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.
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.”
- PIB
