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FDA Advisory Committee Opposes Approving Pfizer / BioNTech Vaccine Booster In US

Sep 17 (Reuters) – A committee of external advisers to the U.S. Food and Drug Administration (FDA) voted on Friday against approving a booster dose of the COVID-19 vaccine from Pfizer Inc / BioNTech SE to people 16 years of age or older.

The panel voted overwhelmingly against approving the boosters for Americans 16 and older, which could undermine President Joe Biden’s administration’s plan to launch third injections of the Pfizer / BioNTech vaccine as soon as the next. week.

The FDA will consider the committee’s recommendation when making its decision on boosters, but may reject the advice, as it did recently when approving Biogen Inc.’s controversial Alzheimer’s drug.

Many committee members were critical of the booster plan, arguing that the data submitted by Pfizer and the FDA is incomplete and that the application for approval for people as young as 16 is too broad.

Most of them said they would support reinforcements for older Americans, but did not believe they were necessary for younger adults yet.

(Report by Manojna Maddipatla in Bengaluru; Edited in Spanish by Javier López de Lérida)

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