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Possible Link Between Blood Type and COVID-19 - Hematology.org

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Possible Link Between Blood Type and COVID-19

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Interim Clinical Considerations for Use of mRNA COVID-19 Vaccines Currently Authorized in the United States

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Interim Clinical Considerations for Use of mRNA COVID-19 Vaccines Currently Authorized in the United States

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The Advisory Committee on Immunization Practices (ACIP) has issued interim recommendations for the use of Pfizer-BioNTech and Moderna COVID-19 vaccines for the prevention of coronavirus disease 2019 (COVID-19) in the United States.

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Background

The Advisory Committee on Immunization Practices (ACIP) has issued interim recommendations for the use of Pfizer-BioNTech and Moderna COVID-19 vaccines for the prevention of coronavirus disease 2019 (COVID-19) in the United States. Both vaccines are lipid nanoparticle-formulated, nucleoside-modified mRNA vaccines encoding the prefusion spike glycoprotein of SARS-CoV-2, the virus that causes COVID-19.

These interim CDC clinical considerations are informed by data submitted to the Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of the vaccines, other data sources, general best practice guidelines for immunization, and expert opinion. These considerations for mRNA vaccines only apply to the currently authorized vaccine products in the United States (i.e., Pfizer-BioNTech and Moderna COVID-19 vaccines). Considerations will be updated as 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 and Modernaexternal icon COVID-19 vaccines.

Authorized age groups

Under the EUAs, the following age groups are authorized to receive vaccination:

Pfizer-BioNTech: ages ≥16 years

Moderna: ages ≥18 years

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

Administration

The mRNA COVID-19 vaccine series consist of two doses administered intramuscularly:

Pfizer-BioNTech (30 µg, 0.3 ml each): three weeks (21 days) apart

Moderna (100 µg, 0.5 ml): one month (28 days) apart

Second doses administered within a grace period of ≤4 days from the recommended date for the second dose are considered valid; however, doses administered earlier do not need to be repeated. The second dose should be administered as close to the recommended interval as possible. However, there is no maximum interval between the first and second dose for either vaccine.

Interchangeability with other COVID-19 vaccine products

Either of the currently authorized mRNA COVID-19 vaccines can be used when indicated; ACIP does not state a product preference. However, these mRNA COVID-19 vaccines are not interchangeable with each other or with other COVID-19 vaccine products. 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. However, if two doses of different mRNA COVID-19 vaccine products are inadvertently administered, no additional doses of either product are recommended at this time. Recommendations may be updated as further information becomes available or other vaccine types (e.g., viral vector, protein subunit vaccines) are authorized.

Coadministration with other vaccines

Given the lack of data on the safety and efficacy of mRNA COVID-19 vaccines administered simultaneously with other vaccines, the vaccine series should be administered alone, with a minimum interval of 14 days before or after administration with any other vaccine. If mRNA COVID-19 vaccines are inadvertently administered within 14 days of another vaccine, doses do not need to be repeated for either vaccine.

Booster doses

The need for and timing of booster doses for mRNA COVID-19 vaccines has not been established. No additional doses beyond the two-dose primary series are recommended at this time.

Vaccination of persons with a SARS-CoV-2 infection or exposure
Persons with a current or prior history of SARS-CoV-2 infection
Data from clinical trials indicate that mRNA COVID-19 vaccines are safe in persons with evidence of a prior SARS-CoV-2 infection. Vaccination should be offered to persons regardless of history of prior symptomatic or asymptomatic SARS-CoV-2 infection. Viral testing to assess for acute SARS-CoV-2 infection or serologic testing to assess for prior infection solely for the purposes of vaccine decision-making is not recommended.
Persons who previously received passive antibody therapy
Vaccination of persons 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 criteria have been met for them to discontinue isolation. This recommendation applies to persons who develop SARS-CoV-2 infection before receiving any vaccine doses as well as those who develop SARS-CoV-2 infection after the first dose but before receipt of the second dose. While there is otherwise no recommended minimum interval between infection and vaccination, current evidence suggests that reinfection is uncommon in the 90 days after initial infection. Thus, persons with documented acute SARS-CoV-2 infection in the preceding 90 days may delay vaccination until near the end of this period, if desired.

For vaccinated persons who subsequently develop COVID-19, prior receipt of an mRNA 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.
Vaccinating persons with a known SARS-CoV-2 exposure or during COVID-19 outbreaks
Currently, there are no data on the safety and efficacy of mRNA COVID-19 vaccines in persons who received monoclonal antibodies or convalescent plasma as part of COVID-19 treatment. Based on the estimated half-life of such therapies as well as evidence suggesting that reinfection is uncommon in the 90 days after initial infection, vaccination should be deferred for at least 90 days, as a precautionary measure until additional information becomes available, to avoid interference of the antibody treatment with vaccine-induced immune responses.

For persons receiving antibody therapies not specific to COVID-19 treatment (e.g., intravenous immunoglobulin, RhoGAM), administration of mRNA 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 other antibody therapies (i.e., those that are not specific to COVID-19 treatment) and mRNA COVID-19 vaccination.

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

Persons in the community or outpatient setting 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 other persons to SARS-CoV-2 during the vaccination visit.

Residents with a known COVID-19 exposure living in congregate healthcare settings (e.g., long-term care facilities), where exposure and transmission of SARS-CoV-2 can occur repeatedly for long periods of time, may be vaccinated. In these settings, healthcare personnel are already in close contact with residents (e.g., entering patient rooms for evaluation and treatment). Vaccinators should employ appropriate infection prevention and control procedures.

Residents of other congregate settings (e.g., correctional and detention facilities, homeless shelters) with a known COVID-19 exposure may also be vaccinated, in order to avoid delays and missed opportunities for vaccination given the increased risk for outbreaks in these settings. However, where feasible, precautions should be taken to limit mixing exposed individuals with other residents or staff (except those essential for the provision of vaccination services, who should employ appropriate infection and control procedures).

Persons residing in congregate settings (healthcare and non-healthcare) who have had an exposure and are awaiting results of SARS-CoV-2 testing may be vaccinated if the person does not have symptoms consistent with COVID-19.

In situations where facility-wide testing is being conducted to identify SARS-CoV-2 infections, facilities should attempt to complete facility-wide testing within a period that allows for test results to be received prior to vaccination in order to isolate those patients with SARS-CoV-2 infection. However, it is not necessary to wait for test results if this would create delays in vaccination. In such situations, persons without symptoms consistent with COVID-19 may be vaccinated. Although not contraindicated, vaccination may be deferred pending outcome of testing in persons with symptoms consistent with COVID-19. Viral testing for acute SARS-CoV-2 infection solely for the purposes of vaccine decision-making is not recommended.
Immunocompromised persons
Vaccination of persons with underlying medical conditions

mRNA COVID-19 vaccines may be administered to persons with underlying medical conditions who have no contraindications to vaccination (see 'contraindications' section below). Clinical trials demonstrated similar safety and efficacy profiles in persons with some underlying medical conditions, including those that place them at increased risk for severe COVID-19, compared to persons without comorbidities. Information on groups with specific underlying medical conditions is included below.
Persons with autoimmune conditions
Persons with HIV infection or other immunocompromising conditions, or who take immunosuppressive medications or therapies might be at increased risk for severe COVID-19. Data are not currently available to establish vaccine safety and efficacy in these groups. Persons with stable HIV infection were included in mRNA COVID-19 vaccine clinical trials, though data remain limited. Immunocompromised individuals may receive COVID-19 vaccination if they have no contraindications to vaccination. However, they should be counseled about the unknown vaccine safety profile and effectiveness in immunocompromised populations, as well as the potential for reduced immune responses and the need to continue to follow all current guidance to protect themselves against COVID-19 (see below). Antibody testing is not recommended to assess for immunity to COVID-19 following mRNA COVID-19 vaccination.
Persons with a history of Guillain-Barré syndrome
At this time, re-vaccination is not recommended after immune competence is regained in persons who received mRNA COVID-19 vaccines during chemotherapy or treatment with other immunosuppressive drugs. Recommendations on re-vaccination or additional doses of mRNA COVID-19 vaccines may be updated as additional information is available.
Persons with a history of Bell's palsy
No data are currently available on the safety and efficacy of mRNA COVID-19 vaccines in persons with autoimmune conditions, though these persons were eligible for enrollment in clinical trials. No imbalances were observed in the occurrence of symptoms consistent with autoimmune conditions or inflammatory disorders in clinical trial participants who received an mRNA COVID-19 vaccine compared to placebo. Persons with autoimmune conditions who have no contraindications to vaccination may receive an mRNA COVID-19 vaccine.

To date, no cases of Guillain-Barré syndrome (GBS) have been reported following vaccination among participants in the Pfizer-BioNTech or Moderna COVID-19 vaccines clinical trials. With few exceptions, ACIP's general best practice guidelines for immunization does not include history of GBS as a contraindication or precaution to vaccination. Persons with a history of GBS may receive an mRNA COVID-19 vaccine unless they have a contraindication to vaccination. Any occurrence of GBS following mRNA COVID-19 vaccination should be reported to the Vaccine Adverse Event Reporting System (VAERS).
Pregnant people
Cases of Bell's palsy were reported following vaccination in participants in both the Pfizer-BioNTech and Moderna COVID-19 vaccines clinical trials. However, the FDA does not consider these to be above the frequency expected in the general population and has not concluded that these cases were causally related to vaccination. Post-authorization safety surveillance will be important to further assess any possible causal association. In the absence of such evidence, persons with a history of Bell's palsy may receive an mRNA COVID-19 vaccine unless they have a contraindication to vaccination. Any occurrence of Bell's palsy following mRNA COVID-19 vaccination should be reported to VAERS.

Vaccination of pregnant or lactating people

Observational data demonstrate that while the absolute risk is low, pregnant people with COVID-19 have an increased risk of severe illness, including illness resulting in intensive care admission, mechanical ventilation, or death. Additionally, they might be at an increased risk of adverse pregnancy outcomes, such as preterm birth.

There are currently few data on the safety of COVID-19 vaccines, including mRNA vaccines, in pregnant people. Limited data are currently available from animal developmental and reproductive toxicity studies. No safety concerns were demonstrated in rats that received Moderna COVID-19 vaccine prior to or during gestation in terms of female reproduction, fetal/embryonal development, or postnatal development. Studies in pregnant people are planned and the vaccine manufacturers are following outcomes in people in the clinical trials who became pregnant. Based on current knowledge, experts believe that mRNA vaccines are unlikely to pose a risk to the pregnant person or the fetus because mRNA vaccines are not live vaccines. The mRNA in the vaccine is degraded quickly by normal cellular processes and does not enter the nucleus of the cell. However, the potential risks of mRNA vaccines to the pregnant person and the fetus are unknown because these vaccines have not been studied in pregnant people.

If pregnant people are part of a group that is recommended to receive a COVID-19 vaccine (e.g., healthcare personnel), they may choose to be vaccinated. A conversation between the patient and their clinical team may assist with decisions regarding the use of a mRNA COVID-19 vaccine, though a conversation with a healthcare provider is not required prior to 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 risks of COVID-19 to the patient and potential risks to the fetus, the efficacy of the vaccine, the side effects of the vaccine, and the lack of data about the vaccine during pregnancy.
Lactating people
Side effects can occur with COVID-19 vaccine use in pregnant people, similar to those expected among non-pregnant people. Pregnant people who experience fever following vaccination may be counseled to take acetaminophen as fever has been associated with adverse pregnancy outcomes. Acetaminophen may be offered as an option for pregnant people experiencing other post-vaccination symptoms as well.

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 mRNA COVID-19 vaccination.

There are no data on the safety of COVID-19 vaccines in lactating people or the effects of mRNA COVID-19 vaccines on the breastfed infant or milk production/excretion. mRNA vaccines are not thought to be a risk to the breastfeeding infant. A lactating person who is part of a group recommended to receive a COVID-19 vaccine (e.g., healthcare personnel) may choose to be vaccinated.

Vaccination of children and adolescents

Adolescents aged 16-17 years are included among persons eligible to receive the Pfizer-BioNTech COVID-19 vaccine under the EUA. While vaccine safety and efficacy data in this age group are limited, there are no biologically plausible reasons for safety and efficacy profiles to be different than those observed in persons 18 years of age and older. Adolescents aged 16-17 years who are part of a group recommended to receive a COVID-19 vaccine may be vaccinated with the Pfizer-BioNTech COVID-19 vaccine with appropriate assent. Children and adolescents younger than 16 years of age are not authorized to receive the Pfizer-BioNTech COVID-19 vaccine at this time.
Vaccine efficacy
Children and adolescents younger than 18 years of age are not authorized to receive the Moderna COVID-19 vaccine at this time.
Reactogenicity
Patient counseling

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%]; Moderna: 94.1% [95% CI: 89.3%, 96.8%]). Limited data are currently available regarding the efficacy of a single dose. Patients should be counseled on the importance of completing the two-dose series (of 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 vs. Moderna), age group, and vaccine dose, approximately 80-89% of vaccinated persons develop at least one local symptom and 55-83% develop 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 1-3 days of onset. These symptoms are more frequent and severe following the second dose and among younger persons compared to older persons (i.e., >55 or ≥65 years [for Pfizer-BioNTech or Moderna vaccines, respectively]). Unless persons develop a contraindication to vaccination (see below), they should be encouraged to complete the series even if they develop local or systemic symptoms following the first dose to optimize protection against COVID-19.

In clinical trials, hypersensitivity-related adverse events were observed in 0.63% of participants who received the Pfizer-BioNTech COVID-19 vaccine and 1.5% of participants who received the Moderna COVID-19 vaccine, compared to 0.51% and 1.1%, respectively, in the placebo groups. Anaphylaxis following vaccination was not observed in the Pfizer-BioNTech or Moderna COVID-19 vaccines clinical trials. However, anaphylactic reactions have been reported following receipt of mRNA vaccines outside of clinical trials.
Public health recommendations for vaccinated persons
Antipyretic or analgesic medications (e.g., acetaminophen, non-steroidal anti-inflammatory drugs) may 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, as information on the impact of such use on mRNA COVID-19 vaccine-induced antibody responses is not available at this time.

