Omicron-specific mRNA booster vaccine gets EUA nod from drug controller

The Omicron-specific mRNA-based Booster vaccine on Tuesday got approval for Emergency Use Authorization (EUA) from India’s drug controller the Drug Control General of India (DCGI). The vaccine has been developed by Gennova Biopharmaceuticals under Mission Covid Suraksha using the indigenous platform technology, implemented by the Biotechnology Industry Research Assistance Council (BIRAC) under the Department of Biotechnology.

The DBT said that it has facilitated establishing Gennova’s mRNA-based next-generation vaccine manufacturing for developing the 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.

“GEMCOVAC-OM is an Omicron-specific mRNA-based booster vaccine developed using the indigenous platform technology by Gennova in collaboration with DBT. GEMCOVAC-OM is a thermostable vaccine which does not require ultra-cold chain infrastructure, making it easy for pan-India deployment,” said DBT in a statement.

Speaking on the development, Sanjay Singh, CEO of Gennova Biopharmaceuticals Ltd, said, “GEMCOVAC-OM getting Emergency Use Authorisation from the office of the Drug Controller General of India 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.

Commending the efforts of DBT, Union Minister (IC) Dr. Jitendra Singh said, “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.

Mr Singh said that, “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.”

The vaccine is delivered intradermally using a needle-free injection device system. Rajesh S Gokhale, Secretary, DBT, and Chairperson, BIRAC, said GEMCOVAC-OM was developed using the mRNA-based disease agnostic platform technology which can be used to make other vaccines in a relatively short development timeline.