GEMCOVAC-OM is an Omicron-specific mRNA-based booster vaccine. Credit: Shaun from Pixabay.

The Drug Controller General of India (DCGI) has granted emergency use authorisation (EUA) for Gennova Biopharmaceuticals’ Omicron-specific mRNA-based Covid-19 booster vaccine, GEMCOVAC-OM.

GEMCOVAC-OM was developed using indigenous platform technology. The project was supported under the Mission Covid Suraksha, which has been implemented by India’s Biotechnology Industry Research Assistance Council (BIRAC).

GEMCOVAC-OM is a thermostable vaccine that does not need ultra-cold chain infrastructure for its storage and transport, unlike other approved mRNA-based vaccines.

It is given intra-dermally via a needle-free injection device.

The vaccine produced significantly higher immune responses when given as a booster.

Clinical findings had showed the need to develop variant-specific vaccines.

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Gennova Biopharmaceuticals CEO Dr Sanjay Singh stated: “When we started the development of this platform technology and took the proposal to the Department of Biotechnology, the government believed in our capability to develop an mRNA technology platform, and we did it.

“GEMCOVAC-OM’s getting EUA from the office of the DCGI is a testimony to our efforts to initiate, nurture and enable this pandemic-ready technology. India has now developed not one but two mRNA vaccines against Covid-19 using this rapid-disease-agnostic platform technology.”

Indian science and technology minister Dr Jitendra Singh stated: “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 [a self-reliant India].

“Infrastructure to deploy the vaccine in India… at 2°C to 8°C exist today and this innovation is tailored for the existing established supply-chain infrastructure.”

Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

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