or Moderna) at least 28 days after the completion of the initial mRNA COVID-19 vaccine series. Available data show that these people don't always build adequate levels of protection after an initial 2-dose primary mRNA COVID-19 vaccine series. The data also show that they may benefit from receiving an additional dose of an mRNA vaccine to develop as much protection as possible against COVID-19.

Currently, CDC is recommending that moderately to severely immunocompromised people receive an additional dose. This includes people who have:

Active treatment for solid tumor and hematologic malignancies

Receipt of solid-organ transplant and taking immunosuppressive therapy

Receipt of CAR-T-cell or hematopoietic stem cell transplant (within 2 years of transplantation or taking immunosuppression therapy)

Moderate or severe primary immunodeficiency (e.g., DiGeorge syndrome, Wiskott-Aldrich syndrome)

Advanced or untreated HIV infection

Active treatment with high-dose corticosteroids (i.e., ≥20mg prednisone or equivalent per day), alkylating agents, antimetabolites, transplant-related immunosuppressive drugs, cancer chemotherapeutic agents classified as severely immunosuppressive, tumor-necrosis (TNF) blockers, and other biologic agents that are immunosuppressive or immunomodulatory.

As a clinician, your answers to patient questions matter. Your strong recommendation can help them make an informed decision and feel confident about getting an additional dose of an mRNA COVID-19 vaccine.

If your patient has questions about receiving an additional dose of an mRNA COVID-19 vaccine:

Discuss the patient's specific situation: Factor in their medical conditions and level of immune suppression; level of COVID-19 community transmission and personal risk of infection; and current or planned immunosuppressive therapies affecting the patient's medical condition and potential response to vaccine.

Explain the difference: An additional mRNA dose following an initial vaccine series is given to people who may not have had a strong enough immune response after receiving the initial vaccine series. A booster dose is a supplemental dose given to groups whose immune response has weakened over time. No booster doses are recommended at this time. This may change as more information becomes available.

Use the same vaccine product, when feasible: People who need an additional dose and received either a Pfizer-BioNTech or Moderna vaccine series should receive a third dose of the same vaccine used.

Explain what Janssen vaccine recipients should know: What we don't know at this time is whether people who are immunocompromised who received the Janssen vaccine (Johnson & Johnson) have an improved immune response following an additional dose of the same vaccine.

I strongly encourage you to get an additional dose.

When making a strong recommendation, focus on personal risk and safety of the vaccines:

Explain the risk and benefit. People who are immunocompromised are more likely to transmit the virus that causes COVID-19 to household contacts. Also, small studies suggest that fully vaccinated immunocompromised people accounted for a large proportion (40-44%) of hospitalized breakthrough cases. Lastly, the Delta variant is surging, and the number of people with COVID-19 is increasing in the United States. Share you want the patient to develop as much protection as possible against COVID-19.

Consider and discuss. The patient's medical condition, risk of infection, and any planned immunosuppressive therapies.

Reaffirm. So far, reactions reported after the third mRNA dose were similar to what people experienced after receiving the two-dose series. Fatigue and pain at injection site were the most commonly reported side effects, and overall, most symptoms were mild to moderate. CDC and FDA will continue to monitor the safety of all COVID-19 vaccines.

If your patients have questions, please guide them to: COVID-19 Vaccines for Moderately to Severely Immunocompromised People

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talk to patients who are immunocompromised

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Additional Dose of mRNA COVID-19 Vaccine for Patients Who Are Immunocompromised | CDC

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About an additional dose of an mRNA COVID-19 vaccine Effective August 13, 2021, CDC recommends that people who are moderately to severely immunocompromised receive an additional dose of an mRNA COVID-19 Vaccine (Pfizer-BioNTech or Moderna) at least 28 days after the completion of the initial mRNA COVID-19 vaccine series.

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Vaccines on the Go: What You Should Know App

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Vaccines on the Go: What You Should Know App

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A free mobile app with resources for parents on all vaccines, including fun trivia games. Created by the Vaccine Education Center at the Children's Hospital of Philadelphia.

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It's easier than ever to get health information. But sometimes, it's difficult to weed out the "good" information, which is scientifically accurate, from the "bad" information, which is not based on science. This is especially true for vaccines.

In a continued effort to provide the public with information about the science, safety and importance of vaccines, the Vaccine Education Center at Children's Hospital of Philadelphia (VEC) recently updated its popular, award-winning mobile app, called Vaccines on the Go: What You Should Know, so anyone can access vaccine information wherever and whenever they need it.

View this video with a transcript

Vaccine app features

The redesigned Vaccines on the Go: What You Should Know mobile app continues to offer information about:

Vaccines and the diseases they prevent

Recommended immunization schedules for children, teens and adults

Vaccine safety concerns, including autism, thimerosal, and too many vaccines

New information includes:

How the immune system works, including what happens during an infection or when a person is immune compromised

Disease and vaccine information related to travel, including descriptions of cholera, Japanese encephalitis virus, typhoid and yellow fever

Enhanced video offerings, including animations related to how viruses attack cells, maternal antibodies and immunizations, and more

Additional features include:

Updated graphics depicting disease characteristics, such as levels of contagiousness and typical disease timelines

An opportunity to receive updates through the app

Vaccine-related trivia

A place to record notes or questions for the next doctor's visit

Ways to stay connected with the VEC, including sending us vaccine-related questions or signing up for Parents PACK, our free monthly e-newsletter

Links to a variety of online resources, including booklets and Q&A sheets

Get more information about the new and updated features of the app, described in the December 2019 issue of Parents PACK.

Providers: Get free posters to share with your patients

If you would like to share information about this app with your patients and their families, you can order free updated posters from the VEC. Posters are 8.5"x11" in size, making them easy to hang in waiting or exam rooms or to add to patient information packets.

App wins two awards

2020 "Award of Distinction"

The Vaccines on the Go mobile app was selected among 6,000 entries as an "Award of Distinction" winner by the Academy of Interactive and Visual Arts in spring 2020, during the 26th Annual Communicator Awards. The Award of Distinction is bestowed on those whose projects "exceed industry standards in quality and achievement."

PRNEWS Digital Awards

The app also earned an honorable mention in the PRNEWS Digital Awards in the Mobile App category. The awards program recognizes the most innovative and industry-altering digital communicators and campaigns.
Learn more about the awards.

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It's easier than ever to get health information. But sometimes, it's difficult to weed out the "good" information, which is scientifically accurate, from the "bad" information, which is not based on science. This is especially true for vaccines.

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Search through a number of printable resources for patients ranging from informational handouts to promotional materials.

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Centers for Disease Control and Prevention

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The following print-only materials are developed to support COVID-19 recommendations. All materials are free for download. They may be printed on a standard office printer, or you may use a commercial printer.

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The following print-only materials are developed to support COVID-19 recommendations. All materials are free for download. They may be printed on a standard office printer, or you may use a commercial printer.

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A range of toolkits and communications materials geared towards different audiences of subjects.

