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Omicron-specific mRNA-based booster vaccine gets DCGI nod

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Omicron-specific mRNA-based booster vaccine gets DCGI nod

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New Delhi: The Department of Biotechnology (DBT) on Tuesday announced that the Omicron-specific mRNA-based Booster vaccine developed using the indigenous platform technology by Gennova Biopharmaceuticals 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 developing the platform technology from proof of concept till phase I clinical trial of the prototype mRNA-based vaccine developed against the Wuhan strain. 

“GEMCOVAC 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 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 DBT press statement. 

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, Gokhale said. 

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Updated: 20 Jun 2023, 09:28 PM IST

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