Government gives EUA to omicron-specific mRNA-based booster vaccine by Gennova

June 20, 2023 | Tuesday | News

GEMCOVAC-OM is an omicron-specific mRNA-based booster vaccine developed using the indigenous platform technology

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The Department of Biotechnology (DBT) has announced that the Omicron-specific mRNA-based booster vaccine developed using the indigenous platform technology by Pune-based Gennova Biopharmaceuticals, and supported under the Mission COVID Suraksha, implemented by Biotechnology Industry Research Assistance Council (BIRAC), has got a nod from the office of the Drug Control General of India (DCGI) for Emergency Use Authorisation (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-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.