Is it time for another COVID-19 booster shot? Here’s what the FDA is said to be considering
Another round of COVID-19 booster shots could be coming this spring, for at least some Americans.
The U.S. Food and Drug Administration is expected to decide within a few weeks whether to allow a second updated booster shot for those who are older or otherwise considered at high risk for COVID-19, The Wall Street Journal reported.
Officials “are moving toward authorizing” the shots but have not yet reached a final decision and could still change their minds, the newspaper said, citing one of several unnamed people familiar with the deliberations.
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The Centers for Disease Control and Prevention would also have to sign off on the additional doses of what’s known as a bivalent vaccine, targeted at both the original strain of COVID-19 as well as versions of the omicron variant that wreaked havoc last winter.
The Wall Street Journal said the FDA is looking specifically at the need for an additional booster dose among Americans who are at least 65 years old or who have weakened immune systems.
Reuters news service said the FDA “continues to closely monitor the emerging data in the United States and globally, and that data will dictate any decision on additional updated boosters,” citing a statement from the federal agency.
The bivalent doses became available last fall, leading to concerns that the protection they provide against infection may be waning. Since the vaccine was updated, newer versions of the virus have become dominant.
Immunization authorities in both the United Kingdom and Canada already have recommended that high-risk individuals should be offered the chance to get the COVID-19 booster shot this spring, according to STAT, a Boston-based medical journalism publication.
STAT reported earlier this month “radio silence” from the FDA about booster shots this spring, “creating frustration among a small but determined group of people who are keen not to have to wait until the autumn to get another dose of COVID vaccine.”
But many Americans appear to be losing interest in following the advice of public health authorities to stay up to date on COVID-19 vaccinations, leading to talk about ways to streamline the process.
Less than 17% of Americans — and fewer than 15% of Utahns — have gotten the current updated booster shot, available to everyone 5 and older as well as some children as young as 6 months old.
Federal authorities have suggested offering an annual COVID-19 shot, updated to reflect current virus strains and rolled out at the same time people are used to getting a flu shot. An additional dose would likely be available to older and medically vulnerable Americans.
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While that plan is still being debated, some experts say there’s no reason to wait on a second dose of the current booster.
“For those who want it and have risks, they should be able to get it,” Michael Osterholm, an epidemiologist and director of the Center for Infectious Disease Research and Policy at the University of Minnesota, told The Wall Street Journal.
Dr. Leana Wen, a health policy professor at George Washington University, noted last month in her column for The Washington Post that whether some people should get a second updated COVID-19 booster shot “is by far the most-asked question.”
Wen told The Wall Street Journal she wants federal authorities to permit the shots for those at high risk.
“People have been doing this anyway by going to pharmacies and saying this is their first booster,” Wen said. “It would be reasonable to say that most people can wait until fall to get an annual shot, but those at highest risk who wish to have additional protection can get them more often.”
But other experts disagree.
“I got zero data to tell you that getting yet another booster is actually going to decrease your risk,” Dr. Gregory Poland, a vaccine researcher at the Mayo Clinic in Rochester, Minnesota, said, according to The Wall Street Journal.
STAT pointed out that a top FDA official acknowledged in an interview last fall that another updated booster dose might be needed for older adults and people who are immunocompromised.
Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, told STAT in October 2022 that he was worried about the speed at which the COVID-19 virus was mutating.
“I would be lying to you if (I said) it doesn’t keep me up at night worrying that there is a certain chance that we may have to deploy another booster — at least for a portion of the population, perhaps older individuals — before next September, October,” Marks said then.
“I’m not saying that’s what’s going to happen, but it’s what keeps me up at night, because we see how fast this virus is evolving.”