Infection prevention and control considerations are available for healthcare personnel and long-term care facility residents (e.g., populations included in phase 1a of vaccine allocation) with systemic signs and symptoms following COVID-19 vaccination. Considerations may be updated as additional information becomes available or additional groups are prioritized for vaccine allocation.

Given the currently limited information on how much the mRNA COVID-19 vaccines may reduce transmission in the general population and how long protection lasts, vaccinated persons should continue to follow all current guidance to protect themselves and others. This includes wearing a mask, staying at least 6 feet away from others, avoiding crowds, washing hands often, following CDC travel guidance, following quarantine guidance after an exposure to someone with COVID-19, and following any applicable workplace or school guidance, including guidance related to personal protective equipment use or SARS-CoV-2 testing.

Contraindications and precautions
Contraindications
While rare, anaphylactic reactions have been reported following vaccination with mRNA COVID-19 vaccines. Although investigations are ongoing, persons with a history of an immediate allergic reaction (of any severity) to an mRNA COVID-19 vaccine or any of its components might be at greater risk for anaphylaxis upon re-exposure to either of the currently authorized mRNA COVID-19 vaccines. 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.

Recommendations for contraindications and precautions are described below and summarized in Appendix A. The following recommendations may change as further information becomes available.

CDC considers a history of the following to be a contraindication to vaccination with both the Pfizer-BioNTech and Moderna COVID-19 vaccines:

Severe allergic reaction (e.g., anaphylaxis) after a previous dose of an mRNA COVID-19 vaccine or any of its components

Immediate allergic reaction of any severity to a previous dose of an mRNA COVID-19 vaccine or any of its components (including polyethylene glycol [PEG])*

Immediate allergic reaction of any severity to polysorbate (due to potential cross-reactive hypersensitivity with the vaccine ingredient PEG)*

* These persons should not receive mRNA COVID-19 vaccination at this time unless they have been evaluated by an allergist-immunologist and it is determined that the person can safely receive the vaccine (e.g., under observation, in a setting with advanced medical care available). See Appendix B for more information on ingredients included in mRNA COVID-19 vaccines.
Precautions
Persons with an immediate allergic reaction to the first dose of an mRNA COVID-19 vaccine should not receive additional doses of either of the mRNA COVID-19 vaccines. 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 (which are not contraindications to receiving the second vaccine dose) (Appendix C).

Healthcare personnel or health departments in the United States can request a consultation from the Clinical Immunization Safety Assessment COVIDvax project for a complex COVID-19 vaccine safety question about an individual patient residing in the United States not readily addressed by CDC guidance.
Neither contraindications nor precautions to vaccination
CDC considers a history of any immediate allergic reaction to any other vaccine or injectable therapy (i.e., intramuscular, intravenous, or subcutaneous vaccines or therapies not related to a component of mRNA COVID-19 vaccines or polysorbate) as a precaution but not a contraindication to vaccination for both the Pfizer-BioNTech and Moderna COVID-19 vaccines. These persons should be counseled about the unknown risks of developing a severe allergic reaction and balance these risks against the benefits of vaccination. Deferral of vaccination and/or consultation with an allergist-immunologist may be considered until further information on the risk of anaphylaxis is available. The following considerations can be used to help the provider conduct a risk assessment for mRNA COVID-19 vaccination in these individuals:
Observation periods following vaccination (for persons without contraindications to mRNA COVID-19 vaccines)

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)

Whether the patient has previously been infected with SARS-CoV-2 and, if so, how long ago
Note: Vaccination is recommended for persons with a history of COVID-19; however, because reinfection is uncommon in the 90 days following infection, persons with a precaution to vaccination and recent COVID-19 may choose to defer vaccination until further information is known about the risk of anaphylaxis following vaccination.

The unknown risk of anaphylaxis (including fatal anaphylaxis) following mRNA 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

Allergic reactions (including severe allergic reactions) not related to vaccines, injectable therapies, components of mRNA COVID-19 vaccines (including PEG), or polysorbates, such as 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 vaccination with either mRNA COVID-19 vaccine. The vial stoppers of these mRNA vaccines are not made with natural rubber latex, and there is no contraindication or precaution to vaccination for persons with a latex allergy. In addition, as the mRNA COVID-19 vaccines do not contain eggs or gelatin, persons with allergies to these substances do not have a contraindication or precaution to vaccination.

CDC recommends an observation period following vaccination with mRNA COVID-19 vaccines. Persons with a history of an immediate allergic reaction of any severity to a vaccine or injectable therapy and persons with a history of anaphylaxis due to any cause should be observed for 30 minutes. All other persons should be observed for 15 minutes.

Reporting of vaccine adverse events

Adverse events that occur in a recipient following mRNA COVID-19 vaccination should be reported to VAERS. Vaccination providers are required by the Food and Drug Administration to report the following that occur after mRNA COVID-19 vaccination under Emergency Use Authorization:

Vaccine administration errors

Serious adverse events

Cases of Multisystem Inflammatory Syndrome

Cases of COVID-19 that result in hospitalization or death

Reporting is encouraged for any other clinically significant adverse event even if it is uncertain whether the vaccine caused the event. Information on how to submit a report to VAERS is available at https://vaers.hhs.govexternal icon or by calling 1-800-822-7967.
Interpretation of SARS-CoV-2 test results in vaccinated persons
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.
Interpretation of tuberculosis test results in vaccinated persons
Laboratory testing

Prior receipt of an mRNA COVID-19 vaccine will not affect the results of SARS-CoV-2 viral tests (nucleic acid amplification or antigen tests). Currently available antibody tests for SARS-CoV-2 assess IgM and/or IgG to one of two viral proteins: spike or nucleocapsid. Because both the Pfizer-BioNTech and Moderna COVID-19 vaccines contain mRNA that encodes the spike protein, a positive test for spike protein IgM/IgG could indicate either prior infection or vaccination. To evaluate for evidence of prior infection in an individual with a history of mRNA COVID-19 vaccination, a testexternal icon specifically evaluating IgM/IgG to the nucleocapsid protein should be used. Antibody testing is not currently recommended to assess for immunity to COVID-19 following mRNA COVID-19 vaccination or to assess the need for vaccination in an unvaccinated person.

Inactive vaccines do not interfere with tuberculosis (TB) test results. There is no immunologic reason to believe either a Tuberculin Skin Test (TST) (administered by intradermal placement of 0.1 cc of purified protein derivative) or blood draw for interferon gamma release assay (IGRA) would affect the safety or effectiveness of mRNA COVID-19 vaccines. We have no data to inform the impact of the COVID-19 mRNA vaccines on either TB test for infection (i.e., TST or IGRA).

For healthcare personnel or patients who require baseline TB testing (at onboarding or entry into facilities) at the same time they are to receive an mRNA COVID-19 vaccine:

Perform TB symptom screening on all healthcare personnel or patients.

If utilizing the IGRA, draw blood for interferon gamma release assay prior to COVID-19 vaccination.

If utilizing the TST, place prior to COVID-19 vaccination.

If vaccination has been given and testing needs to be performed, defer TST or IGRA until 4 weeks after COVID-19 vaccine 2-dose completion.
All potential recipients of COVID-19 vaccination should weigh the risks and benefits of delaying TST/IGRA with their providers.

For healthcare personnel who require testing for other reasons:

Perform TB symptom screening on all healthcare personnel

Test for infection should be done before or at the same time as the administration of COVID-19 vaccination. If this is not possible, prioritization of test for TB infection needs to be weighed with the importance of receiving COVID-19 vaccination based on potential COVID-19 exposures and TB risk factors.

Healthcare personnel with high-risk conditions for TB progression should be fully evaluated as soon as possible.

Healthcare personnel without high-risk conditions for TB progression should proceed with contact tracing (i.e., symptom screening, chest radiograph or other imaging, specimen for microbiologic evaluation) but delay test for TB infection (TST or IGRA) if prioritized for receiving COVID-19 vaccination.

All potential recipients of COVID-19 vaccination should weigh the risks and benefits of delaying TST/IGRA with their providers.

Appendix A: Triage of persons presenting for mRNA COVID-19 vaccination

* See Special Populations section for information on patient counseling in these groups

† Refers only to mRNA COVID-19 vaccines currently authorized in the United States (i.e., Pfizer-BioNTech, Moderna COVID-19 vaccines)

‡ 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.

^ See Appendix B for a list of ingredients. Note: Polyethylene glycol (PEG), an ingredient in both mRNA COVID-19 vaccines, is structurally related to polysorbate and cross-reactive hypersensitivity between these compounds may occur. Information on ingredients of a vaccine or medication (including PEG, a PEG derivative, or polysorbates) can be found in the package insert.

# These persons should not receive mRNA COVID-19 vaccination at this time unless they have been evaluated by an allergist-immunologist and it is determined that the person can safely receive the vaccine (e.g., under observation, in a setting with advanced medical care available)

Appendix B: Ingredients included in Pfizer-BioNTech and Moderna mRNA COVID-19 vaccines

An immediate allergic reaction to any component or previous dose of an mRNA COVID-19 vaccine is a contraindication to vaccination with both the Pfizer-BioNTech and Moderna vaccines. The following is a list of ingredients for the Pfizer-BioNTechexternal icon and Modernaexternal icon COVID-19 vaccines, as reported in the prescribing information for each vaccine.

* Neither vaccine contain eggs, gelatin, latex, or preservatives

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 whether a medication contains PEG, a PEG derivative, or polysorbates as either active or inactive ingredients can be found in the package insert. The National Institutes of Health DailyMed databaseexternal icon may also be used as a resource. Medications that contain PEG and/or polysorbate are also described in the supplementary materials of Stone CA, et al. "Immediate hypersensitivity to polyethylene glycols and polysorbates: more common than we have recognized." The Journal of Allergy and Clinical Immunology: In Practice 7.5 (2019): 1533-1540. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6706272/pdf/nihms-1019221.pdfpdf icon external icon

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

In patients who develop 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 mRNA COVID-19 vaccines. The following table of signs and symptoms is meant to serve as a resource but may not be exhaustive, and patients may 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 Pfizer-BioNTech COVID-19 Vaccine | CDC

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The Advisory Committee on Immunization Practices (ACIP) has issued interim recommendations for the use of Pfizer-BioNTech and Moderna COVID-19 vaccines for the prevention of coronavirus disease 2019 (COVID-19) in the United States. Both vaccines are lipid nanoparticle-formulated, nucleoside-modified mRNA vaccines encoding the prefusion spike glycoprotein of SARS-CoV-2, the virus that causes COVID-19.

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Why do you need boosters for the COVID vaccine to work?

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Why do you need boosters for the COVID vaccine to work?

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With the U.S. facing vaccination delays because of worker shortages and distribution problems, federal health officials now say it's OK to push back the second dose of the two-part vaccine by as much as six weeks.

As an infectious disease doctor, I've been fielding a lot of questions from my patients as well as my friends and family about whether the COVID-19 vaccine will still work if people are late receiving their second dose.

Why you need two doses 3-4 weeks apart

Two doses, separated by three to four weeks, is the tried-and-true approach to generate an effective immune response through vaccination, not just for COVID but for hepatitis A and B and other diseases as well.

The first dose primes the immune system and introduces the body to the germ of interest. This allows the immune system to prepare its defense. The second dose, or booster, provides the opportunity for the immune system to ramp up the quality and quantity of the antibodies used to fight the virus.

In the case of the Pfizer and Moderna COVID-19 vaccines, the second dose increases the protection afforded by the vaccine from 60% to approximately 95%.

Why the CDC decided receiving the second dose within 42 days is OK

In the clinical trial, the second dose of the Pfizer vaccine was administered as early as day 19 and as late as day 42 to 93% of the subjects. Since protection was approximately 95% for everyone who was vaccinated within this time "window," there is little reason not to allow some flexibility in the timing of the second dose 2.

As more vaccine becomes available, the timing of the second dose should be close to four weeks for the Pfizer and Moderna vaccines. But the good news is that even while supplies remain limited, the science suggests that there's nothing bad about getting a second dose as late as 42 days after the first.

What the immune system does between the first and second dose

The biology through which the mRNA vaccines induce their protection from COVID-19 is fundamentally different from that with other vaccines.

Pfizer and Moderna vaccines use messenger RNA that encodes the spike glycoprotein. Upon injection of the vaccine, the mRNA enters into immune cells called dendritic cells. The dendritic cells use the instructions written in the mRNA to synthesize the hallmark spike glycoprotein, which characterizes the SARS-CoV-2 virus that causes COVID-19. These immune cells then show the spike glycoprotein to B-cells, which then make anti-spike antibodies.

The mRNA vaccines are uniquely capable of inducing a special kind of immune cell - called a T-follicular helper cell - to help B-cells produce antibodies. The T-cells do this through direct contact with the B-cells and by sending chemical signals that tell the B-cells to produce antibodies. It is this help in antibody production that makes these vaccines so effective.

But not all B-cells are the same. There are two kinds that make anti-spike antibodies: long-lived plasma cells and memory B-cells. The long-lived plasma cells, as their name implies, live in the bone marrow for years after vaccination, continuously churning out antibody - in this case anti-spike antibody. These long-lived B-cells do not need to be boosted.

The memory B-cells, on the other hand, live in a state akin to hibernation. They do not produce antibodies until stimulated by a booster of the vaccine, or are exposed to infection with the coronavirus that causes COVID-19. That is the reason we need that second dose. Together these two types of B-cells provide a constant level of protection.

What happens if you don't get the Pfizer or Moderna second dose on time?

With current vaccine shortages, and problems with setting up the infrastructure to vaccinate millions of people, many physicians are concerned that the second dose of vaccine won't be delivered in the prescribed three-to-four-week window.

That booster shot is necessary for the T-cells to stimulate the memory B-cells to produce massive quantities of antibodies. If the booster isn't given within the appropriate window, lower quantities of antibodies will be produced that may not provide as powerful protection from the virus.

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This article is republished from The Conversation, a nonprofit news site dedicated to sharing ideas from academic experts. It was written by: William Petri, University of Virginia. William Petri receives research funding from the NIH, the Bill & Melinda Gates Foundation and Regeneron, Inc.