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WELCOME: This internal site helps Virginia communicators stay on top of weekly updates relating to COVID comms resources. We highlight the latest tools from teams across VDH, CDC + partners. Bookmark + come back often.

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VDH Resources for COVID-19 Vaccine Clinics

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VDH Resources for COVID-19 Vaccine Clinics

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Resources from VDH on planning and implementing COVID-19 vaccine clinics.

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Training for Administering COVID-19 Vaccines under VDH COVID-19 Vaccine Product Information COVID-19 Vaccine Clinical Resources COVID-19 Vaccination Best Practices Vaccination Site Access and Functional Needs Guidance Summary of Legal Authorities for Pharmacists to Administer COVID-19 Vaccine Vaccine Adverse Event Reporting System (VAERS) Find COVID Vaccine Providers

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CDC information on booster shots for immunocompromised individuals who originally receive an mRNA vaccine

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Centers for Disease Control and Prevention

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Important update: Healthcare facilities

CDC has updated select ways to operate healthcare systems effectively in response to COVID-19 vaccination. Learn more

COVID-19 Vaccines for People who are Moderately or Severely Immunocompromised

If you are moderately or severely immunocompromised (have a weakened immune system), you are at increased risk of severe COVID-19 illness and death. Additionally, your immune response to COVID-19 vaccination may not be as strong as in people who are not immunocompromised.

As with vaccines for other diseases, you are protected best when you stay up to date with your COVID-19 vaccines as described below.

Use CDC's COVID-19 booster tool to learn if and when you can get boosters to stay up to date with your COVID-19 vaccines.

You may also be eligible for Evusheld, a medicine given by your healthcare provider to help prevent you from getting COVID-19.

You can self-attest to your moderately or severely immunocompromised status. This means that you do not need any documentation of your status in order to receive COVID-19 vaccine doses wherever they are offered.

Pre-teens, Teens and Adults Who Are Moderately or Severely Immunocompromised

Up to Date: 2 weeks after the 2nd dose in primary series, since boosters are not recommended at this time for anyone who has completed the Novavax COVID-19 primary series

Children Ages 6 Months-11 Years Who Are Moderately or Severely Immunocompromised

Up to Date: 2 weeks after 3rd dose in primary series, since boosters are not recommended at this time for any children who have completed the Moderna COVID-19 primary series

1 For the 1st booster, an mRNA vaccine booster is recommended; however, you may consider J&J/Janssen COVID-19 vaccine in some situations. However, J&J/Janssen COVID-19 vaccine cannot be used as a 2nd booster dose.

2 If you have completed your primary series-but are not yet eligible for a booster-you are also considered up to date.

To find COVID-19 vaccine locations near you: Search vaccines.gov, text your ZIP code to 438829, or call 1-800-232-0233.

Who Is Moderately or Severely Immunocompromised?

People are considered to be moderately or severely immunocompromised (have a weakened immune system) due to several types of conditions and treatments. Examples include:

Been receiving active cancer treatment for tumors or cancers of the blood

Received an organ transplant and are taking medicine to suppress the immune system

Received chimeric antigen receptor (CAR)-T-cell therapy (a treatment to help your immune system attach to and kill cancer cells) or received a stem cell transplant (within the last 2 years)

Moderate or severe primary immunodeficiency (such as DiGeorge syndrome, Wiskott-Aldrich syndrome)

Advanced or untreated HIV infection

Active treatment with high-dose corticosteroids or other drugs that may suppress their immune response

Talk to your healthcare provider about COVID-19 vaccination and your medical condition.

If you are moderately or severely immunocompromised or severely allergic to COVID-19 vaccines, you may be eligible for , a medicine given by your healthcare provider to help prevent you from getting COVID-19. Talk to your healthcare provider to find out if this option is right for you.

People Who Were Vaccinated Outside of the United States

People who are moderately or severely immunocompromised and who received COVID-19 vaccines not available in the United States should either complete or restart the recommended COVID-19 vaccine series, including a booster, in the United States. For more information, talk to your healthcare provider, or see the COVID-19 Interim Clinical Considerations.

Frequently Asked Questions

The safety, effectiveness, and benefit of the third primary dose in people who are moderately or severely immunocompromised continues to be evaluated. So far, reactions reported after the third primary dose of an mRNA COVID-19 vaccine are similar to those of the two-dose primary series. Fatigue and pain at the injection site were the most commonly reported side effects-and overall, most symptoms were mild and temporary.

As with the two-dose primary series, serious side effects are rare, but may occur.

If you are moderately or severely immunocompromised, being up to date means you have received all doses in the primary series-plus 2 boosters.

You are also considered up to date if

You have completed your primary series but are not yet eligible for a booster

You have received 1 booster but are not yet eligible for a 2nd booster

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Important update: Healthcare facilities CDC has updated select ways to operate healthcare systems effectively in response to COVID-19 vaccination. Learn more COVID-19 Vaccines for People who are Moderately or Severely Immunocompromised If you are moderately or severely immunocompromised (have a weakened immune system), you are at increased risk of severe COVID-19 illness and death.

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Updated daily, this dashboard includes stats on Virginia's COVID-19 Vaccination efforts.

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This 4 page document created by the IAC contains more in-depth answers to commonly asked questions about MenACWY. It is a moderate to high health literacy level.

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This media hub, created by Pfizer, includes communications materials, including first hand story on those impacted by meningococcal disease, to share with patients and the community.

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A 1-pager that explains the new VA requirements for VA and includes important data about MenACWY vaccination rates. Created by Sanofi Pasteur.

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Meningitis New Mandate State Fact Sheet_Virginia (1)

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CDC's Meningococcal Vaccines Patient Handout

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CDC's Meningococcal Vaccines Patient Handout

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A 1-pager from the CDC on meningococcal disease and vaccines for pre-teens and teens. Moderate to high health literacy level.

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MenACWY Patient Handout - Changes to VA Requirements

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MenACWY Patient Handout - Changes to VA Requirements

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A 1-pager that draws attention to the new immunization requirements in VA. Moderate health literacy level. Created by Sanofi Pasteur

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Data on Adolescent and Adult Iz Rates During Pandemic, Including MenACWY

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Data on Adolescent and Adult Iz Rates During Pandemic, Including MenACWY

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Taken from a report prepared by Avalere, this graphic shows a steep decline in routine vaccination rates for adolescents and adults during the COVID-19 pandemic.

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2021 MenACWY HCP to Patient Email_VIRGINIA (1)

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A brief video created by ImmunizeVA members Ferdaus Hassan and Alissa Wong for HCPs to review the basics of the MenACWY vaccine, including vaccine recommendations.

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A 1-pager from the ACS that highlights the benefits of the HPV vaccine and recommended schedule.

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Vaccines for Preteens & Teens: What Parents Should Know

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Vaccines for Preteens & Teens: What Parents Should Know

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1-pager that reviews what vaccines teens are recommended for teens, when, and the safety of these vaccines. Appropriate for moderate to high literacy levels.

