FDA Approves, Grants EUA for Updated 2024–2025 mRNA COVID-19 Vaccines

Text sign showing Industry News. Business photo text delivering news to the general public or a target public | Image Credit: © Artur - stock.adobe.com

FDA announced in a press release on Aug. 22, 2024 that it has approved and granted an Emergency Use Authorization (EUA) for the updated, 2024–2025 formulas of messenger RNA (mRNA) vaccines manufactured by Moderna and Pfizer (1). These vaccines include a monovalent, or single, component corresponding to the Omicron variant KP.2 strain of SARS-CoV-2.

In a separate press release, Pfizer said its version would begin shipping “immediately” and would be available in pharmacies, hospitals, and clinics across the United States within days (2).

“Vaccination continues to be the cornerstone of COVID-19 prevention,” said Peter Marks, MD, PhD, director of FDA’s Center for Biologics Evaluation and Research, in the FDA press release. “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.”

In anticipation that SARS-CoV-2 variants would continue to develop and emerge, in April 2024 the European Medicines Agency (EMA) published a report, stemming from a workshop in February 2024, on COVID-19 vaccine strains (3). At that time, EMA stressed the importance of developing updated vaccines and reviewing them for approval.

Without even predicting 2024’s late-summer COVID surge, the February workshop anticipated the timeline by which updated vaccines would most likely need to be approved and made available.

“Looking at the global picture, a strain recommendation by regulatory authorities in November/December or April/May should allow all authorized vaccine technologies (mRNA, protein/adjuvanted, inactivated) to meet the start of the autumn vaccination campaign in both hemispheres,” the report, Global Perspectives on COVID-19 Vaccines Strain Update, said (3).

“International convergence on the process and timing of COVID-19 vaccine strain updates are therefore critical in view of the continuous evolution of SARS-CoV-2,” EMA said in a press release detailing the April report (4).

FDA notified manufacturers in June 2024 that the 2024–2025 formula should be a monovalent JN.1-lineage vaccine, and later updated that guidance to inform those manufacturers that KP.2 should be the targeted strain, if possible (1).

FDA published the following guidelines for those wishing to be vaccinated:

• Individuals six months through four years of age are eligible to receive three doses of the updated, authorized Pfizer-BioNTech COVID-19 vaccine or two doses of the updated, authorized Moderna COVID-19 vaccine.
• Individuals six months through four years of age who have previously been vaccinated against COVID-19 are eligible to receive one or two doses of the updated, authorized Moderna or Pfizer-BioNTech COVID-19 vaccines (timing and number of doses to administer depends on the previous COVID-19 vaccine received).
• Individuals five years through 11 years of age regardless of previous vaccination are eligible to receive a single dose of the updated, authorized Moderna or Pfizer-BioNTech COVID-19 vaccines; if previously vaccinated, the dose is administered at least two months after the last dose of any COVID-19 vaccine.
• Individuals 12 years of age and older are eligible to receive a single dose of the updated, approved Comirnaty or the updated, approved Spikevax; if previously vaccinated, the dose is administered at least two months since the last dose of any COVID-19 vaccine.

References

1. FDA. FDA Approves and Authorizes Updated mRNA COVID-19 Vaccines to Better Protect Against Currently Circulating Variants. Press Release. Aug. 22, 2024.
2. Pfizer. Pfizer and BioNTech Receive US FDA Approval & Authorization for Omicron KP.2-adapted COVID-19 Vaccine. Press Release. Aug. 22, 2024.
3. Haigney, S. Report on COVID-19 Vaccine Strains Promotes Updates on Vaccine Compositions. BioPharmInternational.com, Apr. 22, 2024.
4. EMA. COVID-19 Vaccine Strain Updates: Global Regulators Agree on Timing and Data Requirements. Press Release. Apr. 17, 2024.