FDA approves updated COVID-19 vaccines

Sept. 12, 2023

Ahead of respiratory virus season, the FDA announced this week that it has granted approval and emergency use authorization for updated COVID-19 vaccines designed to offer protection against current variants of the virus.

 All individuals aged 5 and older, regardless of prior vaccination status, are eligible for the updated Pfizer and Moderna vaccines. The jabs are approved for individuals aged 12 and older, with emergency use authorization extending to those aged 6 months to 11 years. As a result of this update, the previous bivalent Moderna and Pfizer-BioNTech COVID-19 vaccines will no longer be authorized for use in the U.S.

The agency is recommending a single dose, administered at least 2 months after their last COVID-19 vaccine. Unvaccinated individuals aged 6 months to 4 years can receive either three doses of the updated Pfizer-BioNTech COVID-19 vaccine or two doses of the updated Moderna COVID-19 vaccine.

A CDC advisory panel will meet today to recommend whether the updated COVID-19 shots should be given broadly or just to specific higher risk populations.

The FDA anticipates that the updated vaccines will be available "in the near future."