FDA approves Moderna’s Spikevax for children at increased risk of COVID-19
Ella Day | July 16, 2025 | News story | Medical Communications | COVID-19, Spikevax, US Food and Drug Administration, Vaccine, Virology
Moderna has been granted US Food and Drug Administration (FDA) approval for its COVID-19 vaccine, Spikevax, in children aged six months to 11 years who are at increased risk of COVID-19. The approval broadens the vaccine’s use beyond adults and adolescents, having previously been available for young children under Emergency Use Authorization.
The authorisation covers individuals aged six months to 64 years at increased risk for severe disease, as well as all adults aged 65 and over. These may include individuals with asthma, chronic lung disease, sickle cell disease or those who are immunocompromised.
“COVID-19 continues to pose a significant potential threat to children, especially those with underlying medical conditions,” said Stéphane Bancel, chief executive officer of Moderna. “Vaccination can be an important tool for protecting our youngest against severe disease and hospitalisation.”
The FDA approval comes as Moderna prepares to supply its updated Spikevax vaccine for the 2025-2026 respiratory virus season. Spikevax is an mRNA-based vaccine and part of Moderna’s broader portfolio of mRNA medicines targeting infectious diseases, cancer, rare diseases and autoimmune disorders.
The approval is based on significant evidence demonstrating the vaccine’s safety and efficacy in reducing the risk of severe COVID-19. Known side effects are consistent with those seen in other age groups and include mild-to-moderate injection site reactions, fatigue and fever.
Ella Day
16/7/25
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