Pfizer, BioNTech asks FDA to authorize COVID-19 boosters for all adults
Pfizer and BioNTech is reportedly seeking emergency use authorization from the Food and Drug Administration for a COVID-19 vaccine booster for all individuals aged 18 years old and older.
The companies are seeking an amendment to the existing EUA for booster doses for some adults, according to a CNN report.
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The submission is based on results of a Phase 3 trial involving more than 10,000 participants; it found boosters were safe and had an efficacy of 95% against symptomatic COVID-19 compared with the two-dose vaccine schedule in the period when the highly transmissible Delta was the dominant strain.
Pfizer released the booster efficacy data last month; it has not yet been peer-reviewed or published.
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The FDA is expected to grant the request, as early as before Thanksgiving, according to The New York Times, and would give access to extra shots for 118 million fully vaccinated adults.