The U.S. Food and Drug Administration has granted full approval for Moderna’s COVID-19 vaccine, Spikevax, in children aged 6 months through 11 years who are at an increased risk of the disease, the company said on Thursday.
The shot was previously available for pediatric populations under emergency use authorization. Moderna expects to make its updated vaccine available for eligible U.S. population for the 2025-26 respiratory virus season.
Health secretary Robert F. Kennedy Jr. had in May said the U.S. has stopped recommending routine COVID-19 vaccinations for healthy children and healthy pregnant women.
However, the U.S. Centers for Disease Control and Prevention said shots remain an option for healthy children when parents and doctors agree that it is needed.
The agency recommended updated COVID vaccines for everyone aged six months and older, following the guidance of its panel of outside experts.
Kennedy, who for decades has sown doubt about the safety of vaccines contrary to evidence and research by scientists, oversees the CDC.
He has been sued by several leading medical organizations, arguing that current policies on COVID-19 vaccines pose an imminent threat to public health.
In addition to the directive on COVID vaccines, Kennedy fired all 17 members of the CDC’s Advisory Committee on Immunization Practices, the independent panel of experts that advises on vaccine policy, and replaced them with seven new members, including several who have advocated against vaccines.
Shares of the company rose 2% to $33.45 in premarket trading.
