New India-made Omicron-specific Covid vaccine cleared for use as booster dose

The Department of Biotechnology announced today that the India-made Omicron-specific mRNA-based Booster vaccine for Covid has got for Emergency Use Authorization (EUA) from the office of the Drug Control General of India (DCGI).

The vaccine has been developed using the indigenous platform technology by Pune-based Gennova Biopharmaceuticals Ltd. and supported under the Mission COVID Suraksha, implemented by Biotechnology Industry Research Assistance Council (BIRAC).

The Department of Biotechnology (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 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, according to the official statement.

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.

Dr. Jitendra Singh, Union Minister (IC), Ministry of Science and Technology, commended the efforts of team DBT and said, that “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 the Prime Minister’s vision of Aatmanirbharta.

The minster also said, “Infrastructure to deploy vaccine in India, including LMICs, at 2‑8°C exist 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.”