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FDA approves Moderna COVID-19 vaccine for high-risk children
Moderna's Spikevax COVID-19 vaccine is now FDA-approved for all adults 65 and older and high-risk kids aged from 6 months to 11 years, aligning with new policy recommendations.
The FDA has fully approved Moderna's Spikevax COVID-19 vaccine (mRNA-1273) for children aged between 6 months and 11 years who are at increased risk for severe COVID-19 outcomes, expanding its use beyond emergency authorization.
Expanded pediatric approval
Moderna's biologics license application for Spikevax already covered adults aged 65 and older, as well as individuals aged 6 months through 64 years with at least one risk factor for severe disease.
However, this is the first time the FDA has fully approved a COVID-19 vaccine for children under 12, extending its use beyond the earlier Emergency Use Authorization.
With this approval, Moderna now offers the most extensive range of FDA-authorized mRNA COVID-19 vaccine indications across all age and risk groups. This mRNA-based COVID-19 vaccine is also the first and only product to receive full FDA approval for high-risk children as young as six months.
Updated COVID-19 vaccine recommendations
This FDA approval aligns with recent federal vaccine policy revisions spearheaded by Health and Human Services Secretary Robert F. Kennedy Jr.
In May, Kennedy removed COVID-19 vaccines from the routine immunization schedule for healthy children and pregnant individuals without the input of the CDC's Advisory Committee on Immunization Practices (ACIP).
In June, Kennedy took further steps to reshape federal vaccine oversight by firing all 17 sitting ACIP members. Just days later, he appointed eight new members, several of whom have minimal experience in immunization policy or hold vaccine-skeptical views.
These actions have sparked widespread concern within the public health and scientific communities about the future of vaccine governance, causing several medical organizations to respond with legal action.
Vaccine availability and safety monitoring
Moderna expects the updated Spikevax formulation to be available in time for the 2025–2026 U.S. respiratory virus season.
Even after approval, Moderna remains subject to post-marketing safety monitoring requirements, including continued data collection on rare adverse events such as myocarditis and pericarditis in pediatric populations.
"COVID-19 continues to pose a significant potential threat to children, especially those with underlying medical conditions," Stéphane Bancel, Moderna's Chief Executive Officer, said in a press release. "Vaccination can be an important tool for protecting our youngest against severe disease and hospitalization."
Alivia Kaylor is a scientist and the senior site editor of Pharma Life Sciences.