Monovalent vaccines by these manufacturers are no longer authorized for use in the United States.
The FDA has amended the emergency use authorizations (EUAs) of both the Moderna and Pfizer-BioNTech bivalent mRNA COVID-19 vaccines, according to an agency news release.1
The newly amended EUAs simplify the vaccination schedule for most individuals, authorizing the current bivalent vaccines—original and Omicron BA.4/BA.5) to be used for all doses for all individuals aged 6 months and older, and as an additional dose for certain patient populations. The monovalent vaccines from these manufacturers are no longer authorized for use 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, the virus that causes COVID-19, either from vaccination or infection, that can serve as a foundation for the protection provided by the bivalent vaccines.”
These updated EUAs follow discussions that took place during the January 26 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, as well as supported simplifying the vaccine dosing schedule. Safety and effectiveness of both the Moderna and Pfizer-BioNTech vaccines are based on previous FDA analyses of clinical trial data of the respective monovalent vaccines.
The amended EUAs have led to the following updates:
“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.”
Additional discussions around future vaccination, as well as vaccine strain composition, will be take place during a VRBPAC meeting in June, where the FDA will seek input on which variants and lineages of SARS-CoV-2 are most likely to circulate during the upcoming year. Once these decisions have been made, the FDA expects vaccine manufacturers to make updated vaccine formulations with availability in the fall.
1. Coronavirus (COVID-19) update: FDA authorizes changes to simplify use of bivalent mRNA COVID-19 vaccines. News release. FDA. April 18, 2023. Accessed April 18, 2023. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-changes-simplify-use-bivalent-mrna-covid-19-vaccines