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U.S. FDA vaccine advisers vote against COVID-19 booster shot approval for most Americans, but may vote later on shots for older persons
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U.S. FDA vaccine advisers vote against COVID-19 booster shot approval for most Americans, but may vote later on shots for older persons
Fri, 2021-09-17 16:04 — mike kraftSept 17 (Reuters) - A panel of expert outside advisers to the U.S. Food and Drug Administration voted against approving COVID-19 booster shots for Americans, but may vote on a narrower approval for older adults later on Friday.
The panel voted overwhelmingly against approving boosters for Americans age 16 and older, potentially undermining the Biden administration's plan to roll out third shots of the Pfizer (PFE.N)/BioNTech vaccine as soon as next week.
The FDA will take the panel's recommendation into consideration in making its decision on the boosters. But it can reject the advice as it did recently in approving Biogen Inc's (BIIB.O) controversial Alzheimer's drug
Many committee members were critical of the booster plan, arguing that the data presented by Pfizer and the FDA is incomplete and that the request for approval for people as young 16 years old is too broad. Most of them said they would support boosters for older Americans, but did not think they were needed yet for younger adults. ...
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