Dive Brief:
- The Food and Drug Administration on Thursday granted full approval for Moderna’s COVID-19 vaccine Spikevax in children aged 6 months through 11 years who are at an increased risk for COVID disease.
- The shot was previously available for these individuals under emergency use authorization. The company said it expects to have an updated version of its shot available in time for the 2025-2026 respiratory disease season.
- In May, Health and Human Services Secretary Robert F. Kennedy Jr. announced that COVID vaccines would no longer be recommended for healthy children and pregnant people. The Centers for Disease Control and Prevention currently recommends shared clinical decision-making for healthy children.
Dive Insight:
COVID vaccines have faced increased scrutiny this year under Kennedy’s HHS leadership. Messenger RNA-based shots are especially in the spotlight, but even Novavax’s Nuvaxovid, a vaccine made with older technology, encountered delays.
FDA commissioner Marty Makary and his deputy Vinay Prasad, who leads the FDA office overseeing vaccines, have put out a new, stricter vaccine framework that requires drugmakers gather additional data to win approval for booster shots in healthy adults and children. This new criteria could slow down development.
Outside of the FDA, Kennedy last month abruptly fired all 17 members of an advisory panel to the CDC, replacing them with his own hand-selected advisers, who don’t all have the typical background and experience in epidemiology and vaccine science. This panel, known as ACIP for short, recommends who should receive FDA-approved vaccines. Its guidelines influence insurance coverage.
The new panel members met earlier this month and aggressively questioned evidence supporting the efficacy and safety of COVID vaccines. They did not vote on COVID shot guidelines, however.
This week, six medical associations and a pregnant physician sued Kennedy for his actions removing universal recommendations for COVID shots in children and pregnant women. The lawsuit claims the move is unlawful and puts public health at risk.
While Kennedy and Makary’s actions affect COVID shot makers broadly, Moderna has come under particular stock market pressure. The company aims to seek approval of a combination influenza and COVID shot, but withdrew its initial application after the FDA’s new approval rules were set. Recent study data could pave the way for Moderna to refile.
In an emailed statement on Thursday’s approval, an HHS spokesperson said that “the FDA’s Center for Biologics Evaluation and Research granted this approval following a targeted review of the vaccine’s data, focused specifically on protecting children at highest risk.”
Editor’s note: This story has been updated to include comment from HHS.
