The FDA approved and granted emergency use authorization (EUA) to update the mRNA COVID-19 vaccines for 2024-2025, which include a monovalent component that corresponds to the omicron variant KP.2 strain of SARS-CoV-2.

The mRNA COVID-19 vaccines by Moderna and Pfizer-BioNTech have updated the formula to more closely target circulating variants and to provide better protection against serious consequences of COVID-19, including hospitalization and death, the FDA said in a statement.

In early June, the FDA advised manufacturers the 2024-2025 COVID-19 vaccines 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 advised manufacturers that the preferred JN.1 lineage for the updated COVID-19 vaccines is the KP.2 strain.

The updated mRNA COVID-19 vaccines include Comirnaty (Pfizer-BioNTech) and Spikevax (Moderna), both of which are approved for people 12 years of age and older and mRNA vaccines for children 6 months through 11 years of age, which have an EUA.

Barring the emergence of a markedly more infectious variant of SARS-CoV-2, the FDA anticipates the composition of COVID-19 vaccines should be assessed annually.

“With the upcoming fall respiratory season just around the corner, it’s important for families to stay up to date on their routine vaccines, including COVID-19, to reduce the spread of respiratory illness and protect their individual health,” said Mitchel Rothholz, RPh, MBA, FAPhA, a consultant to the profession of pharmacy. “Keep in mind that your local pharmacist is here to help. Getting vaccinated isn’t just about self-protection; it’s also about protecting those who can’t and are not vaccinated.”

The FDA’s decision is based on a combination of manufacturing and preclinical data, as well as previous clinical, nonclinical and real-world evidence supporting the efficacy and safety of mRNA vaccines. The mRNA COVID-19 vaccines have been administered to hundreds of millions of people in the United States, and the benefits of these vaccines continue to outweigh their risks, the FDA said.

“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,” said StÉphane Bancel, the CEO of Moderna (Preprints 2024 May 30).

“Vaccination continues to be the cornerstone of COVID-19 prevention,” said Peter Marks, MD, PhD, the director of the FDA’s Center for Biologics Evaluation and Research.

Pfizer said its vaccines will start shipping immediately.