Stephen I. Feller , 2025-05-16 18:59:00
Key takeaways:
- An FDA committee will meet May 22 to discuss formulas for the 2025-2026 COVID-19 vaccines.
- WHO recommended maintaining the 2024-2025 vaccine makeup based on currently circulating viral variants.
An FDA advisory committee is scheduled to meet to discuss the formula for the next COVID-19 vaccines after being sidelined during recent discussions about the makeup of next season’s influenza vaccines.
The Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet May 22 to discuss COVID-19 vaccines, according to a notice published May 8 in the Federal Register requesting public comment ahead of the meeting.
An FDA committee will meet to discuss the makeup of next season’s COVID-19 vaccines. Image: Adobe Stock
The notice was published a little closer to the meeting than usual.
“FDA regrets that it was unable to publish this notice 15 days prior to the Vaccines and Related Biological Products Advisory Committee meeting due to technical issues,” the notice says. “Because there is a need for an immediate meeting of the committee, including the time-sensitive need for input and public discussion on the meeting subject, and because qualified members of the committee were available at this time and scheduled to participate in the meeting, the agency concluded that there are exceptional circumstances that support holding this meeting without the customary 15-day public notice.”
The VRBPAC was scheduled to discuss formulations for 2025-2026 influenza vaccines in mid-March, but the FDA canceled that meeting and opted instead to work with the CDC and Department of Defense to determine next year’s influenza vaccine makeup.
According to the notice, the FDA intends to make background materials — which might include information on the efficacy of the latest COVID-19 vaccines and currently circulating strains — available online at least 2 days before the meeting.
WHO this week said that the next COVID-19 vaccines can target the same strains as the shots for the 2024-2025 season, although it noted in a press release that reporting gaps make it difficult to track trends in cases.
Nonetheless, the agency reported that as of this month, the currently circulating SARS-CoV-2 variants are derived from the JN.1 viral strain and its weekly proportion of circulating variants is slowly increasing. The LF.7 viral strain and its descendent strains have also seen increases in circulation, whereas other variants of interest, including KP.3, KP.3.1.1, XEC and LB.1, are declining.
“Overall, the currently approved monovalent JN.1 or KP.2 vaccines continue to elicit broadly cross-reactive immune responses to circulating JN.1-derived variants,” WHO said in the release.
Seasonal vaccine makeup in the United States often mirrors WHO recommendations based on viral strains circulating globally.
References:
Perspective
In my opinion, strain changes for COVID-19 vaccines are a complicated matter. This complication stems from the fact that it’s really still unclear what the actual goal is: protection from infection or protection against severe disease.
One could argue that the original strain vaccine never lost its ability to protect against severe disease even against later variants. The protection against infection conferred by mRNA vaccines, the dominant type of vaccine used, appears transient, even when there is not a major variant shift. There are also some data showing that the non-mRNA Novavax vaccine may have more durability in terms of protection against infection. Given this context, I think the next generation of COVID-19 vaccines need to have more durable protection against infection to solve this problem.
Amesh A. Adalja, MD
Senior Scholar, Johns Hopkins Center for Health Security
Disclosures: Adalja reports participating in an advisory committee for Sanofi.
