The Covid-19 Omicron-Specific mRNA-Based Vaccine receives government approval

The use of an Omicron-specific mRNA-based booster vaccination for Mission Covid Suraksha has received regulatory approval.

The Omicron-specific mRNA-based booster vaccine created by Gennova Biopharmaceuticals has received emergency use authorization, according to a report by the news agency PTI.

According to an official statement, the Department of Biotechnology (DBT) assisted Gennova in setting up its mRNA-based next-generation vaccine manufacturing facility in order to develop the platform technology from proof of concept to the Phase I clinical trial of the prototype 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,” the statement said.

Sanjay Singh, CEO of Gennova Biopharmaceuticals Ltd., was cited in the newspaper as saying, “GEMCOVAC-OM getting Emergency Use Authorization from the office of the Drug Controller General of India is a testimony of our efforts to initiate, nurture and enable this ‘pandemic ready’ technology.”

It is simple to deliver GEMCOVAC-OM throughout India since it is a thermostable vaccine that doesn’t need an ultra-cold chain infrastructure.

It is already possible to deliver vaccines in India at temperatures between 2 and 8 degrees Celsius, and this innovation is specifically designed to work with the extant supply-chain infrastructure. Jitendra Singh, the minister of science and technology, was reported in the newspaper as saying that the vaccine did not need storage and shipping at very low temperatures.

It claimed that a system of needle-free injection devices is used to administer the vaccination intradermally.

The project was funded by DBT’s dedicated Mission Implementation Unit at the Biotechnology Industry Research Assistance Council (BIRAC) under “Mission Covid Suraksha,” the Indian Covid-19 Vaccine Development Mission, for further clinical development and scale-up of the prototype vaccine, which received emergency use authorization in June of last year.

GEMCOVAC-OM was produced utilising the mRNA-based disease agnostic platform technology, which may be utilised to manufacture various vaccines in a reasonably short development timescale, according to Rajesh S. Gokhale, Secretary, DBT, and Chairperson, BIRAC.