WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) has approved and granted emergency use authorization for the latest mRNA COVID-19 vaccines, formulated for the 2024-2025 period. This update focuses on a monovalent component targeting the Omicron KP.2 strain of SARS-CoV-2, aimed at enhancing protection against the evolving virus. ModernaTX Inc. and Pfizer Inc. are the manufacturers behind these updated vaccines.
Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, emphasized the need for vaccination amid waning immunity and rising COVID-19 cases. “Vaccination continues to be the cornerstone of COVID-19 prevention,” Dr. Marks stated, underscoring the necessity for eligible individuals to consider the updated vaccines for better protection against circulating variants.
The updated vaccines, Comirnaty and Spikevax, are approved for individuals aged 12 and older. Meanwhile, the Moderna and Pfizer-BioNTech vaccines are authorized for emergency use in children aged 6 months to 11 years. The FDA outlined specific eligibility: children aged 6 months to 4 years, unvaccinated, can receive three doses of the Pfizer-BioNTech or two doses of the Moderna vaccine. Those previously vaccinated in this age group are eligible for one or two doses, depending on their prior vaccination history. Individuals aged 5 to 11 can receive a single updated dose, with a minimum two-month interval from their last vaccine dose. For those 12 and older, a single updated dose is available after a similar interval.
The FDA has conducted a thorough review of manufacturing and nonclinical data to support the inclusion of the KP.2 strain in the vaccines. These updated vaccines, produced using the same processes as previous versions, have been administered to millions, confirming that their benefits outweigh any risks. The agency anticipates an annual assessment of the vaccines’ composition, akin to influenza vaccines, to address any emerging variants.
Additionally, the FDA will continue its review of other COVID-19 vaccine applications to ensure prompt regulatory action. The approval and EUA amendment for the Comirnaty and Pfizer-BioNTech vaccines were granted to BioNTech Manufacturing GmbH and Pfizer Inc., respectively. Similarly, the approval and EUA for Spikevax and Moderna vaccines were issued to ModernaTX Inc.
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