FDA authorizes single bivalent dose for initial COVID-19 vaccination

The Food and Drug Administration authorized using a single dose of the Moderna or Pfizer bivalent COVID-19 vaccine for primary vaccination as well as for future doses. Under today’s amended emergency use authorizations, the monovalent Moderna and Pfizer-BioNTech COVID-19 vaccines 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, M.D., director of the FDA’s Center for Biologics Evaluation and Research. “Evidence is now available that most of the U.S. 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. 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. The available data continue to demonstrate that vaccines prevent the most serious outcomes of COVID-19, which are severe illness, hospitalization, and death.”

AHA expects the Centers for Medicare & Medicaid Services to clarify in the coming days that a single dose of COVID-19 bivalent vaccine will meet the definition of fully vaccinated for purposes of complying with the vaccine mandate for health care workers and calculating the HCW vaccination rate.