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ARTICLE | Regulation

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

By stephen hansen, associate editor
June 8, 2021 11:41 PM UTC

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...

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