COVID-19 Vaccine Update: FDA Amends Pfizer, Moderna EUAs, Simplifying Use of Bivalent Formulations

The US Food and Drug Administration today amended emergency use authorizations (EUAs) of both the Moderna and Pfizer-BioNTech bivalent mRNA COVID-19 vaccines to broadly simplify the vaccination schedule for the majority of US residents, according to an agency news release.

Leading the EUA amendment is authorization of the current bivalent vaccines (against original and Omicron BA.4/BA.5 strains) from both manufacturers to be used for all vaccine doses in the US given to persons aged ≥6 months and for additional dose/s to be given to adults aged ≥65 years and those who are immunocompromised.

The amendment ends authorization for use of the monovalent formulations of the mRNA COVID-19 vaccines in the United States.

“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, MD, PhD, director of the FDA Center for Biologics Evaluation and Research. “Evidence is now available that most of the US population 5 years of age and older has antibodies to SARS-CoV-2…either from vaccination or infection, that can serve as a foundation for the protection provided by the bivalent vaccines.”

The Agency’s actions follow discussions held during the late January meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC). During that meeting, the committee unanimously recommended “harmonizing the strain composition of COVID-19 vaccines” in the United States, and also fully supported simplification of the dosing schedule.

Support for replacement of the monovalent vaccines with broad use of the bivalent formulations is based on the FDA’s analyses of data from clinical trials of the monovalent Moderna and Pfizer/BioNTech shots.

The Agency said that all fact sheets have been updated and consolidated for both bivalent vaccines, resulting in 1 fact sheet for health care providers and 1 for patients and caregivers rather than the numerous different fact sheets published by authorized age group.

“COVID-19 continues to be a very real risk for many people, and we encourage individuals to consider staying current with vaccination, including with a bivalent COVID-19 vaccine,” Marks said. “The available data continue to demonstrate that vaccines prevent the most serious outcomes of COVID-19, which are severe illness, hospitalization, and death.”

The FDA will convene a meeting of the VRBPAC in early June during which the Agency will request input on which variants and lineages of SARS-CoV-2 are most likely to circulate during the upcoming year, leading to an ultimate decision on vaccine strain composition for fall of 2023.

CLICK HERE for a list of updates related to FDA amendents to Pfizer/BioNTech and Moderna EUAs.