The approval of Moderna’s Spikevax for kids at higher risk of contracting the disease continues the company’s regulatory winning streak, which has also included nods for a next-gen COVID-19 vaccine and an RSV shot.
The FDA granted full approval for Moderna’s COVID-19 vaccine Spikevax for children aged 6 months through 11 years who are at higher risk of contracting the disease.
Spikevax, which was previously only available to children under an emergency use authorization, is now approved for everyone 6 months through 64 years of age who are at increased risk of COVID-19, and all seniors 65 years and up. Moderna expects to make the updated Spikevax shot available ahead of the 2025-2026 respiratory virus season.
The full approval, announced Thursday, continues a regulatory winning streak for Moderna—and comes even as health leaders show increased skepticism of the mRNA technology underlying the vaccine.
Last month, Moderna secured two key approvals for its mRNA vaccine pipeline. The first was for its next-generation COVID-19 shot mNEXSPIKE, which is now cleared for older adults 65 and above, as well as people 12 through 64 years of age who have at least one underlying risk factor. The second was for its respiratory syncytial virus shot, mResvia, which secured a broader coverage including at-risk adults 18 through 59 years.
Aside from regulatory wins, Moderna in June also reported that its flu vaccine mRNA-1010 cleared Phase III testing, outperforming a currently licensed standard-dose shot by 26.6% in adults 50 years and up. A spokesperson at the time confirmed to BioSpace that these data will contribute to Moderna’s plans to refile a biologics license application for its combo flu/COVID-19 vaccine mRNA-1083, but said the company “cannot share specifics on timeline right now.”
Moderna in May voluntarily pulled its application for mRNA-1083 after consulting with the FDA. The company at the time did not reveal a specific reason for the withdrawal, announcing instead that it would resubmit the application following data from mRNA-1010.
This plan “still stands,” a spokesperson told BioSpace on June 29, noting that Moderna still aims to share data from its vaccines with regulators “in due course.”
Despite these wins for Moderna’s vaccine pipeline, high-level barriers remain, not least of which is the continued skepticism over mRNA technology from health authorities.
Health Secretary Robert F. Kennedy Jr., for instance, said in a recent interview with former Fox News pundit Tucker Carlson that “there’s a lot of skepticism in this agency about mRNA vaccines, about mRNA technology . . . about whether it’s safe.” Meanwhile, at least one of the new members of the CDC’s Advisory Committee on Immunization Practices, Robert Malone, has previously testified before Congress to question the safety of mRNA vaccines.
