DCGI Grants Emergency Use Authorisation To Gennova's Omicron-Specific mRNA-Based Booster Vaccine

In a significant development in the fight against COVID-19, the Central government's Department of Biotechnology (DBT) has announced that the Omicron-specific mRNA-based Booster vaccine, named GEMCOVAC-OM, has received Emergency Use Authorization (EUA) from the office of the Drug Controller General of India (DCGI).

This vaccine, developed using indigenous platform technology by Gennova Biopharmaceuticals Ltd, marks a major milestone in India's vaccine research and development efforts.

The GEMCOVAC-OM vaccine was developed under the Mission COVID Suraksha, implemented by the Biotechnology Industry Research Assistance Council (BIRAC), which is part of the DBT.

The DBT facilitated the establishment of Gennova's mRNA-based next-generation vaccine manufacturing, according to a Union Science and Technology Ministry said in a statement on Tuesday (20 June).

From the proof of concept to the Phase I clinical trial of the prototype mRNA-based vaccine developed against the Wuhan strain, the DBT supported the project through the Mission COVID Suraksha.

What sets GEMCOVAC-OM apart is its thermostable nature, eliminating the need for ultra-cold chain infrastructure required by other approved mRNA-based vaccines, the ministry said.

This characteristic makes it easier to deploy across India, including in areas with limited cold storage facilities.

Additionally, the vaccine is delivered intra-dermally using a needle-free injection device system, which enhances convenience and accessibility.

Clinical trials have demonstrated that GEMCOVAC-OM, when administered as a booster shot, generated significantly higher immune responses.

"The clinical outcome demonstrates the need for variant-specific vaccines for desired immune response," the ministry said.

Union Minister (Independent Charge) for Science and Technology Jitendra Singh commended the efforts of the DBT team and said, "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," he said.

"Infrastructure to deploy vaccine in India, including LMICs, at 2‑8°C exist today & this innovation is tailored for the existing established supply-chain Infrastructure. The vaccine does not need ultra-low temperature conditions for transport and storage," the minister added.