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[Originally published: Oct. 2, 2023. Updated: Oct. 4, 2023.]
Note: Information in this article was accurate at the time of original publication. Because information about COVID-19 changes rapidly, we encourage you to visit the websites of the Centers for Disease Control & Prevention (CDC), World Health Organization (WHO), and your state and local government for the latest information.
There will be better protection against severe disease, hospitalization, and death from COVID-19 in the coming months now that newly updated (2023-2024 formula) mRNA COVID vaccines are available. The new shots are expected to keep more people from getting seriously ill with the virus through the winter, when infections and hospitalizations tend to tick upwards. And unlike the spring booster that targeted people ages 60 and older, these updated vaccines are for everyone ages 6 months and older.

The Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) approved the updated vaccines by Pfizer-BioNTech and Moderna in mid-September. (In early October, they also authorized an updated Novavax vaccine for use in individuals 12 and older; more on that below.)

The vaccines target XBB.1.5, a subvariant of Omicron that dominated the United States-and the world-from November 2021 until earlier this year. The CDC said the updated vaccines should also work against currently circulating variants of the SARS-CoV-2 virus-many of which descended from, or are related to, the XBB strain. This includes EG.5, the dominant strain in the U.S., and BA.2.86, a new subvariant sparking concern because it has more than 30 mutations to its spike protein.

While COVID-19 has been causing mostly mild illness recently, Yale Medicine infectious diseases specialist Onyema Ogbuagu, MBBCh, reminds people that the disease can still lead to hospitalization and death. "Infections can have long-term consequences," Dr. Ogbuagu says, adding that even healthy people can develop Long COVID -a condition in which new, continuing, or recurring (and sometimes debilitating) symptoms are present four or more weeks after an initial coronavirus infection.

Below, Yale experts tell you what you need to know about the updated COVID vaccine.

1. Why would another COVID vaccination help?

The updated vaccines are not expected to prevent all cases of COVID, including those causing mild illness; rather, their aim is to reduce severe illness, hospitalization, and death from infection. According to the CDC, COVID is still a major cause of serious respiratory illness, with more than 200,000 reported deaths since January 2022. That figure includes more than 600 deaths in adolescents and children ages 19 and younger.

Older people (especially those ages 50 and older) are more likely than younger people to get very sick from COVID. Immunocompromised people and those with chronic medical conditions, such as diabetes or heart disease, are at the highest risk of severe disease and death, but some young, healthy people have also gotten very ill and died from COVID. In addition, the CDC recommends the vaccine for pregnant women to protect both mother and baby.

An analysis by the CDC suggested that making its vaccine recommendation universal could prevent 400,000 hospitalizations and 40,000 deaths in the U.S. over the next two years.

2. How is the updated COVID vaccine different from the previous one?

The bivalent booster, which is no longer available, was introduced in the fall of 2022. It targeted the BA.4 and BA.5 Omicron subvariants and the original SARS-CoV-2 virus. The new vaccine is monovalent, designed to prevent severe disease from the Omicron XBB.1.5 subvariant. By September, the long-running XBB.1.5 accounted for only about 3% of cases in the U.S., but most of the strains circulating now are descended from (or closely related to) it.

That's a good example of how the virus has evolved-and it's still evolving-so rapidly that it may be impossible to match each new vaccine update to the variants circulating at the time it is released, explains Scott Roberts, MD, a Yale Medicine infectious diseases specialist. "But we know from experience that the vaccines hold up very well, even against multiple variants, unless there is a significant shift like we saw with Delta to Omicron in the winter of 2021," he says. "Basically, if you have some immunity to a variant and are exposed to a new offshoot of it, you'll have some protection."

3. Why isn't the new COVID vaccine considered a booster?

The FDA is calling the new shots "updated vaccines" in anticipation of needing to provide updated formulas annually, similar to the flu shot, which changes each year.

A booster shot gives a "boost" to the recipient's existing immunity from a previous vaccination. Updated vaccines are different in that they are expected to provide protection against currently circulating variants, helping the body build a new response to those variants. "Barring the emergence of a markedly more virulent variant, the FDA anticipates that the composition of COVID-19 vaccines may need to be updated annually, as is done for the seasonal influenza vaccine," the FDA noted in its approval and authorization of the new vaccine.

"I think we're going to fall into a pattern very similar to the flu, where every year the virus is going to mutate slightly, and the vaccine formulation for the fall will be an educated guess," says Dr. Roberts. "We will make a vaccine targeted against whatever we predict or whatever is currently circulating and hope our vaccines are a good match, because we will be developing them before we know what variants will be circulating in the fall."

