FDA Approves Updated COVID-19 Vaccines

On Aug. 22, the U.S. Food and Drug Administration (FDA) approved updated mRNA COVID-19 vaccines manufactured by ModernaTX Inc. and Pfizer Inc. The 2024-2025 formulas include a single component that corresponds to the Omicron variant KP.2 strain of SARS-CoV-2. 

The COVID-19 vaccines have been updated with this formula to more closely target currently circulating variants and provide better protection against serious consequences of COVID-19, including hospitalization and death. The shots should be available within days.

“Vaccination continues to be the cornerstone of COVID-19 prevention,” said Peter Marks, M.D., Ph.D., FDA’s Center for Biologics Evaluation and Research director. “These updated vaccines meet the agency’s rigorous, scientific standards for safety, effectiveness, and manufacturing quality. 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.”

The updated mRNA COVID-19 vaccines include Comirnaty and Spikevax, both of which are approved for individuals 12 years of age and older, and the Moderna COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine, both of which are authorized for emergency use for individuals 6 months through 11 years of age.

As CMM previously reported, last year’s new vaccine rollout was in mid-September, but the U.S. is fighting a summer wave of infections. The U.S. Centers for Disease Control and Prevention reported that the number of people testing positive for COVID-19 keeps rising and that emergency room visits and hospitalizations are too.