Bivalent mRNA COVID-19 Vaccines Become Simplified

The U.S. Food and Drug Administration (FDA) today confirmed it had amended the authorizations of the COVID-19 bivalent mRNA vaccines produced by Moderna and Pfizer-BioNTech.

The fact sheets have been updated and consolidated with today's authorizations for the Moderna COVID-19 Vaccine, Bivalent, and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent.

As of April 18, 2023, each vaccine now has one fact sheet for healthcare providers and one for recipients and caregivers, rather than different fact sheets for the various authorized age groups. 

"At this stage of the pandemic, data support simplifying the use of the authorized mRNA bivalent COVID-19 vaccines, and the agency believes that this approach will help encourage future vaccination," said Peter Marks, M.D., Ph.D., director of the FDA's Center for Biologics Evaluation and Research, in an FDA media release.

Today's authorizations follow discussions during a meeting with the FDA's Vaccines and Related Biological Products Advisory Committee on January 26, 2023.

At that time, unanimously, the committee recommended harmonizing the strain composition of COVID-19 vaccines used in the U.S.

There was also support for simplifying the vaccine dosing schedule. 

And this June, the FDA will hold another meeting to discuss the strain composition of the COVID-19 vaccines for fall of 2023.

Much like the FDA does yearly with the influenza vaccines, the agency will seek input from the committee on which SARS-CoV-2 variants and lineages are most likely to circulate in the upcoming year.

Once the specific strains are selected for the COVID-19 vaccines, the FDA expects manufacturers to make updated formulations of the vaccines for availability in Fall 2023.