: FDA approves single booster dose of bivalent COVID vaccine for people aged 65 and older or those with immunocompromise

The U.S. Food and Drug Administration has approved an additional single dose of the bivalent COVID vaccines for individuals above the age of 65 and those with immunocompromise at least four months after their initial dose. The bivalent vaccine targets omicron and its variants as well as the original virus. The FDA amended its emergency use authorization for the vaccines developed by Moderna Inc. MRNA and Pfizer Inc. PFE and German partner BioNTech SE BNTX, and no longer allows the original monovalent vaccines for use in the U.S. Unvaccinated Americans can receive a single dose of a bivalent vaccine, rather than multiple doses that were administered using the original vaccine. “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,” said Dr. Peter Marks, director of the Fda’s Center for Biologics Evaluation and Research. “The available data continue to demonstrate that vaccines prevent the most serious outcomes of COVID-19, which are severe illness, hospitalization, and death.”

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