Advisers to the U.S. Food and Drug Administration (FDA) on June 5 advised the regulatory agency to direct vaccine manufacturers to produce new COVID-19 shots targeting the JN.
1 virus variant. Advisers voted 16–0 to recommend monovalent updated shots, after being barred from considering bivalent formulations. They then made clear that the updated shots should target JN.
1, versus one of the dominant or soon-to-be dominant strains. According to federal surveillance, JN.1 was dominant as of April 27 but was estimated to have been displaced soon after by KP.
2, a JN.1. sublineage.
Officials with Pfizer, Moderna, and Novavax presented data to the advisers from animal testing that suggested shots targeting JN.1 worked against the variant and its sublineages. While Pfizer and Moderna can more quickly switch to different formulations, Novavax is already producing a protein-based JN.
1 shot with an eye toward a fall release, helping convince advisers to stick with a recommendation for a JN.1 formulation across the board. “The potential for immunogenicity from JN.
1 vaccine to cover those variants seems to be pretty good. Antigenically, they’re very close,” Dr. Archana Chatterjee, one of the advisers, said during the meeting.
“We’re not going to try to chase variants. Whatever we recommend today is probably not going to be circulating a few weeks or a few months from now.” Dr.
Mark Sawyer said that he “did not hear a compelling reason to favor a different strain” while ot.
