The FDA on Thursday gave its nod to the updated COVID-19 vaccines for the 2024-25 season, preparing for an expected spike in cases this upcoming fall and winter.
Both Pfizer’s and Moderna’s updated vaccines are granted full approval for people age 12 and older, and they’re authorized for emergency use for children 6 months to 11 years old. The approval comes as COVID-19 infection rates have increased this summer, according to wastewater data collected by the Centers for Disease Control and Prevention.
Experts predict that COVID-19 will spike twice per year, in the summer and winter, based on how the virus has evolved in past years. The FDA is planning to update the vaccines once per year, on the same timeline that annual flu vaccines are updated, depending on which strain is circulating.
“These updated vaccines meet the agency’s rigorous, scientific standards for safety, effectiveness, and manufacturing quality,” Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research, said in a statement. “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.”
Unvaccinated children between the ages of 6 months and 4 years can receive either three doses of Pfizer’s vaccine or two of Moderna’s. If they have been previously vaccinated, they can receive either one or two doses of Moderna’s. The number and timing of doses will depend on when they received their last shot, according to the FDA. People age 5 and older are eligible for an updated shot at least two months after their last COVID-19 vaccine, FDA said.
Back in June, the FDA directed vaccine manufacturers to make monovalent vaccines targeting the JN.1 variant, but the agency later told manufacturers to instead target the KP.2 strain if possible, given how the virus had evolved.
Still, getting people to take the updated shots has been an uphill battle for public health officials. The majority of people who were hospitalized for COVID-19 last year hadn’t received an up-to-date vaccine, according to data presented to the CDC’s vaccine advisers this past June.
As of May, hospitals are no longer required to report data on COVID-19 hospitalizations to the CDC, although the agency still encourages voluntary reporting.
“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 in a statement. “We appreciate the U.S. FDA’s timely review and encourage individuals to speak to their healthcare providers about receiving their updated COVID-19 vaccine alongside their flu shot this fall.”
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