FDA Makes a Big Shift on COVID Vaccine Policy

The Food and Drug Administration announced a major shift Tuesday on how COVID-19 vaccines will be approved—and it could mean that not everybody who wants a COVID shot this fall will be able to get one. In a paper published in the New England Journal of Medicine, top FDA officials said vaccines would be approved for people over 65 and those with certain medical conditions, but new clinical trials would be required before COVID boosters are approved for healthy people under 65, the New York Times reports. "The FDA will approve vaccines for high-risk persons and, at the same time, demand robust, gold-standard data on persons at low risk," they wrote.

• A "stark break." The AP describes the new policy as a "stark break" from previous federal guidance that recommended an annual booster for everybody six months and older. In the paper FDA Commissioner Martin Makary and Vinay Prasad, the agency's vaccine division chief, said boosters offer "uncertain" benefits for younger people who have been vaccinated previously or who have had COVID. The Times notes that Makary and Prasad strongly criticized vaccine mandates during the pandemic.

• Vaccines might not be updated every year. Makary and Prasad said Tuesday that COVID shots for children and healthy adults will no longer be routinely approved in the the way flu shots are, NBC News reports. They also suggested that the shot might not be updated every year. "Instead of having a COVID strategy that's year to year, why don't we let the science tell us when we should change?" Prasad said. "The virus doesn't have a calendar." In the paper, they noted that other high-income countries changed their recommendations years ago while the US stuck with a "one-size-fits-all regulatory framework."
• Criticism. Some experts said that while the concerns may be legitimate, the announcement appears to usurp the role of the CDC's advisory panel on vaccines, the AP reports. Others expressed concerns that the new framework could limit vaccine access for healthy people who are exposed to COVID because of their jobs. "I think that changes like this will lead to more unnecessary deaths," Daniel Griffin, a physician who has treated thousands of COVID patients, tells the Times. "What they're really doing is they're very slowly reducing vaccination in the country."

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