SHERIDAN, WYOMING – July 12, 2025 – Moderna has received full approval from the U.S. Food and Drug Administration for its COVID-19 vaccine, Spikevax, for children aged 6 months through 11 years who are at higher risk of contracting the disease, reinforcing the company’s position as a key innovator in the mRNA vaccine space.
Spikevax, which had previously been available to children only under an emergency use authorization, is now fully approved for:
- Children 6 months through 11 years at increased risk
- Individuals aged 6 months through 64 years at increased risk
- All adults 65 years and older
Moderna expects to make the updated Spikevax shot available ahead of the 2025-2026 respiratory virus season.
Momentum Across Moderna’s mRNA Vaccine Pipeline
The pediatric approval follows a series of regulatory successes for Moderna. Last month, the company secured two key approvals that broaden the reach of its mRNA-based vaccine portfolio.
“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.”
These authorizations build on the company’s strategic goal of offering targeted protection to populations most vulnerable to respiratory infections.
Flu Vaccine Advancements and Combination Shot Plans
In June, Moderna also reported strong clinical data for its flu vaccine candidate. “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.”
These results are expected to support a re-filing of its biologics license application for a combination flu/COVID-19 vaccine.
“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.’”
The company had voluntarily withdrawn its initial application for mRNA-1083 after consulting with the FDA.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.”
That intention remains in place. “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.’”
mRNA Skepticism Persists Among Health Officials
Despite Moderna’s regulatory gains, concerns around mRNA technology remain present among some public health figures. “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.”
These views continue to spark debate, but Moderna’s clinical and regulatory progress underscores the platform’s growing role in future vaccine strategies.
Learn more at www.modernatx.com