FDA advisers recommend updating COVID shots to JN.1 strain

A panel of advisers to the U.S. Food and Drug Administration (FDA) has recommended that for the upcoming fall and winter immunization campaigns, COVID-19 vaccine makers should formulate their shots to target the JN.1 coronavirus strain.

In a meeting on Thursday convened for the first time during President Donald Trump’s second term, all nine members of the FDA’s Vaccine and Related Biological Products Advisory Committee voted in favor of updating COVID shots to JN.1, unchanged from their guidance last year.

Pfizer (NYSE:PFE), which has developed the Comirnaty COVID vaccine with its German partner BioNTech (NASDAQ:BNTX), and other leading U.S. vaccine makers Moderna (NASDAQ:MRNA) and Novavax (NASDAQ:NVAX) all said they are ready to deliver JN.1-targeting shots for the season.

Moderna (NASDAQ:MRNA) submitted an application to the FDA for review of its Spikevax 2025-2026 formula, targeting the SARS-CoV-2 variant LP.8.1.

However, Novavax (NASDAQ:NVAX) had reservations about manufacturing timelines if asked to target a newer Omicron variant called LP.8.1, currently the dominant COVID strain in the U.S.

“Although currently prevalent, LP.8.1 is unlikely to be the prevalent strain by the start of the 2025-2026 respiratory season and, in fact, could be reaching its peak relatively soon,” FirstWord Pharma reported, quoting Tonya Colpitts, global project head for vaccines at Sanofi (SNY), Novavax’s (NASDAQ:NVAX) partner for its COVID-19 vaccine, Nuvaxovid.

The FDA’s advisory committees issue non-binding recommendations. However, the regulator usually follows them before arriving at a final decision on authorizations.