Updated COVID-19 vaccines from Pfizer-BioNTech and Moderna have been approved and authorized for emergency use by the US Food and Drug Administration (FDA).

Pfizer-BioNTech’s COVID-19 vaccine, Comirnaty, and Moderna’s COVID-19 vaccine, Spikevax, are approved for individuals 12 years of age and older. The vaccines are authorized for emergency use for children 6 months through 11 years of age. 

The new monovalent formulations of the vaccines have been updated to include spike proteins for the XBB.1.5 sublineage of SARS-CoV-2. The previous bivalent Pfizer-BioNTech and Moderna COVID-19 vaccines are no longer authorized for use in the US.

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The FDA’s decision to approve the updated vaccines was based on recent studies suggesting that immune responses observed with the updated vaccines against currently circulating variants, including EG.5 and BA.2.86, appear to be similar to what was previously seen with prior versions of the vaccines against prior corresponding variants.

Individuals 5 years of age and older are eligible to receive a single dose of an updated mRNA COVID-19 vaccine at least 2 months after the last dose of any COVID-19 vaccine. Children under the age of 5 who have previously been vaccinated are eligible to receive 1 to 2 doses of an updated vaccine (depending on the previous COVID-19 vaccine received). Children 6 months through 4 years of age who have not been vaccinated are eligible to receive 3 doses of the updated Pfizer-BioNTech COVID-19 vaccine or 2 doses of the updated Moderna COVID-19 vaccine.

The updated vaccines are expected to be available in the coming days. The US Centers for Disease Control and Prevention (CDC)’s Advisory Committee on Immunization Practices is scheduled to meet today to discuss recommendations on who should receive an updated vaccine.


US Food and Drug Administration. FDA takes action on updated mRNA COVID-19 vaccines to better protect against currently circulating variants. Accessed September 11, 2023. https://www.fda.gov/news-events/press-announcements/fda-takes-action-updated-mrna-covid-19-vaccines-better-protect-against-currently-circulating

Pfizer and BioNTech receive US FDA approval for 2023-2024 COVID-19 vaccine. News release. Pfizer Inc and BioNTech SE. September 11, 2023. https://www.businesswire.com/news/home/20230907854671/en/Pfizer-and-BioNTech-Receive-U.S.-FDA-Approval-for-2023-2024-COVID-19-Vaccine

Moderna receives US FDA approval for updated COVID-19 vaccine. News release. Moderna. September 11, 2023. https://news.modernatx.com/news/news-details/2023/Moderna-Receives-U.S.-FDA-Approval-for-Updated-COVID-19-Vaccine/default.aspx

This article originally appeared on MPR