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Pfizer Requests FDA Authorization For Its COVID-19 Vaccine In Kids 12 To 15

Discussion in 'General Discussion' started by The Good Doctor, Apr 10, 2021.

  1. The Good Doctor

    The Good Doctor Golden Member

    Aug 12, 2020
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    The request is based on data from a Phase 3 trial that found the vaccine was 100% effective in this age group.

    Pfizer has asked the U.S. Food and Drug Administration (FDA) to expand the emergency use authorization of its COVID-19 vaccine to include kids ages 12 to 15.


    In an announcement on Friday (April 9), the company said its request for expanded authorization is based on data from its Phase 3 trial in adolescents, which found the vaccine was 100% effective in this age group.

    "Pending regulatory decision, our hope is to make this vaccine available to the 12-15-year-old age group before the start of the 2021 school year," the company said in a post on Twitter.

    The vaccine is currently authorized for emergency use in people ages 16 and older, and Pfizer's request asked the FDA to amend this authorization to allow the vaccine in adolescents. The company said it plans to make similar requests to regulatory authorities worldwide in the coming days.


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