FDA approves this season’s Moderna, Pfizer COVID-19 vaccines

The Food and Drug Administration (FDA) announced Thursday the approval of both Pfizer’s and Moderna’s updated COVID-19 vaccines for the 2024-2025 respiratory viral season.

The updated vaccines are designed to target the KP.2 strain of the SARS-CoV-2 virus.

“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,” the agency said in its announcement.

“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, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement.

The vaccines are approved for people 12 years old and older.

“COVID-19 remains a significant health risk and is the leading cause of respiratory illness-related hospitalization, regardless of age or health condition. In the 2023-24 season, we saw more than 600,000 hospitalizations due to COVID in the U.S. Staying up to date with your COVID-19 vaccine remains one of the best ways for people to be protected and prevent severe illness,” Moderna CEO Stéphane Bancel said.

The Hill has reached out to Pfizer for comment.

Emergency use authorization has been granted for three doses of the updated Pfizer COVID-19 vaccine or two doses of the Moderna vaccine to be administered to unvaccinated children aged between six months and 4 years of age. Children in this same cohort who’ve previously been vaccinated can receive one or two doses of either updated vaccine.

Children between 5 and 11 can receive one dose of either updated vaccine regardless of prior vaccination status. If they’ve previously been vaccinated, the FDA advised that they wait at least two months before getting the updated shots.

Moderna said it expects its updated vaccine to be available in the “coming days.” This approval comes while the U.S. is in the midst of a summer surge in cases. All U.S. regions monitored by the Department of Health and Human Services are currently reporting COVID-19 test positivity rates of 10 percent or higher.