Pfizer had originally proposed approving a booster shot for everyone 16 and older. But the advisers rejected that idea out of concern that the data to support such a broad application was thin and there could be risks, especially for younger people.
“It’s not clear to me that the data we’re seeing right now is applicable or necessary for the general population,” said National Institutes of Health scientist Michael Kurilla. Another panelist, Paul Offit of the Children’s Hospital of Philadelphia, said he wanted to see more data on the risk of heart inflammation in younger men.
Instead, the panel voted 18-0 in favor of an emergency-use authorization -- a more limited clearance than a full approval -- for people 65 and older or individuals at high risk of severe Covid-19. The vote didn’t specify what was meant by “high risk,” though panelists later agreed the authorization could include people who may be exposed to Covid-19 because of their jobs, such as health-care workers.
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Arnold Monto, acting chair of the advisory committee, also left the door open for the group to recommend emergency use authorization for boosters in younger people later, when more information becomes available about potential side effects and effectiveness.
“That’s the beauty of an EUA,” he said. “It can be changed based on changing data.”