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Why it takes 2 shots to make mRNA vaccines do their antibody-creating best - and what the data shows on delaying the booster dose

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After a second dose of the COVID-19 mRNA vaccine, a swarm of antibodies attacks the virus. Kateryna Kon/Science Photo Library via Getty ImagesWith the U.S. facing vaccination delays because of worker shortages and distribution problems, federal health officials now say it's OK to push back the second dose of the two-part vaccine by as much as six weeks.

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Moderna, a Massachusetts-based vaccine developer, partnered with the National Institutes of Health to develop and test a coronavirus vaccine known as mRNA-1273. A clinical trial demonstrated that the vaccine has an efficacy rate of 94.1 percent in preventing Covid-19.

A Piece of the Coronavirus

The SARS-CoV-2 virus is studded with proteins that it uses to enter human cells. These so-called spike proteins make a tempting target for potential vaccines and treatments.

Like the Pfizer-BioNTech vaccine, Moderna's vaccine is based on the virus's genetic instructions for building the spike protein.

mRNA Inside an Oily Shell

The vaccine uses messenger RNA, genetic material that our cells read to make proteins. The molecule - called mRNA for short - is fragile and would be chopped to pieces by our natural enzymes if it were injected directly into the body. To protect the vaccine, Moderna wraps the mRNA in oily bubbles made of lipid nanoparticles.

Because of their fragility, the mRNA molecules will quickly fall apart at room temperature. Moderna's vaccine will need to be refrigerated, and should be stable for up to six months when shipped and stored at -4°F (-20°C).

Entering a Cell

After injection, the vaccine particles bump into cells and fuse to them, releasing mRNA. The cell's molecules read its sequence and build spike proteins. The mRNA from the vaccine is eventually destroyed by the cell, leaving no permanent trace.

Some of the spike proteins form spikes that migrate to the surface of the cell and stick out their tips. The vaccinated cells also break up some of the proteins into fragments, which they present on their surface. These protruding spikes and spike protein fragments can then be recognized by the immune system.

Spotting the Intruder

When a vaccinated cell dies, the debris will contain many spike proteins and protein fragments, which can then be taken up by a type of immune cell called an antigen-presenting cell.

The cell presents fragments of the spike protein on its surface. When other cells called helper T cells detect these fragments, the helper T cells can raise the alarm and help marshal other immune cells to fight the infection.

Making Antibodies

Other immune cells, called B cells, may bump into the coronavirus spikes on the surface of vaccinated cells, or free-floating spike protein fragments. A few of the B cells may be able to lock onto the spike proteins. If these B cells are then activated by helper T cells, they will start to proliferate and pour out antibodies that target the spike protein.

Stopping the Virus

The antibodies can latch onto coronavirus spikes, mark the virus for destruction and prevent infection by blocking the spikes from attaching to other cells.

Killing Infected Cells

The antigen-presenting cells can also activate another type of immune cell called a killer T cell to seek out and destroy any coronavirus-infected cells that display the spike protein fragments on their surfaces.

Remembering the Virus

Moderna's vaccine requires two injections, given 28 days apart, to prime the immune system well enough to fight off the coronavirus. But because the vaccine is so new, researchers don't know how long its protection might last.

It's possible that in the months after vaccination, the number of antibodies and killer T cells will drop. But the immune system also contains special cells called memory B cells and memory T cells that might retain information about the coronavirus for years or even decades.

An early study found that Moderna's vaccine provides protection for at least three months.

For more about the vaccine, see Moderna's Covid Vaccine: What You Need to Know.

Preparation and Injection

Each vial of the vaccine contains 10 doses of 0.5 milliliters. The vials need to be warmed to room temperature before injection. No dilution with saline is required.

Vaccine Timeline

Moderna announces that the United States government will provide $483 million in support for the design and testing of Moderna's vaccine. Researchers at the National Institutes of Health will oversee much of the research, including the clinical trials.

Moderna announces preliminary data from its Phase 3 trial. Researchers estimate that the vaccine has an efficacy rate of 94.1 percent, far higher than experts had expected when vaccine testing began.

The company expects to produce 20 million doses by the end of this year, and up to a billion doses in 2021. Each vaccinated person will require two doses.

Sources: National Center for Biotechnology Information; Nature; Florian Krammer, Icahn School of Medicine at Mount Sinai.

Tracking the Coronavirus

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Moderna, a Massachusetts-based vaccine developer, partnered with the National Institutes of Health to develop and test a coronavirus vaccine known as mRNA-1273. A clinical trial demonstrated that the vaccine has an efficacy rate of 94.1 percent in preventing Covid-19. The SARS-CoV-2 virus is studded with proteins that it uses to enter human cells.

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The longer COVID-19 rages on, the more the United States appears to be hanging its hopes on the development and rapid, mass distribution of a vaccine.

Getting a safe and effective vaccine out to the public could be a game changer, health experts believe. But stopping the virus's spread will only happen if enough people choose - or are required - to get vaccinated.

But while some people may see it as their " patriotic duty " to get vaccinated, others won't.

Opponents may challenge vaccination requirements based on claims of religious liberty or under specific laws that would allow for a religious exemption from any COVID-19 vaccine mandates. In some states including Indiana and Massachusetts, there are laws allowing parents to cite religious reasons to opt out of childhood immunization requirements.

As a public health lawyer and ethicist who has researched issues related to vaccination policy, I'm often asked about the role a vaccine mandate could play in our COVID-19 response. My answer is a common lawyer's response: "It depends," as this question raises numerous questions of its own.

'Safe and effective'?

Whether or not a vaccine mandate is appropriate will depend upon how safe the vaccine is determined to be, what it protects against and how well it offers protection. The Food and Drug Administration Commissioner Stephen Hahn has been adamant that the agency "will not cut corners" in their vaccine review process, and that the decision " will be based on science and data." Any suggestion otherwise would damage public trust.

But public hesitancy to vaccines was already one of the biggest global public health concerns even before the COVID-19 pandemic.

Added to this are the vaccine misinformation and conspiracies that have flourished during the epidemic.

These may explain why 35% of Americans say they will not get the vaccine. While troubling, it's unclear how many in this camp will keep that opinion if COVID-related illnesses, injuries and disruptions to our lives continue, and a vaccine becomes readily available.

And we do not know enough about COVID-19 immunity yet to know what share of the population would need to be vaccinated for a community to achieve herd immunity and stop the virus's spread. A mandate may not be necessary, although those refusing vaccination tend to cluster, leaving potential pockets of continued vulnerability.

'If/then' mandates

Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, has said he would be " pretty surprised " if vaccination became mandatory for any part of the population.

But other experts have raised the possibility of a vaccine being mandatory as part of a "if/then" proposition - in other words, someone can only do something if they are first vaccinated. For example, proof of vaccination could be required to engage in certain jobs, such as prison staff or line workers in meat processing plants. Some businesses, such as nursing homes and hospitals might require vaccination for those who work with certain high-risk populations.

It also could be required to gain access to certain spaces, such as schools or sporting events, or to qualify for certain benefits, like freedom to travel to other states without having to quarantine. These types of rules already exist, for example, in many universities, which require students living in dorms be vaccinated against meningitis.

Another approach would be to mandate the vaccine for certain populations based upon risk characteristics, such as those who live in nursing homes.

Under these scenarios, would religious or personal exemptions override any mandate? That depends on who issues the mandate.

Recent guidance from the U.S. Equal Employment Opportunity Commission suggests that a request to be exempted from an employer's flu vaccination mandate based on "sincerely held religious belief, practice, or observances" would be protected under Title VII of the 1964 Civil Rights Act. The guidance doesn't explicitly state that the same rule would apply for COVID-19 - because there is no COVID-19 vaccine at this time - but it seems clear that the commission would prefer that "employers consider simply encouraging employees" to get vaccinated.

That said, there is a provision under the law that would allow businesses not to honor this exemption if it created "undue hardship." In care facilities, where employees interact regularly with vulnerable populations, employers likely will be able to make "undue hardship" arguments and prevent exemptions. But people working in a typical office environment, or in a service industry position, would probably be able to make a religion-based claim to opt out.

It gets a little more complicated when it comes to any state-issued vaccine mandate. A number of states have created laws protecting religious rights beyond the First Amendment. Florida and Texas, for example, allow parents to opt their children out of school vaccinations citing deeply held religious beliefs or philosophical opposition.

Twenty-one states have religious freedom laws prohibiting even minimal interference with residents' right to practice their faith. In states with these laws, legislatures may need to amend the statute to avoid challenges and allow for universal vaccination mandates for adults.

These exemptions for religious beliefs are political choices. There are no Constitutional or ethical obligations to require an opt out to a vaccine that may be key to stopping a pandemic, should a state wish to prioritize protecting their residents from COVID-19 through mandating vaccination.

Even during this pandemic, most courts, including the Supreme Court, have been hesitant to interfere with the decisions made by state officials taking steps to keep the community safe from a dangerous outbreak. As Chief Justice Roberts recently described, these are emergency circumstances " fraught with medical and scientific uncertainties," and moment-to-moment management of such situations are best left to the elected officials who are directly accountable to the public.

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'No liberty to expose community'

A requirement that someone be vaccinated imposes a greater burden on personal liberty than, say, having to attend church virtually as opposed to in person. However, as the Supreme Court stated in 1941, "The right to practice religion freely does not include liberty to expose the community ... to communicable disease." Justice Antonin Scalia, speaking for the court nearly 50 years later, came to a similar conclusion that laws advancing civic obligations such as compulsory vaccination may override claims of religious freedom.

In any case, as Dr Fauci alludes to: Talk of a mandate may be moot. Almost two-thirds of the American public have said they would get the vaccine if it were available today. Should a safe, effective vaccine be developed, there will likely be tremendous demand to get the shot.

But should states or businesses feel it is necessary to require vaccination to bring about the end of the pandemic, I believe it is likely that courts will support them in these protective efforts.

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Vaccine mandates vs. religious beliefs -- the legal arguments for the upcoming coronavirus lawsuits

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The longer COVID-19 rages on, the more the United States appears to be hanging its hopes on the development and rapid, mass distribution of a vaccine. Getting a safe and effective vaccine out to the public could be a game changer, health experts believe.

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How COVID-19 Attacks The Brain And May Cause Lasting Damage

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How COVID-19 Attacks The Brain And May Cause Lasting Damage

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Early in the pandemic, people with COVID-19 began reporting an odd symptom: the loss of smell and taste.

The reason wasn't congestion. Somehow, the SARS-CoV-2 virus appeared to be affecting nerves that carry information from the nose to the brain.

That worried neurologists.

"We were afraid that SARS CoV-2 was going to invade the brain," says Dr. Gabriel de Erausquin, an investigator at the Glenn Biggs Institute for Alzheimer's and Neurodegenerative Diseases at the University of Texas Health Science Center at San Antonio.

Their fears proved well-founded - though the damage may come from the body and brain's response to the virus rather than the virus itself.

Many patients who are hospitalized for COVID-19 are discharged with symptoms such as those associated with a brain injury. These include "forgetfulness that impairs their ability to function," de Erausquin says. "They complain about trouble with organizing their tasks, and that entails things such as being able to prepare a meal."

But COVID-19 also appears to produce many other brain-related symptoms ranging from seizures to psychosis, a team reports in the Jan. 5 issue of the journal Alzheimer's & Dementia. The team, which included de Erausquin, says severe COVID-19 may even increase a person's risk of developing Alzheimer's disease.

For many affected patients, brain function improves as they recover. But some are likely to face long-term disability, de Erausquin says.

"Even if the proportion, the rate, is not very high, the absolute number of people who will suffer these consequences is likely to be high," he says, because so many people have been infected.

Scientists are still trying to understand the many ways in which COVID-19 can damage the brain.

It's been clear since early in the pandemic that the infection can lead to blood clots that may cause a stroke. Some patients also suffer brain damage when their lungs can no longer provide enough oxygen.

To understand other, less obvious mechanisms, though, scientists needed brain tissue from patients with COVID-19 who died. And early in the pandemicthey couldn't get that tissue, says Dr. Avindra Nath of the National Institute of Neurological Disorders and Stroke.

"Because it was such an infectious organism, people were not conducting autopsies at most places," Nath says. They simply lacked the protective gear that would allow them to remove a brain safely.

That's changing, though, says Nath, who was part of a team that studied brain tissue from 19 COVID-19 patients.

The team saw widespread evidence of inflammation and damage, they reported Dec. 30 in The New England Journal of Medicine.

They also found a possible explanation for the damage.

"What we found was that the very small blood vessels in the brain were leaking," Nath says. "And it wasn't evenly - you would find a small blood vessel here and a small blood vessel there."

The injuries resembled those from a series of tiny strokes occurring in many different areas of the brain, Nath says.

The finding may explain why COVID-19 patients have such a wide range of brain-related symptoms, Nath says, including some related to brain areas that control functions such as heart rate, breathing and blood pressure.

"They complain of heart racing," he says, or that "when they stand up they get quite dizzy. Or they can have urinary problems."

Still others report feeling extreme fatigue, which can also be caused by a brain injury.

What's more, the inflammation and leaky blood vessels associated with all these symptoms may make a person's brain more vulnerable to another type of damage.

"We know that those are important in Alzheimer's disease and we're seeing them play a key role here in COVID-19," says Heather Snyder, vice president of medical and scientific operations at the Alzheimer's Association. "And what that may mean in later life, we need to be asking that question now."

So the association and researchers from more than 30 countries have formed a consortium to study the long-term effects of COVID-19 on the brain. The effort will enroll people who were hospitalized or who are already participating in international research studies of COVID-19.

Findings from that research should help answer some important questions about what happens to COVID-19 patients after an infection, Snyder says. Researchers will assess patients' "behavior, their memory, their overall function" at six-month intervals, she says.

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How COVID-19 Attacks The Brain And May Cause Lasting Damage

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Early in the pandemic, people with COVID-19 began reporting an odd symptom: the loss of smell and taste. The reason wasn't congestion. Somehow, the SARS-CoV-2 virus appeared to be affecting nerves that carry information from the nose to the brain. That worried neurologists.

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Decades of budget-cutting and market reforms laid the ground for a wave of death in Swedish nursing homes.

The Sabbatsbergsbyn nursing home in Stockholm, which is owned and operated by Sweden's largest for-profit operator of nursing homes, struggled to control the spread of the coronavirus. Credit... Felix Odell for The New York Times

In the popular imagination, Sweden does not seem like the sort of country prone to accepting the mass death of grandparents to conserve resources in a pandemic.

