New Delhi: The Drug Controller General of India (DGCI) has approved the emergency use authorisation (EUA) for an Omicron-specific mRNA-based booster vaccine, a senior officer of the department of biotechnology (DBT) said on Tuesday.
The mRNA-based booster vaccine has been developed using indigenous platform technology by Gennova Biopharmaceuticals Ltd. and supported under the mission COVID suraksha, being implemented by Biotechnology Industry Research Assistance Council (BIRAC).
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DBT 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. The Indian COVID-19 vaccine development mission’ by DBT’s dedicated mission implementation unit at BIRAC, for further clinical development and scaling 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, said a DGCI official.
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Union minister for science and technology Jitendra Singh commended the efforts of team DBT and 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 Aatmanir Bharat.”
“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 minister added.
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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, 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 sbject expert committee of CDSCO and the vaccine expert committee of BIRAC monitoring the project, it would not have been possible.”