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1-pager on why the HPV vaccine is needed, when to get vaccinated, and vaccine safety. Appropriate for moderate to high health literacy levels.

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'HPV. It's About Cancer Education' Patient Handout.

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'HPV. It's About Cancer Education' Patient Handout.

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This 1-page handout for patients provides information on who is at risk and for what. It is appropriate for a low to moderate health literacy level. Document produced by Merck.

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HPV Case Study from Nationwide Children's Hospital

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HPV Case Study from Nationwide Children's Hospital

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A case study from the Nationwide Children's Hospital in Columbus Ohio on the early initiation of HPV Vaccination. Document produced by Merck.

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NCH Early Initiation HPV Case Study - US-GSL-00032 for Upload to VKCL Central (1)

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2021 Call to Action & Tips for HPV Catch Up

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2021 Call to Action & Tips for HPV Catch Up

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A spring call to action with tips to help teens catch up on missed HPV Vaccinations

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Full Action Guide for HPV Cancer Prevention

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Full Action Guide for HPV Cancer Prevention

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Cancer Prevention Through HPV Vaccination in Your Practice: An Action Guide for MDs, PAs, and NPs.

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1-page action guide for cancer prevention through HPV vaccination for MDs, PAs, and NPs.

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Strategies to Incorporate Updated Recommendations for Hep A Catch Up Vaccination

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Strategies to Incorporate Updated Recommendations for Hep A Catch Up Vaccination

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4 steps to incorporate the new Hep A vaccine recommendations for catch up vaccines. Document produced by Merck

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Includes answers to questions about disease issues, vaccine recommendations, administering the vaccine, vaccine safety, contraindications and precautions and storage and handling, among others.

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Hepatitis A

Disease Issues

Hepatitis A is a liver disease common in many parts of the world and caused by hepatitis A virus (HAV), a picornavirus that causes acute inflammation of the liver. It is not related to the common viruses that cause hepatitis B or C.

Illness caused by HAV infection cannot be distinguished from other types of acute viral hepatitis, but it typically has an abrupt onset that can include fever, malaise, anorexia, nausea, abdominal discomfort, dark urine, and jaundice. The likelihood of having symptoms with HAV infection is related to age. In children younger than age 6 years, 70&percnt; of infections are asymptomatic. When illness does occur in young children, it is typically not accompanied by jaundice. In older children and adults, infection typically is symptomatic, with jaundice occurring in more than 70&percnt; of patients.

Hepatitis A signs and symptoms usually resolve in 2-3 months, although 10&percnt; to 15&percnt; of symptomatic people have prolonged illness (usually referred to as relapsing hepatitis A) lasting up to 6 months and should be considered infectious during that time.

Person-to-person spread through the fecal-oral route is the primary means of HAV transmission. Peak infectivity in infected people occurs during the two week period before the onset of jaundice when the concentration of virus in the stool is highest and most people are no longer infectious one week after jaundice onset. Before routine vaccination of children was recommended, children were a key source of infection because most infected children had no symptoms and could shed virus in stool for weeks or months. Transmission currently occurs primarily among susceptible adults.

Common-source outbreaks and sporadic cases can occur from exposure to fecally-contaminated food or water. Uncooked HAV-contaminated foods have been recognized as a source of outbreaks. Cooked foods also can transmit HAV if the temperature during food preparation is inadequate to kill the virus or if food is contaminated after cooking, as occurs in outbreaks associated with infected food handlers. Transmission of the virus from infected food handlers to food service establishment patrons is rare, accounting for 0.2&percnt; of the nearly 23,000 outbreak-associated cases of hepatitis A investigated by state health departments during 2016-2019.

Until 2017, US incidence rates of hepatitis A were driven by occasional outbreaks, often linked to viral contamination of imported food. Since 2017, communitywide outbreaks have occurred more frequently, predominantly among people who are connected by specific risk factors, such as drug use, and their close contacts.

HAV can produce either asymptomatic or symptomatic infection in humans after an average incubation period of 28 days (range: 15-50 days).

In infected people, HAV replicates in the liver, is excreted in bile, and is shed in stool. Peak infectivity occurs during the 2-week period before onset of jaundice or elevation of liver enzymes, when concentration of virus in stool is highest. Concentration of virus in stool declines after jaundice appears, with most people no longer infectious about a week after jaundice appears. Children can shed HAV for longer periods than adults, up to 10 weeks or longer after onset of clinical illness.

The incidence of hepatitis A in the US increased more than 10-fold from 2015 to 2019, with over 18,800 cases reported to CDC in 2019. This number is an underestimate of the actual number of infections: CDC estimates that about 37,700 cases actually occurred in 2019.

Yes. Death as a result of fulminant hepatic failure is rare, however, older age (over 40 years) and preexisting chronic liver disease increases the risk of severe disease and death from hepatitis A. The person-to-person U.S. multistate outbreaks that began in 2016 have disproportionately affected adults with chronic liver disease and other health problems related to drug use and unstable housing. From 2016 through November 2021, CDC received reports of nearly 43,000 cases of acute HAV infection. Of these, approximately 61&percnt; have been hospitalized and 1&percnt; (more than 400 people) have died.

Who is most at risk for acquiring HAV infection?

People who are at increased risk for acquiring HAV infection include the following:

People with clotting factor disorders were originally recommended to receive hepatitis A vaccine (HepA) in 1996. At that time, the process used to make clotting factor supplements did not reliably inactivate hepatitis A viruses and recipients of these products had an increased risk of HAV infection. Modern blood donor screening and virus reduction steps have drastically reduced that risk. In addition, more than 80&percnt; of people with clotting factor disorders now receive recombinant clotting factor concentrates that are sterilized and have no risk of HAV transmission. As a result of these factors, people with clotting factor disorders now have no greater risk of hepatitis A than the general population and are no longer recommended to receive HepA vaccine unless it is otherwise indicated.

Historically, HAV infection was highly endemic in institutions for people with developmental disabilities as a result of poor hand hygiene, close living conditions and diaper use. As fewer children have been institutionalized and as conditions in institutions have improved, the incidence and prevalence of HAV infection have decreased, although outbreaks can occur in these settings. All children with developmental disabilities should receive HepA according to U.S. routine vaccine recommendations, including catch up vaccination of all children through age 18 years.

As a strategy to further reduce the risk of hepatitis A outbreaks and reach adults in settings with a high proportion of people with risk factors for HAV infection, the current ACIP recommendations suggest considering HepA vaccination of residents and staff in facilities where hygiene is difficult to maintain, such as group homes for people with developmental disabilities and homeless shelters.

No. People with chronic liver disease are not at increased risk for acquiring HAV infection. However, they are at an increased risk for life-threatening, fulminant (severe and sudden) hepatitis if they become infected with hepatitis A. People considered to have chronic liver disease include those with hepatitis B or C infection, cirrhosis, fatty liver disease, alcoholic liver disease, and autoimmune hepatitis.

Hepatitis A cannot be differentiated from other types of viral hepatitis on the basis of clinical or epidemiological features alone. Appropriate blood tests must be used.

