Serum Institute of India announced the launch of the country’s first-ever indigenously developed pneumococcal vaccine, named ‘Pneumosil’, on Monday, 28 December, in the presence of Dr Harsh Vardhan, Minister of Health and Family Welfare.
Pneumococcal disease is a significant contributor to the under-five mortality rate worldwide. Annually, India witnesses an estimated 71% of pneumonia deaths and 57% of severe pneumonia cases.
Recognizing its widespread fatality, WHO recommends the inclusion of Pneumococcal Conjugate Vaccine (PCV) in routine childhood immunization programs in all countries.
Following this, Polysaccharide Conjugate Vaccines (PCV) work directly to reduce the incidence of pneumococcal pneumonia by preventing Streptococcus pneumonia.
Pneumosil - a three-dose (2+1) regimen starting from when a baby is about a month-and-a-half to two-months-old - is specially tailored to the prevailing serotype prevalence of the top 10 serotypes of S. pneumoniae in India and other regions of the world. The vaccine is a result of a collaboration between SII, PATH and Bill and Melinda Gates Foundation that spanned over a decade.
It is also WHO pre-qualified for its procurement by United Nations Agencies and GAVI.
“This significant milestone is aimed at improving pneumococcal conjugate vaccine affordability and enabling sustainable access for low- and middle-income countries,” SII stated in its press release.
Talking about the launch of Pneumosil, Adar Poonawalla, CEO of Serum Institute of India shared, “We have developed this PCV with a unique composition based on the serotype prevalence in India. This makes our PCV an ideal choice for protecting our children from pneumococcal disease. While the vaccine itself is of the highest quality and grade available, vaccine accessibility is of utmost importance as well, and to ensure ease of access by making it available at an affordable price. With the best PCV, we hope to bring down the mortality rate significantly while also making our country self-sufficient with a robust public health care system."
“The vaccine will provide effective and long-lasting protection for children against pneumococcal diseases.”Serum Institute of India
What Will Pneumosil Be Priced At?
Speaking about the price, Poonawalla said that it is roughly at half the price of some of the other imported vaccines in the private market.
“It will be about Rs 1000-2000 as a final cost to the customer. We are pricing it as a fraction of that to the government of India - around $3 a dose. Just like we have done with our COVID-19 vaccines. The private market cost is about Rs 1000 but we are giving it to the government at a far lower price.”Adar Poonawalla
“We have a capacity of 100 million doses and have already started supplies to UNICEF and GAVI. The Indian govt has floated a tender of around 20-30 million doses. We will supply that volume to them,” he added.
What Clinical Trials Was the Vaccine Approval Based On?
Elaborating on the research trials undertaken, a human phase 1 safety study in adults was first conducted in India, followed by a phase 2 study in toddlers. In parallel, a phase 1/2 study in the Gambia, Africa was also conducted, before finally reaching the target population of infants. Once phase 1/2 were completed and the data was presented, a large study was undertaken on over 2000 infants in Africa and a phase 3 experience study in India - culminating into a comprehensive data package of five clinical trials, and two are ongoing in India and Africa. The company also plans to put in place an impact study in India once the vaccine is in use.
Implications for COVID-19 Management in Children
A vaccine for pneumonia would also help with COVID-19 management in children. Pneumonia can be an outcome of viral infections, and since we will not have a COVID vaccine for infants, getting them vaccinated with Pneumonia vaccine becomes even more relevant.
Speaking about the launch, Dr Harsh Vardhan, Union Minister, Ministry of Health & Family Welfare said, “It is a significant milestone for the country’s public health care which will ensure that children are protected better against Pneumococcal disease with an affordable and high-quality vaccine.”
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