FDA Approves Updated mRNA COVID-19 Vaccines for KP.2 Strain

The FDA has “approved and granted emergency use authorization 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.” Their website has the release.

The mRNA COVID-19 vaccines “have been updated with this formula to more closely target currently circulating variants and provide better protection against serious consequences of COVID-19, including hospitalization and death.” Peter Marks, director of the FDA’s Center for Biologic Evaluation and Research, touts the new vaccines in the face of “waning immunity of the population from previous exposure to the virus and from prior vaccination.”

The updated vaccines include Comirnaty and Spikevax, “both of which are approved for individuals 12 years of age and older, and the Moderna COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine, both of which are authorized for emergency use for individuals 6 months through 11 years of age.”

Similar side effects are expected for individuals who receive an updated mRNA vaccine as “those reported by individuals who previously received mRNA COVID-19 vaccines and as described in the respective prescribing information or fact sheets. The updated vaccines are expected to provide protection against COVID-19 caused by the currently circulating variants. Barring the emergence of a markedly more infectious variant of SARS-CoV-2, the FDA anticipates that the composition of COVID-19 vaccines will need to be assessed annually, as occurs for seasonal influenza vaccines.”