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Thursday, November 21, 2024
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    FDA Vaccine Advisory Committee rejects Pfizer’s application for booster shots

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    GNB Desk
    GNB Desk
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    FDA’s Vaccines and Related Biological Products Advisory Committee on Friday rejected Pfizer-BioNTech’s supplemental Biologics License Application for the administration of a third dose, or “booster” dose, of the COVID-19 vaccine in individuals 16 years of age and older, saying the committee needs more data.

    The vote by the Vaccines and Related Biological Products Advisory Committee was 16-2.

    The Vaccines and Related Biological Products Advisory Committee was on a virtual meeting since early Friday morning to discuss whether the data presented by Pfizer support the safety and effectiveness of a booster dose of COMIRNATY administered 6 months post-primary vaccination series.

    The meeting is continuing and there may be another vote on boosters for a limited age group.

    (This is a breaking story and will be updated)

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