Swedes pay some of the highest taxes on earth in exchange for extensive government services, including state-furnished health care and education, plus generous cash assistance for those who lose jobs. When a child is born, the parents receive 480 days of parental leave to use between them.

Yet among the nearly 6,000 people whose deaths have been linked to the coronavirus in Sweden, 2,694, or more than 45 percent, had been among the country's most vulnerable citizens - those living in nursing homes.

That tragedy is in part the story of how Sweden has, over decades, gradually yet relentlessly downgraded its famously generous social safety net.

Since a financial crisis in the early 1990s, Sweden has slashed taxes and diminished government services. It has handed responsibility for the care of older people - mostly living at home - to strapped municipal governments, while opening up nursing homes to for-profit businesses. They have delivered cost savings by relying on part-time and temporary workers, who typically lack formal training in medicine and elder care.

This is how the nursing staff at the Sabbatsbergsbyn nursing home in the center of Stockholm found itself grappling with an impossible situation.

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When the pandemic hit, the Swedish government recommended social distancing, but it kept schools open along with shops, restaurants and nightclubs. Credit... Felix Odell for The New York Times

It was the middle of March, and several of the 106 residents, most of them suffering dementia, were already displaying symptoms of Covid-19. The staff had to be dedicated to individual wards while rigorously avoiding entering others to prevent transmission. But when the team presented this plan to the supervisors, they dismissed it, citing meager staffing, said one nurse, who spoke on the condition on anonymity, citing concerns about potential legal action.

The facility was owned and operated by Sweden's largest for-profit operator of nursing homes, Attendo, whose stock trades on the Nasdaq Stockholm exchange. Last year, the company tallied revenue in excess of $1.3 billion.

On weekends and during night shifts, the nurse was frequently the only one on duty. The rest of the staff lacked proper protective gear, said the nurse and a care aide, who spoke on condition of anonymity for fear of being fired. Management had given them basic cardboard masks - "the kind house painters wear," the nurse said - while instructing them to use the same ones for days in a row. Some used plastic file folders and string to make their own visors.

By the time the nurse quit in May, at least 20 residents were dead, she said.

"The way we had to work went against everything we learned in school regarding disease control," the nurse said. "I felt ashamed, because I knew that we were spreaders."

The lowest-wage workers - who are paid hourly and lack the protection of contracts - continued showing up for shifts, even after falling ill, because government-furnished sick pay did not cover all of their lost wages, the care aide said.

Management at the Sabbatsbergsbyn nursing home gave staff basic cardboard masks while instructing them to use the same ones for days in a row. Credit... Felix Odell for The New York Times

"This is an undervalued part of the labor market," said Marta Szebehely, an expert in elder care at Stockholm University. "Some care workers are badly paid, badly trained and have really bad employment conditions. And they were supposed to stop a transmission that nobody knew anything about, and without much support."

Vulnerability in another area was central to the devastation: Over the last two decades, Sweden has substantially reduced its hospital capacity. During the worst of the initial outbreak, elderly people in nursing homes were denied access to hospitals for fear of overwhelming them.

When nursing home residents displayed Covid symptoms, guidelines in force in Stockholm in the initial phase of the pandemic encouraged physicians to prescribe palliative care - forgoing efforts to save lives in favor of keeping people comfortable in their final days - without examining patients or conducting blood or urine tests, said Dr. Yngve Gustafson, a professor of geriatrics at Umea University. He said that practice amounted to active euthanasia, which is illegal in Sweden.

"As a physician," Dr. Gustafson said, "I feel ashamed that there are physicians who haven't done an individual assessment before they decide whether or not the patient should die."

In the United States, some 40 percent of total coronavirus deaths have been linked to nursing homes, according to a New York Times database. In Britain, Covid has been directly blamed in more than 15,000 nursing home deaths, according to government data.

But these are countries characterized by extreme levels of economic inequality. An estimated 45,000 Americans die every year for lack of health care, according to one report. Britons endured a decade of punishing austerit y that battered the national health system.

Sweden is supposed to be immune to such dangers. Yet this country of only 10 million people has been ravaged by the coronavirus, with per capita death rates nearly as high as the United States, Britain and Spain, according to World Health Organization data.

Co-working spaces in Stockholm. As the coronavirus spread, Sweden did not require people to wear masks. Credit... Elisabeth Ubbe for The New York Times

One element appears to have substantially increased the risks: Sweden's decision to avoid the lockdowns imposed in much of the rest of Europe as a means of limiting the virus. Though the government recommended social distancing, and many people worked from home, it kept schools open along with shops, restaurants and nightclubs. It did not require that people wear masks.

"There's been more society transmission, and it's been more difficult to hinder it from entering the care homes," said Joacim Rocklov, an epidemiologist at Umea University. "The most precious time that we lost, our mistake was in the beginning."

Those who operate private nursing homes in Sweden assert that residents have been the victims of the government's failure to limit the spread of the virus.

"It's the total transmission in society, that's the key," said Martin Tivéus, chief executive of Attendo, the company that owns the Sabbatsbergsbyn home in Stockholm.

Investigations by Swedish media have concluded that private nursing homes suffered lower death rates than their public counterparts. But experts say private and public homes are governed by the same decisive force: Municipalities handle elderly care, and taxpayers have been inclined to pay less.

For decades aggressive public spending was the rule in Sweden, rendering joblessness a rarity. By the beginning of the 1990s, a sense had taken hold that the state had overdone it. It was subsidizing industries that were not internationally competitive. Wages were rising faster than productivity, yielding inflation.

In 1992, Sweden's central bank lifted interest rates as high as 75 percent to choke off inflation while preventing a plunge in the national currency, the krona. The next year, amid a tightening of credit, Sweden's unemployment rate surged above 8 percent. The economy contracted, depleting municipal tax revenues.

This played out just as the policy sphere became infused with the thinking of economists like Milton Friedman, whose neoliberal principles placed faith in shrinking the state and lowering taxes as a source of dynamism.

A subway platform in Stockholm. Sweden's decision to avoid the lockdowns imposed in much of the rest of Europe increased the risk of the coronavirus spreading. Credit... Felix Odell for The New York Times

From the middle of the 1990s through 2013, Sweden dropped its top income tax rate to 57 percent from 84 percent while eliminating levies on property, wealth and inheritance. The net effect was a reduction in government revenue equivalent to 7 percent of national economic output.

Under a 1992 law, Swedish elder care shifted from a reliance on nursing homes to an emphasis on home care. Part of the alteration was philosophical. Policymakers embraced the idea that older people would better enjoy their last years in their own homes, rather than in institutional settings.

But the shift was also driven by budget imperatives.

As a share of its economy, Sweden spends 3.2 percent a year on long-term care for the elderly, according to the Organization for Economic Co-operation and Development, compared with 0.5 percent in the United States and 1.4 percent in Britain. Only the Netherlands and Norway spend more.

But that expenditure is now spread across a population with greater needs. With home care the rule, nursing homes are reserved for older people suffering from complex ailments.

Attendo said it had enough protective gear to satisfy Swedish guidelines, and more than public nursing homes had, but not enough to manage the pandemic. When the company realized it needed more, it confronted a global shortage.

"It took five or six weeks to get the volumes outside of China," said Mr. Tivéus, the Attendo chief executive.

The shortages at Swedish nursing homes underscore the extent to which budget math has taken precedence over social welfare, say those who have watched the refashioning.

"What this pandemic has done is demonstrate a number of system errors that have gone under the radar for years," said Olle Lundberg, secretary general of Forte, a health research council that is part of the Swedish Ministry of Health and Social Affairs. "We totally rely on the global production chain and just-in-time delivery. The syringes we need today should be delivered in the morning. There is no safety margin. It may be very economically efficient in one way, but it's very vulnerable."

Mia Grane was unaware of the systemic issues when she moved her parents into the Sabbatsbergsbyn home in the summer of 2018.

In their younger days, her mother had been an Olympic swimmer. Now, she was descending into Alzheimer's. Her father used a wheelchair.

The home sat in the center of Stockholm, a 15-minute bike ride from her apartment, with lovely gardens that were used for midsummer parties.

"It was a perfect place," said Ms. Grane, 51. "They felt at home."

But her confidence evaporated as the pandemic spread. When she asked the nursing home staff how it planned to manage the danger, it reassured her that everything was fine.

"I thought, 'If this virus gets into this place,'" she said, "'a lot of people are going to die.'"

A week later, she read in a local newspaper that a prominent Swedish musician had died. He had lived in the same ward as her parents. She called the home and was told that her father was suffering cold symptoms. A test showed that he had contracted Covid.

Ms. Grane urged the staff to transfer her father to the hospital. It told her that no one was making that journey, she said.

Nursing homes lack advanced medical equipment like ventilators, and hospitals were effectively off limits to nursing home residents.

Mia Grane with her parents, both of whom died in the Sabbatsbergsbyn nursing home in Stockholm.

"We knew that Sweden had fewer intensive care beds per inhabitants than Italy," said Dr. Michael Broomé, a physician at an intensive care unit in Stockholm. "We had to think twice about whether to put elderly people with other conditions on ventilators."

This forced the nursing home to administer comfort care, easing the pain with opioids as death approached.

Ms. Grane's father died on April 2. "He was all alone," she said.

She begged the staff to save her mother - "the most important person in my life." But she wasn't eating. A week later, her mother died, too.

Ms. Grane struggles to make sense of it - the staff not having proper masks, the hospital deemed off limits, the lack of concern about the nature of the threat.

"For me, it's clear that they wanted to save costs," she said. "In the end, it's the money that talks."

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Pandemic Exposes Holes in Sweden's Generous Social Welfare State

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Decades of budget-cutting and market reforms laid the ground for a wave of death in Swedish nursing homes. In the popular imagination, Sweden does not seem like the sort of country prone to accepting the mass death of grandparents to conserve resources in a pandemic.

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New Yorkers should not hesitate to take one of the new COVID-19 vaccines when they become available, mainly because the benefits far outweigh any possible risks, medical experts said.

But participants in clinical trials for a vaccine developed by pharmaceutical and biomedical company Pfizer have reported side effects including redness, swelling and pain at the injection site, as well as chills, fever and joint pain, according to documents filed with the U.S. Food and Drug Administration.

Researchers said those issues are short term and usually resolve within a day.

"Safety data from the clinical trials do not suggest any immediate risk," said Dr. Bruce Polsky, chairman of medicine at NYU Langone Hospital-Long Island and an infectious disease specialist. "Ultimately, we await long-term data. However, most vaccine-associated problems occur within the first weeks to months following administration."

Pfizer's vaccine could receive final approval by the FDA by the end of the week, after it is reviewed by the agency's independent advisors on Thursday.

Two people with a history of significant allergies had a serious reaction after receiving the Pfizer-BioNTech vaccine in the United Kingdom this week. Both recovered, but the incidents prompted British regulators to declare the vaccine should not be administered to people with certain allergies to food and medicine.

The vaccine is being tested in 150 clinical trial sites in six countries, including 39 in the United States, according to New York City-based Pfizer. More than 42,000 people in the clinical trials have received a second vaccination. Other short-term side-effects included muscle pain, and fatigue and in fewer instances vomiting and diarrhea.

The company said the vaccine has proved to be 95% effective.

If Pfizer's vaccine clears the FDA, it could be rolled out almost immediately. Later this month, the FDA is set to review another vaccine - from pharmaceutical company Moderna.

"I think everyone realizes we're living in a time where over 3,000 people a day are dying and many, many more people are getting sick [from COVID-19]," said Dr. Bruce Farber, chief of infectious diseases at Northwell Health. "The data so far that has come out has demonstrated that this vaccine is much more efficacious and effective than any of us could have dreamed of ... It's really a grand slam."

The first doses in New York are set to go to nursing home staff and residents, followed by health care workers, Gov. Andrew M. Cuomo said. The state will work with the federal government in administering the first shots, Cuomo said.

"The vaccine is really going to get us back to the new normal," said Dr. Reynold A. Panettieri Jr., professor of medicine at Robert Wood Johnson Medical School in New Brunswick, New Jersey. "It is not going to eliminate the disease completely, but it will have a profound effect, as we know, in about 95% of patients, which is pretty good.

"That means 5% will still get infected, but the severity of the disease should be attenuated," he added. "So, hopefully they won't need a hospital. They won't go into an ICU."

Older people with chronic illnesses and compromised immune systems should be eager to get the vaccine, since they are at great risk of falling seriously ill from COVID-19, Panettieri said.

Panettieri said people also should be reassured that the medical community will be closely tracking the impact of the vaccine. "We are all going to be vigilant in looking for adverse effects," he said.

There still will be skeptics, though. Despite the growing number of positive cases across the state, polls and surveys show some people may opt out of taking the vaccine due to safety concerns.

A nextLI survey conducted this past summer for Newsday found only 53% of Long Islanders would get a COVID-19 vaccine, with 16% saying they wouldn't and 31% unsure.

"The issue is not just whether or not people trust this vaccine, it's also that people need to be educated about how to access this vaccine," said Rebecca Sanin, president and CEO of the Health & Welfare Council of Long Island. "It's really important that there is a strong effort around education and quite frankly an honest conversation to talk about people's concerns about safety."

Farber said people who are fearful of the vaccine should be mindful of the illnesses and deaths caused by COVID-19.

"The risks of the vaccine, at this point, are theoretical," he said. "The risks of the COVID virus are very real."

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Benefits vs. risks: Doctors recommend vaccine, despite side effects

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New Yorkers should not hesitate to take one of the new COVID-19 vaccines when they become available, mainly because the benefits far outweigh any possible risks, medical experts said.

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Centers for Disease Control and Prevention

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In the United States, there is not yet an authorized or approved vaccine to prevent coronavirus disease 2019 (COVID-19). With the possibility of a limited supply of one or more COVID-19 vaccines becoming available before the end of 2020, accurate vaccine information is critical.

FACT: COVID-19 vaccines will not give you COVID-19

None of the COVID-19 vaccines currently in development in the United States use the live virus that causes COVID-19. There are several different types of vaccines in development. However, the goal for each of them is to teach our immune systems how to recognize and fight the virus that causes COVID-19. Sometimes this process can cause symptoms, such as fever. These symptoms are normal and are a sign that the body is building immunity. Learn more about how COVID-19 vaccines work.

