New COVID-19 boosters authorized and recommended

Updated versions of the mRNA vaccines against COVID-19 were authorized by the FDA and recommended by the CDC last week.

On Aug. 31, the FDA amended the emergency use authorizations (EUAs) of the Moderna and Pfizer-BioNTech COVID-19 vaccines to authorize bivalent formulations that contain both the original strain of SARS-CoV-2 and one in common between the BA.4 and BA.5 lineages of the omicron variant. The updated vaccines are to be given as a single booster dose at least two months following primary or booster vaccination. The Moderna booster is authorized for those 18 years of age and older, and the Pfizer-BioNTech is authorized for those 12 years of age and older. With this announcement, the original booster vaccines were no longer authorized for use in those 12 years and older, according to an FDA press release. The agency noted that the new EUAs were based on the safety and effectiveness of the original vaccines, safety and immunogenicity data from a trial of a formulation that included the BA.1 omicron variant, and nonclinical data on the latest formulations.

The CDC's Advisory Committee on Immunization Practices (ACIP) met on Sept. 1 to vote on a recommendation about use of the updated boosters. After review and discussion of data on the vaccines and projections for the future of the pandemic, ACIP members voted 13 to 1 to recommended the updated boosters for the populations included in the EUA, CNN reported. Later that day, CDC director Rochelle P. Walensky, MD, MPH, FACP, issued a statement endorsing the ACIP recommendations and making them CDC policy. A press release added that the CDC expects to recommend updated boosters for other pediatric populations in the coming weeks. “This recommendation followed a comprehensive scientific evaluation and robust scientific discussion. If you are eligible, there is no bad time to get your COVID-19 booster and I strongly encourage you to receive it,” Dr. Walensky said in the statement.