FDA Updates COVID Vaccine Guidance as RFK Jr. Limits Use

The FDA has advised vaccine makers to update COVID-19 shots for fall and winter to target the JN.1 strain, focusing on the LP.8.1 subvariant. Moderna and Pfizer plan updates, with Moderna already applying for FDA approval of an LP.8.1 shot.

New FDA leaders, Martin Makary and Vinay Prasad, have set stricter approval rules, requiring stronger evidence for broad use. Meanwhile, Health Secretary Robert F. Kennedy Jr. announced the CDC removed COVID vaccines from recommended schedules for healthy children and pregnant women, possibly affecting insurance coverage.

The FDA’s updated standards allow approvals based on immune response in high-risk groups but require placebo-controlled trials for healthy individuals. Regulators align on monovalent vaccines targeting JN.1/LP.8.1. Novavax, approved for older adults and high-risk groups, is evaluating updates under these guidelines.

28-05-2025