The regulator on Thursday said the mRNA vaccines, Pfizer-BioNTech’s Comirnaty and Moderna’s Spikevax, will better protect against currently circulating variants as COVID continues to surge in many parts of the U.S.
The FDA on Thursday approved updated mRNA COVID-19 vaccines from Moderna and Pfizer/BioNTech, which are designed to target the KP.2 strain of the virus’ Omicron variant.
According to the regulator, these shots will help protect people from the currently circulating SARS-CoV-2 variants, while also helping prevent “serious consequences” of COVID-19 including hospitalization and death. The updated shots are monovalent, meaning they contain only a single antigen.
Both updated COVID-19 shots are fully approved for patients aged 12 years and older and are cleared for emergency use in children six months through 11 years of age. According to their respective announcements , Moderna and Pfizer/BioNTech will make the vaccines “in the coming days.”
“Vaccination continues to be the cornerstone of COVID-19 prevention,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement, noting that the U.S. population is currently facing “waning immunity” from prior exposure to the virus and to previous vaccinations.
“We strongly encourage those who are eligible to consider receiving an updated COVID-19 vaccine to provide better protection against currently circulating variants,” Marks said.
Novavax, which is also developing an updated vaccine, was left out of Thursday’s approvals. The company filed an application for its vaccine candidate in June 2024, saying at the time that its reformulated shot elicits protection against the KP.2 and KP.3 Omicron strains.
A Novavax spokesperson in a statement to Endpoints News said the company continues to work with the FDA on the review. “We expect to have authorization in time for peak vaccination season.”
The new vaccine formulations represent notable departures from the FDA’s previous preference for bivalent COVID-19 vaccines—those that target the Omicron and the original SARS-CoV-2 variant.
However, in June 2023, the regulator’s Vaccines and Related Biological Products Advisory Committee recommended that the agency switch to monovalent shots moving forward, focusing on what is currently the most prevalent variant. The FDA’s guidance now states that bivalent formulations of the vaccine “should no longer be used.”
Thursday’s approvals come as COVID-19 appears to surging in many parts of the U.S. with case counts climbing in at least 25 states, according to the Centers for Disease Control and Prevention (CDC). COVID-19’s reproduction rate indicates that infections are growing across the country. The CDC’s wastewater dashboard shows that activity across the nation is “very high.”
