2024-2025 COVID-19 Vaccines: What You Need to Know The U.S. Food and Drug Administration (FDA) has recently approved and granted emergency use authorization (EUA) for updated mRNA COVID-19 vaccines for the 2024-2025 season. These vaccines, produced by ModernaTX Inc. and Pfizer Inc., are now formulated to include a monovalent component specifically targeting the Omicron variant strain KP.2 of SARS-CoV-2. This update is designed to more effectively protect against currently circulating COVID-19 variants and reduce the risk of severe outcomes, including hospitalization and death. In June 2024, the FDA recommended that the updated COVID-19 vaccines should focus on the KP.2 variant, an offshoot of the JN.1 lineage, due to the ongoing evolution of SARS-CoV-2 and a rise in COVID-19 cases. The new formula aims to offer enhanced protection as immunity from previous infections or vaccinations diminishes over time. Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, emphasized that vaccination remains a fundamental strategy in preventing COVID-19 and that these updated vaccines meet the FDA’s rigorous safety, efficacy, and quality standards. The updated mRNA COVID-19 vaccines, including Comirnaty (Pfizer-BioNTech) and Spikevax (Moderna), are approved for individuals 12 years and older, while younger children from 6 months to 11 years are eligible under EUA. The specific dosing recommendations are: Children aged 6 months to 4 years: Unvaccinated children are eligible for three doses of the Pfizer-BioNTech vaccine or two doses of the Moderna vaccine. Previously vaccinated children may receive one or two additional doses, depending on their prior vaccination history. Children aged 5 to 11 years: Regardless of prior vaccination status, they are eligible for a single dose of the updated vaccine, administered at least two months after their last dose. Individuals aged 12 years and older: They are eligible for a single dose of the updated Comirnaty or Spikevax vaccines, also at least two months following their previous dose. Immunocompromised individuals: Additional doses are authorized for certain immunocompromised patients aged 6 months to 11 years, as detailed in the vaccines' fact sheets. The updated vaccines are expected to become available in pharmacies, clinics, and hospitals across the U.S. soon. With increasing COVID-19 cases, hospitalizations, and detections in wastewater, the FDA and CDC are urging eligible individuals to receive the updated vaccines to boost their protection against currently circulating variants. While minor side effects similar to those observed with previous mRNA COVID-19 vaccines may occur, the updated formulations are anticipated to offer robust protection. The FDA will continue to monitor vaccine safety and effectiveness and assess any additional vaccine applications. The agency expects that the composition of COVID-19 vaccines will be reviewed annually, similar to the approach taken with seasonal flu vaccines.
