JUST IN: Pfizer and BioNTech say they're seeking emergency use authorization from the FDA 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.
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 Pfizer released the booster efficacy data last month; it has not yet been peer-reviewed or published.
The new request from Pfizer and BioNTech comes as federal health officials have made clear their concern about waning immunity as the nation heads into the winter months. Read MoreThe Pfizer/BioNTech vaccine is already authorized for use in people from ages 5 to 15, and approved for people age 16 and older.