4. Will this COVID shot protect against Omicron strains EG.5 and BA.2.86?

It's a good question, considering EG.5 made up 29.4% of cases at the end of September, more than any other SARS-CoV-2 virus strain at the time, followed by another XBB descendent called FL 1.51, which accounted for 13.7% of cases. "The XBB characteristics of the shot are genetically similar to EG.5," Dr. Roberts says. "They're not identical, but they're pretty close. So, there's going to be protection with the updated vaccine."

There is still more to learn about BA.2.86, which appeared in the U.S. in August and is not reported to be widespread in this country at this point. The multiple mutations to its spike protein could be a sign that it is more transmissible or could cause more severe disease, although so far, nobody knows for sure. However, the CDC says the new shots should work against the new strain.

5. How safe is the updated COVID vaccine?

The benefits of the COVID-19 vaccine continue to outweigh any potential risks, and serious reactions after COVID-19 vaccination are rare, according to the CDC. The agency cited a study showing the risk of cardiac complications, including myocarditis (an inflammation of the heart muscle), in males 12-17 years old was 1.8-5.6 times higher after a COVID-19 infection than after COVID-19 vaccination.

6.Are there any special COVID vaccine recommendations for children?

The FDA approved the updated mRNA vaccines for adolescents and teenagers ages 12 and older and authorized them for emergency use in children ages 6 months through 11 years.

Children are less likely to get seriously ill with COVID, but some still do, says Magna Dias, MD, a Yale Medicine pediatric hospitalist. She tells parents who are still not sure whether they should get the vaccine for their children to talk to their pediatrician, especially if their child is immunocompromised. "In that case, I think it's a no-brainer to protect them," she says.

7. Is there an updated COVID vaccine from Novavax?

The FDA authorized an updated version of a vaccine Novavax developed to target the XBB.1.5 strain. Individuals 12 and older previously vaccinated with a COVID-19 vaccine (and who have not already been vaccinated with a recently updated mRNA COVID-19 vaccine) are eligible to receive one dose; unvaccinated individuals can receive two doses.

According to the FDA, the updated vaccine addresses currently circulating variants to provide better protection against serious consequences of COVID-19, including hospitalization and death.

The Pfizer-BioNTech and Moderna vaccines use messenger RNA (mRNA) technology, which instructs the body's cells to make proteins that trigger an immune response against COVID-19. The Novavax protein-based vaccine uses an older, more traditional technology and a different mechanism-it directly injects the spike protein (formulated in a laboratory) and another ingredient into the body, leading to the production of virus-fighting antibodies and T cells. The Novavax vaccine is the only non-mRNA COVID-19 vaccine available in the U.S.

8.When should I get the updated COVID vaccine?

Dr. Roberts encourages people to get their shot in October for immunity that will last through the middle of winter, when cases are expected to peak. The shot will boost immunity within two weeks, and maximal vaccine protection is usually in the first three months after the shot, he says. "I would say October is when you want to start thinking about getting it, anticipating that November, December, and January will be the rough period."anticipating that November, December, and January will be the rough period."

People 5 years and oldermay get one dose of the updated vaccine at least two months after the last dose of any previous COVID vaccine. Babies and young children usually need more doses than older children and teens. Anyone who recently had COVID-19 may consider delaying their vaccine by 3 months.

9. Should I get the updated COVID vaccine and other seasonal shots at the same time?

The CDC considers it safe to get the COVID shot and annual flu vaccine simultaneously. There is even research in progress to explore the effects of administering both vaccines in a single shot.

But the respiratory syncytial virus (RSV) vaccines for older adults and pregnant women (who can pass the antibodies along to their newborns) are brand new this fall, and there isn't data to say for sure whether giving those at the same time as the other two shots is the best strategy.

10. Where can I get the updated COVID vaccine?

As with previous COVID-19 vaccines, this one will be available at participating pharmacies and provider offices. To find a location near you that carries the vaccine and to schedule an appointment, go to Vaccines.gov. You can also call 1-800-232-0233 (TTY 1-888-720-7489). Be aware that current distribution and insurance issues may delay availability of the vaccines temporarily in some places.

According to the CDC, the vaccines are covered by insurance, including private insurance, Medicare plans, and Medicaid plans. Uninsured children and uninsured adults also have access through the Vaccine for Children Program and Bridge Access Program, respectively.
Information provided in Yale Medicine articles is for general informational purposes only. No content in the articles should ever be used as a substitute for medical advice from your doctor or other qualified clinician. Always seek the individual advice of your health care provider with any questions you have regarding a medical condition.

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The Updated COVID Vaccines Are Here: 10 Things to Know

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The FDA approved updated (2023-2024 formula) COVID-19 vaccines, which are expected to keep more people from getting seriously ill with the virus, including recent strains EG.5 and BA.2.86.

