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PATH congratulates India on approving first locally produced pneumococcal vaccine

August 19, 2020 by PATH

Serum Institute of India’s pneumococcal conjugate vaccine, PNEUMOSIL®, has received marketing authorization in India—adding a quality-certified and more affordable option to the country’s pneumonia prevention toolkit.

Seattle, Washington and Delhi, India, August 18, 2020—PATH welcomes the news that India’s national regulatory authority, the Drug Controller General of India, has approved Serum Institute of India, Pvt. Ltd.’s pneumococcal conjugate vaccine (PCV), PNEUMOSIL®, for marketing authorization. This approval licenses the vaccine to be brought to market and marks an important milestone in the fight against pneumonia and other pneumococcal diseases in India, where approximately 70,000 Indian children die from pneumococcal disease each year—the most in the world. PNEUMOSIL® is designed to provide a similar level of protection as other proven PCVs, but much more affordably.

The pneumococcus bacterium is the leading cause of severe childhood pneumonia worldwide and is responsible for other deadly diseases like meningitis and sepsis. PCVs are the best way to prevent pneumococcal disease in children, but historically high PCV prices have made these lifesaving tools cost-prohibitive for many countries and have required organizations like Gavi, the Vaccine Alliance to step in with financial support to help countries gain access. The Gavi price for other PCVs is around $3 per dose. PNEUMOSIL®, alternatively, is being made available for the unprecedentedly low price of $2 per dose (over 30% savings) for use in Gavi-supported countries. Importantly, PNEUMOSIL® is also expected to be more affordable than other PCVs for non-Gavi low- and middle-income countries, who otherwise face higher prices for PCVs that make introducing or sustaining PCV programs difficult or even impossible.

With Gavi support, phased regional PCV rollouts in India’s Universal Immunization Program began in 2017 and have saved countless lives; however, many children have yet to be reached and Gavi support is expected to end this year—making a more affordable PCV like PNEUMOSIL® important for building upon progress. A more affordable option will also be a welcome addition in India’s private market.

For the first time ever, India has a locally produced PCV option that could help protect more Indian children at less cost.

PNEUMOSIL® is the result of a collaboration between Serum Institute and PATH, which brought the vaccine through the full development process. The partnership aligned around the end goal of producing a PCV that could be affordable and accessible for low- and middle-income countries. Informing the marketing authorization process in India were combined data from Phase 3 clinical trials led by Serum Institute with partners in India and by PATH with partners in The Gambia. PATH’s role throughout the collaboration was supported by a grant from the Bill & Melinda Gates Foundation.

For the first time ever, India has a locally produced PCV option that could help protect more Indian children at less cost—helping funds go farther against pneumococcal disease and other public health priorities. Remarkably, Serum Institute is only the third supplier (and the first developing country vaccine manufacturer) to have its PCV nationally licensed and prequalified by WHO—marking important progress toward improving PCV supply and evolving the marketplace to bring prices down for more equitable PCV access in India and the world.

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