Covid: India's First Omicron-Specific Booster Vaccine Gets Drug Controller Nod
GEMCOVAC-OM is an mRNA-based booster vaccine aimed at the Omicron variant of Covid-19.
The Drug Control General of India (DCGI) has granted emergency use authorisation (EUA) to an Omicron-specific booster vaccine developed by Gennova Biopharmaceuticals Ltd. The vaccine has been developed by Gennova Biopharmaceuticals in collaboration with the Department of Biotechnology (DBT) under the 'Mission COVID Suraksha'.
The mRNA-based vaccine, GEMCOVAC-OM, was developed using the indigenous platform technology. It can be administered as a booster in participants who have received two doses of Covishield and Covaxin.
GEMCOVAC-OM is a thermostable vaccine, meaning that it does not require ultra-cold chain infrastructure used for other approved mRNA-based vaccines, making it easy for deployment across India.
The vaccine is delivered intra-dermally using a needle-free injection device system instead of traditional syringes, eliminating the fear and anxiety associated with needles.
"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," the government said in a press release.
Speaking on GEMCOVAC-OM getting DCGI nod, Jitendra Singh, Minister 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."
"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," he further said.
Rajesh S Gokhale, secretary, DBT, said GEMCOVAC-OM was developed using the mRNA-based disease agnostic platform technology that can be used to make other vaccines in a relatively short development timeline.
The clinical trial results of the vaccine found it to be safe and well tolerated and no vaccine-related serious adverse events were observed.
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