The U.S. Food and Drug Administration approved and authorized updated 2024-2025 formula mRNA COVID-19 vaccines targeting the Omicron variant KP.2 strain to provide better protection against serious outcomes like hospitalization and death. According to the FDA, the updated shots from Pfizer-BioNTech and Moderna are designed to match currently circulating variants amid waning population immunity.
FDA Authorization Details for 2024-2025 Formula Vaccines
The regulatory action covers updated mRNA vaccines manufactured by ModernaTX Inc. and Pfizer Inc. According to the FDA, the agency initially advised manufacturers in early June to target the JN.1 lineage. Officials subsequently updated that guidance to recommend the KP.2 strain as the preferred component for the 2024-2025 formula to better match the evolving SARS-CoV-2 virus.
“Vaccination continues to be the cornerstone of COVID-19 prevention,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, in a public statement. Marks noted that the updated products meet rigorous scientific standards for safety and effectiveness.
Product Approvals and Emergency Use Authorizations
Regulatory status varies by specific product name and age group, according to the FDA:
- Comirnaty and Spikevax: Fully approved for individuals 12 years of age and older.
- Moderna COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine: Authorized under emergency use for individuals 6 months through 11 years of age.
The agency anticipates that vaccine strain composition will need to be evaluated annually, similar to seasonal influenza vaccines, barring the emergence of a significantly more infectious variant.
Dose Guidelines Across Age Groups
Dosing schedules depend heavily on prior vaccination history and current age, as outlined by the FDA:
- Unvaccinated children (6 months through 4 years): Eligible for three doses of the Pfizer-BioNTech vaccine or two doses of the Moderna vaccine.
- Previously vaccinated children (6 months through 4 years): Eligible to receive one or two doses, with exact timing determined by their previous vaccine history.
- Children (5 through 11 years): Eligible for a single dose regardless of past vaccination status; if previously vaccinated, the dose is administered at least two months after any prior COVID-19 dose.
- Individuals 12 and older: Eligible for a single dose of Comirnaty or Spikevax; if previously vaccinated, the dose is administered at least two months after their last previous dose.
Additional doses remain authorized for certain immunocompromised individuals aged 6 months through 11 years according to product-specific fact sheets. Side effects are expected to match those reported from previous mRNA formulations.
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