Development strategy and lessons learned for a 10-valent pneumococcal conjugate vaccine ( <i>PNEUMOSIL®</i> )
Mark R. Alderson, Vistasp Sethna, Lauren Newhouse, Steve Lamola, Rajeev Dhere
Abstract
) received World Health Organization prequalification in December 2019 - making it just the third PCV to be certified as an option for Gavi, the Vaccine Alliance-eligible countries - and is being made available at a Gavi price of US$2/dose. The task of developing a state-of-the-art, yet lower-priced, PCV required public-private collaboration across geographies and yielded a variety of successes and learnings useful to the vaccine development field. Key among the learnings were factors related to manufacturing strategy and optimization, serotype selection, flexibility, early risk detection and mitigation, partner trust and continuity across similar-class products, complementary business philosophies, and early clarity of purpose.