FDA Greenlights Updated mRNA COVID-19 Vaccines for Current Variants

SILVER SPRING, Md., Aug. 22, 2024 – The U.S. Food and Drug Administration (FDA) has approved and granted emergency use authorization (EUA) for updated mRNA COVID-19 vaccines for the 2024-2025 season. These vaccines now include a monovalent component that targets the Omicron variant KP.2 strain of SARS-CoV-2, aiming to better protect against current strains and reduce the severity of COVID-19, including hospitalizations and fatalities. The updated vaccines are produced by ModernaTX Inc. and Pfizer Inc.

In June, the FDA recommended that manufacturers adopt a monovalent JN.1 formulation for the upcoming COVID-19 vaccines. With the further evolution of the virus and an increase in COVID-19 cases, the agency advised that the JN.1-lineage vaccines should ideally be based on the KP.2 strain.

"Vaccination remains a crucial part of COVID-19 prevention," stated Peter Marks, M.D., Ph.D., director of the FDA's Center for Biologics Evaluation and Research. "These updated vaccines have met our stringent standards for safety, efficacy, and manufacturing quality. Given the waning immunity from prior exposures and vaccinations, we strongly encourage eligible individuals to consider getting the updated vaccine for better protection against circulating variants."

The updated mRNA COVID-19 vaccines include Comirnaty and Spikevax, approved for individuals aged 12 and older. Moderna and Pfizer-BioNTech vaccines are authorized for emergency use for those aged 6 months through 11 years.

Key Points:
- Unvaccinated children aged 6 months to 4 years can receive three doses of the updated Pfizer-BioNTech vaccine or two doses of the updated Moderna vaccine.
- Vaccinated children aged 6 months to 4 years can get one or two doses of the updated Moderna or Pfizer-BioNTech vaccines, depending on their previous vaccination.
- Children aged 5 to 11 years are eligible for a single dose of the updated Moderna or Pfizer-BioNTech vaccines, with a minimum two-month gap since their last COVID-19 dose.
- Individuals aged 12 and older can receive a single dose of the updated Comirnaty or Spikevax, also with a two-month gap if previously vaccinated.
- Extra doses for certain immunocompromised individuals aged 6 months to 11 years are authorized as detailed in the vaccine fact sheets.

Those receiving the updated mRNA vaccines may experience similar side effects to previous mRNA vaccines. These updated vaccines are expected to offer protection against the currently circulating variants. Unless a significantly more infectious variant emerges, the FDA plans to assess the composition of COVID-19 vaccines annually, similar to the approach taken with seasonal influenza vaccines.

In their review to authorize the updated vaccines, the FDA evaluated manufacturing and nonclinical data supporting the 2024-2025 formula. The new mRNA vaccines are produced using methods similar to those used for previous versions. Having already been administered to hundreds of millions of people in the U.S., these vaccines' benefits continue to outweigh their risks.

The FDA will continue to review any new COVID-19 vaccine applications and take appropriate regulatory actions. Comirnaty (2024-2025 formula) was approved for BioNTech Manufacturing GmbH, while the EUA for the Pfizer-BioNTech vaccine was issued to Pfizer Inc. Similarly, Spikevax (2024-2025 formula) was approved for ModernaTX Inc., and the EUA for the Moderna vaccine was issued to ModernaTX Inc.