FDA briefing materials point to immune bridging studies for pediatric COVID-19 vaccines

COVID-19 vaccine manufacturers may be able to rely on neutralizing antibody titers as a surrogate for efficacy in pediatric patients.

Briefing documents published ahead of Thursday’s Vaccines and Related Biological Products Advisory Committee meeting noted that the milder disease course observed in children infected with SARS-CoV-2 would likely make it infeasible to adequately power a study designed to measure clinical outcomes...