Yes. On rare occasions, HAV infection has been transmitted by transfusion of blood or blood products collected from donors during the viremic phase of their infection (i.e., when HAV is in the donor's blood). Since 2002, tests to detect the presence of hepatitis A virus RNA in donated plasma have drastically reduced the risk of hepatitis A transmission from products derived from blood plasma.

In experimentally infected nonhuman primates, HAV has been detected in saliva during the incubation period; however, transmission by human saliva has not been reported.

Hospital-acquired HAV infection is rare. In the past, outbreaks were observed in neonatal intensive care units when infants acquired infection from HAV-infected transfused blood and subsequently transmitted HAV to other infants and staff. Outbreaks of hepatitis A caused by transmission from adult patients to healthcare personnel (HCP) are typically associated with fecal incontinence and inadequate hand hygiene, although the majority of hospitalized patients who have hepatitis A are admitted after onset of jaundice, when they are beyond the point of peak infectivity. Transmission in healthcare settings also has resulted from breakdowns in standard infection control practices and transmission from one healthcare provider to another.

Depending on conditions, HAV can be stable in the environment for months; freezing does not inactivate (i.e., render non-infectious) HAV. HAV is inactivated by heating foods to temperatures greater than 185°F (85°C) for 1 minute. In addition, HAV on surfaces is inactivated by disinfecting surfaces with a 1:100 dilution of sodium hypochlorite (i.e., household bleach) in tap water.

Adequately chlorinating water through water treatment processes and dilution in public water systems kills HAV. Spas and swimming pools that are adequately treated are not likely to pose a risk for HAV outbreaks.

No, there is no chronic (long-term) infection. Even the small proportion of people who develop relapsing HAV recover after about 6 months. Once you have had HAV infection and recovered, you cannot get it again.

Vaccination with the full series of hepatitis A vaccine (HepA) is the best way to prevent HAV infection. Immune globulin (IG) also can be used for short-term protection in certain situations.

Recommended dosages and schedules of hepatitis A vaccines

Vaccine
Age group Dose Volume # Doses Schedule

*El.U. = Elisa Units **U = Units

Combination vaccine using hepatitis A and hepatitis B vaccines

Vaccine
Age group Antigens used Volume # Doses Schedule

4
0, 7, 21-30 days, 12 months***

*** Accelerated schedule may be used for rapid protection prior to travel or for rapid protection of an unexposed but at-risk person who also would benefit from hepatitis B protection. Twinrix is not recommended for use as post-exposure prophylaxis.

Yes, a number of studies indicate that the two brands of HepA, Havrix (GSK) and Vaqta (Merck), are interchangeable.

The Advisory Committee on Immunization Practices (ACIP) recommends routine HepA vaccination for the following groups:

HepA vaccination is not routinely recommended for healthcare personnel, food handlers, sewage workers, or day care providers because there is no evidence that their occupational risks of HAV exposure are significantly higher than the general population. However, any person who desires protection from HAV infection may be vaccinated.

Yes, unless the person is allergic to any of the vaccine components. HepA vaccination is safe and effective and is recommended for any person who wishes to obtain immunity.

No. The minimum interval between dose #1 and #2 of HepA vaccine is 6 calendar months, not 24 weeks.

Yes. The second dose was given more than 4 days before the minimum interval of 6 calendar months, so it is considered invalid and should be repeated. The repeat dose should be administered the proper minimum interval (6 months) after the invalid dose. If this repeat dose is inadvertently given less than 6 months after the invalid dose, it does not need to be repeated again as long as the interval between the initial HepA vaccine and the most recent dose is at least 6 calendar months.

Healthy people who have completed the HepA vaccination series at any time do not need additional PEP if they are exposed to HAV. People who have recently been exposed to HAV and who have not received HepA vaccine previously should receive PEP as soon as possible, within 2 weeks of exposure.

People age 12 months and older exposed to HAV within the past 14 days and who have not previously completed the HepA vaccine series should receive a single dose of HepA vaccine as soon as possible. In addition to vaccine, immune globulin (IG; 0.1 mL/kg) may be administered to people older than age 40 years depending on the providers' risk assessment. For long-term immunity, the HepA vaccine series should be completed with a second dose at least 6 months after the first dose. However, the second dose is not necessary for PEP. A second dose should not be administered sooner than 6 calendar months after the first dose, regardless of HAV exposure risk.

People age 12 months or older who are immunocompromised or have chronic liver disease, and who have been exposed to HAV within the past 14 days and have not previously completed the HepA vaccination series, should receive both IG (0.1 mL/kg) and HepA vaccine at the same visit in a different anatomic site (for example, separate limbs) as soon as possible after exposure. For long-term immunity, the HepA vaccination series should be completed with a second dose at least 6 months after the first dose. However, the second dose is not necessary for PEP. A second dose should not be administered sooner than 6 calendar months after the first dose, regardless of HAV exposure risk.

People with HIV infection develop protective levels of antibody more slowly and are less likely to develop protective antibody levels after vaccination with HepA, especially if their CD4+ count is low at the time of vaccination. Protection following vaccination of a person with HIV may wane over time. Vaccine should be administered if the exposed individual is not fully vaccinated; however, CDC also advises clinicians to consider administering IG PEP to an individual with HIV after a high-risk exposure (such as a household or sexual contact) even if the individual has been fully vaccinated.

Twinrix contains half the amount of hepatitis A antigen as a standard single-dose adult HepA vaccine. Twinrix should not be used for PEP but may be used to confer protection to at-risk but not yet exposed persons during an outbreak.

Infants younger than age 12 months and persons for whom vaccine is contraindicated should receive IG (0.1 mL/kg) instead of HepA vaccine as soon as possible and within 2 weeks of exposure. MMR and varicella vaccines should not be administered sooner than 6 months after IG administration in order to avoid possible IG interference with the effectiveness of MMR and varicella vaccines.

Prevaccination serologic testing for HAV (measuring either total anti-HAV or IgG anti-HAV) is not indicated for children because of the low prevalence of infection in children. It also is not routinely recommended for adults but may be considered in some settings to reduce costs associated with vaccinating people who are already immune. Prevaccination testing should not be used if it poses a barrier to vaccinating susceptible people, especially people who are difficult to access.

Prevaccination testing is most likely to be cost-effective for adults who were either born in or lived for long periods of time in areas of the world with high or intermediate hepatitis A endemicity. When evaluating people from populations with high rates of previous HAV infection, vaccination history also should be obtained, if feasible. If testing or vaccination history is not available, do not postpone vaccinating. There is no harm in vaccinating a person who has had natural infection or previous doses of vaccine.

