FDA Advisers Urge COVID Shots to Target JN.1 Variant Strains

Key Highlights:

• FDA advisers recommend targeting LP.8.1, a JN.1 subvariant, for 2025–26 COVID-19 vaccines.
• Vaccine makers face tighter FDA scrutiny, raising potential costs under new leadership.
• Moderna, Pfizer-BioNTech, and Novavax prepare to supply updated vaccines pending approval.

A panel of advisers to the U.S. Food and Drug Administration (FDA) unanimously recommended that COVID-19 vaccines for the 2025–26 season target updated strains of the JN.1 variant, and particularly the rapidly spreading LP.8.1 subvariant, which currently accounts for about 70% of the cases in the U.S. The recommendation is based on the fact that the virus is constantly mutating, and is meant to boost effectiveness of the vaccine.

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With new leadership at the FDA, Commissioner Martin Makary and vaccines chief Vinay Prasad, both of whom were critical of previous COVID-19 vaccine policies, have imposed stricter requirements on vaccine manufacturers that could result in higher costs of manufacturing. Panel members reiterated the need for frequent updates to the vaccines—and any public health interventions—because of the rapidly evolving nature of the virus, while naturally being cautious about suggesting updating the vaccines more than annually would become a burden for vaccine manufacturers.

Eric Rubin from Harvard T.H. Chan School of Public Health stated that LP.8.1 may provide broad protection. Archana Chatterjee, dean of Chicago Medical School, noted the need for flexibility depending on the population receiving the vaccines, especially at-risk groups that currently require doses twice a year.

Novavax announced it was ready to make the updated vaccine, and Pfizer-BioNTech and Moderna also said they would have new versions available quickly, with Moderna aiming to launch in mid-August. We should expect FDA guidance soon on vaccine strain updates.