The Food and Drug Administration on Thursday approved new COVID shots manufactured by Pfizer-BioNTech and Moderna, as “currently circulating variants” continue to contribute to a surge in the number of COVID-related hospitalizations and deaths across most of the country.
The updated vaccines, which are expected to be available within days, are designed to target the KP.2 strain, a descendant of the highly contagious JN.1 variant.
A third drug manufacturer, Novavax, is expected to obtain authorization for a vaccine designed to target JN.1 “in time for peak vaccination season.”
“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. “These updated vaccines meet the agency’s rigorous, scientific standards for safety, effectiveness, and manufacturing quality.”
COVID-19, which continues to be the leading cause of respiratory illness-related hospitalizations, was responsible for more than 600,000 hospital stays in the U.S. in the 2023-24 season, according to Moderna CEO Stéphane Bancel.
“Staying up-to-date with your COVID-19 vaccine remains one of the best ways for people to be protected and prevent severe illness,” Bancel said.
While most people have some degree of immunity from previous exposure to the virus or from prior vaccination, that protection wanes over time, which is why Marks “strongly” encourages anyone who’s eligible “to consider receiving an updated COVID-19 vaccine to provide better protection against currently circulating variants.”
Even though a different variant, KP.3.1.1 has been singled out by the National Center for Immunization and Respiratory Diseases as the “only major variant increasing in proportion nationally — accounting for between 31% and 43% of COVID-19 clinical specimens for the two-week-period ending Aug. 17 — the newly approved vaccines “generate a substantially improved response” against multiple virus sublineages, when compared to last fall’s shot, according to a Pfizer spokesperson.