The vaccine advisory committee for the Food and Drug Administration met Thursday to discuss potential changes to the formula for COVID-19 vaccines for 2025-2026.
"We are asking for guidance to help the FDA decide what strain to select for COVID-19 vaccines going forward," the Center for Biologics Evaluation and Research director Dr. Vinayak Prasad said at the beginning of the meeting.
The panel's meeting is routine, and formula changes are normal for vaccines to ensure they continue to protect against evolving viruses, according to Dr. Giridhar Mallya, a family physician and a senior policy officer at the Robert Wood Johnson Foundation.
"COVID is a virus that changes pretty regularly," Mallya said. "So, each year you need to make sure the vaccine is effective for the virus variants that are circulating among the population."
The meeting took place two days after the FDA announced new rules on access to the COVID-19 booster.
Under its new guidance, access to those shots will be restricted for younger, healthy Americans. The agency said it will limit the approval of the booster to adults 65 and older and anyone older than six months who has at least one risk factor.
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In an op-ed published in the New England Journal of Medicine announcing the decision, FDA leadership said it "anticipates the need for randomized, controlled trial data evaluating clinical outcomes" of the vaccines before it grants approval for other groups.
The agency says the guidance is in line with other high-income countries, but some medical experts say the decision should have come following a recommendation from an independent panel.
"The FDA and the CDC typically rely on the advice of independent advisory committees, and I think that's what would have been ideal here as well," Mallya said. "They very well could have come to the same conclusion as the FDA directors have, but we could have had even more confidence that a group of people who are independent from the FDA and CDC reviewed the data and made the best decision for the public health."
Opponents of the new guidance also say it still leaves out some people who are vulnerable to the virus.
"There are millions of people that may be at risk of severe COVID illness or even death that may not be able to access the vaccine because of these new recommendations," Mallya said. "The threshold they have set for the vaccine being approved for these people may not be practical or ethical."
Those groups could include younger adults who work in health care and are often exposed to older people who may be sick and people who live with someone who's immunocompromised.
In making its decision, the FDA also cited data showing a decline in the overall number of people getting the COVID-19 vaccine booster.
According to data from the Centers for Disease Control and Prevention, 23% of American adults received an updated 2024-2025 COVID-19 vaccine.
