Updated COVID-19 Vaccines Approved by FDA to Defend Against Circulating Variants

The FDA has granted emergency use authorization and approved updated mRNA vaccines manufactured by Pfizer and ModernaTX for COVID-19, using a new 2024-2025 formula, which includes a monovalent component corresponding to KP.2, a strain of the Omicron variant of SARS-CoV-2, according to a news release by the agency.¹

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These newly-approved vaccines have updated formula that more closely targets currently circulating variants, and provides better protection against the serious consequences possible due to COVID-19, including death and hospitalization.¹

“These updated vaccines meet the agency’s rigorous, scientific standards for safety, effectiveness, and manufacturing quality,” Peter Markers, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in the news 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 September 2023, the FDA issued similar guidance, approving new vaccines to include components against the Omicron variant’s XBB.1.5 for the 2023-2024 COVID-19. The new guidance released follows the pattern, updating the vaccine to better protect against versions of the virus that are more prevalent than previous strains that have waned.²

Earlier this summer, the FDA advised the manufacturers of COVID-19 vaccines to, if feasible, include a monovalent JN.1-lineage vaccine of the KP.2 strain. 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.³

This specific request for a strain to be targeted was made “to ensure that the COVID-19 vaccines more closely match circulating SARS-CoV-2 strains,” according to the agency. FDA then relayed the update to the vaccine manufacturers, which have been able to effectively produce the vaccines, and lead to this approval.³

“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,” read a news release from Pfizer-BioNTech. “This season’s Pfizer and BioNTech COVID-19 vaccine will begin shipping immediately and be available in pharmacies, hospitals, and clinics across the US beginning in the coming days.”⁴

Similar adverse events to previous versions of the vaccine may be observed in these new vaccines, the FDA wrote. They predicted that the composition of COVID vaccines would continue to be evaluated on a seasonal basis, as they do for influenza vaccines.¹

Stéphane Bancel, CEO of Moderna, applauded the approval of these new vaccines in a news release from Moderna. "We appreciate the US 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,” Bancel said in the news release.⁵

REFERENCES

1. FDA. FDA approves and authorizes updated mRNA COVID-19 vaccines to better protect against currently circulating variants. News Release. Released 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. Gallagher A. FDA authorizes updated COVID-19 vaccine formulations for current variants. Pharmacy Times. Published September 11, 2023. Accessed August 22, 2024. https://www.pharmacytimes.com/view/fda-authorizes-updated-covid-19-vaccine-formulations-for-current-variants

3. FDA. FDA updates advice to manufacturers of COVID-19 vaccines (2024-2025 formula): if feasible use KP.2 strain of JN.1-lineage. 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

4. BioNTech. Pfizer and BioNTech receives US FDA approval & authorization for omicron KP.2-adapted COVID-19 vaccine. News Release. Released August 22, 2024. Accessed August 22, 2024. https://investors.biontech.de/news-releases/news-release-details/pfizer-and-biontech-receive-us-fda-approval-authorization

5. Moderna. Moderna receives US FDA approval for updated COVID-19 vaccine targeting KP.2 variant of SARS-CoV-2. News Release. Released August 22, 2024. Accessed August 22, 2024. https://www.accesswire.com/906024/moderna-receives-us-fda-approval-for-updated-covid-19-vaccine-targeting-kp2-variant-of-sars-cov-2