FDA authorizes Pfizer/BioNTech and Moderna coronavirus vaccines for all adults
The agency extended emergency use authorization to booster doses of both mRNA vaccines beyond those previously eligible; booster boosters have been authorized for anyone 65 years of age or older who has received the Pfizer or Moderna vaccine at least six months ago and for certain adults at high risk of infection or severe illness.
Pfizer and BioNTech requested authorization last week based on the results of a Phase 3 trial with more than 10,000 participants; it found that boosters were as safe and effective against symptomatic Covid-19 as 95% of the two-dose vaccination schedule during a period when the highly transmissible Delta was the dominant strain. Pfizer released enhanced efficacy data last month; it has not yet been peer-reviewed or published.
Moderna requested authorization of a 50-microgram booster dose for all adults on Wednesday.
Recent studies suggest that immunity from a Covid-19 vaccine may begin to wane and protection against milder and asymptomatic disease, in particular, may decline. Studies have shown that boosting doses restore that immunity.
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told CNN that recent data from Israel shows that, in people 60 years of age and older, who get booster shots are less likely to be at risk. get sicker than those who are vaccinated. don’t get a booster. Rates of severe illness remain highest among unvaccinated people.
The U.S. Centers for Disease Control and Prevention’s vaccine advisory committee will meet on Friday to discuss expanding booster eligibility. The booster could officially be used by all adults after CDC Director Dr. Rochelle Walensky signs the proposal.
However, the majority of adults are already eligible to receive boosters, and some states have officially opened boosters to all adults.
According to CDC data, more than 32 million people in the United States — about 16% of those fully immunized — have received a booster dose of the Covid-19 vaccine.