Monovalent COVID Vaccine De-Authorized, Second Bivalent Booster OK’d for 65+

The FDA has updated emergency use authorizations for the Pfizer-BioNTech and Moderna COVID-19 bivalent mRNA vaccines to allow individuals 65 years and older to receive a second booster dose at least four months after the first bivalent dose.

The FDA also authorized use of the current bivalent vaccines for everyone six months of age and older.

The monovalent versions of the Pfizer-BioNTech and Moderna COVID-19 vaccines are no longer authorized for use in the U.S.

“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, FDA CBER director.

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