It typically takes a few weeks for the body to build immunity after vaccination. That means it's possible a person could be infected with the virus that causes COVID-19 just before or just after vaccination and get sick. This is because the vaccine has not had enough time to provide protection.

FACT: COVID-19 vaccines will not cause you to test positive on COVID-19 viral tests

Vaccines currently in clinical trials in the United States won't cause you to test positive on viral tests, which are used to see if you have a current infection.

If your body develops an immune response, which is the goal of vaccination, there is a possibility you may test positive on some antibody tests. Antibody tests indicate you had a previous infection and that you may have some level of protection against the virus. Experts are currently looking at how COVID-19 vaccination may affect antibody testing results.

FACT: People who have gotten sick with COVID-19 may still benefit from getting vaccinated

Due to the severe health risks associated with COVID-19 and the fact that re-infection with COVID-19 is possible, people may be advised to get a COVID-19 vaccine even if they have been sick with COVID-19 before.

At this time, experts do not know how long someone is protected from getting sick again after recovering from COVID-19. The immunity someone gains from having an infection, called natural immunity, varies from person to person. Some early evidence suggests natural immunity may not last very long.

We won't know how long immunity produced by vaccination lasts until we have a vaccine and more data on how well it works.

Both natural immunity and vaccine-induced immunity are important aspects of COVID-19 that experts are trying to learn more about, and CDC will keep the public informed as new evidence becomes available.

FACT: Getting vaccinated can help prevent getting sick with COVID-19

While many people with COVID-19 have only a mild illness, others may get a severe illness or they may even die. There is no way to know how COVID-19 will affect you, even if you are not at increased risk of severe complications. If you get sick, you also may spread the disease to friends, family, and others around you while you are sick. COVID-19 vaccination helps protect you by creating an antibody response without having to experience sickness. Learn more about how COVID-19 vaccines work.

FACT: Receiving an mRNA vaccine will not alter your DNA

mRNA stands for messenger ribonucleic acid and can most easily be described as instructions for how to make a protein or even just a piece of a protein. mRNA is not able to alter or modify a person's genetic makeup (DNA). The mRNA from a COVID-19 vaccine never enter the nucleus of the cell, which is where our DNA are kept. This means the mRNA does not affect or interact with our DNA in any way. Instead, COVID-19 vaccines that use mRNA work with the body's natural defenses to safely develop protection (immunity) to disease. Learn more about how COVID-19 mRNA vaccines work. ​

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With the possibility of a limited supply of one or more COVID-19 vaccines becoming available before the end of 2020, accurate vaccine information is critical. It can be difficult to know which sources of information you can trust. Learn more about common myths and misconceptions about COVID-19 vaccination.

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Can you be fired for refusing to take COVID Vaccine?

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Can you be fired for refusing to take COVID Vaccine?

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The COVID-19 vaccines represent protection and a sense of relief for many people, but the shots are a source of worry for others.

More than a quarter of Americans, 26%, said they "probably" or "definitely" will not get vaccinated, according to an AP-NORC poll conducted in July.

Overall, only 28% of those surveyed said they're very confident the current COVID-19 vaccines will protect people against the new variants of the coronavirus.

Previous polls found many people who were reluctant to get immunized worried about the safety of a vaccine that was developed with unprecedented speed.

But lots of people opting out would put others at risk, so some officials support compulsory immunizations.

Can the federal government require Americans to get the shot?

Dr. Anthony Fauci, chief medical adviser to President Biden, has said there should be more vaccine mandates at the local level, but "it's not going to be centrally mandated from the federal government," he told The Washington Post in May.

That's consistent with his comments last year.

"You don't want to mandate and try and force anyone to take the vaccine. We've never done that. You can mandate for certain groups of people like health workers, but for the general population you cannot," Fauci said in the summer of 2020.

"We don't want to be mandating from the federal government to the general population. It would be unenforceable and not appropriate."

It's a different story for orders issued by states, cities or businesses, but even then, mandatory vaccination wouldn't be forced vaccination.

"Nobody's talking about coming to your house, holding you down and vaccinating you," Dorit Reiss, a law professor at the University of California Hastings College of the Law in San Francisco, told TODAY.

Refusing to follow a mandate could mean a fine, tax or other penalty, said Reiss, who studies legal and policy issues related to vaccines.

Here's what to know about the COVID-19 vaccine and U.S. law:

Can the federal government mandate the vaccine for the general population?

Almost certainly not, Reiss said. It has limited powers expressly spelled out in the Constitution; the rest belong to the states.

But the federal government has some ways to get people to vaccinate, imposing it as a condition of getting a passport, for example.

That hasn't happened before, but such a requirement would be within the federal government's powers, Reiss noted.

Can states or cities mandate a vaccine?

States have the authority to regulate public health and they have in the past mandated vaccines. The classic case in this area of law, Jacobson v. Massachusetts in 1905, was decided by the Supreme Court after a smallpox outbreak.

Cities have powers, too: In 2019, New York City required people living in four ZIP codes in Williamsburg, Brooklyn, to get the measles vaccine, prove they've already had it or face a $1,000 fine.

But any vaccine mandates must reasonable, proportional and enforced in a nondiscriminatory fashion, Reiss said. She expected COVID-19 hot spots would make the vaccine a requirement for their residents.

In August 2021, New York became the first major city in the U.S. to require vaccination proof for indoor dining and gym use. The program will be fully enforced beginning the week of Sept. 13.

Can the vaccine be made compulsory for certain groups of people?

Yes, health workers are the classic example. Hospitals often require some staff to get a flu or hepatitis B vaccine.

Universities may mandate students, faculty and staff to be immunized for certain diseases before coming on campus. Schools may have the same requirements for children.

In August 2021, a federal appeals court in Chicago ruled Indiana University can require students and employees to get the COVID-19 vaccine - the highest court decision regarding college immunization mandates, the Associated Press reported.

Can an employer fire you if you refuse to get immunized?

Yes, with some exceptions.

"It's perfectly legitimate for an employer to regulate to make the workplace safer," Reiss said. "They can certainly fire you if you don't want to follow health and safety rules."

Tyson Foods, Microsoft and United Airlines are among a growing list of companies issuing mandates for their workers. The Equal Employment Opportunity Commission has issued guidance noting that employers can require employees to be vaccinated and offer incentives for them to do so.

Employees who are part of a union may be exempt from the vaccine requirement.

Anti-discrimination laws also provide some limits. If you can't get the vaccine for medical reasons, that could be a disability under the Americans with Disabilities Act, which would require an employer to accommodate you. That could mean requiring you to wear a mask on the job or have limited contact with other people, Reiss said.

The Civil Rights Act of 1964 may protect people who have a religious objection to a vaccine. An employer would have to make a reasonable accommodation as long as it's not too costly for the business.

These laws apply only to companies with 15 or more employees, so smaller businesses are exempt.

"We think about employers as this huge, amorphous thing, but under the law, they're also private entities with rights, especially if it's a small mom and pop shop," Reiss noted.

Can airlines, restaurants, stores and stadiums make the vaccine a condition of doing business with you?

Yes, within the anti-discrimination laws mentioned above.

"They can decide to refuse service to you for pretty much any reason," Reiss said, pointing out a policy most shoppers are already familiar with: no shirt, no shoes, no service.

People who are covered by anti-discrimination laws can't just demand a business let them do whatever they want. The company just has to give you a reasonable accommodation, so a store might refuse you entry but offer curbside pick-up of groceries.

Given the backlash against wearing masks, Reiss suspected many businesses won't have a vaccine mandate because it's difficult to enforce.

"There are people who don't like mandates, period, and they won't like this either," Reiss said.

"I expect there are also going to be a lot of workers who are grateful that their employer is trying to make the place safer for themselves and others."

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Can an employer mandate the COVID-19 vaccine?

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The COVID-19 vaccines represent protection and a sense of relief for many people, but the shots are a source of worry for others. More than a quarter of Americans, 26%, said they "probably" or "definitely" will not get vaccinated, according to an AP-NORC poll conducted in July.

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COVID-19 vaccine 'Freedom of choice' petition circulated by legislator

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CHARLESTON, WV (WOWK) West Virginia is just weeks away from receiving its first COVID-19 vaccine shipment, but one legislator is working to prevent getting vaccinated a mandate. Derrick Evans is a newly-elected republican delegate representing Wayne County who says he already has over 1,000 signatures on a petition he's circulating on his social media pages.

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Dec. 1, 2020 -- An influential government committee has recommended that health care workers and people who reside in long-term care facilities get the first doses of COVID-19 vaccines when they become available.

In a 13-to-1 vote, the Advisory Committee for Immunization Practices (ACIP) said health care workers and residents of nursing homes and other residential care facilities should be first in line to get COVID-19 vaccines.

Health care workers include any paid staff or volunteers who work in health care settings. Long-term care facility residents include adults who live in facilities that provide medical or personal care to people who cannot live independently.

The vote follows months of deliberation by the committee to determine the most effective and fairest way to distribute scarce early doses. It follows similar recommendations made by the National Academies of Sciences in October.

The ACIP is made up of 15 voting members, eight nonvoting members from other government agencies, and 30 nonvoting members of other organizations that have expertise and interest in vaccination. The committee has met frequently this year to prepare for the COVID-19 vaccine rollout.

If the recommendation is approved by CDC Director Robert Redfield, MD, it will be passed on to states, which have already been working with the agency to create their distribution plans.

This recommendation is not binding, though states usually follow the ACIP's guidance.

The ACIP prioritized health care workers for vaccination because of a "multiplier effect" -- keeping them healthy ensures the health of others. The CDC says there are roughly 21 million health care workers in the U.S. More than 3 million Americans are residents in skilled nursing or assisted living facilities or other group care homes.

In making its recommendation, the committee prioritized saving lives over using the vaccine to slow disease transmission.

"I think everyone pretty much across the board agrees that with a limited number of doses, the best approach is to try to protect as many of the high-risk people as possible. That places health care workers at the very top," says Josh Michaud, PhD, associate director of global health policy for the Kaiser Family Foundation in Washington, D.C.

"If you wanted to quash transmission, you would target your vaccination programs to those who do the most transmission in the United States, which is sort of young adults," he says.

It is generally expected that vaccine acceptance will be high among health care workers, a group that will also be closely watched for any side effects related to the vaccines. The CDC has developed a voluntary cellphone-based system called V-Safe that will monitor health care workers via regular text messages and phone calls.

But survey results presented at a previous ACIP meeting revealed significant worry about the vaccines even among this group. In a CDC survey of health care workers, 63% of them said they would get the vaccine. A separate survey by the American Nurses Foundation found only 34% of nurses said they would get the vaccine if their employer doesn't require them to do it, 36% said they would not get a COVID-19 vaccine, and 31% said they were unsure.

CVS and Walgreens have signed agreements with the federal government to give vaccines to residents of long-term care facilities, agreeing to make three visits per facility to dole out shots.

Initial doses of a vaccine could be sent out as early as mid-December, Vice President Mike Pence told governors during a call on Monday.

Once a vaccine is approved, things will move quickly.

Nancy Messonnier, MD, director of the National Center for Immunization and Respiratory Diseases, says most jurisdictions expect to be able to vaccinate all their health care workers within about 3 weeks of vaccine approval.

After the first vaccine deliveries, 5 million to 10 million more doses could be delivered each week on a rolling basis.

The FDA is scheduled to make a decision about Pfizer's emergency use authorization for its COVID vaccine after an advisory panel meets on Dec. 10 to review the company's application.

The ACIP will meet and vote again on recommendations for specific products after they are approved by the FDA. Those recommendations trigger financial reimbursements by the federal government's health plans like Medicare and Medicaid.

Ultimately, the governors of each state will decide how early doses of the vaccines are distributed.

"In the final say, it will be our nation's governors in implementing the distribution plans to tell us ... where to ship, and they will decide who the vaccine is given to. We hope our recommendations will carry weight with them, but at the end of the day, they will make that decision," Health and Human Services Secretary Alex Azar said in an Operation Warp Speed news briefing last week.

He said the vaccine would be distributed to states according to a formula based on each state's adult population.

Gen. Gus Perna, chief operating officer of Operation Warp Speed, said in a Nov. 23 news briefing that he was planning for at least 6.4 million vaccine doses to go to states in the first push.

Operation Warp Speed has not yet released the list of the doses that will be allocated to each state.

For a short time, supplies of vaccine won't cover everyone even in the groups flagged for first priority. So states will have to decide which workers and residents most need the vaccine.

On Tuesday, the CDC further recommended that health care workers who have direct contact with patients and can't telework be first of the first. They also suggested that residents in nursing homes get priority over residents of other kinds of residential facilities because they tend to be older and more physically frail.

One major issue to be ironed out is what to do for health care workers who are pregnant or nursing. The CDC says 75% of health care workers are women, and as many as 330,000 may be pregnant when a vaccine becomes available. While COVID poses a greater risk to pregnant women, the CDC says it has no data on mRNA vaccines, like the type made by Pfizer and Moderna, in pregnancy. The agency says it's awaiting information from the clinical trials for review.

On Monday, California Gov. Gavin Newsom announced that his state expected to receive 327,000 doses of Pfizer's vaccine in mid-December. The state has more than 2 million health care workers, meaning that the first doses will fall far short of meeting the full demand even for people who get first priority.

According to a graphic released by Operation Warp Speed, Pfizer will distribute its own vaccines, which require ultracold storage. The Moderna vaccine will be distributed by McKesson, which has a longstanding contract with the CDC and distributed vaccines during the H1N1 flu epidemic. McKesson also distributes seasonal flu vaccines to states.

Both Pfizer's and Moderna's vaccines require two doses per person. Pfizer's vaccine needs a booster 3 weeks after the first dose. Moderna's second dose is given 4 weeks later.

In the Nov. 23 news briefing, Azar, the HHS secretary, said he expected to have enough vaccine to vaccinate those who are most vulnerable by the end of December.

Sources

Josh Michaud, PhD, associate director of global health policy, Kaiser Family Foundation, Washington, D.C.

Live webcast, CDC, Advisory Committee for Immunization Practices emergency meeting, Dec. 1, 2020.

News briefing, Operation Warp Speed, Nov. 23, 2020.

