FDA’s Center for Biologics Evaluation and Research director Vinay Prasad overruled unanimous agency reviewers to limit Moderna’s Spikevax COVID-19 vaccine full approval to children aged 6 months to 11 years with heightened disease risk. Prasad cited insufficient data for healthy children and concerns over long-term safety unknowns amid evolving viral landscape and widespread immunity. This marks the third recent instance of agency leadership modifying vaccine authorization decisions, reflecting ongoing internal agency debates around pediatric COVID-19 immunization.