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Opinion: Covid vaccines are a modern miracle. We might not have them without these protections | CNN Business

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While society will marvel at the science behind these vaccines for years to come, policymakers should not overlook two important factors that together have made vaccine development possible: intellectual property (IP) protections that encourage private sector research and development and access to investor capital.

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The new COVID-19 vaccine is now available at participating pharmacies and health care providers, and the Centers for Disease Control (CDC) recommends it for everyone 6 months of age and older - yet not all health experts are on board.

Dr. Joseph Ladapo, Florida's surgeon general, spoke on camera to Fox News Digital about his concerns surrounding the updated COVID shot.

"It's just a really terrible idea," Ladapo said. "And it's remarkable and really spellbinding that [the CDC] would make that kind of recommendation in the absence of evidence."

By "evidence," Ladapo is referring to clinical trials, which were not conducted for the new vaccine.

"The FDA and CDC could have compelled Pfizer or Moderna to conduct clinical trials - that's something that's totally doable - and they didn't do it," he noted.

'The risks are very real'

In addition to the rare risk of myocarditis - inflammation of the heart muscle - Ladapo shared his concerns about other potentially dangerous side effects of the vaccine.

"The risks are very real, which adds to the madness of the way that the CDC and the FDA are making decisions right now," the Florida surgeon general said.

One of those risks, he said, is something called "negative effectiveness" - a phenomenon in which contact among vaccinated people can result in the vaccines becoming less effective.

Multiple studies across various countries and time periods have demonstrated that after a few months of boosters, the vaccine effectiveness appears to "go negative," according to Ladapo.

While there are other potential scientific explanations, the doctor said there appears to be some effect on immunity - and an increased risk of infection - stemming from the many COVID-19 vaccines.

"I suspect that it is a real finding and a major safety concern," he said. "And they're pushing the product on human beings. That is an anti-human approach ... an anti-human policy."

Another potential risk of the new COVID vaccine, according to Ladapo, is that multiple studies have linked it to the presence of spike protein in the body, up to six months after injection.

The spike protein - which is found on the surface of SARS-CoV-2, the virus that causes COVID-19 - helps to enable the entry of the virus into healthy cells.

"There are so many reasons to say 'pause' at this point. Instead, the CDC and FDA are saying 'full steam ahead.'"

"The CDC was vocal about the spike protein being a very short-lived phenomenon ... and now we have people who, for prolonged periods of time, seem to have evidence of spike proteins circulating in their tissues," Ladapo said. "Is that a safe outcome? I don't think so."

He added, "It raises serious questions about the appropriateness of using these products in human beings."

"Human beings deserve better than these products that have very high rates ... of serious adverse events."

Ladapo cited a 2022 study led by UCLA and the University of Maryland - published in the journal Vaccine - which found that there was a 16% higher risk of serious adverse events in mRNA vaccine recipients.

"There are so many reasons to say 'pause' at this point," he said.

"Instead, the CDC and FDA are saying 'full steam ahead.'"

Ladapo clarified that he is not against therapies that have proven to be safe and effective, such as the antiviral drug Paxlovid.

"The risks are very real, which adds to the madness of the way that the CDC and the FDA are making decisions right now."

"We're very supportive of treatment," he told Fox News Digital. "The problem with considering this many COVID-19 vaccines for any population right now is that there's no clinical evidence for them. That's a major problem."

The "real shame," Ladapo said, is that it would have been easy for health agencies to run trials and gather evidence of the vaccine's safety.

"COVID circulates year-round, and high-risk individuals tend to have higher rates of infection. We could have found the answer to that question."

As a physician, Ladapo said he would be "very uncomfortable recommending the new COVID vaccine to anyone at this point in time, given the absence of clinical data."

He went on, "With the questions about negative efficacy, the persistence of spike protein, and then the stuff we've seen related to thromboembolic events like strokes and cardiac injury, I don't feel comfortable ... recommending [the vaccine] to any living being on this planet."

To protect themselves, Ladapo recommends that people try to "be as healthy as they can" and take medications as needed.

"But they should be safe medications," he clarified. "This is really an insult to humanity to be pushing this medication on them."

Dr. Marc Siegel, a clinical professor of medicine at NYU Langone Medical Center and a Fox News medical contributor, said he recommends the vaccine for kids who are at a higher risk, elderly people, and those who have underlying conditions including obesity, heart disease, cancer, lung disease and immunodeficiencies.

"The virus itself is more concerning than the potential for vaccine side effects," the doctor told Fox News Digital.

Those who have had COVID recently or who have had a bad reaction to previous vaccines, however, "should probably not take it," Siegel said.

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New COVID vaccine push is 'anti-human,' says Florida surgeon general: 'Major safety concern'

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Dr. Joseph Lapado, Florida's surgeon general, spoke with Fox News Digital about his concerns about the updated COVID shot, which the CDC recommends for everyone 6 months of age and older.