Gennova’s GEMCOVAC-OM Omicron-specific mRNA-based booster vaccine gets EUA in India

The Department of Biotechnology (DBT), part of the Indian Ministry of Science & Technology, has revealed that the Omicron-specific mRNA-based booster vaccine, developed by Pune-based Gennova Biopharmaceuticals, has received Emergency Use Authorization (EUA) from the Drug Control General of India (DCGI).

This significant development has been facilitated through the Mission COVID Suraksha initiative, managed by the Biotechnology Industry Research Assistance Council (BIRAC).

Dr Jitendra Singh, Union Minister (IC), Ministry of Science and Technology, 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.”

Gennova Biopharmaceuticals utilized its indigenous platform technology, supported by DBT, to develop the mRNA-based next-generation vaccine. The platform was used from the proof-of-concept stage through the Phase I clinical trial of the prototype mRNA-based vaccine developed against the Wuhan strain of the coronavirus. The technology was then adapted to create the Omicron-specific booster vaccine, GEMCOVAC-OM.

This endeavor was further backed by the ‘Indian COVID-19 Vaccine Development Mission’ by DBT’s dedicated Mission Implementation Unit at BIRAC. The prototype vaccine, which earned EUA on 29th June 2022, was escalated for further clinical development and production.
GEMCOVAC-OM, a thermostable vaccine, doesn’t require ultra-cold chain infrastructure like other approved mRNA-based vaccines, making it more accessible for widespread use across India.

The vaccine is administered intradermally via a needle-free injection device. Clinical results show that the booster vaccine significantly enhances immune responses when administered to participants, indicating the necessity for variant-specific vaccines to generate the desired immune response.

Dr Sanjay Singh — Gennova Biopharmaceuticals CEO said: “When we started the development of this platform technology and took the proposal to DBT, 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 DCG(I) is a testimony of 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.”