FAQ: Updated FDA Recommendations for COVID-19 Vaccines

17 June, 2024

There have been several updates to COVID-19 recommendations since the initial rollout of the vaccines. The most recent update was recommended by FDA on June 5, 2024: Monovalent COVID-19 vaccines coming this fall/winter season should contain an antigen against JN.1. This FAQ covers that update and the reasons for FDA’s recommendation.

What is the most recent update?

On June 5, 2024, FDA’s Vaccines and Related Biological Products Advisory Committee recommended that COVID-19 vaccines for the 2024-2025 fall/winter season should include an Omicron JN.1-specific antigen. This is a different from current vaccines, which contain an Omicron XBB.1.5 spike antigen. The 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.) The recommendation was also supported by limited existing evidence that JN.1 antigens may provide protection across JN.1 variants such as KP.2 and KP.3. 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 early June 2024, an FDA committee recommended that for this coming fall/winter season, COVID vaccines should be updated to better protect against JN.1.


What are the next steps?

CDC’s Advisory Committee on Immunization Practices will likely discuss this change and is expected to recommend the updated vaccine. This discussion is expected to be similar to ACIP’s existing procedures surrounding seasonal influenza vaccine recommendations. It is expected that COVID-19 vaccines with a JN.1-specific antigen will be available during this coming fall/winter. In the meantime, current COVID-19 vaccines are still approved for use.

Plain language summary: It is likely that CDC will soon recommend an updated vaccine to better protect against new COVID-19 variants. The updated COVID-19 vaccines should be available this coming fall/winter.


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