US FDA recommends that next-generation COVID-19 vaccines should target the JN.1 variant

The US Food and Drug Administration (FDA) on June 7 recommended that COVID-19 vaccine makers target the JN.1 variant that spread widely earlier this year for next-generation vaccines for the fall of 2024, similar to recommendations from the World Health Organization (WHO) and the European Union.

The FDA made the announcement after its advisers said the vaccine should target the JN.1 variant rather than the new KP.2 variant. The advisers said JN.1 is the only variant that Novavax, one of the vaccine makers, claims its vaccine will protect against. Novavax plans to commercially distribute a vaccine targeting the JN.1 variant in the US market in September.

Moderna said on June 7 that it had submitted an application to the FDA for authorization of a vaccine targeting the JN.1 variant. Moderna expects to receive authorization in August, while Pfizer and its partner BioNTech said they would be ready to provide new vaccines as soon as they are authorized.

According to data from the US Centers for Disease Control and Prevention, JN.1 was the dominant variant in the US earlier this year, but is no longer spreading widely. It is estimated that this variant caused 3.1% of COVID-19 cases in the US in the two weeks from May 26 to June 8. Meanwhile, the KP.2 variant caused about 22.5% of cases, and the KP.3 variant is now dominant with 25% of cases.