New Delhi: The Department of Biotechnology (DBT) on Tuesday announced that the Omicron-specific mRNA-based booster vaccine developed by Genova Biopharmaceuticals using indigenous platform technology has received the approval from the Office of the Drug Control General of India (DCGI) for emergency use authorisation. Is. (the one of the European Union).
DBT has facilitated the development of platform technology from proof of concept to Phase I clinical trial of the prototype mRNA-based vaccine developed against the Wuhan strain and has facilitated the manufacture of mRNA-based next-generation vaccines by Gennova.
“GEMCOVAC is an Omicron-specific mRNA-based booster vaccine developed using indigenous platform technology by Gennova in collaboration with DBT. Like the prototype vaccine, GEMCOVAC is a thermostable vaccine that does not require the ultra-cold chain infrastructure used for other approved mRNA-based vaccines, making it easier to deploy across India. It is delivered intra-dermally using a needleless injection device system. When administered intradermally as a booster in participants, it generated a significantly higher immune response, said the DBT press statement. Clinical results indicate the need for variant-specific vaccines for the desired immune response.
Dr. Rajesh S Gokhale, Secretary, DBT, and Chairman, BIRAC said that driving and creating an ecosystem for technological innovation requires strategic investment of funds, and DBT did exactly that when it launched the country’s first mRNA-based provided support for the development of platform technology. “It is a disease-agnostic platform and can be used to make other vaccines in a relatively short developmental timeline. The clinical trial network was supported by NBM-DBT with consortia of hospitals and the same sites were used for the mRNA vaccine”.
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Updated: June 20, 2023, 09:28 PM IST