The Drug Control General of India (DCGI) has granted Emergency Use Authorization (EUA) to an Omicron-specific booster vaccine, the Department of Biotechnology (DBT) said on Tuesday.

The mRNA-based vaccine, GEMCOVAC-OM, was developed by Gennova Biopharmaceuticals using the indigenous platform technology, and supported under the Mission COVID Suraksha, implemented by Biotechnology Industry Research Assistance Council (BIRAC).

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.

“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,” Jitendra Singh, Union Minister (IC), Ministry of Science and Technology, 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,” he added.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.”