Bivalent mRNA COVID-19 Vaccines No Longer Authorized

When the U.S. Food and Drug Administration (CDC) approved and authorized newer mRNA COVID-19 vaccines yesterday, they also withdrew the current mRNA vaccine use in the U.S.

The FDA stated in a September 11, 2023, press release that the bivalent Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized.

The FDA approved and authorized the emergency use of updated mRNA COVID-19 vaccines formulated to more closely target currently circulating variants and provide better protection against serious consequences of COVID-19, including hospitalization and death.

These enhanced mRNA vaccines are unavailable at health clinics or pharmacies as of September 12, 2023.

This news indicates Novavax Inc.'s protein-based COVID-19 vaccine is the only one in use until the new vaccines arrive.

Furthermore, the U.S. CDC's Advisory Committee on Immunization Practices did vote affirmatively today on its recommendation for the new mRNA vaccines. The final authorization step is for the CDC's Director to issue her approval.