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CDC Panel Votes on Who Should Get COVID Vaccines First

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Dec. 1, 2020 -- An influential government committee has recommended that health care workers and people who reside in long-term care facilities get the first doses of COVID-19 vaccines when they become available. In a 13-to-1 vote, the Advisory Committee for Immunization Practices (ACIP) said health care workers and residents of nursing homes and other residential care facilities should be first in line to get COVID-19 vaccines.

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You might assume that 95 out of every 100 people vaccinated will be protected from Covid-19. But that's not how the math works.

Experts say it's easy to misconstrue early results because the language that vaccine researchers use to talk about their trials can be hard for outsiders to understand. Credit... EPA, via Shutterstock

The front-runners in the vaccine race seem to be working far better than anyone expected: Pfizer and BioNTech announced this week that their vaccine had an efficacy rate of 95 percent. Moderna put the figure for its vaccine at 94.5 percent. In Russia, the makers of the Sputnik vaccine claimed their efficacy rate was over 90 percent.

"These are game changers," said Dr. Gregory Poland, a vaccine researcher at the Mayo Clinic. "We were all expecting 50 to 70 percent." Indeed, the Food and Drug Administration had said it would consider granting emergency approval for vaccines that showed just 50 percent efficacy.

From the headlines, you might well assume that these vaccines - which some people may receive in a matter of weeks - will protect 95 out of 100 people who get them. But that's not actually what the trials have shown. Exactly how the vaccines perform out in the real world will depend on a lot of factors we just don't have answers to yet - such as whether vaccinated people can get asymptomatic infections and how many people will get vaccinated.

Here's what you need to know about the actual effectiveness of these vaccines.

The fundamental logic behind today's vaccine trials was worked out by statisticians over a century ago. Researchers vaccinate some people and give a placebo to others. They then wait for participants to get sick and look at how many of the illnesses came from each group.

In the case of Pfizer, for example, the company recruited 43,661 volunteers and waited for 170 people to come down with symptoms of Covid-19 and then get a positive test. Out of these 170, 162 had received a placebo shot, and just eight had received the real vaccine.

From these numbers, Pfizer's researchers calculated the fraction of volunteers in each group who got sick. Both fractions were small, but the fraction of unvaccinated volunteers who got sick was much bigger than the fraction of vaccinated ones. The scientists then determined the relative difference between those two fractions. Scientists express that difference with a value they call efficacy. If there's no difference between the vaccine and placebo groups, the efficacy is zero. If none of the sick people had been vaccinated, the efficacy is 100 percent.

A 95 percent efficacy is certainly compelling evidence that a vaccine works well. But that number doesn't tell you what your chances are of becoming sick if you get vaccinated. And on its own, it also doesn't say how well the vaccine will bring down Covid-19 across the United States.

Efficacy and effectiveness are related to each other, but they're not the same thing. And vaccine experts say it's crucial not to mix them up. Efficacy is just a measurement made during a clinical trial. "Effectiveness is how well the vaccine works out in the real world," said Naor Bar-Zeev, an epidemiologist at the Johns Hopkins Bloomberg School of Public Health.

It's possible that the effectiveness of coronavirus vaccines will match their impressive efficacy in clinical trials. But if previous vaccines are any guide, effectiveness may prove somewhat lower.

The mismatch comes about because the people who join clinical trials are not a perfect reflection of the population at large. Out in the real world, people may have a host of chronic health problems that could interfere with a vaccine's protection, for example.

The Centers for Disease Control and Prevention has a long history of following the effectiveness of vaccines after they're approved. On Thursday, the agency posted information on its website about its plans to study the effectiveness of coronavirus vaccines. It will find opportunities to compare the health of vaccinated people to others in their communities who have not received a vaccine.

The clinical trials run by Pfizer and other companies were specifically designed to see whether vaccines protect people from getting sick from Covid-19. If volunteers developed symptoms like a fever or cough, they were then tested for the coronavirus.

But there's abundant evidence that people can get infected with the coronavirus without ever showing symptoms. And so it's possible that a number of people who got vaccinated in the clinical trials got infected, too, without ever realizing it. If those cases indeed exist, none of them are reflected in the 95 percent efficacy rate.

People who are asymptomatic can still spread the virus to others. Some studies suggest that they produce fewer viruses, making them less of a threat than infected people who go on to develop symptoms. But if people get vaccinated and then stop wearing masks and taking other safety measures, their chances of spreading the coronavirus to others could increase.

"You could get this paradoxical situation of things getting worse," said Dr. Bar-Zeev.

Vaccines don't protect only the people who get them. Because they slow the spread of the virus, they can, over time, also drive down new infection rates and protect society as a whole.

Scientists call this broad form of effectiveness a vaccine's impact. The smallpox vaccine had the greatest impact of all, driving the virus into oblivion in the 1970s. But even a vaccine with extremely high efficacy in clinical trials will have a small impact if only a few people end up getting it.

"Vaccines don't save lives," said A. David Paltiel, a professor at the Yale School of Public Health. "Vaccination programs save lives."

On Thursday, Dr. Paltiel and his colleagues published a study in the journal Health Affairs in which they simulated the coming rollout of coronavirus vaccines. They modeled vaccines with efficacy rates ranging from high to low, but also considered how quickly and widely a vaccine could be distributed as the pandemic continues to rage.

The results, Dr. Paltiel said, were heartbreaking. He and his colleagues found that when it comes to cutting down on infections, hospitalizations and deaths, the deployment mattered just as much as the efficacy. The study left Dr. Paltiel worried that the United States has not done enough to prepare for the massive distribution of the vaccine in the months to come.

"Time is really running out," he warned. "Infrastructure is going to contribute at least as much, if not more, than the vaccine itself to the success of the program."

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2 Companies Say Their Vaccines Are 95% Effective. What Does That Mean?

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You might assume that 95 out of every 100 people vaccinated will be protected from Covid-19. But that's not how the math works. The front-runners in the vaccine race seem to be working far better than anyone expected: Pfizer and BioNTech announced this week that their vaccine had an efficacy rate of 95 percent.

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The past few weeks have been sort of like first dates with three different Covid-19 coronavirus vaccines. They were positive first dates, but first dates nonetheless.

Since November 9, three vaccine manufacturers, Pfizer, followed by Moderna and then AstraZeneca, have offered some preliminary results from their Phase 3 clinical trials. And those numbers have looked good. Pfizer mentioned a vaccine efficacy of above 90% for its mRNA-based vaccine candidate, BNT162b2, Moderna a vaccine efficacy of 94.5% for its mRNA-1273, and AstraZeneca a vaccine efficacy of up to 90% for its AZD1222.

Ninety percent is an impressive number. However, before you say, "you had me at 90%," keep in mind that these are still very preliminary results. Don't start dreaming about starting a new life with the vaccines just yet. Instead, consider the following eight limitations to all of these initial results:
1. They still may confound what you are looking for.
Recall how the three manufacturers have put together and are conducting their trials. I described AstraZeneca's Phase 3 clinical trial design previously for Forbes. Each trial has involved recruiting a large number of volunteers and giving one group of study participants the vaccine and another group a placebo, which essentially is a fake vaccine. The participants don't know who is getting what. The trial then will entail following both groups for months and periodically testing them for the presence of Covid-19 coronavirus infections. Over time, the trial investigators then can determine what percentage of each group ends up developing Covid-19 coronavirus infections. From these numbers, they can then use the following formula to calculate vaccine efficacy in the trial:
Vaccine efficacy = (Percentage of the unvaccinated group who get Covid-19 − Percentage of the vaccinated group who get Covid-19)/Percentage of the unvaccinated group who get Covid-19
Therefore, if 10% of the unvaccinated group and 1% of the vaccinated group were to end up getting Covid-19, the calculated vaccine efficacy would then be 10% minus 1%, which is 9%, divided by 10%, which turns out to be 90%. The vaccine efficacy would be 90% as well if 0.1% of the unvaccinated group and 0.01% of the vaccinated group were to end up getting Covid-19.

The challenge, of course, is not every study participant will have the same risk of getting infected by the virus in the first place with or without the vaccine. Your risk of becoming infected depends heavily on the precautions that you and those around you in your community are taking. For example, picking fights with others at Costco while not wearing a face mask may increase your risk. So might being in a community where people think and act like the Covid-19 coronavirus is no big deal.

This is a big reason why clinical studies like the current the Covid-19 coronavirus vaccine clinical trials have to include large numbers of study participants, tens of thousands in the case of the vaccine trials. The studies are trying to even out potential differences between those who receive the vaccine and those who get the placebo. Say you were to test whether people prefer bacon on their breakfast plate versus all over their body. Selecting just 20 people for the study would run the risk of by chance choosing too many from the "I like bacon on my body" crowd. Enrolling thousands of people in the study would be more representative of the percentage of the population that mistake meat products for clothing.

Similarly, having a larger number of study participants will make it more likely that on average the vaccine and placebo groups will have the same risk of being exposed to the virus. It's also why you should be cautious about preliminary results that only cover a few months of a trial and not all of the expected participants.
2. Duration of protection matters.
Speaking of several months. Imagine if someone were to tell you, "there's a 90% chance that I will rock your world during the first few months. After that the relationship is going to be really, really terrible." Would that encourage you to have a second date? Maybe, depending on how bored you currently are and what's on TV to watch. But it wouldn't bode well for a stable relationship and a longer-term feeling of security.

In the same vein, being protected by a vaccine for just a few months is very different from being protected for half a year to a year or longer. Although the Pfizer, Moderna, and AstraZeneca Covid-19 vaccines may eventually offer longer protection than just a few months, the trials have not been going on long enough to determine how long the vaccines may offer protection. Judy Stone mentioned for Forbes this and other issues with the Pfizer announcement. In fact, the trials may not even have gone on long enough for everyone to have been exposed to virus.
3. The results have been from the Summer and early Fall.
As Olivia Newton John and John Travolta told us in the song "Summer Nights" from the movie Grease, things don't always remain the same after the Summer ends. The song doesn't quite go, "It turned colder and less humid and that's where it ends." But such would be a reminder that the clinical trial data to date is largely from the Summer and possibly early Fall. As I have detailed for Forbes previously, Covid-19 coronavirus cases have picked up substantially over the past month as temperatures and relative humidity have dropped. So the risk of infection could be much higher now than it was during the first few months of the trials. The question then is whether vaccine efficacy will decrease as the risk of getting infected increases.
4. It's not clear how vaccine efficacy may vary from person-to-person.
What would you say if a clinical trial had determined that a particular pair of underwear fits on people? Your first question might be, why did they do such a clinical trial? Your second and third questions could be, whom did they include in the clinical trial and how did the results vary from person-to-person? Similarly, vaccine efficacy and ultimately vaccine effectiveness (which is vaccine efficacy in the real world) may vary significantly based on a person's age, size, physiology, immune system, and other factors. The press releases did not break down the results by such different characteristics.
5. Testing can be variable.
Testing for the Covid-19 coronavirus is not like determining whether there is a hedgehog on your head. Usually, it's quite easy to tell whether a hedgehog is on your head, unless, of course, you are wearing a beret over the hedgehog. Even then, an additional step, "excuse me, could you remove your beret so that I can tell whether you have a hedgehog on your head," will make the diagnosis relatively easy. The same is not true for the Covid-19 coronavirus. For the standard nasopharyngeal and oropharyngeal tests, getting a proper sample requires sticking a cotton swab all the way up your nose and to the back of your throat. This ain't easy to do, so the samples may vary in quality. Other types of tests, like spit tests, may not be as accurate as the nasopharyngeal and oropharyngeal tests. Therefore, knowing more specifically how testing was done, what were the specific results, and what variations from protocol may have occurred will help better assess the vaccine efficacy findings.
6. What are the other outcomes?
Telling you that you are positive for the Covid-19 coronavirus is not like telling you that there is a hedgehog on your head in more ways than one. Sure the hedgehog can be striking different poses and doing different things. For example, the hedgehog may be reading a very small copy of the book The Power of Positive Thinking or twerking. Regardless, though, such possibilities may not dramatically change what needs to be done next: get the hedgehog off your head.

By contrast, there is much more variability in what may happen when you are infected with the severe acute respiratory syndrome coronavirus 2. You may end up having no symptoms or just mild symptoms, requiring not much more than isolation and maybe some over-the-counter medications. Or things could get worse, much worse. Furthermore, problems may persist well beyond the infection. So the question remains what is vaccine efficacy (and effectiveness) in preventing different types and severity of Covid-19 coronavirus infections? How effective are the vaccines in preventing various possible outcomes?
7. A clinical trial setting is not the real world.
A clinical trial is like a reality television show. While it is supposed to mimic reality, it nevertheless is not the same as reality. It's usually not a good idea to have a wedding-themed photo shoot on the first date as they did on The Bachelor. But reality shows and clinical trials carefully screen people before they are enrolled in a clinical trial. Someone who enrolls in a Covid-19 vaccine clinical trial may not be your typical or average person in the U.S. They may, for example, be more likely to be more knowledgeable of the virus and more likely to follow Covid-19 coronavirus precautions.

Moreover, both reality TV and clinical trials demonstrate the Hawthorne Effect: people are more likely to change their behavior when they are being watched. Most people won't go topless on a first date and say, "My heart is gold and my vagine is platinum," as Corinne Olympios did on The Bachelor. On the flip side, those participating in a vaccine clinical trial may be more careful about preventing Covid-19 coronavirus infections because they know that they are being followed.

Plus, things can go a lot more smoothly on reality TV and in clinical trials compared to real life because a lot more people are paying attention and providing support. Jacuzzis don't magically appear as they do on The Bachelor. The closest some people will come to a jacuzzi is breaking wind in a bathtub. A clinical trial may offer support that may not exist for everyone in real life. For example, the set-up of a clinical trial can make sure that vaccines are properly stored and participants tend to get the right doses at the right times (well, most of the time, at least). All of this is why it's called "vaccine efficacy" when it's measured in a clinical trial and "vaccine effectiveness" when it is measured in the real world. Typically, vaccine effectiveness is lower than vaccine efficacy for a given vaccine.

