The FDA is considering a new booster schedule, but vaccine experts say more information is needed.

By Rachel Nania,  AARP

January 27, 2023 

If the space on your vaccine card is running low, you’re not alone.

In the roughly two years since the first COVID-19 vaccines became available, millions of Americans have rolled up their sleeves multiple times: first for the initial shots, then for a booster, even two, followed by an updated version of the vaccine — what’s known as a bivalent booster. 

But keeping up with the COVID vaccine schedule could get a lot simpler. The U.S. Food and Drug Administration (FDA) is proposing that many Americans get the COVID vaccine every year, just like the flu shot. So far, however, experts aren’t sure that’s the best way to go.

David Kaslow, M.D., director of the FDA’s Office of Vaccines Research and Review, explained in a Jan. 26 FDA advisory committee meeting that at this point in the pandemic, the majority of the U.S. population has some form of immunity to the virus that causes COVID-19, either because they’ve been infected or vaccinated or both, “such that a single dose of a COVID-19 vaccine would induce or restore vaccine effectiveness.” 

Some individuals who are immunocompromised or at high risk for severe disease because of their age, for example, may require more than one annual dose. The same goes for young children who have not been previously immunized.

 Simplifying the booster schedule could increase vaccinations. 

Public health experts hope that simplifying the booster schedule to one shot a year could improve vaccination rates. More than 80 percent of the U.S. population has received at least one dose of the coronavirus vaccine; about 70 percent have gotten two. But participation drops off when it comes to additional shots, which for adults have rolled out every six months or so. Only about 15 percent of Americans have gone back for the bivalent booster, according to data from the Centers for Disease Control and Prevention (CDC).

“If we recommend boosting too frequently, it won’t be accepted. And we’ve learned that; there’s vaccine fatigue out there,” says William Schaffner, M.D., a professor in the Division of Infectious Diseases at the Vanderbilt University School of Medicine and medical director of the National Foundation for Infectious Diseases. “So we’re going to have to pick an interval that’s acceptable.” 

Giving the shot annually would also allow vaccine experts and manufacturers time to update the formula to more closely match the strains of the virus that are circulating, similar to the process followed for the flu shot. “This virus, like the influenza virus, mutates; it changes periodically,” explains Schaffner, who is not a member of the committee that advises the FDA. 

Jerry Weir, with the FDA’s Office of Vaccines Research and Review, assured advisory committee members that routinely updating the vaccine does not mean the agency would be chasing variants, which are constantly emerging and fighting for a dominant spot. “None of us think that’s realistic,” he said. “But I think our experience so far with the bivalent vaccines indicates that we can continue to make improvements to the vaccine.” 

Research shows that the newly updated bivalent shots — which target the original strain of the coronavirus, plus two recently circulating omicron strains — offer superior protection against severe illness. One study recently published in the New England Journal of Medicine found the bivalent booster to be about 62 percent effective against hospitalization and death from COVID-19, while the original (monovalent) booster is now about 25 percent effective. 

Experts seek more answers

The committee of vaccine experts who met to discuss the FDA’s proposal, however, say more answers are needed before adopting a sweeping schedule change, including knowing how long vaccine protection lasts against severe disease and who, exactly, is considered high risk. Though hospitalization and death rates from COVID-19 have plummeted since this time last year, more than 3,700 Americans are still dying each week from the illness, federal data shows.

“We need the CDC to tell us exactly who it is that’s getting hospitalized and dying from this virus,” said advisory committee member Paul Offit, M.D., an infectious disease expert at Children’s Hospital of Philadelphia. “What are their ages? What, specifically, are their comorbidities? If they are immune compromised, in what manner are they immune compromised? Did they recently get a vaccine? Were they treated with antivirals, etc.?” 

Another concern that’s been raised: When is the best time to deliver an annual COVID-19 booster? The flu shot is pushed out each year in the fall — by the end of October is the ideal time to be vaccinated, the CDC says, since flu activity typically peaks between December and February. But COVID-19 hasn’t settled into a seasonal pattern yet; waves continue to hit throughout the year. 

Still, timing an annual COVID booster with the flu shot might be the best route, Schaffner says, the idea being that people only need to make one trip to the clinic or pharmacy. What’s more, vaccine manufacturers are working to create a combined COVID-flu vaccine, “which would make that much easier because then you just have to get one shot,” he adds. 

The committee did not vote on whether to implement the annual booster schedule, but Schaffner says it appears to be moving “in that direction.” Even if it is adopted, Schaffner says we’ll need to remain flexible. If the course of the pandemic changes, vaccine recommendations will probably change too. 

Phasing out the original vaccines 

The vaccine advisory committee did, however, vote in favor of phasing out the original (monovalent) versions of the COVID-19 vaccines, which are still being used to inoculate people for their initial two shots, while the bivalent vaccines are being used for boosters.

The committee is recommending that the FDA make the bivalent vaccines the only option going forward — both for those initial shots and for boosters. Doing so would “simplify things very greatly,” Schaffner says, both for the public and for health care providers who stock and administer the vaccines. 

“There’s so much confusion about these different formulations that I think anything we can do to ease up on that confusion and simplify things is going to be a good thing,” said advisory committee member Archana Chatterjee, M.D., dean of Chicago Medical School.


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