FDA Approves EUA for New Moderna, Pfizer COVID-19 Vaccines

The Food and Drug Administration approved updated Moderna and Pfizer mRNA COVID-19 boosters for emergency use today to target the current variants like the Omicron XBB1.5, and to provide better protection against COVID-related hospitalization and death.

According to a news release from the agency, the updated mRNA vaccines are approved for individuals aged 12 years and older and are authorized under emergency use for individuals 6 months to 11 years of age.

As part of today’s approval, the bivalent COVID-19 vaccines by both Moderna and Pfizer-BioNTech are no longer authorized for use in the United States.

Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, said in the release by the agency, “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.”

In August, Moderna announced clinical trial data showing that the updated vaccine prompted an immune response against EG.5 and FL.1.5.1, the current dominant variants. Trial data also shared at the beginning of September confirmed an immune response against BA.2.86.

According to a Pfizer press release, approval of the updated Pfizer-BioNTech vaccine is “based on the full body of previous clinical, nonclinical, and real-world evidence supporting the safety and efficacy of the COVID-19 vaccines.”

The FDA outlined eligibility for the new vaccines, which includes:

• Individuals aged 5 years and older, regardless of previous vaccination, 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.
• Individuals aged 6 months through 5 years who have previously been vaccinated against COVID-19 are eligible to receive either 1 or 2 doses of an updated mRNA COVID-19 vaccine. Timing and the number of doses administered depends on the previous COVID-19 vaccine that was received.
• Unvaccinated individuals aged 6 months to 4 years are eligible to receive 3 doses of the updated Pfizer-BioNTech vaccine or 2 doses of the updated Moderna vaccine.

The U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) will meet Sept. 12 to discuss clinical recommendations on who should receive an updated vaccine, as well as further considerations for specific populations such as immunocompromised and older individuals.

Vaccine manufacturers have publicly announced that the boosters would be ready this fall, and the FDA anticipates they will be available “in the near future.”