The US is poised to make COVID-19 shots more like an annual flu shot, a major change in strategy despite a long list of questions about how best to protect against a still rapidly mutating virus.
The Food and Drug Administration asked its scientific advisers on Thursday to help lay the groundwork for making the switch to once-a-year boosters for most Americans — and how and when to update the prescription of shots regularly.
“This is a follow-up meeting to determine if we have reached the point in the pandemic that allows for simplification of the use of current COVID-19 vaccines,” said Dr. FDA’s David Kaslow.
The advisory panel broadly agreed with the FDA’s approach.
COVID-19 vaccines have saved millions of lives, and booster doses continue to help those most vulnerable even as more contagious variants have emerged. But the protection wears off and the shots don’t ward off milder infections for long.
And people are tired of getting vaccinated. While more than 80% of the US population has received at least one COVID-19 vaccination, only 16% of those eligible for the latest boosters — called bivalent doses that have been updated to better match newer strains of the virus — have one receive.
This makes difficult decisions about how to proceed: Who really needs an injection, how often and which one?
“Thank God we’re still protected from serious diseases,” even after the last mutant omicron strains have emerged, noted FDA adviser Dr. Paul Offit, a vaccines expert at Children’s Hospital of Philadelphia.
The first step: The FDA advisory panel voted unanimously that people should receive the same vaccine formula whether they get their primary vaccine or a booster vaccine. Today, Americans get their first two or three doses with a formula based on the original strain of coronavirus that emerged in 2020 — and their latest refresh is a combination syringe from Pfizer or Moderna that adds Omicron protection.
The FDA would have to decide how to introduce this change.
But “this isn’t just a practical thing” to avoid confusion about different types of vaccinations, said Dr. Archana Chatterjee, Dean of Chicago Medical School.”
Who needs another shot and when did it spark more debate?
Looking ahead, the FDA said most Americans should be fine with an annual refresher aimed at the latest variants in the fall. The agency asked whether some people might need two doses – adults with weakened immune systems and very young children who have never been vaccinated before. This is similar to how teenagers get their very first flu shot.
But more data is needed to show exactly who may need two annual doses — such as a careful count of who is still being hospitalized with COVID-19 despite today’s immunizations, Offit said.
“Only then can we really decide best who gets vaccinated and with what,” he said.
It’s also not clear that younger, healthier people would need a COVID-19 refresher every year.
“It’s hard to say at this point that it will be annual,” said Dr. Eric Rubin of Harvard.
The fall may not even be the best time for a booster, which would depend on when infections start to rise and how long a booster’s protection might last, FDA adviser Dr. Arthur Reingold from the University of California, Berkeley.
Unlike the flu, which circulates primarily in the late fall and winter in the United States, waves of COVID-19 have occurred year-round.
As for the prescription, the FDA plans to convene its advisory panel for another meeting in late May or early June to decide whether the vaccine prescription needs to be adjusted — including the target virus strain and whether it should be single-strain or multi-strain. stress shot. Pfizer and Moderna said this would give them enough time to make the needed doses by the fall, while a third manufacturer, Novavax, pushed for any formulation changes to begin earlier.
Also on Thursday, US officials updated how they track that the latest COVID-19 boosters are safe. The Centers for Disease Control and Prevention has discovered a possible warning sign that seniors who get Pfizer’s updated booster shot may be at slightly higher risk of stroke. But FDA safety expert Richard Forshee said data from Medicare and several other health systems — including in other countries — found no signs of problems, leading the government to conclude the red flag is unlikely to be genuine.
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AP Health writer Matthew Perrone contributed to this report.
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