FDA Grants Approval, EUA for Updated mRNA COVID-19 Vaccines

The updated COVID-19 vaccines will include a monovalent component corresponding to KP.2, a strain of the Omicron variant of SARS-CoV-2.

The US Food and Drug Administration (FDA) today approved and granted emergency use authorization (EUA) for updated mRNA COVID-19 vaccines for this fall that include a monovalent component corresponding to KP.2, a strain of the Omicron variant of SARS-CoV-2.1

The FDA awarded approval for Pfizer’s Comirnaty and Moderna’s Spikevax vaccines (2024-2025 formulations) for individuals 12 years and older and granted EUA for both vaccines for individuals 6 months through 11 years, according to the agency’s statement.1

The updated 2024-2025 vaccine formulation more closely targets currently circulating SARS-CoV-2 variants and provides better protection against the serious consequences related to COVID-19, including hospitalization and death.1

Recap of Recommendations for Updated Vaccines1

  • Unvaccinated persons aged 6 months to 4 years are eligible to receive 3 doses of Comirnaty or 2 doses of Spikevax.
  • Individuals aged 6 months to 4 years who have been previously vaccinated are eligible to receive 1 or 2 doses of Comirnaty or Spikevax (timing and number of doses depends on the previous COVID-19 vaccine received).
  • Individuals aged 5 to 11 years, regardless of previous vaccination, can receive a single dose of Comirnaty or Spikevax; if previously vaccinated, administer this dose at least 2 months after the last dose of any COVID-19 vaccine.
  • Individuals 12 years and older are eligible to receive a single dose of Comirnaty or Spikevax; if previously vaccinated, administer the dose at least 2 months after the last dose of any COVID-19 vaccine.
  • Additional doses are authorized for certain immunocompromised individuals aged 6 months through 11 years.

“These updated vaccines meet the agency’s rigorous, scientific standards for safety, effectiveness, and manufacturing quality,” Peter Marks, MD, PhD, director, Center for Biologics Evaluation and Research, FDA, said in the press release. “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.”1

In early June, the FDA advised licensed and authorized COVID-19 vaccine manufacturers that the 2024-2025 formulations should be monovalent JN.1 vaccines. However, after a rise in COVID-19 cases and continued evolution of the SARS-CoV-2 virus, the FDA determined and subsequently advised manufactures that the preferred JN.1 lineage for the COVID-19 vaccines is the KP.2 strain, if feasible.1 This update was based on a recommendation from the FDA’s Vaccines and Related Biological Products Advisory Committee, which voted unanimously to recommend that composition be included in 2024-2025 vaccines.2

“Staying up to date on vaccinations in line with the Centers for Disease Control and Prevention recommendations remains important, particularly in light of COVID-19 cases on the rise again,” Pfizer said in a press release today. “This season’s Pfizer and BioNTech COVID-19 vaccine will begin shipping immediately and be available in pharmacies, hospitals, and clinics across the U.S. beginning in the coming days.”3

Adverse events similar to those seen with previous formulations of the vaccine may be observed after receipt of these new vaccines, as described in their respective prescribing information or fact sheets, the FDA wrote. Unless a more virulent strain of SARS-CoV-2 emerges, requiring a vaccine reformulation, the FDA expects that the composition of COVID vaccines will continue to be evaluated on a seasonal basis, as it is for influenza vaccines.1

References:

  1. FDA approves and authorizes updated mRNA COVID-19 vaccines to better protect against currently circulating variants. News item. FDA. August 22, 2024. Accessed August 22, 2024. https://www.fda.gov/news-events/press-announcements/fda-approves-and-authorizes-updated-mrna-covid-19-vaccines-better-protect-against-currently
  2. Updated COVID-19 vaccines for use in the United States beginning in fall 2024. FDA. Updated August 13, 2024. Accessed August 22, 2024. https://www.fda.gov/vaccines-blood-biologics/updated-covid-19-vaccines-use-united-states-beginning-fall-2024
  3. Pfizer and BioNTech Receive U.S. FDA approval & authorization for Omicron KP.2-adapted COVID-19 vaccine. News item. Pfizer. August 22, 2024. Accessed August 22, 2024. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-receive-us-fda-approval-authorization

Related Content:

FDA NewsCoronavirusInfectionImmunization
Online Misinformation on UTIs, ASB is Common and Dangerous: New Research
FDA Clears Phase 2 Study of Cannabis for PTSD Treatment in Veterans
New UTI Guideline Offers Treatment Clarity, but Reveals Pressing Gaps in Research