Recently, the U.S. Food and Drug Administration approved and granted emergency use authorization (EUA) for updated mRNA COVID-19 vaccines (2024-2025 formula) to include a monovalent (single) component that corresponds to the Omicron variant KP.2 strain of SARS-CoV-2. The updated mRNA COVID-19 vaccines target currently circulating variants more closely and provide better protection against severe outcomes, including hospitalization and death. These actions relate to updated mRNA COVID-19 vaccines manufactured by ModernaTX Inc. and Pfizer Inc.

However, In early June, the FDA advised manufacturers of licensed and authorized COVID-19 vaccines that the COVID-19 vaccines (2024-2025 formula) should be monovalent JN.1 vaccines. Based on the further evolution of SARS-CoV-2 and a rise in cases of COVID-19, the agency subsequently determined and advised manufacturers that the preferred JN.1-lineage for the COVID-19 vaccines (2024-2025 formula) is the KP.2 strain, if feasible.

Also Read: Pfizer and BioNTech Update on mRNA Vaccine Program for Flu and COVID-19

“Vaccination continues to be the cornerstone of COVID-19 prevention, These updated vaccines meet the agency’s rigorous, scientific standards for safety, effectiveness, and manufacturing quality. Given waning immunity of the population from previous exposure to the virus and from prior vaccination, we strongly encourage those who are eligible to consider receiving an updated COVID-19 vaccine to provide better protection against currently circulating variants.” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research.

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