US regulators have granted Moderna Inc. full approval for its COVID-19 vaccine, Spikevax, for children aged 6 months through 11 years, but only for those at increased risk from the virus. The move marks a shift in federal policy under Health and Human Services Secretary Robert F. Kennedy Jr., who has led a controversial effort to scale back universal access to pediatric COVID shots.
The Food and Drug Administration’s decision, announced Thursday, means that healthy children in this age group will no longer have routine access to the vaccine unless it is prescribed off-label. Moderna’s shares rose more than 4% in early trading in New York following the announcement.
Under emergency use authorization during the pandemic, COVID-19 vaccines from Moderna and Pfizer were made widely available to all children. But Kennedy, a longtime vaccine skeptic, has reversed course. In 2021, he petitioned the FDA to revoke temporary approval for children’s vaccines, citing low risk of severe illness in healthy children. Now, the vaccine’s full approval ensures it remains available for high-risk kids, but also restricts broader access.