FDA authorizes Pfizer and Moderna COVID-19 vaccine boosters for all adults

AP Photo/Jeff Chiu

(CNN) – The US Food and Drug Administration on Friday authorized boosters of the Pfizer/BioNTech and Moderna Covid-19 vaccines for all adults.

The agency expanded emergency use authorization for booster doses of both the mRNA vaccines beyond who was previously eligible; boosters had been authorized for anyone 65 and older who was vaccinated with the Pfizer or Moderna vaccines at least six months ago and for certain adults at high risk of infection or of severe disease.

Pfizer and BioNTech requested authorization last week 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 Pfizer released the booster efficacy data last month; it has not yet been peer-reviewed or published.

Moderna requested authorization of its 50-microgram booster dose for all adults on Wednesday. The company said the FDA based the EUA on the “totality of scientific evidence shared by the company,” including data that showed neutralizing antibodies had waned at about six months.

Recent real-world studies suggested that immunity from Covid-19 vaccines may begin to wane and protection against milder and asymptomatic disease, in particular, may drop. Studies have shown that booster doses restore that immunity.

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told CNN that recent data from Israel show that, among people age 60 and older, those who received a booster were less likely to become severely ill than vaccinated people who had not received a booster. Rates of severe disease remained highest among those who weren’t vaccinated.

“Throughout the course of the COVID-19 pandemic, the FDA has worked to make timely public health decisions as the pandemic evolves. COVID-19 vaccines have proven to be the best and highly effective defense against COVID-19. Authorizing the use of a single booster dose of either the Moderna or Pfizer-BioNTech COVID-19 vaccine for individuals 18 years of age and older helps to provide continued protection against COVID-19, including the serious consequences that can occur, such as hospitalization and death,” Acting FDA Commissioner Dr. Janet Woodcock said in a statement.

The US Centers for Disease Control and Prevention’s vaccine advisory committee will meet Friday to discuss expanding booster eligibility. Boosters could officially be administered to all adults after CDC Director Dr. Rochelle Walensky signs off on a recommendation.

However, the majority of adults are already eligible to receive boosters, and several states have officially opened up boosters to all adults already.

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