The Food and Drug Administration (FDA) has advised COVID-19 vaccine manufacturers to update their shots to target the JN.1 variant, focusing specifically on a subvariant known as LP.8.1, in preparation for the upcoming fall and winter season.
This decision follows a vote by the FDA’s advisory panel, which supported the JN.1 lineage as the best option for updated vaccines, continuing the strategy used the previous year. Vaccine makers Moderna and Pfizer have said they expect to make the necessary updates in time. Moderna submitted an application to the FDA on Friday for a vaccine targeting LP.8.1.
Under the agency’s new leadership, however, the process for approving COVID vaccines is changing. FDA Commissioner Martin Makary and vaccine policy chief Vinay Prasad have introduced stricter approval standards. In a related move, Health and Human Services Secretary Robert F. Kennedy Jr. announced on Tuesday that COVID-19 vaccines are no longer part of the Centers for Disease Control and Prevention’s (CDC) recommended schedule for healthy children and pregnant women.
Kennedy and the FDA’s new leadership are moving quickly to revise vaccine policies. They argue that earlier guidelines encouraged broad vaccine use without strong supporting evidence. “Last year, the Biden administration pushed healthy children to get another COVID shot, even though there was no clinical data justifying repeat boosters for them,” Kennedy said on social media platform X.
Taking COVID shots off the CDC’s official schedule could lead to some insurers no longer covering vaccination for healthy children and pregnant women.
The CDC’s advisory committee is expected to meet next month to vote on who should be eligible for updated COVID boosters.
Going forward, the FDA will evaluate booster shot applications based on new standards. These standards allow for approval in older adults or high-risk groups based on immune response data but require more rigorous placebo-controlled trials for healthy adults and children.
At a recent FDA advisory meeting, some panel members questioned whether these rules would apply to strain updates, which could delay the availability of new boosters. Jerry Weir, director of the FDA’s Division of Viral Products, said it was still unclear whether the new framework would apply.
The advisory panel voted unanimously to support a vaccine update based on the JN.1 lineage but debated whether to recommend focusing more narrowly on the LP.8.1 subvariant. Both the World Health Organization and the European Medicines Agency support using monovalent vaccines targeting JN.1 or KP.2, although the EMA prefers LP.8.1.
The FDA has taken a similar stance. “To better match current SARS-CoV-2 strains, COVID-19 vaccines for use in the U.S. starting in fall 2025 should be monovalent and based on the JN.1 lineage, preferably the LP.8.1 strain,” the agency said.
Recently, the FDA granted full approval to Novavax’s COVID-19 vaccine, but only for adults over 65 and people aged 12 to 64 who are at high risk of severe illness. At Thursday’s meeting, Novavax noted that updating its vaccine to target LP.8.1 might be more challenging, though the FDA’s guidance could offer some flexibility.
On Tuesday, Novavax told BioPharma Dive that the company and its partner Sanofi plan to offer a COVID-19 vaccine for the upcoming season and are reviewing feedback from regulators. They said they would share updates about the selected strain soon.
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