Development strategy and lessons learned for a 10-valent pneumococcal conjugate vaccine (PNEUMOSIL®)

ABSTRACT

Pneumococcal conjugate vaccines (PCVs) have proven to be the best way to prevent severe childhood pneumococcal disease but until recently have been difficult for many countries to afford sustainably. In 2008, the Serum Institute of India, Pvt. Ltd. and PATH entered into a collaboration, funded in part by the Bill & Melinda Gates Foundation, to respond to this problem by developing a PCV designed to be affordable, accessible, and protective against the pneumococcal serotypes causing the most morbidity and mortality in low- and middle-income countries. The resulting 10-valent PCV (PNEUMOSIL®) 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.

KEYWORDS:

• Pneumococcus
• pneumococcal conjugate vaccine
• vaccine development
• low- and middle-income countries
• collaboration
• SIIPL
• PATH

Acknowledgments

The authors gratefully acknowledge the enormous contributions made by team members from SIIPL, PATH, the Bill & Melinda Gates Foundation; clinical sites in India and The Gambia, and the testing laboratories, CROs, consultants, and scientific advisory boards supporting (see Table 4).

Disclosure of potential conflicts of interest

Drs. Dhere and Sethna are employed by SIIPL, the manufacturer of PNEUMOSIL. They have process patents pending for PNEUMOSIL and SIIPL has received grants from the Bill & Melinda Gates Foundation for pneumococcal vaccine research and development work that is not related to the work described in this paper. Dr. Alderson, Ms. Newhouse, and Dr. Lamola are employed by PATH, a collaborator on PNEUMOSIL’s development, and have no other conflicts of interest to disclose.

Additional information

Funding

This work is based on research funded in part by the Bill & Melinda Gates Foundation under Grants OPP39922 and OPP1034537 to PATH. The findings and conclusions contained within are those of the authors and do not necessarily reflect positions or policies of the foundation. Other funding came from SIIPL.