FDA poised to authorize booster shot of Pfizer Covid-19 vaccine

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The Food and Drug Administration will authorize a booster dose of Pfizer and BioNTech’s Covid-19 vaccine for people 65 and older as soon as Wednesday night, three people familiar with the decision told POLITICO.

The move is expected to align with the recommendation the agency’s independent vaccine advisers made last week, although some details of the agency’s ultimate decision — and the timing — remain unclear. The FDA announcement could slip until Thursday, the sources said.

The FDA vaccine advisory committee on Friday endorsed offering boosters people at high risk of severe disease as well as those 65 and older. In a separate, unofficial vote, the group also backed the notion of offering boosters to people with high on-the-job exposure to Covid-19, such as health workers.

The agency is expected to issue its decision before the Centers for Disease Control and Prevention’s own outside advisers convene a meeting at noon Thursday to further refine how the Pfizer-BioNTech booster should be administered, culminating in a vote to endorse the shot’s use.

The FDA declined to comment. The White House didn’t immediately respond to a request for comment.

The Biden administration had hoped to begin a broader booster rollout this week, after top federal health officials endorsed the idea of offering third does of the Pfizer-BioNTech and Moderna Covid-19 vaccines to most adults on that timetable. But in the weeks after that announcement, scientists in and out of the federal government pushed back against the idea, arguing there was not convincing evidence for the plan.

Two of FDA’s top vaccine regulators decided to retire from the agency, at least in part over disagreements related to the administration’s booster timeline.

FDA’s vaccine advisory panel threw a wrench in the administration’s original booster plans on Friday when its members rejected the notion of fully approving the Pfizer-BioNTech booster for people 16 and older, citing concerns about the quality of existing data on safety and effectiveness. The panel instead endorsed narrower use of the shot.