New Delhi: India’s drug controller has granted emergency use authorisation for the Omicron-specific mRNA-based booster vaccine developed by Genova Biopharmaceuticals under Mission Covid Suraksha, the Department of Biotechnology said on Tuesday.
The Department of Biotechnology (DBT) had facilitated the establishment of 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 vaccine developed against the Wuhan strain, an official statement said.
“GEMCOVAC-OM is an Omicron-specific mRNA-based booster vaccine developed using the indigenous platform technology by Gennova in collaboration with DBT,” it 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,” Sanjay Singh, CEO of Genova Biopharmaceuticals Ltd, said.
GEMCOVAC-OM is a thermostable vaccine which does not require ultra-cold chain infrastructure, making it easy for pan-India deployment.
“Infrastructure to deploy vaccines in India at 2-8 degrees Celsius exists today and this innovation is tailored for the existing established supply-chain infrastructure. The vaccine does not need ultra-low temperature conditions for transport and storage,” Science and Technology Minister Jitendra Singh said.
The vaccine is delivered intradermally using a needle-free injection device system.
The project was supported under ‘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 emergency use authorisation in June last year.
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.
India has now developed two mRNA vaccines against COVID-19 using this rapid-disease-agnostic platform technology.
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