We’re celebrating recent news that Serum Institute of India, Pvt. Ltd’.s pneumococcal conjugate vaccine (PCV), PNEUMOSIL®, has received marketing authorization in India. We asked PATH India’s country director Neeraj Jain to explain why this is so exciting.
Globally, pneumonia is the #1 killer of children under age five and the pneumococcus is the most common cause of severe childhood pneumonia. But, what about in India?
The same is true here. Pneumonia and other deadly pneumococcal diseases like meningitis and sepsis are huge problems. In fact, more kids in India die from pneumococcal disease than anywhere else in the world. We lose nearly 70,000 children annually to it. Tragically, most of these deaths are vaccine preventable.
What’s the history of PCVs and why is PNEUMOSIL needed?
PCVs are the best way to prevent childhood pneumococcal disease and have helped dramatically reduce death and illness around the world where used. They are, however, expensive and many countries, including India, have historically struggled to introduce and/or sustain these vaccines in their national immunization programs without financial support from donors like Gavi, the Vaccine Alliance. The pneumococcal Advance Market Commitment (AMC) financing mechanism has also helped incentivize vaccine companies to expand PCV production capacity for use in Gavi-supported countries. The Gavi price per dose for traditional PCVs is around US$3; so, with three doses recommended by the World Health Organization (WHO), we’re talking around $9 per child. Many countries ineligible for financial support face paying far more than that—a prospect too often cost-prohibitive.
PNEUMOSIL is an important addition to the arsenal because it’s designed to provide the same level of protection as the other WHO-prequalified PCVs, but at the unprecedentedly low Gavi price of $2 per dose—or $6 per child. The more than 30% savings will help Gavi and country funds go farther against pneumococcal disease and other health priorities. For non-Gavi low- and middle-income countries, PNEUMOSIL will be far more affordable than other PCVs, which could help spark introductions and sustain PCV programs that wouldn’t otherwise be possible.
In India, marketing authorization means that a drug or vaccine product is permitted to be sold in the country. Think of it as the equivalent of ‘licensure’ in other countries. Having received marketing authorization, PNEUMOSIL is now licensed for use here. This approval was based on a combination of positive data generated by Phase 3 clinical studies led by Serum Institute with partners in India and by PATH with partners in The Gambia.
“What I find exciting is that, for the first time ever, India has an affordable PCV option produced locally that could help protect more of our children.”— Neeraj Jain, PATH India
Will PNEUMOSIL be immediately available in India?
Not exactly. Like with any vaccine, there is typically a lag time between achieving licensure and attaining market share. As that lag time elapses though, PNEUMOSIL is likely to reach the private sector first (at more affordable pricing) while discussions ensue nationally around if and how to incorporate the new vaccine into the Universal Immunization Program. As these dynamics play out though, the big picture is that India’s PCV options are now expanded with PNEUMOSIL’s licensure.
This is a big deal because India’s pneumococcal disease burden is the highest in the world and because PCV cost has been a major barrier to sustainable and equitable access here. Although our private market has had these vaccines for quite a while, prices are high (ranging from $29 to $50 per dose depending on the PCV) and make access inequitable. We did introduce PCVs into the Universal Immunization Program that makes vaccine publicly available for free in 2017 with the help of support from Gavi, which enables us to procure at the Gavi price. Regional rollouts are occurring in phases and have saved many lives, but not all children have access yet. Meanwhile, Gavi support is set to end this year, so we urgently need a more affordable option like PNEUMOSIL if we’re to build upon progress and reach every last child.
How did PNEUMOSIL come about?
The vaccine is the result of a longstanding collaboration between Serum Institute and PATH’s US and India offices, with PATH’s role funded by a grant from the Bill & Melinda Gates Foundation. Beginning in 2008, we brought the vaccine from preclinical development all the way through clinical studies in India led by Serum Institute for marketing authorization and in Africa (The Gambia) led by PATH for WHO prequalification. In December 2019, PNEUMOSIL received WHO prequalification certifying its quality and eligibility for global procurement and, in June 2020, Serum Institute entered into an AMC agreement to supply 100 million doses over 10 years at $2 per dose.
What about PNEUMOSIL’s market entry is most exciting to you?
What I find exciting is that, for the first time ever, India has an affordable PCV option produced locally that could help protect more of our children. And, if the vaccine can be successful here, we can be an inspiration for other countries as they explore affordable vaccine options for their own populations.
What is the significance of PNEUMOSIL for India’s role as the world’s vaccine hub?
PNEUMOSIL is something to be proud of, not just for Serum Institute, but for India as a global vaccine supply hub. Conjugate vaccines are some of the most complex vaccines to manufacture and Serum Institute is only the third supplier (and the first developing country vaccine manufacturer) to have its PCV nationally licensed and prequalified by WHO. To be able to supply this high-quality PCV at such large volume and low cost is quite a feat. It will, I hope, also spur the development and manufacture of more vaccines in India that can reduce the world’s disease burden.
At PATH, we congratulate Serum Institute and are honored to have had a key role in PNEUMOSIL’s development since the beginning. We look forward to the impact it’s destined to have in India—and the world.