The World Health Organisation has pre-qualified a vaccine, PNEUMOSIL®, a vaccine against a leading cause of deadly childhood pneumonia – the pneumococcus bacterium.
The vaccine was developed through a collaboration spanning over a decade between Serum Institute of India, Pvt. Ltd. (SIIPL) and PATH and with funding from the Bill & Melinda Gates Foundation. The vaccine 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. The news marks an important milestone in alleviating one of the biggest barriers to sustainable access to a pneumococcal conjugate vaccine that countries face-price. Also, the pre-qualification allows the drug to be procured by 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 per cent less than the current Gavi price for these kinds of vaccines,” said Dr Rajeev Dhere, Executive Director of SIIPL.
The Director of PATH’s pneumococcal vaccine project Dr Mark Alderson said that the vaccine provides an alternate vaccine for low- and middle-income countries to ensure lifesaving access to pneumococcal disease prevention over the long term.
The drug addresses a need for a more affordable option that can make access easier for nations and free up country and donor funds for other health priorities.
“There has been unprecedented demand for the pneumococcal vaccine from Gavi-supported countries,” said 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,” he added.
In the study, the vaccine met all primary and secondary endpoints 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.
Apart from 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 bacterium most likely to cause serious illness in low and middle-income countries. Its manufacturing process has been optimized to make it more efficient – reducing costs while preserving vaccine quality and making the vaccine a more affordable option for countries with the highest burdens of pneumococcal disease.

Source: Biospectrum India, Business Standard.

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