FDA Authorizes Bivalent COVID-19 Boosters

FDA has issued an emergency use authorization for both the Pfizer-BioNTech and Moderna bivalent COVID-19 boosters.

FDA amended the emergency use authorizations of the Moderna and Pfizer-BioNTech COVID-19 vaccines on Aug. 31, 2022 to authorize bivalent formulations of the vaccines for use as a single booster dose two months after a primary or booster vaccination. The updated boosters contain both the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant. The Moderna vaccine is authorized for individuals aged 18 and older; the Pfizer-BioNTech vaccine for individuals aged 12 and older.

“The COVID-19 vaccines, including boosters, continue to save countless lives and prevent the most serious outcomes (hospitalization and death) of COVID-19,” said Robert M. Califf, Commissioner, FDA, in an agency press release. “As we head into fall and begin to spend more time indoors, we strongly encourage anyone who is eligible to consider receiving a booster dose with a bivalent COVID-19 vaccine to provide better protection against currently circulating variants.”

According to the press release, these approvals were based on positive findings from separate clinical trials. Both trials found the immune response against BA.1 was stronger among participants who received the bivalent vaccine than those who had received the monovalent vaccine.

“The FDA has extensive experience with strain changes for annual influenza vaccines. We are confident in the evidence supporting these authorizations,” said Peter Marks, director of the Center for Biologics Evaluation and Research, FDA, in the press release. “The public can be assured that a great deal of care has been taken by the FDA to ensure that these bivalent COVID-19 vaccines meet our rigorous safety, effectiveness and manufacturing quality standards for emergency use authorization.”

Source: FDA