Pfizer/ BioNTech seek FDA authorization for Covid-19 vaccine booster for all adults

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Tue, 2021-11-09 18:17 — mike kraft

Pfizer and BioNTech seek FDA authorization for Covid-19 vaccine booster for all adults Pfizer and BioNTech said on Tuesday they're seeking emergency use authorization from the US Food and Drug Administration for a Covid-19 vaccine booster for all individuals age 18 and older. The companies are seeking an amendment to the existing EUA for booster doses for some adults. Amanda Sealy and Jamie Gumbrecht, CNN CNN

CNN) -- ...

The companies said 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 Pfizer released the booster efficacy data last month; it has not yet been peer-reviewed or published.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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