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FDA panel votes against broad rollout of Pfizer booster shot, but may endorse narrower use

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A Food and Drug Administration advisory panel voted 16-2 Friday to advise the agency against approving a booster dose of the Pfizer-BioNTech Covid-19 vaccine.

The vote is non-binding, but it is an unexpected roadblock for the Biden administration's plan to begin administering boosters widely as early as next week. Pfizer is seeking approval from FDA to offer the booster to people 16 and older, while Moderna has applied for authorization to market boosters for people 18 and older.

The advisory panel's unexpected no vote came after an hourslong debate that centered on concerns about the amount and quality of data available to weigh the booster's long-term effectiveness and its safety in young people. The independent committee is now debating whether to endorse a more limited use of the Pfizer-BioNTech booster for older people and those who are considered to be at higher risk of severe disease because of their underlying health or occupational exposure.

The meeting comes amid heated debate among federal and outside scientists about whether evidence supports the Biden administration's plan to begin rolling out boosters widely as early as next week. The FDA panel's vote is not binding, but the agency usually follows the recommendations of its advisory committee. Should the FDA sign off on booster doses, a CDC expert panel will meet next week to iron out the specifics of who should receive boosters and when.

Peter Marks, FDA's top vaccine regulator, asked committee members to examine "the totality of the evidence in order to make your recommendation for us,” including data from Israel showing that booster doses slashed the risk of severe Covid infections in its older population.

"The decision FDA needs to make is based on complex data evolving in front of our eyes," he said. "There are different views. Differing opinions are critical to assisting in regulatory determination. It's no secret here.”

But the panel's independent members voiced concerns about the lack of data on the safety and efficacy of a booster dose for the general public, especially people younger than 60.

"While I........

© Politico

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