FAQ: Updated FDA Recommendations for COVID-19 Vaccines

19 July, 2024

There have been several updates to COVID-19 vaccine recommendations since the initial rollout of COVID-19 vaccines. The most recent update was recommended by CDC’s Advisory Committee on Immunization Practices (ACIP) on June 27, 2024; monovalent COVID vaccines this coming fall/winter season should contain an antigen against JN.1. This FAQ covers that update and the reasons for the FDA’s recommendation.

What is the most recent update?

This update is a recommendation by CDC’s Advisory Committee on Immunization Practices (ACIP) that COVID-19 vaccines for the 2024-2025 winter season should include an Omicron JN.1-specific antigen. The recommendation states that everyone 6 months of age and older should receive an updated COVID-19 vaccine during the fall/winter of 2024/2025. Updated vaccines with JN.1-specific antigens will be available from Moderna, Pfizer, and Novavax later this year, likely beginning in September.

This follows a similar approval issued in June 2024 from FDA’s Vaccines and Related Biological Products Advisory Committee. This recommendation for JN.1-specific vaccines marks a difference from vaccines currently available, which instead contain an Omicron XBB.1.5 spike antigen. The updated recommendation was made because of the sharp increase in prevalence of the JN.1 variant and its subvariants from April 2024 to June 2024, as well as limited existing evidence that JN.1-specific variants may be more transmissible than other Omicron variants. (Antigenic cartography indicates that JN.1 and XBB are antigenically separate and evolve in parallel.) This recommendation was also supported by limited existing evidence that JN.1 antigens may provide cross-protection across JN.1 variants such as KP.2 and KP.3, whereas cross-reactivity of human sera against emerging variants such as KP.2 remains unknown.

Plain language summary: Updates to COVID-19 vaccines are needed because of changes that happen with the virus. Those changes include a recent increase in an Omicron subvariant called JN.1. In late July 2024, CDC recommended that everyone 6 months of age and older should receive an updated COVID-19 vaccine during the 2024-2025 fall/winter season.

 

What are the next steps?

It is expected that monovalent COVID-19 vaccines with a JN.1-specific antigen will be available during the 2024-2025 fall/winter season. In the meantime, current COVID-19 vaccines are still approved for use.

Plain language summary: It is likely that updated COVID-19 vaccines will be available beginning in September 2024 for this coming fall/winter season. Everyone 6 months of age and older should receive an updated COVID-19 vaccine during the 2024-2025 fall/winter season.

 

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