FDA Grants Approvals for Two Updated COVID-19 Vaccines

The FDA has granted approval and emergency use authorization (EUA) for updated mRNA COVID-19 vaccines from Pfizer and Moderna. The updated vaccines include a single component that corresponds to the Omicron variant KP.2 strain of SARS-CoV-2, which the FDA indicates is the preferred strain for the 2024-2025 fall and winter season.

Both vaccines are approved for people 12 years of age and older, and both are authorized for emergency use for people 6 months through 11 years of age.

“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,” Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, said in a news release.

Pfizer and Moderna officials indicated in news releases that the vaccines will be available in the coming days.

Both companies said the approval was based on previous clinical, nonclinical, and real-world evidence supporting safety and effectiveness, as well as manufacturing and nonclinical data on the KP.2-adapted vaccine.

Infections and hospitalizations from COVID-19 have been increased over the summer, according to the CDC’s surveillance. In June, the FDA had advised manufacturers of that the updated vaccines should include monovalent JN.1. The agency had updated that guidance after a rise in cases of COVID-19 and an analysis revealed the circulating vaccines contained the Omicron JN.1 sublineage KP.2.

The CDC is recommending that everyone ages 6 months and older receive an updated 2024-2025 COVID-19 vaccine. The CDC also suggests that for those who have recently had a COVID-19 infection can wait three months before receiving a vaccine.

“Even if you’ve already received a previous COVID-19 vaccine, getting the latest version helps your immune system keep pace with the everchanging characteristics of the virus which is crucial to prevent severe consequences of an acute infection and protect you from the lasting and often devastating impacts such as long COVID,” said Phillip Levy, M.D., professor of Emergency Medicine and associate vice president of Translational Science at Wayne State University.