FDA Grants EUA for Updated mRNA COVID-19 Vaccines Targeting Omicron Variant KP2

The FDA has granted emergency use authorization (EUA) for updated mRNA COVID-19 vaccines, including those from ModernaTX Inc and Pfizer Inc. These 2024-2025 vaccines feature a monovalent component targeting the Omicron variant KP2 strain. The updated formula is designed to protect against currently circulating variants and aims to reduce serious outcomes such as hospitalization and death.

Eligibility guidelines for COVID-19 vaccinations vary by age group; Unvaccinated children aged 6 months through 4 years are eligible to receive three doses of the updated Pfizer-BioNTech COVID-19 Vaccine or two doses of the updated Moderna COVID-19 Vaccine. Those in this age group who have previously been vaccinated are eligible for one or two doses of the updated Pfizer-BioNTech or Moderna COVID-19 vaccines, depending on their prior vaccination history.

Children aged 5 through 11 years are eligible for a single dose of the updated Moderna or Pfizer-BioNTech COVID-19 vaccines, regardless of their previous vaccination status. If they have been previously vaccinated, this dose should be administered at least 2 months after their last COVID-19 vaccine dose.

For those aged 12 years and older, a single dose of the updated Comirnaty or Spikevax vaccines is recommended. If they have been previously vaccinated, this dose should be given at least 2 months after their last dose of any COVID-19 vaccine.

Additionally, certain immunocompromised individuals aged 6 months through 11 years are authorized to receive additional doses, as specified in the Moderna and Pfizer-BioNTech COVID-19 Vaccine fact sheets.

The approval of Comirnaty and Spikevax, along with the EUA amendments for Pfizer-BioNTech and Moderna vaccines, comes after an evaluation of manufacturing and nonclinical data. These updated vaccines utilize a similar process to earlier formulas and are anticipated to offer enhanced protection against COVID-19.

In June, the FDA advised vaccine manufacturers to consider including the KP2 strain in the 2024-2025 COVID-19 vaccine formula due to evolving data on SARS-CoV-2 strains and rising COVID-19 cases. The FDA's updated guidance shifts from recommending a monovalent JN1-lineage vaccine to emphasizing the KP2 strain, based on recent data showing its significant presence among COVID-19 cases. The KP2 strain, part of the JN1 lineage, is now seen as a key component for better aligning vaccines with circulating variants.

The authorization updates to mRNA COVID-19 vaccines target the Omicron variant KP2 strain. These vaccines are intended to improve protection against current COVID-19 variants and reduce severe outcomes. Eligibility guidelines outline the number of doses required for different age groups. This update reflects the need to adapt vaccine formulas based on new data and aims to address changes in the virus. The FDA will continue to review and adjust vaccine recommendations as necessary.

References

1. FDA Approves and Authorizes Updated mRNA COVID-19 Vaccines to Better Protect Against Currently Circulating Variants. 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. June 13, 2024. Accessed August 22, 2024. https://www.fda.gov/vaccines-blood-biologics/updated-covid-19-vaccines-use-united-states-beginning-fall-2024