Additionally, vaccine effectiveness ultimately will depend on how many people around get vaccinated. The more who get vaccinated, the less the virus can spread and the more effective the vaccine becomes. The reverse is true as well.
8. The data and results have not gone through peer-review by the scientific community.
Remember, to date, the vaccine effectiveness numbers have come from press releases and not peer-reviewed publications in reputable scientific journals. Pretty much anyone can put forth a press release. In theory, you could easily issue a press release that you had delicious brownie for dessert or used hot dogs to create a replica of a Thanksgiving turkey. Publishing findings as a peer-reviewed original research paper in a reputable scientific journal is a different story. Most scientific journals do not have a "Things Made Out of Hot Dogs" section and have a much higher bar that needs to be met for publication.

Press releases also tend to focus mainly on positive news. A company is less likely to issue a press release that says, "yeah, our product is sort of weak" or "oh boy, did we mess up." Naturally, positive press releases can help a company get more support for its product. That's why it's so important for independent scientists to review the results in a transparent manner to determine whether the conclusions actually matched the data and methods used.

Again, while the results from Pfizer, Moderna, and AstraZeneca are encouraging, don't make plans for a post-vaccine world just yet. As Guns N' Roses have told us, all we need is a just a little patience. Treat the results so far like you would the first date in a series of dates. There's still much to learn about the vaccine's eventual effectiveness, duration of protection, and potential side effects. For now, it looks some second dates are in order.
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How Effective Will Covid-19 Coronavirus Vaccines Be? 8 Reasons It's Too Early To Tell

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The past few weeks have been sort of like first dates with three different Covid-19 coronavirus vaccines. They were positive first dates, but first dates nonetheless. Since November 9, three vaccine manufacturers, Pfizer, followed by Moderna and then AstraZeneca, have offered some preliminary results from their Phase 3 clinical trials.

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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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37. Myocarditis and pericarditis following mRNA COVID-19 vaccination. Centers for Disease Control and Prevention. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/myocarditis.html. Accessed Jan. 20, 2022.

38. Key things to know about COVID-19 vaccines. Centers for Disease Control and Prevention. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/keythingstoknow.html. Accessed Jan. 19, 2022.

39. Moderna COVID-19 vaccine: Fact sheet for recipients and caregivers. U.S. Food and Drug Administration. https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/moderna-covid-19-vaccine#additional. Accessed Jan. 21, 2022.

40. Edelman A, et al. Association between menstrual cycle length and coronavirus disease 2019 (COVID-19) vaccination: A U.S. cohort. Obstetrics & Gynecology. 2022; doi: 10.1097/AOG.0000000000004695.

41. Pregnant and recently pregnant people. Centers for Disease Control and Prevention. https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/pregnant-people.html. Accessed Feb. 28, 2022.

42. Halasa NB, et al. Effectiveness of maternal vaccination with mRNA COVID-19 vaccine during pregnancy against COVID-19-associated hospitalization in infants aged < 6 months - 17 states, July 2021-January 2022. MMWR Morbidity and Mortality Weekly Report. 2022; doi:10.15585/mmwr.mm7107e3.

43. Use and care of masks. Centers for Disease Control and Prevention. https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/about-face-coverings.html. Accessed Feb. 28, 2022.

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45. Neutralization of the SARS-CoV-2 omicron BA.1 and BA.2 variants. The New England Journal of Medicine. 2022; doi: 10.1056/NEJMc2201849.

46. COVID data tracker: Variant proportions. Centers for Disease Control and Prevention. https://covid.cdc.gov/covid-data-tracker/#variant-proportions. Accessed July 7, 2022.

47. Coronavirus (COVID-19) update: FDA authorizes second booster dose of two COVID-19 vaccines for older and immunocompromised individuals. U.S. Food and Drug Administration. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-second-booster-dose-two-covid-19-vaccines-older-and. Accessed March 30, 2022.

48. Coronavirus (COVID-19) update: FDA limits use of Janssen COVID-19 vaccine to certain individuals. U.S. Food and Drug Administration. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-limits-use-janssen-covid-19-vaccine-certain-individuals. Accessed May 9, 2022.

49. Coronavirus (COVID-19) update: FDA expands eligibility for Pfizer-BioNTech COVID-19 vaccine booster dose to children 5 through 11 years. U.S. Food and Drug Administration. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-expands-eligibility-pfizer-biontech-covid-19-vaccine-booster-dose. Accessed May 18, 2022.

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51. 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.

52. 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.

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

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55. 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.

56. 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.

57. 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.

58. 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.

59. 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.

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63. 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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As we get closer to a COVID-19 vaccine, it's exciting to imagine a day when the virus is gone. But a vaccine will not be a magic bullet. In fact, it may be only about 50% effective.

Dr. Anthony Fauci, chief of the National Institute of Health and Infectious Disease, has tried to set realistic expectations when discussing the importance of a vaccine. "We don't know yet what the efficacy might be. We don't know if it will be 50% or 60%," Fauci said during a Brown University event in August.

"I'd like it to be 75% or more," Fauci said, but he acknowledged that may not be realistic.

The Food and Drug Administration has said that once a vaccine is shown to be safe and at least 50% effective, it could be approved for use in the U.S.
So what does 50% efficacy mean?
"When we talk 'vaccine effectiveness,' what we're talking about is, 'How effective was the vaccine at preventing actual disease?' " explains scientist L.J. Tan,chief strategistof the nonprofit Immunization Action Coalition.

In other words, Tan says, "If you vaccinate 100 people, 50 people will not get disease."

This may not sound like an impressive rate of infection prevention, but there are other potential benefits to individuals and the community from getting vaccinated.

"It's possible that the [COVID-19] vaccine will reduce the severity of disease" in the other 50% who do get sick, says physician Bill Miller of The Ohio State University College of Public Health. "It may mean that people are less likely to be hospitalized, require ICU care or die."

"That's certainly the case with the influenza vaccine," Miller adds. "People who get the vaccine may still get the flu, but, for the most part, theirdisease is milder than if they hadn't had the vaccine."

Michael Ison, an infectious disease physician at Northwestern University Feinberg School of Medicine, echoes that sentiment. While it's true that 50 out of 100 people who get the vaccine could still end up getting infected with the coronavirus,"hopefully, the majority will have milder disease," Ison says. But he cautions there's a lot to learn in that regard, given that the studies of COVID-19 vaccine candidates are still very much underway.

"We really need to get some information from the trials that are ongoing to best understand what the impact will be," he says. Ison is a member of the research team at Northwestern that is conducting studies on COVID-19 and on influenza vaccines.

And here's the next reality check: The extent to which any vaccine that emerges will help halt the COVID-19 pandemic depends on how many people get the immunization.

In order to put this pandemic in the rearview mirror, a large percentage of the population needs to either be vaccinated or gain immunity via an infection with the virus (a much riskier route that would include many more deaths).

When a large portion of the population has immunity to the virus because of this sort of "herd immunity," it's unlikely to keep spreading. Even people who haven't been vaccinated (such as very young babies and those with compromised immune systems) are protected once this level of immunity in a population is achieved, because the illness has little opportunity to spread within the community - most people who run into the virus in this scenario are immune.

For the coronavirus, Ison says, " 'herd immunity' is seen when we have somewhere between 60% to 70% of the population having some degree of protection."

So - here's a little math - if 20% of the U.S. population ends up getting exposed to the virus and developing an infection before we have a vaccine (as is estimated to be the level of immunity in the New York City metro area right now), then we would still need an additional 40% of the population to gain protection via a vaccine.

And in order to get 40% of a population immune through vaccination - if you have a vaccine with 50% efficacy - "you're going to have to vaccinate 80% of the population," says Carlos del Rio, an infectious disease expert at Emory University. "So it's not going to happen right away."

For starters, Michael Ison says, there are logistical challenges to getting everyone vaccinated, given the mammoth undertaking of manufacturing and distributing a vaccine.

"It's going to take us months to get the entire population vaccinated if they are willing to get vaccinated," he says - which is another big "if." An NPR/PBS/Marist poll in August found that more than a third of Americans - 35% - say they won't get vaccinated when a vaccine comes available.

What's more, most of the candidate vaccines now being tested would require two separate doses to trigger their most effective protection, Ison says. So at a minimum, he notes, you've got a full month between the two doses of vaccine and a short period of time after the second dose before someone who was been vaccinated would be protected.

It's also still not known how long the immunity gained through any of the current COVID-19 vaccine candidates will last or to what extent the virus might mutate or change in a way that makes that vaccine less effective.

"What we will only know once we have the vaccine [approved and rolled out] is how effective it is, how long lasting the protection is and how much pressure it applies to the virus to change, to escape the pressures of the vaccine," Ison says.

Despite all these remaining unknowns, it is safe to say that any such vaccine against the coronavirus could play a significant role in reducing the spread of the virus.

"If a vaccine is 50% effective, that's still good," Miller says. That means that you have a good possibility of being protected. He says we should think about its effectiveness the way we do about the benefits of cancer treatments, for example.

"In some severe cancers, we'd be pretty happy to get a drug that gets us to 50% effectiveness," he notes.
Why do we need to test a proposed vaccine in so many people?
For now, it's important to see the experimental trials of each vaccine candidate through to the end, Miller says. The phase 3 trials will tell us a lot about the safety of a vaccine as well as its effectiveness.

The large studies now underway are being conducted as double-blind, placebo-controlled trials, which is considered the gold standard in scientific research. This means half the participants get the real vaccine and "half the patients get a placebo - a water shot," Ison says. And nobody - not the researchers nor the participants - will know until after the study is complete who got the placebo and who got the real vaccine.

"What we would like to see is that there's a difference in the rate of COVID-19 - with a much lower rate in patients who get the vaccine than in the patients who get the placebo," Ison says. But it takes time and a lot of people to see that sort of effect and to answer questions about safety.

The vaccine makers are aiming to enroll about 30,000 people in each trial.

"Side effects of vaccines [can be] very rare, so you need a lot of people to see if the vaccine causes any unexpected problems," Bill Miller explains. "These side effects must also be monitored carefully post-marketing to ensure that every important problem is identified."

Ison notes that there's another benefit to a large study - it helps researchers know how strong the immune response to a vaccine needs to be to be protective.
Will the vaccine protect older people? And what if I'm heavy?
With age, the immune system often mounts a lesser response to vaccination; that's why, for example, adults 65 and older can opt for a high-dose flu shot - that's thought to help bolster their protection. And scientists also know from prior research that the flu vaccine is less effective in people who carry a lot of extra weight. Ison says it's too soon to know if obesity or age will be a factor in the immune response to the COVID-19 vaccine candidates now being considered for use.

In research results so far, he says, "the small, phase 1 data shows that you can generate antibody responses even in older adults, but it'll be these larger studies that will tell us [whether] we need to use higher doses or more doses of the vaccine in certain cases." Resultsfrom phase 3 trials of safety and effectiveness are expected in the coming months.

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A COVID-19 Vaccine May Be Only 50% Effective. Is That Good Enough?

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As we get closer to a COVID-19 vaccine, it's exciting to imagine a day when the virus is gone. But a vaccine will not be a magic bullet. In fact, it may be only about 50% effective. Dr. Anthony Fauci, chief of the National Institute of Health and Infectious Disease, has tried to set realistic expectations when discussing the importance of a vaccine.

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Americans will likely experience at least one side effect from the COVID-19 vaccine, but doctors say that's normal and you should still get vaccinated.

In Moderna's Phase 3 trials, the company said the most common side effects were fatigue, muscle soreness and aches, joint pain and headache, plus pain, redness or swelling at the injection site.

More than half of Moderna's study participants had side effects from the vaccine in Phase 1 trials, according to a preliminary report published in July in the New England Journal of Medicine.

In Pfizer/BioNTech Phase 3 trials, the probability of fatigue or headaches was 3.8% and 2%, respectively.

Experts say we'll know more details about who is more likely to experience what side effects when the U.S. Food and Drug Administration finishes reviewing the Phase 3 trial data for both vaccines and releases that information to the public. The earliest that could happen is Dec. 10.

Physicians emphasize that the side effects are not just normal but also a sign that the body is reacting properly to the vaccine.

Dr. Melanie Swift, an occupational medicine physician helping lead the COVID-19 vaccination plan at the Mayo Clinic, said it's important to educate Americans about a vaccine's side effects or it may deter people from getting a second dose as needed.

"Just because you're sore doesn't mean that (the vaccine) didn't work or wasn't effective. It just means that your body responded the way it's supposed to," she said. "It's important to take both doses, or that first dose was all for nothing."
In Dr. Fauci's words: Coronavirus vaccine Q&A: When can you get it? Will you have to take it every year? Why Americans shouldn't fear a vaccine authorized by the FDA
Side effects are not adverse events

Though companies and agencies tend to interchange the terms "side effects" and "adverse effects," experts warn that "adverse events" are a very different experience.

Side effects are common and don't disrupt daily life. Adverse events are more unanticipated effects of a drug. Some adverse events from other vaccines reported over the decades include rare neurological events or vaccine-induced immune enhancement, said Dr. Len Horovitz, pulmonary specialist at Lenox Hill Hospital.

But while 10% to 15% of patients who get the flu vaccine experience side effects, Swift said adverse events likely occur in under .1% of patients.
Is this ethical? Continuing COVID-19 vaccine trials may put some volunteers at unnecessary risk
"Adverse events are rarer events. ... Side effects are common, self-limited and benign," Horovitz said. Most side effects can be treated with a Tylenol, he said.

For example, if you work out at the gym and leave feeling sore, that's a common and expected side effect, Swift said. But if you leave the gym and get pink eye, that's a reportable adverse event. And if enough people get pink eye, then there's a problem with the gym.

If someone is going to have a bad reaction to a vaccine, it is likely to occur in the first six weeks after vaccination, according to medical experts. But experts still don't know the long-term effects of the COVID-19 vaccines and won't know until after the trials are completed and researchers monitor participants in the real world for years after.

Drug and Safety Monitoring Boards for both Pfizer and Moderna reported no serious safety concerns for their vaccines. If there was an adverse event, Swift said, the board would have likely halted the trial.

That happened to Johnson & Johnson in October when its large-scale COVID-19 vaccine trial was paused after an unexplained illness in a volunteer. Another trial, run by AstraZeneca, was halted Sept. 8 after a participant in the U.K. was diagnosed with a neurological condition, believed to be transverse myelitis.

