Serum Institute of India launches India’s first fully indigenously developed pneumococcal vaccine, 'PNEUMOSIL'

• The vaccine called PNEUMOSIL® will primarily help to fight against pneumococcal pneumonia amongst children and will be available at an affordable competitive price with an advantage of presence of serotypes 6A and 19A in the vaccine.
• The unique feature of this WHO pre-qualified PCV is its composition which is specially tailored to the prevailing serotype prevalence of S. pneumoniae in India and other regions of the world.
• With this SII further cements its position as the leader in the conjugate vaccines with several patents to its credit making it the first developing country vaccine manufacturer to access the global PCV market and world’s third supplier of pneumococcal conjugate vaccines (PCV) under the pneumococcal Advance Market Commitment (AMC).

New Delhi & Pune, 28^th December 2020: Serum Institute of India, the largest vaccine manufacturer in the world by doses, announces the launch of India’s first indigenously developed pneumococcal vaccine – PNEUMOSIL®; in the presence of Dr. Harsh Vardhan, Minister of Health and Family Welfare today. PNEUMOSIL® as been developed through a collaboration spanning over a decade among Serum Institute of India Pvt Ltd, PATH and Bill and Melinda Gates foundation. This significant milestone is aimed at improving pneumococcal conjugate vaccine affordability and enabling sustainable access for low-and middle-income countries.

Driven by the philanthropic commitment of SII to protect every family with affordable vaccines, PNEUMOSIL® comes with the advantage of presence of stereotypes 6A & 19A. The composition of the WHO pre-qualified vaccineis specially tailored as per the prevalence of the Top 10 serotypes of S. pneumoniae in India and other regions of the world, which is the unique feature of this conjugate vaccine. The vaccine will provide effective and long-lasting protection for children against pneumococcal diseases.

With this, SII further cements its position as the leader in the conjugate vaccines. It has several patents related to the manufacturing of this vaccine to its credit. This makes PNEUMOSIL® relatively cost-efficient at high-volumes and more accessible over the long term for the countries that need it most.

Speaking about the launch, Dr. Harsh Vardhan, Union Minister, Ministry of Health & Family Welfare said, “It is a great moment of pride to witness Serum Institute take forward the ‘Make in India’ legacy, with the launch of India’s first indigenously developed Pneumococcal Conjugate Vaccine. 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. I am sure, Serum Institute of India will continue their endeavour to develop many more life saving vaccines in future also on the lines of clarion call of our Hon’ble Prime Minister “VOCAL FOR LOCAL” and fulfill our Hon’ble Prime Minister’s dream 'ATMANIRBHARBHARAT'”.

Talking about the launch of Pneumosil, Mr. Adar Poonawalla, CEO of Serum Institute of India shared, “Over the years our constant endeavor has been to provide high quality vaccines with regular supplies which ensures excellent immunization coverage to children and families worldwide. With that thought 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."

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. Every year nearly 67,800 children under 5 years of age die India from pneumococcal diseases in 2018, recognizing it’s 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.

The vaccine makes the Serum Institute of India the world’s third supplier of pneumococcal conjugate vaccines (PCV) under the pneumococcal Advance Market Commitment (AMC), and the first developing country vaccine manufacturer to access the global PCV market.

About PNEUMOSIL®
PNEUMOSIL® (Pneumococcal Conjugate Vaccine – adsorbed, 10 Valent), a well-designed vaccine with relevant serotypes, yet more affordable than the existing PCVs and provide comparable protection by targeting the most prevalent serotypes of the bacterium causing serious illness in developing countries.

As a PCV, PNEUMOSIL® is similar as the pediatric pneumococcal vaccine already on the market and targets serotypes 1, 5, 6A, 6B, 7F, 9V, 14, 19A, 19F & 23F.

PNEUMOSIL® is WHO pre-qualified for its procurement by United Nations Agencies and GAVI. This marks an important milestone towards accelerated access of this much needed affordable vaccine for the countries with high disease burden.

PNEUMOSIL® developed through a collaboration spanning over a decade among Serum Institute of India Pvt Ltd, PATH and Bill and Melinda Gates foundation. Through the collaboration, the vaccine has advanced from preclinical and clinical development to WHO pre-qualification.

PNEUMOSIL® safety and immunogenicity profile is favorably comparable to both currently available licensed and WHO pre-qualified PCVs worldwide. Various seroprevalence assessment estimates PNEUMOSIL® serotype coverage similar to other PCVs in high disease burden countries, including countries with high seroprevalence of 6A and 19A.

Notes to editors

About Serum Institute of India Pvt. Ltd. (SIIPL)
Driven by the philanthropic philosophy of affordable vaccines;Serum Institute of India Pvt, Ltd.(SIIPL) is the world's largest vaccine manufacturer by number of doses produced and sold globally (more than 1.5 billion doses), supplying the world's cheapest and WHO accredited vaccines to as many as 170 countries. It was founded in 1966 with the aim of manufacturing lifesaving immunobiological drugs including vaccines worldwide. With a strong commitment towards global health, the institute’s objective has been proliferated by bringing down the prices of newer vaccines such as such as Diphtheria, Tetanus, Pertussis, Hib, BCG, r-Hepatitis B, Measles, Mumps and Rubella vaccines. SII is credited with bringing world-class technology to India, through its state-of-the-art equipped multifunctional production facility in Manjri, Pune; association with Zipline and government agencies to transform emergency medicine and critical care along with spearheading the race of vaccine development against the COVID-19 pandemic.

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Mayank Sen
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