Elasomeran

iStock, Veronique D 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 re 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.

The FDA on Thursday approved Moderna’s Covid-19 shot for kids six months through 11 years old who are at higher risk of severe disease, the latest move that fits the agency’s new vaccine framework. The decision expands full approval of Spikevax to younger children ahead of the upcoming respiratory season. The vaccine was previously available for this age group under emergency use authorization. It’s now fully approved for all adults 65 and older and at-risk individuals six months through 64. “We appreciate the FDA’s diligent scientific review and approval of Spikevax for pediatric populations at increased risk for Covid-19 disease,” Moderna CEO Stéphane Bancel said in a release. The approval is also the latest in a series of FDA green lights for Moderna vaccines despite concerns from top health officials about mRNA technology. In the past six weeks, Moderna also won FDA approval for its next-generation Covid vaccine, mNexspike , and an expanded label for its RSV vaccine to cover adults 18 to 59 at higher risk of severe illness. When asked in a recent interview with Tucker Carlson whether he was satisfied that the mRNA vaccines were safe, HHS chief Robert F. Kennedy Jr. said he wasn’t. “I would say there’s a lot of skepticism in this agency about mRNA vaccines, about mRNA technology, about the status of it now, about whether it’s safe,” he said. FDA Commissioner Marty Makary and CBER Director Vinay Prasad announced in May that new Covid vaccine approvals would be limited to adults 65 and older and at-risk younger people. Companies would be strongly recommended to run post-marketing, placebo-controlled studies in adults 50-64 to try and expand those labels to healthy people younger than 65. Makary and Prasad defended that framework in response to criticism from clinicians and researchers published in a top medical journal on Wednesday. In a response to letters to the editor published in the New England Journal of Medicine , the two officials reiterated that the agency no longer believes the benefits of Covid-19 vaccination outweigh the risks in younger healthy adults. They also addressed more regulatory action if the newly-required post-marketing studies are delayed or fail. “If postmarketing commitments are not completed or if the findings are negative, the FDA may take additional actions in this space,” they said. The officials also rejected an argument laid out by two researchers that vaccination reduces the risk of long Covid, an umbrella term for people who have experienced a post-infection chronic illness. Survey data from CDC researchers published in December found that 8.4% adults in the US reported ever having a post-Covid condition. “Absent substantial evidence, the FDA has never permitted manufacturers to make claims about transmission or long Covid in the package inserts of Covid-19 vaccines,” Makary and Prasad wrote.