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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