Moderna's COVID-19 Vaccine Gains Full Approval for At-Risk Children Amid Regulatory Shifts

Moderna's COVID-19 vaccine, Spikevax, has received full approval from the U.S. Food and Drug Administration (FDA) for use in children aged 6 months through 11 years who are at higher risk of contracting COVID-19. This approval extends the vaccine's availability beyond its previous emergency use authorization, marking a significant milestone in Moderna's regulatory journey.

Expanded Approval and Upcoming Availability

The FDA's decision grants full approval for Spikevax in individuals 6 months through 64 years of age who are at increased risk of COVID-19, as well as all adults 65 years and older. Moderna anticipates making an updated version of Spikevax available ahead of the 2025-2026 respiratory virus season, aligning with the evolving landscape of COVID-19 prevention strategies.

Moderna's Recent Regulatory Successes

This approval continues Moderna's string of regulatory achievements. Last month, the company secured two key approvals: one for its next-generation COVID-19 shot, mNEXSPIKE, approved for older adults and at-risk individuals 12 and above, and another for its respiratory syncytial virus (RSV) vaccine, mResvia, which received broader coverage for at-risk adults aged 18 to 59.

Additionally, Moderna reported positive Phase III results for its flu vaccine mRNA-1010, outperforming a standard-dose shot by 26.6% in adults 50 years and older. These data are expected to contribute to Moderna's plans to refile a biologics license application for its combination flu/COVID-19 vaccine, mRNA-1083.

Regulatory Challenges and Skepticism

Despite these successes, Moderna faces challenges in the evolving regulatory environment. Health Secretary Robert F. Kennedy Jr. has expressed skepticism about mRNA technology, stating in a recent interview that there is "a lot of skepticism in this agency about mRNA vaccines... about whether it's safe." This sentiment is echoed by at least one new member of the CDC's Advisory Committee on Immunization Practices, Robert Malone, who has previously questioned the safety of mRNA vaccines before Congress.

The FDA, under commissioner Marty Makary and deputy Vinay Prasad, has implemented a stricter vaccine framework requiring additional data for booster shot approvals in healthy adults and children. This new criteria could potentially slow down vaccine development processes.