Serologic testing for immunity is not necessary after routine vaccination of infants, children or adults. Testing for the presence of anti-HAV antibody one month or more after completing the HepA vaccination series is recommended only for people whose future clinical management depends on knowing their immune status and for whom revaccination might be indicated, such as people living with HIV and other immunocompromised persons (such as transplant recipients and people vaccinated while receiving chemotherapy). In such individuals, if the results of postvaccination testing do not show an adequate immune response (10 mIU/mL or higher), revaccination with a complete series is recommended, followed by a second postvaccination serologic test. If that second test remains negative, no additional vaccination is recommended; however, the patient should be counseled on strategies to avoid exposure to HAV and the need for IG if an exposure occurs. If vaccination results in seroconversion, insufficient data are available to make recommendations concerning repeat testing, booster doses or revaccination.

ACIP recommends vaccination against HAV infection for all previously unvaccinated people who anticipate having close personal contact with an international adoptee from a country of high or intermediate endemicity during the first 60 days following the adoptee's arrival in the U.S. In addition to the adoptee's new parents and siblings, this group might include grandparents, other household members, regular babysitters and other caregivers. The first dose of HepA should be given to close contacts as soon as adoption is planned, ideally at least 2 weeks before the arrival of the adoptee. A second dose should be given no sooner than 6 months after the first dose.

The 2020 ACIP recommendations for the prevention of hepatitis A define a person experiencing homelessness as 1) a person who lacks housing (regardless of whether the person is a member of a family), including a person whose primary residence during the night is a supervised public or private facility (e.g., shelter) that provides temporary living accommodations and a person who is a resident in transitional housing, 2) a person without permanent housing who might: live on the streets, stay in a shelter, mission, single-room occupancy facility, abandoned building, vehicle, or any other unstable or nonpermanent situation, or 3) who is "doubled up", a term that refers to a situation where persons are unable to maintain their housing situation and are forced to stay with a series of friends or extended family members. In addition, previously homeless persons who are to be released from a prison or a hospital might be considered homeless if they do not have a stable housing situation to which they can return. The instability of a person's living arrangements is critical to the definition of homelessness.

While a complete series of HepA is recommended for long-term protection, even a single dose of HepA vaccine has been demonstrated to provide protection against hepatitis A for more than 10 years and can prevent or control outbreaks of hepatitis A. People who are experiencing homelessness may have difficulty protecting themselves from exposure to HAV in other ways because of their living conditions. They should be vaccinated when possible and provided a record of immunization. Reporting the HepA vaccination to a state immunization information system also can facilitate immunization assessment at future healthcare encounters.

No. A number of studies have shown that HCP are not at significantly increased risk of HAV infection because of their occupation. However, if HCPs are going to work (or vacation) in a country with a high or intermediate endemic rate of HAV infection, they are at risk of HAV infection and should be vaccinated. The only occupational indications for routine HepA vaccination are work with non-human primates or live HAV in a laboratory setting.

No. In the past, outbreaks of hepatitis A occurred among children in child care centers, infecting employees of those centers, especially those caring for infants and toddlers. Following widespread adoption of early childhood vaccination against hepatitis A, outbreaks in child care centers are now rare.

Although not at increased risk for HAV infection, people with chronic liver disease are at increased risk for fulminant hepatitis A, hospitalization and death if they become infected with HAV. For this reason, hepatitis A vaccination is recommended for them.

In published reports of three serologic surveys conducted among United States wastewater workers and appropriate comparison populations, no substantial or consistent increase in the prevalence of anti-HAV was identified among wastewater workers. No work-related instances of HAV transmission have been reported among wastewater workers in the United States. In addition, in the United States, outbreaks of hepatitis A caused by flooding, which can carry raw sewage, have not been reported.

People with clotting factor disorders were originally recommended to receive hepatitis A vaccine (HepA) in 1996. At that time, the process used to make clotting factor supplements did not reliably inactivate hepatitis A viruses and recipients of these products had an increased risk of HAV infection. Modern blood donor screening and virus reduction steps have drastically reduced that risk. In addition, more than 80&percnt; of people with clotting factor disorders now receive recombinant clotting factor concentrates that are sterilized and have no risk of HAV transmission. As a result of these factors, people with clotting factor disorders now have no greater risk of hepatitis A than the general population and are no longer recommended to receive HepA vaccine unless it is otherwise indicated.

Because of measles. Measles is highly communicable and poses a serious threat to the health of unvaccinated infants. For this reason, all infants age 6 through 11 months who travel internationally are recommended to receive a dose of measles, mumps, and rubella vaccine (MMR) to reduce the risk of measles infection during travel.

The antibodies in immune globulin (IG) typically used to prevent HAV infection in infants before the first birthday can interfere with the effectiveness of MMR vaccine. An infant who is given IG should not be vaccinated with MMR or varicella vaccines for at least 6 months after IG administration. If an infant age 6 through 11 months is traveling to a destination where protection from infection with HAV is desired, ACIP recommends off-label use of HepA vaccine (not IG) in addition to MMR. The HepA and MMR doses administered before the first birthday do not count toward the routine vaccination series of either vaccine: these infant travelers will still need two doses of HepA and two doses of MMR when age appropriate.

Hepatitis A vaccine (HepA) should be administered intramuscularly (IM), using the appropriate injection site and needle size as determined by the patient's age and body mass.

Yes. Other inactivated and/or live virus vaccines can be administered at the same time as HepA vaccine, but should be given at a different anatomical site, if possible. If given in the same muscle, separate the injections by a minimum distance of 1 inch.

Yes, VFC-supported HepA vaccine is available for children 12 months through 18 years who are VFC-eligible. In addition, combination HepA and HepB vaccine (Twinrix; GSK) is also available for people who are age 18 years who are VFC-eligible.

You do not need to start the series over again. The immunogenicity of 1 dose of HepA vaccine is 94&percnt; to 100&percnt;; studies have shown persistent protection from a single dose lasting more than 10 years. To ensure optimal long-term protection it is important to administer the second dose.

A person should receive the dosage of HepA vaccine appropriate for their age at the time of administration. You should give the patient one adult dose of HepA to complete the 2-dose series. It is not necessary to restart the vaccine series.

In general, if the error is discovered on the same clinic day, you can administer the other "half" of the dose on that same day. If the error is discovered later, the dose should not be counted, and then the person should be recalled to the office and given a full age-appropriate repeat dose.

If you give more than an age-appropriate dose (for example, an adult dose of HepA vaccine given to a child), count the dose as valid and notify the patient/parent about the error. There may be an increased risk of a local adverse reaction when more than the recommended dose is given. If the error occurred with the first dose of the series the child should still receive the second dose on schedule. Giving a "double" dose for the first dose does not negate the need for a second dose.

Avoid such errors by checking the vaccine vial label 3 times.

The efficacy data from the clinical trials were based on age at time of vaccination, and not on the weight of the individual. Hence, the dosage recommendations reflect this age-based efficacy data. The same holds true for HepB vaccine. In addition, higher response rates are expected in younger people, even if their weights are above the norm.

Twinrix (GSK) is an inactivated combination vaccine containing both hepatitis A virus (HAV) and hepatitis B virus (HBV) antigens. The vaccine contains 720 EL.U. of hepatitis A antigen (half of the Havrix adult dose) and 20 mcg of hepatitis B antigen (the full Engerix-B adult dose).

