Omicron-specific mRNA-based Booster vaccine developed using the indigenous platform technology

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 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 29th 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.

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. 

PIB

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