De-risking vaccine development: lessons, challenges, and prospects.

Abstract

Vaccine development is long and costly. Technical, clinical, regulatory, and manufacturing risks throughout the development cycle hampered manufacturers' efforts towards more challenging and financially less rewarding targets, with profound implications for public health. Early de-risking strategies can help closing the vaccine productivity gap and support sustainable access to vaccines. Illustrated by examples of early and efficient decision-making, the herein proposed strategies can ultimately increase the success rates of vaccine programs.