The US Food and Drug Administration (FDA) has granted full approval for Moderna’s COVID-19 vaccine, Spikevax, for children aged 6 months to 11 years who are at increased risk of severe illness. Until now, the vaccine had been available to children under emergency use authorisation.
Moderna announced the development on Thursday, adding that it aims to roll out an updated version of the vaccine for eligible populations during the 2025–2026 respiratory virus season.
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This decision comes amid a shifting landscape in US vaccination policy. In May, US Health Secretary Robert F. Kennedy Jr. declared that routine COVID-19 vaccination is no longer recommended for healthy children and pregnant women. However, the Centers for Disease Control and Prevention (CDC) maintained that COVID shots remain available as an option when families and healthcare providers believe they are necessary.
The CDC continues to recommend updated COVID vaccines for everyone aged six months and older, following input from its external advisory panel.
Kennedy recently dismissed all 17 members of the CDC’s Advisory Committee on Immunization Practices and replaced them with seven new members, including several known for their anti-vaccine views. Multiple medical organizations have since filed lawsuits, arguing that these moves present a serious threat to public health.
Meanwhile, Moderna’s shares rose 2% in premarket trading, reaching $33.45, following the FDA’s announcement.
