On May 22, an FDA advisory committee unanimously recommended COVID-19 vaccine manufacturers target the JN.1 variant in their formulations.
The Vaccines and Related Biological Products Advisory Committee made the same recommendation in summer 2024, suggesting COVID-19 vaccine makers focus on the JN.1 variant.
This year, the World Health Organization said JN.1 and KP.2 vaccines are appropriate and one targeting LP.8.1 is a suitable alternative. The European Medicines Agency preferred the LP.8.1 variant, adding that JN.1- and KP.2-focused vaccines are acceptable.
In the U.S., the LP.8.1 variant accounts for 70% of COVID-19 infections and JN.1 accounts for 0%, according to CDC data. And although the CDC is not tracking NB.1.8.1, the emerging variant is behind a COVID-19 surge in China, CBS News reported May 22.
While the FDA considers the advisory committee’s proposal, the agency has already instructed COVID-19 shot manufacturers to provide stronger clinical evidence of vaccine efficacy for healthy adults younger than 65. The existing approval process is the same for adults older than 65 and Americans with underlying conditions.
The FDA said the new rules reflect growing uncertainty about the benefit of repeated boosters in low-risk populations.