In the U.S., Twinrix is licensed for use in people who are age 18 years or older. It can be administered to people who are at risk for both hepatitis A and hepatitis B, such as certain international travelers, people with HIV infection, people with chronic liver disease not caused by hepatitis B, men who have sex with men, illegal drug users, or to people who simply want to be immune to both diseases. Primary immunization consists of 3 doses given intramuscularly on a 0, 1, and 6 month schedule. In 2007, the FDA also approved a 4-dose schedule for Twinrix. It consists of 3 doses given within 4 weeks, followed by a booster dose at 12 months (0, 7 days, 21-30 days, and 12 months). The 4-dose schedule could benefit individuals needing rapid protection from hepatitis A and hepatitis B, such as people traveling to high-prevalence areas imminently.

Twinrix cannot be used for postexposure prophylaxis.

Twinrix is licensed as a 3-dose series for people age 18 years and older. If Twinrix is not available or if you choose not to use Twinrix to complete the Twinrix series, you should do the following: If 1 dose of Twinrix was given, complete the series with 2 adult doses of hepatitis B vaccine and 2 adult doses of hepatitis A vaccine. If 2 doses of Twinrix were given, complete the schedule with 1 adult dose of hepatitis A vaccine and 1 adult dose of hepatitis B vaccine.

Another way to consider this is as follows:

A dose of Twinrix contains a standard adult dose of hepatitis B vaccine and a pediatric dose of hepatitis A vaccine. Thus, a dose of Twinrix can be substituted for any dose of the hepatitis B series but not for any dose of the hepatitis A series.

No. Twinrix contains 50&percnt; less hepatitis A antigen component than Havrix, GSK's monovalent hepatitis A vaccine [720 vs. 1440 El. U.], so the patient would not receive the recommended dose of hepatitis A vaccine antigen. For this reason, 3 doses of Twinrix must comprise the series.

Immune globulin (IG, GamaSTAN, Grifols Therapeutics) is a sterile preparation of concentrated antibodies (i.e., immunoglobulins) made from pooled human plasma processed by cold ethanol fractionation. GamaSTAN is the only IG product licensed in the United States for the prevention of hepatitis A. Only plasma that has tested negative for hepatitis B surface antigen, antibody to human immunodeficiency virus (HIV), and antibody to hepatitis C virus (HCV) is used to produce IG. In addition, the Food and Drug Administration requires that the process used to produce IG include a viral inactivation step or that final products test negative for HCV-RNA by polymerase chain reaction. Anti-HAV concentrations differ among IG lots and decreasing concentrations have been observed over the past 30 years, probably because of the decreasing prevalence of previous HAV infection among plasma donors. In 2017, the dosing of GamaSTAN for HAV prevention was increased to reflect this change in anti-HAV potency.

IG provides protection against HAV infection through passive transfer of antibody. Depending on the IG dosage, protection lasts from 1 to 2 months.

When administered for preexposure prophylaxis, a dose of 0.1 mL/kg will provide protection for up to 1 month and a dose of 0.2 mL/kg will provide protection for up to 2 months. If longer term protection is required and vaccination is contraindicated, a dose of 0.2 mL/kg can be repeated every 2 months. There is no maximum number of times the bimonthly doses of IG may be repeated as long as hepatitis A prophylaxis is required.

For postexposure prophylaxis, the recommended dosage is 0.1 mL/kg.

Intramuscular IG is available in single-use vials (2 mL and 10 mL). It should be administered intramuscularly, preferably in the anterolateral aspects of the upper thigh and the deltoid muscle of the upper arm. Do not use the gluteal region as an injection site because of the risk of injury to the sciatic nerve.

Serious adverse events from GamaSTAN IG are rare. Anaphylaxis has been reported after repeated administration to people with known immunoglobulin A (IgA) deficiency; thus, IG should not be administered to these people. IG products including GamaSTAN have been associated with the formation of blood clots (thrombosis) after administration, particularly if the patient has other risk factors for thrombosis. Patients should be counseled about this risk.

Yes. Pregnancy or lactation is not a contraindication to IG administration if clearly needed.

Yes. IG may be given any time before or after inactivated vaccines. However, the antibodies in IG may interfere with the effectiveness of certain live-virus vaccines, such as measles, mumps, and rubella (MMR) and varicella vaccines. CDC recommends waiting at least 6 months from the date of IG administration before administering MMR and varicella vaccines.

Below is a brief summary of the recommendations:

Preexposure prophylaxis with IG for travel to areas of intermediate or high hepatitis A endemicity:

Postexposure prophylaxis with IG within 2 weeks after exposure to hepatitis A virus (HAV):

Healthy people age 12 months through 40 years who are planning travel to an area with high or intermediate HAV endemicity and have not received HepA vaccine should receive a single dose of HepA vaccine as soon as travel is considered and should complete the 2-does series according to the routine schedule.

People with chronic liver disease as well as adults older than 40 years of age, immunocompromised persons, and persons with other chronic medical conditions planning to depart to an area with high or intermediate HAV endemicity in less than 2 weeks should receive the initial dose of HepA vaccine and may also simultaneously be administered IG at a separate anatomic injection site (for example in separate limbs).

ACIP revised its recommendations for preexposure hepatitis A vaccination for travelers in 2018 to include vaccination of infants 6 through 11 months of age. All infants of this age traveling internationally should be given a dose of measles, mumps, rubella vaccine (MMR) before travel. Due to the potential interference of hepatitis A immune globulin (IG) with MMR vaccine effectiveness, an off-label dose of HepA vaccine is recommended instead of IG in this situation. The travel-related dose for infants 6-11 months of age should not be counted toward the routine 2-dose series. The routine 2-dose HepA and MMR vaccination series should be initiated at age 12 months according to the routine, age-appropriate vaccination schedule.

Infants younger than 6 months and travelers who elect not to receive vaccine or for whom vaccine is contraindicated should receive a single 0.1 mL/kg dose of IG before travel when protection against HAV is recommended. If travel is for more than 1 month, a dose of 0.2 mL/kg should be administered. A 0.2 mL/kg dose can be repeated every 2 months for travel of more than 2 months duration.

Yes. If time allows, use the standard Twinrix schedule of 3 doses given intramuscularly on a 0, 1, and 6 month schedule. If travel is imminent the accelerated 4-dose Twinrix schedule can be used, which is 3 doses given on days 0, 7, and 21-30 days and a booster dose at 12 months.

No. There is no recommendation for a booster dose of HepA if a patient has completed the 2-dose series at any age.

Yes. Data have shown that people acquire HAV infection even in such places as 4-star hotels located in Latin America.

No. Just give the final dose of HepA vaccine prior to travel.

Possibly. Since IG protects against HAV infection for only 1 to 2 months, depending on the dosage given, additional IG may be needed if the infant is not yet age 6 months. Once the child has reached six months of age, HepA vaccine should be given.

