THIS Covid vaccine for children under 12 gets full FDA approval in US

The US FDA has granted full approval to Moderna’s COVID-19 vaccine Spikevax for use in children aged six months to 11 years who are at increased risk.

Moderna, in a statement on Thursday, confirmed the FDA's decision, noting that the shot had previously been available under emergency use authorisation. The company said it expects to roll out an updated version ahead of the 2025–26 respiratory virus season.

The development comes against the backdrop of sweeping changes at the US Centers for Disease Control and Prevention (CDC). 

In May, Health Secretary Robert F Kennedy Jr announced that the government had “stopped recommending routine COVID-19 vaccinations for healthy children and healthy pregnant women.”

However, the CDC has maintained that updated COVID-19 vaccines remain an option across all age groups. “The agency recommended updated COVID vaccines for everyone aged six months and older, following the guidance of its panel of outside experts,” it said.

Kennedy, a long-time vaccine sceptic, has taken steps to reshape US immunisation policy. He recently dismissed all 17 members of the CDC’s Advisory Committee on Immunization Practices—the independent expert panel that advises on national vaccine guidelines—and replaced them with seven new members, including several who have previously opposed mainstream vaccine recommendations.

Several US medical associations have since filed lawsuits against Kennedy, arguing that his approach to COVID-19 vaccines “poses an imminent threat to public health.”

Despite the ongoing policy dispute, the FDA's full approval of Spikevax for at-risk children under 12 marks a key regulatory milestone for Moderna. 

(With inputs from Reuters)