PNEUMOSIL®, the new pneumococcal vaccine, achieves WHO prequalification, a key step toward improving access and affordability

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Leaders from PNEUMOSIL® collaborators—the Serum Institute of India and the Bill & Melinda Gates Foundation—to speak at the first-ever Global Forum on Childhood Pneumonia on January 29-31, 2020

PNEUMOSIL® brings forward a more affordable option that can make a pneumococcal vaccine accessible and free up country and donor funds for other health priorities.

The World Health Organization (WHO) has prequalified PNEUMOSIL®, a vaccine against a leading cause of deadly childhood pneumonia—the pneumococcus bacterium. This is a major step toward improving pneumococcal conjugate vaccine affordability and enabling sustainable access for children and families in low- and middle-income countries.
The vaccine was developed through a collaboration between Serum Institute of India, Pvt., Ltd. (SIIPL) and PATH with a grant from the Bill & Melinda Gates Foundation. It is expected to protect children on par with other pneumococcal conjugate vaccines at a price that is more affordable for low- and middle-income countries.

Representatives from the Serum Institute of India, Pvt., Ltd. and the Bill & Melinda Gates Foundation will speak about the development and WHO prequalification of PNEUMOSIL® at the first-ever Global Forum on Childhood Pneumonia on January 29-31, 2020.

The announcement of this prequalification is an important milestone toward alleviating one of the biggest barriers that countries face in sustainably accessing pneumococcal conjugate vaccines—price. WHO prequalification allows PNEUMOSIL® to be procured by the United Nations agencies and Gavi, the Vaccine Alliance. “PNEUMOSIL® can be manufactured at high volume with current capacity at 100 million doses per annum, which will be augmented to over 150 million doses per annum in two to three years. It will be made available at a target Gavi price of around US$2 per dose, which is roughly 30% less than the current Gavi price for these kinds of vaccines,” says Dr. Rajeev Dhere, executive director of SIIPL.

“The vaccine provides an alternate vaccine for low- and middle-income countries to ensure lifesaving access to pneumococcal disease prevention over the long term,” explains Dr. Mark Alderson, director of PATH’s pneumococcal vaccine project.

Pneumococcal conjugate vaccines are difficult for many countries to afford without considerable donor financial support but have helped significantly reduce pneumococcal deaths and illness where introduced. And though donor support has been key in helping to increase country access, implementing and sustaining pneumococcal vaccine programs continues to be difficult for many countries. PNEUMOSIL® brings forward a more affordable option that can make a pneumococcal vaccine accessible and free up country and donor funds for other health priorities.

“There has been unprecedented demand for the pneumococcal vaccine from Gavi-supported countries,” says Dr. Seth Berkley, CEO of Gavi, the Vaccine Alliance. “Within the last decade, we have supported the vaccination of 185 million children against this leading killer of children—but there is still work to be done. This new vaccine gives us more options in the fight to ensure no child dies from this preventable and treatable disease.”

“Vaccines are one of the best investments we can make to give every child a healthy start at life and build stronger communities and economies,” said Dr. Keith Klugman, director of the pneumonia team at the Bill & Melinda Gates Foundation. “As pneumonia continues to be the leading cause of death for young children worldwide, we welcome this new vaccine that will allow for more children to be protected from this debilitating disease.”

In addition to pneumonia, the pneumococcus bacterium causes other serious, life-threatening diseases like meningitis and sepsis. It is estimated to cause nearly 400,000 deaths in children under five years of age each year worldwide.
PNEUMOSIL® covers the types of the bacterium most likely to cause serious illness in low- and middle-income countries and is manufactured in the most efficient way possible. This reduces costs while preserving quality.

“Pneumococcal conjugate vaccines are among the most complex vaccines to manufacture. As a vaccine developed and produced in India that will benefit the world, PNEUMOSIL®’s WHO prequalification is a landmark achievement,” adds Mr. Neeraj Jain, PATH country director in India.

A recent PATH-sponsored Phase 3 clinical study of PNEUMOSIL® in infants in The Gambia was conducted prior to WHO prequalification at the MRC Unit in The Gambia—part of the London School of Hygiene and Tropical Medicine—and provided the pivotal results for the data package required for WHO prequalification. The vaccine met all primary and secondary endpoints in the study, with key findings showing the vaccine to have an acceptable safety profile and to generate a protective immune response similar to a WHO-prequalified comparator pneumococcal vaccine without interfering with other routine childhood immunizations. These results were presented at the 2019 European Symposium on Pediatric Infectious Diseases and a study manuscript is in preparation for peer-reviewed publication. Other study collaborators included FHI Clinical and the WHO Reference Laboratory for Pneumococcal Serology at the Great Ormond Street Institute of Child Health, University College London.

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Additional resources for media: Fact sheet: pneumococcal disease, pneumococcal conjugate vaccines, and PNEUMOSIL®

About Serum Institute of India, Pvt., Ltd.
Serum Institute of India, Pvt., Ltd. (SIIPL), based in Pune, India, today is the largest manufacturer of diphtheria, tetanus, pertussis (DTP) and measles, mumps, rubella (MMR) vaccines and supplies its products to United Nations agencies and more than 160 countries. SIIPL’s MenAfriVac® meningococcal serogroup A conjugate vaccine, which was specifically developed for sub-Saharan Africa, is acknowledged as a remarkable success by the vaccine community. It is a policy and commitment of SIIPL to make new vaccines available at affordable prices to the children of the developing world. http://www.seruminstitute.com.

About PATH
PATH is a global organization that works to accelerate health equity by bringing together public institutions, businesses, social enterprises, and investors to solve the world’s most pressing health challenges. With expertise in science, health, economics, technology, advocacy, and dozens of other specialties, PATH develops and scales solutions—including vaccines, drugs, devices, diagnostics, and innovative approaches to strengthening health systems worldwide. http://www.path.org

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Megan Sather
GMMB
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Michael Vernekar
Serum Institute of India Pvt. Ltd.
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