Yes. ACIP recommends that all children age 1 year through 18 years should be vaccinated against hepatitis A. VFC HepA vaccine may be administered to any eligible child, including those recommended for vaccination at 6 through 11 months of age as a result of travel to an HAV-endemic area.

It depends on whether that person has a history of HAV infection. Unless there are medical records that document prior HAV infection, serologic testing for immunity (positive test for total anti-HAV) is the only way to determine if vaccination is necessary. For people from countries with high rates of HAV infection, such as Vietnam and Mexico, serologic testing might be done to prevent unnecessary vaccination. The cost effectiveness of serologic testing, however, should be balanced against the possibility of delaying needed vaccination while awaiting test results.

No, as long as there are medical records that document that the person was previously infected with HAV (i.e., positive test for total anti-HAV). If there is any doubt that the person actually was infected with HAV, HepA vaccine and/or IG should be given. The vaccine or IG will not harm a person who is already immune.

No serious adverse events have been attributed definitively to HepA vaccine. Among adults, the most frequently reported side effects are soreness at the site of the injection and headache. In children, the most frequently reported side effect is soreness at the injection site. The frequency of side effects after administration of Twinrix is similar to those reported when the two single-antigen vaccines were administered.

Hepatitis A vaccine is contraindicated for people with a history of a severe allergic reaction to a previous dose of HepA vaccine or to a vaccine component. As with all other vaccines, there is a precaution when giving it to anyone who is moderately or severely ill.

Yes. HepA vaccine is an inactivated vaccine and poses no harm to the nursing infant.

Yes. All people age 1 year or older living with HIV infection should be vaccinated against hepatitis A if they have not been vaccinated, regardless of their CD4+ count.

If any immunocompromised person has a risk factor that places them at increased risk of hepatitis A (e.g., international travel, drug use), they should be vaccinated with HepA vaccine.

Yes. HepA vaccine should be given to all susceptible patients with chronic liver disease. HepA vaccine is very immunogenic.

Vaccine Storage and Handling

All hepatitis A-containing vaccine should be stored at refrigerator temperature at 2°C to 8°C (36°F to 46°F). The vaccine must not be frozen. Any vaccine exposed to freezing temperature should not be used. Do not use these or any other vaccines after the expiration date shown on the packaging. Any vaccine administered after its expiration date is not valid and should be repeated.

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Hepatitis A Disease Issues Hepatitis A is a liver disease common in many parts of the world and caused by hepatitis A virus (HAV), a picornavirus that causes acute inflammation of the liver. It is not related to the common viruses that cause hepatitis B or C.

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5 page FAQ document on Hep A and the vaccine for patients. Appropriate for moderate health literacy levels.

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A very basic one-pager on the transmission of Hep A, risk factors for children, and vaccine recommendations. Appropriate for low health literacy levels.

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CDC Hep A Vaccine Information Statement.

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CDC Hep A Vaccine Information Statement.

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Provides a basic overview of the vaccine, why it's important and who should get it. Appropriate for a moderate to high health literacy level.

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A 2-page document that provides answers to FAQs. Appropriate for moderate to high health literacy levels.

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'Learn about rotavirus, for your baby's sake' Handout

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'Learn about rotavirus, for your baby's sake' Handout

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This is a 2-page handout for parents produced by Merck. It is appropriate patients with a moderate level of health literacy.

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Provides information on disease issues, vaccine recommendations, schedule and administering the vaccine, contraindications and precautions, vaccine safety, and storage and handling

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Before rotavirus vaccines were available, rotavirus was the most common cause of severe gastroenteritis in infants and young children in the United States and worldwide. Almost all children were infected by age 5 years. Before vaccine was introduced in the United States, rotavirus was responsible each year for about 3 million episodes of gastroenteritis, 410,000 physician visits, 205,000–272,000 emergency department visits, 55,000–70,000 hospitalizations, and between 20 and 60 deaths among children younger than age 5 years.

Rotavirus is contagious and the infection is usually spread from person to person, through the fecal-oral route. Fecal-oral transmission occurs when bacteria or viruses found in the stool of one person are swallowed by another person. This can occur when small amounts of fecal matter may be found on surfaces such as toys, books, clothing, etc. and on the hands of parents or child-care providers; but are usually invisible. Rotavirus may also be transmitted through intake of fecally-contaminated water or food or by respiratory droplets that people sneeze, cough, drip, or exhale. Rates of the illness among children in developed and less developed countries are similar.

Two rotavirus vaccines are available in the United States. RotaTeq (RV5; Merck) is recommended for routine oral administration for all infants as a 3-dose series. The usual schedule is at ages 2, 4, and 6 months. Rotarix (RV1; GlaxoSmithKline) is recommended as a 2-dose series at ages 2 and 4 months.

The minimum interval between doses of rotavirus vaccine is 4 weeks. The minimum age for the first dose is 6 weeks and the maximum age for dose #1 is 14 weeks 6 days. Vaccination should not be initiated for infants age 15 weeks 0 days or older because there are insufficient data on the safety of dose #1 in older infants. The maximum age for the last dose of rotavirus vaccine is 8 months and 0 days.

The two rotavirus vaccine products differ in composition and schedule of administration. RotaTeq was approved by the Food and Drug Administration (FDA) in 2006. It contains five reassortant rotaviruses developed from human and bovine parent rotavirus strains; 3 doses are given in the series. Rotarix was approved by the FDA in 2008 and contains an attenuated human rotavirus strain; 2 doses are given in the series.

ACIP recommendations and package inserts do not always match. Occasionally, ACIP may use different data to formulate its recommendations, or try to add flexibility to its recommendations (as was the case in this situation), which results in a recommendation different than the package insert. Published recommendations of national advisory groups (such as ACIP or AAP's Committee on Infectious Diseases) should be considered equally as authoritative as those on the package insert. You should consider 8 months 0 days as the maximum age for a dose of rotavirus vaccine.

ACIP recommends that the rotavirus vaccine series be completed with the same product whenever possible. However, vaccination should not be deferred because the product used for a previous dose is not available or is unknown. In these situations, the provider should continue or complete the series with the product available. If any dose in the series was RotaTeq, or the vaccine product is unknown for any dose in the series, a total of 3 doses of rotavirus vaccine should be administered. The minimum interval between doses of rotavirus vaccine is 4 weeks. All doses should be administered by age 8 months and 0 days.

ACIP recommends that infants who have had rotavirus gastroenteritis before receiving the full series of rotavirus vaccination should still start or complete the schedule according to the age and interval recommendations because the initial rotavirus infection might provide only partial protection against subsequent rotavirus disease.

ACIP supports vaccination of preterm infants according to the same schedule and precautions as full-term infants and under the following conditions: if the infant's chronological age meets the age requirements for rotavirus vaccine (for example, age 6 weeks to 14 weeks 6 days for dose #1), the infant is clinically stable, and the vaccine is administered at the time of discharge from the hospital or after discharge from the hospital.

