The Department of Biotechnology (DBT) has announced that the Omicron-specific mRNA-based Booster vaccine developed using the indigenous platform technology by Gennova Biopharmaceuticals Ltd. and supported under the Mission COVID Suraksha, implemented by Biotechnology Industry Research Assistance Council (BIRAC), has got a nod from the office of the Drug Control General of India (DCGI) for Emergency Use Authorization (EUA).

DBT has facilitated establishing Gennova's mRNA-based next-generation vaccine manufacturing for developingthe platform technology from proof of concept till Phase I clinical trial of the prototype mRNA-based vaccine developed against the Wuhan strain. The project was further supported under the'Mission COVID Suraksha. The Indian COVID-19 Vaccine Development Mission' by DBT's dedicated Mission Implementation Unit at Biotechnology Industry Research Assistance Council (BIRAC), for further clinical development and Scale up of the prototype vaccine, which received EUA on 29^th June 2022. The platform technology developed was used to develop an Omicron-specific booster vaccine for COVID-19.

GEMCOVAC^®-OM is an Omicron-specific mRNA-based Booster vaccine developed using the indigenous platform technology by Gennova in collaboration with DBT. Like the prototype vaccine, GEMCOVAC®-OM is a thermostable vaccine, which does not require ultra-cold chain infrastructure used for other approved mRNA-based vaccines, making it easy for deployment pan India. It is delivered intra-dermally using a needle-free injection device system. When administered intradermally in participants as a booster,it generated significantly higher immune responses.The clinical outcome demonstrates the need for variant-specific vaccines for desired immune response.

Dr. Jitendra Singh, Union Minister (IC), Ministry of Science and Technology, commended the efforts of team DBT and said, that"I take great pride in DBT fulfilling its mission yet again – enabling technology-driven entrepreneurship through creating this indigenous mRNA-platform technology. We have always supported technology-driven innovation towards the creation of a 'future-ready' technology platform in line with the Prime Minister’s vision of Aatmanirbharta. Minster also said, "Infrastructure to deploy vaccine in India, including LMICs, at 2‑8°C exist today & this innovation is tailored for the existing established supply-chain Infrastructure. The vaccine does not need ultra-low temperature conditions for transport and storage."

Dr Rajesh S Gokhale, Secretary, DBT, and Chairperson, BIRAC said that Strategic infusion of funds is essential to drive and create an ecosystem for technological innovation, and DBT did just that when it provided support for the development of the nation’s first mRNA-based platform technology. This is a disease-agnostic platform and can be used to make other vaccines in a relatively short developmental timeline. "Clinical Trial Networks, with Consortia of Hospitals was supported by NBM-DBT and the same sites were used for the mRNA vaccine “clinical trials, he said.”

Speaking on the development, CEO of Gennova Biopharmaceuticals Ltd, Dr. Sanjay Singh, said, "When we started the development of this platform technology and took the proposal to DBT, the Government believed in our capability to develop an mRNA technology platform, and we did it. GEMCOVAC®-OM's getting EUA from the office of the DCG(I) is a testimony of our efforts to initiate, nurture and enable this 'pandemic ready' technology. India has now developed not one but two mRNA vaccines against COVID-19 using this rapid-disease-agnostic platform technology. I am proud that my team has worked tirelessly over the last two years to develop the nation's first mRNA vaccine. This is a team effort & without the guidance of the Subject Expert Committee of CDSCO and the Vaccine Expert Committee of BIRAC monitoring the project, it would not have been possible."

About DBT

The Department of Biotechnology (DBT), under the Ministry of Science & Technology, promotes and accelerates the development of biotechnology in India, including the growth and application of biotechnology in the areas of agriculture, healthcare, animal sciences, environment, and industry.

About BIRAC:

Biotechnology Industry Research Assistance Council (BIRAC) is a not-for-profit Section 8, Schedule B, Public Sector Enterprise, set up by the Department of Biotechnology (DBT), Government of India, as an Interface Agency to strengthen and empower the emerging Biotech enterprises to undertake strategic research and innovation, addressing nationally relevant product development needs.

About Gennova

Gennova Biopharmaceuticals Ltd., headquartered in Pune, India, is a biotechnology company dedicated to the research and development, production, and commercialization of biotherapeutics (biologics and vaccines) to address life-threatening diseases across various indications. To find out more, visit https://gennova.bio

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