FDA Greenlights Updated COVID-19 Vaccines; Bivalent Vaccines No Longer Authorized

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The bivalent Pfizer-BioNTech and Moderna COVID-19 vaccines are no longer authorized for use in the United States.

Updated COVID-19 vaccines from Pfizer-BioNTech and Moderna have now been approved and authorized for emergency use by the Food and Drug Administration (FDA). The new monovalent formulation has been updated to include spike proteins for the XBB.1.5 sublineage of SARS-CoV-2 to protect against currently circulating variants. As of today, the bivalent Pfizer-BioNTech and Moderna COVID-19 vaccines are no longer authorized for use in the US.

The FDA’s decision was based on recent studies demonstrating 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. These robust neutralizing antibody responses indicate that this season’s vaccines will likely be a good match against currently circulating variants.

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

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 this season’s 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 COVID-19 vaccines are expected to be available in the coming days. The Centers for Disease Control and Prevention (CDC)’s Advisory Committee on Immunization Practices will be meeting on September 12th to discuss recommendations on who should receive an updated vaccine.

“Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research. “The public can be assured that these updated vaccines have met the agency’s rigorous scientific standards for safety, effectiveness, and manufacturing quality. We very much encourage those who are eligible to consider getting vaccinated.”


  1. 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.
  2. Pfizer and BioNTech receive US FDA approval for 2023-2024 COVID-19 vaccine. News release. Pfizer Inc and BioNTech SE. September 11, 2023.
  3. Moderna receives US FDA approval for updated COVID-19 vaccine. News release. Moderna. September 11, 2023.