If the product used for a previous dose is unknown, and the infant is at an age when the vaccine can still be given, give a total of 3 doses of rotavirus vaccine. All doses should be administered by age 8 months and 0 days.

Infants for whom the first dose of rotavirus vaccine was inadvertently administered at age 15 weeks or older should receive the remaining doses of the series at the routinely recommended intervals. Timing of the first dose should not affect the safety and efficacy of the remaining doses. Rotavirus vaccine should not be given after age 8 months 0 days even if the series is incomplete.

Try to follow general guidelines for oral administration of liquid vaccines. First, give this vaccine at the beginning of the office visit, while the baby is still happy, and before you administer injections or perform other procedures. Second, make every effort to aim the dropper containing the vaccine down one side and toward the back of the child's mouth. Don't put the dropper so far back that you gag the child. You may find the following information from the RotaTeq manufacturer helpful: www.merckvaccines.com/Products/RotaTeq/Pages/dosageandadministration. You can also find a pictorial description of both reconstitution and administration of Rotarix at www.gsksource.com/pharma/content/gsk/source/us/en/brands/rotarix/pi/dosing.html.

The manufacturer has not addressed this issue but CDC considers administration of rotavirus vaccine via gastrostomy tube to be acceptable practice. There should be no problem flushing the tube after vaccine has been administered.

Yes. The effectiveness concerns with antibody-containing blood products (ACBP) do not apply to rotavirus vaccine, since it is administered orally and replication of the vaccine virus occurs in the GI tract, "separate" from the site of the ACBP. Note that the child should be carefully screened for other potential contraindications or precautions to vaccination since administration of immune globulin could indicate immunosuppression.

Yes. Rotavirus vaccine virus is shed during the first weeks after administration of rotavirus vaccine. Handwashing after diaper changing is always recommended.

Do not give rotavirus vaccine to an infant who has a history of a severe allergic reaction (for example, anaphylaxis) after a previous dose of rotavirus vaccine or to a vaccine component. The oral applicator for Rotarix contains natural latex rubber so infants with a severe (anaphylactic) allergy to latex should not be given Rotarix; the RotaTeq (Merck) dosing tube is latex-free. Rotavirus vaccine is contraindicated in infants with the rare disorder severe combined immunodeficiency (SCID) and in infants with a history of intussusception.

Practitioners should consider the potential risks and benefits of administering rotavirus vaccine to infants with known or suspected altered immunocompetence, including those whose mothers received immunosuppressive biologics (such as infliximab) during pregnancy. Consultation with an immunologist or infectious diseases specialist is advised.

Children and adults who are immunocompromised because of congenital immunodeficiency, hematopoietic transplantation, or solid organ transplantation sometimes experience severe or prolonged rotavirus gastroenteritis. However, few safety or efficacy data are available for the administration of rotavirus vaccine to infants who are immunocompromised or potentially immunocompromised, including 1) infants with primary and acquired immunodeficiency, cellular immunodeficiency, and hypogammaglobulinemia and dysgammaglobulinemia; 2) infants with blood dyscrasias, leukemia, lymphomas, or other malignant neoplasms affecting the bone marrow or lymphatic system; 3) infants on immunosuppressive therapy (including high-dose systemic corticosteroids); and 4) infants who are HIV-exposed or infected.

Infliximab is an IgG monoclonal antibody that neutralizes the biological activity of tumor necrosis factor-alpha. Like other IgG antibodies infliximab crosses the placenta. Infliximab has been detected in the blood of infants up to 6 months following birth. Consequently, these infants may be at increased risk of serious infection.

Neither ACIP nor CDC provides specific guidance on this issue because there are few data on safety or efficacy in children exposed to potentially immunosuppressive biologics during pregnancy. As noted above, practitioners should consider the potential risks and benefits of administering rotavirus vaccine to infants with known or suspected altered immunocompetence. Consultation with an immunologist or infectious diseases specialist is advised.

The manufacturer recommends that live vaccines (rotavirus and BCG) be deferred for at least six months after birth for infants whose mothers received infliximab during pregnancy. Hence, if a practitioner follows the manufacturers recommendation the child would not be eligible to receive rotavirus vaccine because according to ACIP guidelines the rotavirus vaccine series should not to be started after age 15 weeks 0 days.

Inactivated vaccines should be given on schedule.

In the RotaTeq clinical trials in the first week after any dose vaccine recipients had a small but statistically significant increased rate of diarrhea (18.1% in the RotaTeq group, 15.3% in the placebo group) and vomiting (11.6% in the RotaTeq group, 9.9% in the placebo group). During the 42-day period following any dose, statistically significantly greater rates of diarrhea, vomiting, otitis media, nasopharyngitis and bronchospasm occurred in RotaTeq recipients compared with placebo recipients.

In the Rotarix clinical trials, in the first week after vaccination, Grade 3 (i.e., those that prevented normal everyday activities) cough or runny nose occurred at a slightly but statistically higher rate in the Rotarix group (3.6 %) compared with placebo group (3.2%). During the 31 day period after vaccination, these unsolicited adverse events occurred at a statistically higher incidence among vaccine recipients: irritability (11.4% in Rotarix group, 8.7% in placebo group) and flatulence (2.2% in Rotarix group, 1.3% in placebo group).

In clinical trials of both vaccines the occurrence of intussusception was studied very carefully (see next Q&A).

Large pre-licensure clinical trials of both RotaTeq and Rotarix did not find an increased risk for intussusception among vaccine recipients. A large post-licensure study of more than 1.2 million rotavirus vaccine recipients found a very small increased risk of intussusception (1 to 1.5 additional cases of intussusception per 100,000 vaccinated infants) in the 7 to 21 days following the first dose. No increased risk of intussusception was found after the second or third doses. CDC and the Food and Drug Administration (FDA) continue to believe that the benefits of rotavirus vaccination outweigh the risks associated with vaccination and that routine vaccination of infants should continue.

A study conducted by the CDC Vaccine Safety Datalink (VSD) between May 2006 to February 2010 found no increased risk of intussusception following vaccination with RotaTeq. However, the study indicated an increased risk of intussusception following dose 1 and dose 2 of Rotarix. Over 200,000 doses of Rotarix have been given to children monitored in VSD. Based on these findings, one case of intussusception would be expected for approximately each 20,000 children who are fully vaccinated.

Both vaccines should be stored at refrigerator temperature and protected from light. Do not administer the vaccine if it has been frozen or exposed to freezing temperatures.

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Before rotavirus vaccines were available, rotavirus was the most common cause of severe gastroenteritis in infants and young children in the United States and worldwide. Almost all children were infected by age 5 years.

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Patient Education on 10 Vaccine Preventable Chilldhood Diseases

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Patient Education on 10 Vaccine Preventable Chilldhood Diseases

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An overview of 10 vaccine-preventable childhood diseases, including Rotavirus. This document was created by Merck and has a moderate to high level of health literacy.

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Handout for patients that provides a basic overview of the vaccine. The health literacy level is moderate to high.

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CDC Rotavirus Vaccine Information Statement