FDA Alert

As Infections Increase, FDA Approves Updated Vaccines to Protect Against COVID-19 Variants

Anthony Calabro, MA

The FDA approved and authorized updated mRNA COVID-19 vaccines from Moderna and Pfizer-BioNTech for 2023-2024 to better target the Omicron XBB.1.5 subvariant.

“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.”

Most individuals aged 5 years and older are eligible to receive a single dose of an updated mRNA vaccine, despite prior vaccination status. The FDA, however, authorized additional doses for those who are immunocompromised.

Children aged younger than 5 years are potentially eligible for multiple doses of the updated mRNA vaccine if they did not complete the dose series from earlier vaccines. According to the FDA, unvaccinated individuals aged 6 months through 4 years can receive three doses of the updated authorized Pfizer-BioNTech COVID-19 vaccine or two doses of the updated authorized Moderna COVID-19 Vaccine.

And as part of the FDA’s actions, the bivalent Moderna and Pfizer/BioNTech COVID-19 vaccines are no longer authorized for use in the United States.

“Based on an evaluation of the totality of the evidence, the benefit-risk profile is favorable for individuals 6 months of age and older to receive an updated COVID-19 mRNA vaccine,” The FDA noted in a press release. “Although serious outcomes from COVID-19 are less common in younger individuals, they do occur, and it has been demonstrated that recently receiving a COVID-19 vaccine reduces the risk of such serious outcomes.”

The CDC’s Advisory Committee on Immunization Practices met on September 12, 2023 to discuss the clinical recommendations for the updated vaccines. The FDA anticipates that the updated vaccines will be available to the public in the near future.


FDA takes action on updated mRNA COVID-19 vaccines to better protect against currently circulating variants. News release. US Food and Drug Administration; September 11, 2023. Accessed September 13, 2023.