Both trials resumed after regulators found no evidence the vaccines caused the volunteers to fall ill.

"We have an extremely high standard for safety and adverse events," Swift said, adding that Moderna and Pfizer probably would not have been able to submit their vaccines for FDA authorization if an adverse event were reported during trials.

CDC adds an extra layer of safety monitoring for COVID-19 vaccine

The U.S. Centers for Disease Control and Prevention has national monitoring systems in place to track reportable adverse events from vaccines. However, the agency added another layer of safety monitoring for the COVID-19 vaccine: V-SAFE.
Follow Adrianna Rodriguez on Twitter: @AdriannaUSAT. Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.
It's a new smartphone-based, post-vaccination health checker for essential workers who receive the vaccine. For those who enroll, the program will use texting messaging and web surveys to check in with people for health problems after vaccination.

The CDC said it plans to enroll up to 20 million people during the first few months of the program. Text messages and emails will be sent daily for the first week after vaccination and then weekly for six weeks.

The agency will not only ask about side effects and possible adverse events but also will ask about coronavirus infection to better understand effectiveness and how long vaccine protection may last.

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Side effects from the COVID-19 vaccine means 'your body responded the way it's supposed to,' experts say

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Americans will likely experience at least one side effect from the COVID-19 vaccine, but doctors say that's normal and you should still get vaccinated. In Moderna's Phase 3 trials, the company said the most common side effects were fatigue, muscle soreness and aches, joint pain and headache, plus pain, redness or swelling at the injection site.

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Can you be fired for refusing to take COVID Vaccine?

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Can you be fired for refusing to take COVID Vaccine?

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The country's first Covid vaccine could be authorized for emergency use as soon as Thursday. If Pfizer and BioNTech get the green light, distribution is set to begin within days.

But as difficult as the research, development and distribution stages have been, some experts argue the hardest part of fighting the virus is actually what comes next: convincing the U.S. population to take the vaccine.

Roughly four in ten Americans say they would "definitely" or "probably" not get a vaccine, according to a recent survey by the Pew Research Center. While this is higher than it was two months ago, to achieve herd immunity, experts say that about 70% of the population needs to be vaccinated or have natural antibodies.

Employers, however, may not be taking "no" for an answer.

Under the law, an employer can force an employee to get vaccinated, and if they don't take it, fire them.

Dallas labor and employment attorney

"A couple of my corporate clients are leaning toward making the Covid vaccine mandatory," said Rogge Dunn, a Dallas labor and employment attorney.

His clients range from companies in manufacturing to food and beverage - industries that have been battered for months due to the pandemic and government-mandated lockdowns. A vaccine promises employers a return to some form of normal, which is desperately needed as businesses look to recover profits.

One of Dunn's clients in the restaurant sector thinks a compulsory inoculation requirement could be a game changer for business.

"They think it gives them a competitive advantage," explained Dunn. "They could say to their customers, 'Hey, our restaurant is safe. All of our employees have been vaccinated.'"

It may be, in part, a PR tactic, but Dunn said it is totally within an employer's rights to implement this kind of requirement.

"Under the law, an employer can force an employee to get vaccinated, and if they don't take it, fire them," said Dunn.

Dorit Reiss, a professor at the University of California Hastings College of Law, said that private businesses have pretty extensive rights. "Requiring a vaccine is a health and safety work rule, and employers can do that," said Reiss.

Take the health-care system. Dr. Hana El Sahly, who oversees a clinical trial for Moderna's vaccine candidate, believes hospitals could eventually make Covid inoculation a condition of employment, similar to how the annual influenza vaccine is required of all medical staff.

"We all have to demonstrate that we took our flu shot before we go out and see our patients on the wards," said El Sahly. "When we are sick, we cannot deliver vital functions to the community."

There are, however, a few notable exceptions to this kind of blanket requirement. If a work force is unionized, the collective bargaining agreement may require negotiating with the union before mandating a vaccine.

Anti-discrimination laws also provide some protections. Under the Americans with Disabilities Act, workers who don't want to be vaccinated for medical reasons are eligible to request an exemption. In this case, an employer would have to provide reasonable accommodation, such as allowing the employee to work remotely.

Under Title VII of the Civil Rights Act of 1964, if taking the vaccine is a violation of a "sincerely held" religious belief, they, too, would potentially be able to opt out.

When the FDA meets this week, they will decide whether to grant an emergency use authorization, or an EUA, to Pfizer and BioNTech. It may seem like semantics, but an EUA is not the same thing as full approval.

"An emergency use authorization is not a license," said Reiss. "There's a legal question as to whether you can mandate an emergency observation. The language in the act is somewhat unclear on that."

Mandatory vaccination protocols, therefore, may have to wait until the FDA completes the entire approval process for the Pfizer-BioNTech vaccine.

What is clear, however, is that if an employer does choose to mandate the Covid vaccine, a company is not liable should an employee develop side effects from a vaccine. Instead, experts say that any claims would be routed through worker's compensation programs and treated as an on-the-job injury.

For now, Dunn is advising his clients to wait three months until after a significant number of the population has been vaccinated. In the meantime, some of the businesses Dunn represents are considering incentives instead.

There are a few carrots that employers could offer. "One option is that if you get the vaccine, you don't have to have your temperature taken every day, or you don't have to wear the same level of PPE," Reiss said.

There's also talk of offering financial perks to employees who opt in to taking the vaccine. Dunn said some of his clients, including a restaurant and one company in the manufacturing sector, are seriously considering giving a cash bonus to employees who get inoculated.

And for those who still refuse? Rather than firing them, Reiss said employers could require that they complete an educational course that delves into trial efficacy data and the experience of participants.

Yasir Batalvi, a 24-year-old living in the Boston area, was one of 30,000 people who joined the trial for the Moderna vaccine. Despite initial concerns about the potential side effects, he said he's no longer worried.

"I'm not too concerned about actual long-term effects," said Batalvi. "We know from most vaccination trials that any adverse events show up in the first couple of months."

Ultimately, the U.S. is still in the midst of an employment crisis. Record unemployment numbers have put immense pressure on the labor market, especially in service-based industries, where workers are most at risk. That is a big part of why the Centers for Disease Control and Prevention has advised prioritizing frontline employees in the queue for inoculation.

So workers may not have much of a choice if they want to keep a job.

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Yes, your boss can fire you if you refuse to get a Covid vaccine

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The country's first Covid vaccine could be authorized for emergency use as soon as Thursday. If Pfizer and BioNTech get the green light, distribution is set to begin within days. But as difficult as the research, development and distribution stages have been, some experts argue the hardest part of fighting the virus is actually what comes next: convincing the U.S.

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Past vaccine disasters show why rushing a coronavirus vaccine now would be 'colossally stupid'

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Vaccine experts are warning the federal government against rushing out a coronavirus vaccine before testing has shown it's both safe and effective. Decades of history show why they're right.

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While the way the COVID-19 vaccine will be administered look the same, what is inside the vials and syringes is groundbreaking.

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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 Are Safe, Effective, and Free

Everyone 6 months and older should get an updated COVID-19 vaccine.

Stay Up to Date

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Healthcare and Public Health

Search for and find historical COVID-19 pages and files. Please note the content on these pages and files is no longer being updated and may be out of date.

Visit archive.cdc.gov for a historical snapshot of the COVID-19 website, capturing the end of the Federal Public Health Emergency on June 28, 2023.

Visit the dynamic COVID-19 collection to search the COVID-19 website as far back as July 30, 2021.

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Learn about COVID-19 vaccine planning, how vaccine recommendations will be made, and the work going into ensuring the safety of COVID-19 vaccines.

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By Ernie Mundell

HealthDay Reporter

TUESDAY, Nov. 24, 2020 (HealthDay News) - At least three new COVID-19 vaccine candidates are already in the pipeline, with a roll-out expected early in the new year. But on Monday, experts attending a meeting of an advisory committee to the U.S. Centers for Disease Control and Prevention stressed that Americans who get a shot shouldn't be surprised if they feel under the weather for a few days afterwards.

"These are immune responses, so if you feel something after vaccination, you should expect to feel that. And when you do, it's normal that you have some arm soreness or some fatigue or some body aches or even some fever," Patricia Stinchfield of Children's Hospitals and Clinics of Minnesota, told the meeting of the CDC's Advisory Committee on Immunization Practices. She represents the National Association of Pediatric Nurse Practitioners, and said providers must be ready to explain this to people who line up to get any COVID-19 vaccine.

Vaccines work to fight disease by producing an immune response within the body. And sometimes that means flu-like symptoms, such as aches, headache and fever.

Already, some volunteers in trials of candidate vaccines from drug companies Moderna, Pfizer and AstraZeneca have reported flu-like symptoms after immunization. And experts worry that those reports might keep people away from vaccination, or from required second doses.

The CDC's Dr. Sara Oliver told the committee during the five-hour-long meeting that, depending on the survey, anywhere between 40% and 80% of Americans say they'd be willing to get vaccinated.

Dr. Paul Hunter, of the city of Milwaukee health department and a voting member of the committee, said the testimonials of the first batches of people who get a COVID-19 vaccine could be crucial to wider acceptance.

"The people who highly value getting the vaccine soon and fast, early, are going to be really helpful to everyone else. And I think we really are going to need to honor them, because they are going to let us know how it feels," he told the committee. "And I think these people are likely to be health care workers who are likely to be up for that kind of task."

Continued

Another vaccine candidate

Americans were greeted with a possible advance against coronavirus as Thanksgiving week began: A third vaccine candidate shows good results in shielding recipients against the virus.

Meanwhile, U.S. coronavirus cases continued to explode: More than 179,000 new cases were recorded on Monday, with more than 12.4 million Americans now known to be infected.

Hopes for the roll-out of another effective vaccine brightened on Monday, however. Drug giant AstraZeneca announcing that late-stage clinical trials of its coronavirus shot showed it to be 70.4% effective, The New York Times reported.

The trials were conducted in the United Kingdom and Brazil in collaboration with the University of Oxford. The AstraZeneca vaccine becomes the third shot to show good effectiveness, following on the heels of promising data on vaccines from Pfizer and Moderna. Both of the latter two shots had effectiveness around 95%.

The AstraZeneca results were based on the results of two dosing regimens for the vaccine: One regimen showed an effectiveness of 62%, the company said, while the other showed a 90% effectiveness.

The regimen showing a 90% effectiveness involved a first dose given at half strength and a second dose given at standard strength. No severe cases of COVID-19 emerged among any recipients, and there was a reduction in asymptomatic infections, suggesting that the vaccine was reducing transmission of the virus, AstraZeneca said.

Worsening spread

In the meantime, the new coronavirus is spreading across America with unprecedented speed, the White House Coronavirus Task Force said in its first briefing in four months on Thursday.

"This is more cases, more rapidly, than what we had seen before," Dr. Deborah Birx said during the briefing. "You can see the increase in test positivity to around 10%." That's the number of people tested who get a positive diagnosis.

Birx pointed to a map of the country that is covered in red, highlighting the number of daily hospitalizations, which now regularly tops 70,000, CNN reported. Birx said she has been crisscrossing the country as she tries to encourage state and local leaders to take measures to stop the spread of the virus.

Continued

Still, task force members spoke out against the idea of nationwide lockdowns or schools, even as New York City returned to remote learning this week, CNN reported.

"We do know what to do and we are asking every American to do those things today," Birx stressed. That starts with wearing masks, but also staying apart and limiting gatherings, she said.

The virus spreads even when people do not show symptoms, Birx noted. "It is because of this asymptomatic spread that we are asking people to wear a mask indoors," she said. "Decreasing those friend-and-family gatherings where people come together and unknowingly spread the virus," will also help slow the spread, she added.

Earlier Thursday, the U.S. Centers for Disease Control and Prevention asked Americans not to travel for Thanksgiving. More than 187,000 cases were announced nationwide on Thursday, another single-day record, and daily tallies have been rising in 47 states, according to The New York Times.

In California, officials reported more than 13,000 new cases, a single-day record, prompting the state to announce a 10 p.m. curfew for all but essential workers, the Times reported.

Even if the current seven-day national average of about 166,000 daily cases plateaued until the end of the year, nearly 7 million more people would still contract COVID-19, the Times said.

Though talk of two highly effective vaccines came this week, they will not be widely available until spring of 2021.

"We are in for a rough period through the end of February," Dr. Jessica Justman, a professor of epidemiology at Columbia University, told the Times. "It looks hard to find a way to break it."

A global scourge

By Tuesday, the U.S. coronavirus case count passed 12.4 million while the death toll neared 258,000, according to a Times tally. According to the same tally, the top five states in coronavirus cases as of Tuesday were: Texas with nearly 1.2 million; California with just over 1.1 million; Florida with over 944,000; Illinois with nearly 666,000; and New York with almost 607,000.

Continued

Curbing the spread of the coronavirus in the rest of the world remains challenging.

Many European countries are tightening restrictions, the Associated Press reported. France has entered a nationwide lockdown, and Germany and Austria have started partial lockdowns as government officials across the continent scramble to slow a sharp rise in infections that threatens to overwhelm their health care systems.

England has followed suit, while Italy, Greece and Kosovo also announced new measures, the AP reported.

Things are no better in India, where the coronavirus case count has passed 9 million on Tuesday, a Johns Hopkins University tally showed. More than 134,000 coronavirus patients have died in India, according to the Hopkins tally, but when measured as a proportion of the population, the country has had far fewer deaths than many others. Doctors say this reflects India's younger and leaner population. Still, the country's public health system is severely strained, and some sick patients cannot find hospital beds, the Times said. Only the United States has more coronavirus cases.

Meanwhile, Brazil passed 6 million cases and had nearly 170,000 deaths as of Tuesday, the Hopkins tally showed.

Worldwide, the number of reported infections topped 59 million on Tuesday, with nearly 1.4 million deaths recorded, according to the Hopkins tally.

More information

The U.S. Centers for Disease Control and Prevention has more on the new coronavirus.

SOURCES: CNN; The New York Times; Associated Press

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Experts: COVID Vaccine May Cause Side Effects

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Americans who get a shot shouldn't be surprised if they feel under the weather for a few days afterwards, expert say. Vaccines work to fight disease by producing an immune response within the body. And sometimes that means flu-like symptoms, such as aches, headache and fever.