Vinay Prasad, head of the FDA’s vaccine regulation office, overruled agency reviewers to narrowly approve Moderna’s Spikevax COVID-19 vaccine only for children aged 6 months to 11 years at increased risk of severe disease. Prasad expressed skepticism about benefits in healthy children, citing insufficient certainty and noting changing pandemic dynamics with widespread immunity and viral mutations. This marks the third time Prasad has overridden FDA vaccine staff, reflecting diverging views within the agency on COVID vaccine approvals.