The country’s first mRNA-based Covid-19 booster vaccine has got the Drug Controller General of India’s nod for emergency use in those over 18 years.
The Omicron-vairant-specific vaccine was developed using indigenous technology from Pune-based Gennova Biopharmaceuticals, with support from the Department of Biotechnology (DBT). A key feature of the vaccine is its thermo-stability. This facilitates its adoption, as it would not require an ultra-cold-chain infrastructure, as required by other Covid-19 mRNA vaccines.
The vaccine would be rolled out in a matter of weeks,company representatives said, without divulging its price. About 12 lakh doses have reportedly been cleared for use.
The original vaccine was supported by the Mission COVID Suraksha that was implemented by Biotechnology Industry Research Assistance Council (BIRAC) and received an emergency use authorisation, a year ago (June 29th).
Branded GEMCOVAC-OM, the booster would be delivered intra-dermally using a needle-free injection device system. “When administered intradermally in participants as a booster,it generated significantly higher immune responses,” a DBT note said.
Clinical trials
Dr Sanjay Singh, Chief Executive, Gennova Biopharmaceuticals (a subsidiary of Emcure), said: “There is a realization that the COVID-19 will remain and keep mutating, and therefore we need to be prepared with vaccines to deal with emerging variants.”
The vaccine is a lyophilized (freeze dried) vaccine, stable at 2- 8 °C. It is delivered through the skin using a device called Tropis, developed by PharmaJet (US).
Meanhwile, the company said, GEMCOVAC-OM had demonstrated robust immune responses in Phase III clinical trials conducted at 20 centers across 13 cities in India. About 3,000 individuals received the vaccine in Phase II/III trials and it was safe and well tolerated, it said.
The approved vaccines used as a precautionary or booster dose was designed against the ancestral strain of SARS-CoV-2. “Although these will increase the antibody titers, their ability to neutralize the circulating Omicron variant of SARS-CoV-2 is limited.” it said. Developing antibodies and memory immune responses specific to the Omicron variant would reduce the probability of infection and hospitalization, it added.
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