TDB supports M/s Sapigen Biologix Private Limited to develop and commercialize two indigenous vaccines- Intranasal Vaccine for COVID & Malaria Vaccine

Dr Jitendra Singh calls for equal stake participation by Industry to sustain Start-Ups

Technology Development Board, M/o Science & Technology supports M/s Sapigen Biologix Private Limited, Hyderabad for development & commercialization of two novel vaccines – “Intranasal Covid-19 Vaccine and RTS, S Malaria Vaccine”
This initiative will ensure equal stake with equal partnership and responsibility for the industry for sustainable start-ups, says, Dr. Jitendra Singh

India’s vaccine strategy brings together pharma, industry and academia together in a partnership with an eye on meeting the current as well as possible future challenges, under the leadership of Prime Minister Modi

India -leading the way to fight Covid-19 pandemic to save mankind with the development of “Intranasal Covid-19 Vaccine” and set to play even bigger role in worldwide drug security

TDB-DST supported Sapigen helmed by Dr Krishna Murthy Ella to set up state -of- the -art world- class vaccine manufacturing facility in Bhubaneswar, Odisha

TDB-DST supported Sapigen to commercially produce world’s first malaria vaccine and India’s first intranasal covid-19 vaccine

Posted On: 26 MAR 2022 6:29PM by PIB Delhi

Union Minister of State (Independent Charge) Science & Technology; Minister of State (Independent Charge) Earth Sciences; MoS PMO, Personnel, Public Grievances, Pensions, Atomic Energy and Space, Dr. Jitendra Singh today called for equal stake participation by Industry to sustain StartUps.

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The Union Minister was speaking at the ceremony to sign an Agreement between Technology Development Board (TDB) of the Ministry of Science & Technology and M/s Sapigen Biologix Private Limited, Hyderabad helmed by Dr Krishna Ella of Bharat Biotech Ltd for development & commercialization of two novel vaccines – “Intranasal Covid-19Vaccine and RTS, S Malaria Vaccine”. Further Dr Krishna Ella, CMD Bharat Biotech has agreed to support another initiative, where he has agreed to give ₹200 Crores & TDB will contribute the matching ₹200 crores to form a ₹400 Crores Corpus Fund which will be used exclusively to support Startups. Through this fund, Startups will be supported in different fields across India using services of professional agencies at relaxed terms and conditions.

Dr. Jitendra Singh said that this initiative will ensure equal stake with equal partnership and responsibility for the Industry for sustainable StartUps. He said that the vaccine strategy of India symbolises Prime Minister Narendra Modi’s idea of an Atma Nirbhar Bharat. He said that India’s vaccine strategy brings together pharma, industry and academia together in a partnership with an eye on meeting the current as well as possible future challenges, under the leadership of Prime Minister Modi.

The Union Minister said that the idea behind initiatives like this is to have a sustainable partnership in the long run and provide a sustainable source of livelihood to India’s youth. Dr. Singh opined that the Government of India, led by Prime Minister Modi, is encouraging industrial outreach by extending all possible support.

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Dr. Jitendra Singh said this is not only an agreement of equal stake and partnership but also equal social responsibility. He termed it as a new beginning in India’s vaccine strategy and expressed hope that it will give further impetus to research and development in the country.

The Minister noted that today, within only a couple of years of the pandemic, the Indian pharmaceutical industry has been able to develop its own indigenous vaccines. It has also shown the technology absorption capacity to support manufacturing of nearly all the COVID vaccines that have been developed, that too in a cost effective manner, thus emerging as the “pharmacy of the world”. As of March 2021, India exported 5.84 crore doses of COVID vaccines to 70 countries. This has been possible due to availability of low-cost skilled manpower and a well-established manufacturing ecosystem.

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Under the agreement signed today, Technology Development Board has approved financial support of ₹100 Crores out of the total project cost estimated at ₹311.30 Crores to M/s SapigenBiologix Private Limited, Hyderabad for development & commercialization of two novel vaccines – Intranasal Covid-19 Vaccine” and “RTS, S Malaria Vaccine”.  The company aims to set up a state-of-the art cGMP facility in Bhubaneswar, in compliance with latest global standards, for manufacturing Intranasal Covid-19 Vaccine and (RTS, S) Malaria Vaccine initially and later expand the product portfolio by adding other vaccines. The 2 vaccines to be developed and commercialised are :-

A: Nasal Coronavirus vaccine: In contrast to the Intramuscular (IM) corona virus vaccine currently in use, the intra nasal vaccine can generate mucosal immune response thereby protecting both the upper and lower respiratory system of a vaccinated individual and break the cycle of infection and transmission. The present project uses the technology platform developed by Washington University, School of Medicine in St Louis for the SARS-COV-2 chimpanzee adenovirus in inactivate or killed virus form.

This platform has several advantages:These vaccines express surface antigens which retain their epitope conformations to play an important role in inducing strong preventative humoral responses especially with reference to SARS-CoV-2. Scaling up is relatively easier. Easy delivery (single dose of 0.1 ml as against 2 doses of 0.5 ml each of I-generation vaccines).Can be administered even by untrained health worker and self-immunization also possible, No requirement of syringe, needle, and alcohol swabs. Safer to use

B: RTS, S Malaria Vaccine: In view of the public health potential, World Health Organization WHO’s top advisory bodies for malaria and immunization have jointly recommended phased introduction of the vaccine in selected areas of sub-Saharan Africa. Three countries – Ghana, Kenya, and Malawi – began introducing the vaccine in selected areas of moderate and high malaria transmission in 2019. Vaccinations are being provided through each country’s routine immunization program. As per the forecast of GAVI, the demand for malaria vaccine would be 75 million doses by 2035.

Both the Vaccines are novel and will come under the ambit of commercial production for the first time.

The company aims to produce 100 million doses/annum of intranasal Covid-19 vaccine by April 2023 and 15 million doses/ annum RTS, S Malaria vaccine by the end of April 2025.

Sh. Rajesh Kumar Pathak, IP&TAFS, Secretary, TDB, said that “The Indian pharma companies, not only providing the yeoman service to the nation but also are instrumental in providing the medicines and vaccines at affordable cost to the entire world and thus transforming India as “The Pharmacy of the World”. TDB’s support to such Indian pharma companies over the years, engaged in indigenous manufacturing of vaccines has contributed immensely to the development & setting up of the vaccine manufacturing ecosystem in India and meeting the Prime Minister’s vision of Atmanirbhar Bharat (Self-Reliant India Mission)”.


 

PIB Delhi