Editor's note: This article was updated on November 1, 2021 to reflect new progress in the pneumococcal vaccine field.
Imagine it’s 2008. A pediatric pneumococcal vaccine has been available for years and made incredible strides against pneumonia and other pneumococcal diseases (like meningitis, sepsis, and disabling middle-ear infections). In the United States and other high-income countries, that is.
Hundreds of thousands of kids still die from pneumococcal disease unnecessarily in low- and middle-income countries. Barriers such as vaccine price and availability are preventing them from accessing this lifesaving tool. Furthermore, the vaccine doesn’t yet target some of the most threatening kinds (serotypes) of the pneumococcus bacterium for children in these parts of the world.
That same year, Serum Institute of India, Pvt., Ltd. and PATH kick off a collaboration with funding from the Bill & Melinda Gates Foundation to do the difficult job of developing a pneumococcal vaccine that not only provides the protection that children in these settings need but breaks down inherent price barriers to access.
Jump ahead to today and there’s reason for excitement. The Serum Institute vaccine that was merely an ambitious idea over a decade ago is now prequalified by the World Health Organization (WHO) and available for use in low- and middle-income economies for just US$2 per dose, an unprecedentedly low price for any pneumococcal vaccine. It's also authorized for use in India, with more countries to come.
Each year, more than 300,000 children under five years of age die globally from pneumococcal disease, mostly in Africa and Asia. WHO prequalification opens the door for this newest pneumococcal vaccine, PNEUMOSIL®, to bolster the prevention toolkit and fulfill its purpose—to save more lives by enabling access that countries in these regions can afford and sustain long term.
Why is price so important?
Pneumococcal vaccines that can be given to children are conjugate vaccines, which are the most complex kinds of vaccine to manufacture and relatively expensive as a result. In Pan American Health Organization countries, for instance, they ran around US$12.85 to 14.50 per dose depending on the vaccine in 2020. And these vaccines require at least three doses in kids. Working together through complex financing mechanisms, global health donors and vaccine manufacturers have helped pneumococcal conjugate vaccines become available for low-income economies at significantly reduced prices—enabling rollouts in these settings since 2009. This supported price is around $3 per dose today, which countries co-pay with heavy contributions from Gavi, the Vaccine Alliance.
Although such support has enabled broader access and saved countless lives, pneumococcal vaccine programs continue to be difficult for many low-income economies to sustain due to cost and are at even greater risk once countries graduate from Gavi financial support. Other countries ineligible for financial support (especially middle-income nations) have never even introduced pneumococcal vaccines into their national immunization programs, one factor being because prices are prohibitive. Paying for pneumococcal vaccines also consumes a disproportionate amount of donor resources compared to other vaccines—nearly half of Gavi’s funding for vaccine acquisition, for example.
Overall, PNEUMOSIL®'s target $2 per dose price is roughly 30% lower than the Gavi price and dramatically lower for non-Gavi low- and middle-income countries. Such savings will not only help more countries sustain and/or introduce pneumococcal immunizations, but donor and country funds could be freed up for other important public health priorities—contributing even more broadly to improving health and survival. Lower prices also complement other efforts to leverage common resources to fight multiple diseases at once such as pneumonia and diarrheal disease.
A child receives routine immunizations, including pneumococcal vaccine, at a clinic in The Gambia. Photo: PATH/Lauren Newhouse
What does it take to bring the price down?
Prior to partnering on PNEUMOSIL®, Serum Institute and PATH had already worked together with other partners on another high-quality, low-priced conjugate vaccine against meningitis A—MenAfriVac®. Developed upon request from health ministers in Africa’s meningitis belt, the vaccine has essentially wiped out meningitis A disease where introduced. For this successful vaccine, Serum Institute optimized more efficient conjugate vaccine manufacturing processes that it, in turn, applied to bring PNEUMOSIL®'s price down as well. Overall, innovating on PNEUMOSIL®'s conjugation technology and working out the process to generate very high yields contributed greatly to producing higher volumes of vaccine more quickly—and helped lower the prices substantially.
Selecting the most appropriate serotypes to target with PNEUMOSIL® was also key to minimizing cost. The pneumococcus has over 90 serotypes that vary by region, but conjugate vaccines are only able to cover a limited number of them. Since each serotype added to a conjugate vaccine adds cost, those included in PNEUMOSIL® are among the 10 likeliest to sicken and kill children in Africa, Asia, and Latin America. This maximizes coverage where the vaccine is intended for distribution without the added cost of unnecessary serotypes. In this way, PNEUMOSIL®'s coverage is estimated to be comparable in these regions to other prequalified pneumococcal vaccines on the market.
WHO prequalification opens the door for this vaccine to save more lives by enabling access that countries can afford and sustain long term.
And then there were three
Two other pneumococcal vaccines for kids are currently WHO prequalified and are effective at preventing disease caused by the serotypes of pneumococcus they are designed to protect against. Achieving the landmark of WHO prequalification for a new PCV, however, is not easy. Since the initial licensure of the first PCV decades ago, only one other vaccine manufacturer has managed to achieve this goal. To become WHO prequalified, a vaccine must meet international standards for manufacturing quality and perform well in a series of rigorous preclinical and clinical evaluations designed to demonstrate safety and acceptable immune responses.
Accordingly, PNEUMOSIL® has undergone the required clinical development programs sponsored by Serum Institute in India and by PATH in The Gambia—with Phase 3 Gambian study results supporting the vaccine’s safety and ability to elicit comparable infant immune responses to a prequalified vaccine. In short, this means that the vaccine is expected to perform on par with other vaccines in its class, expanding the suite of options from which countries can choose.
Since WHO prequalification, PNEUMOSIL® also received marketing authorization in India in 2020 allowing the vaccine to be sold in the country. Soon after, it joined predecessor pneumococcal vaccines in being offered via the pneumococcal Advance Market Commitment—an innovative financing mechanism that supports vaccine manufacturers to produce and supply suitable and affordable vaccines for Gavi-eligible low-income economies.
What now?
Having entered the global market, now's the time to set about additional work that will help PNEUMOSIL® achieve its full public health potential and impact. In this vein, PATH and partners in The Gambia are putting the finishing touches on a clinical study to examine an additional WHO-recommended dosing schedule. Spreading the word about this new addition to the toolkit is also important so that countries can make informed decisions for pneumococcal prevention and other public health priorities. Additional studies will also be needed to evaluate the vaccine’s performance post-licensure and in real life prevention of pneumococcal disease, once sufficiently rolled out into communities.
Now, after more than a decade of hard work, we finally have a new tool that could help overcome some of the most persistent roadblocks plaguing pneumococcal disease prevention. Let’s make sure to put it to good use.
