FDA Authorizes Updated Boosters to Protect Against Omicron

By Jonathan Springston, Editor, Relias Media

The FDA issued an emergency use authorization (EUA) booster tailored to protect against the omicron variant, ahead of a possible surge of COVID-19 cases this coming fall and winter.

The agency granted an EUA to Moderna and Pfizer-BioNTech for their bivalent vaccines, commonly referred to as “updated boosters.” These solutions include two mRNA components of SARS-CoV-2, one of the original viral strain and the other one in common between the BA.4 and BA.5 lineages of the omicron variant. The Moderna shot can be administered as a single dose to people age 18 years and older. The Pfizer-BioNTech solution also can be administered as one shot, but for individuals age 12 years and older.

“The FDA has been planning for the possibility that the composition of the COVID-19 vaccines would need to be modified to address circulating variants. We sought input from our outside experts on the inclusion of an omicron component in COVID-19 boosters to provide better protection against COVID-19. We have worked closely with the vaccine manufacturers to ensure the development of these updated boosters was done safely and efficiently. The FDA has extensive experience with strain changes for annual influenza vaccines. We are confident in the evidence supporting these authorizations,” said Peter Marks, MD, PhD, director of the FDA Center for Biologics Evaluation and Research. “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.”

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