FDA targets January for Pfizer COVID-19 vaccine approval decision
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The Food and Drug Administration (FDA) will weigh full approval for the Pfizer-BioNTech COVID-19 vaccine in people aged 16 and older by January, the companies announced Friday.
The FDA granted a "priority review" designation for the companies’ Biologics License Application (BLA) completed in May, which included late-stage trial data on safety and efficacy up to six months post-second dose.
The FDA has not yet approved any COVID-19 vaccine, but has given emergency use authorization (EUA) to vaccines developed by Pfizer-BioNTech, Moderna and Johnson & Johnson.
The FDA did not respond to FOX Business' request for comment at the time of publication.
This is a developing story. Check back for updates.
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