DCGI nod to India's first mRNA based Omicron-specific booster vaccine
GEMCOVAC-OM is delivered intradermally using a needle-free device called Tropis, developed by PharmaJet, USA.;
Pune: Gennova Biopharmaceuticals Ltd, a Pune based company, has announced that its mRNA COVID-19 booster vaccine – GEMCOVAC-OM - against the Omicron variant of SARS-CoV-2 has received Emergency Use Authorization (EUA) from the office of the Drugs Controller General of India (DCGI).
GEMCOVAC-OM is the first booster COVID-19 vaccine developed in India against the highly transmissible Omicron variant. GEMCOVAC-OM has demonstrated robust immune responses in the phase 3 clinical trial conducted at 20 centers across 13 cities in India In Phase-II/ III trials, approximately 3000 individuals received GEMCOVAC-OM and the vaccine was safe and well tolerated.
The currently approved vaccines used as precautionary/ booster doses are 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. Developing antibodies and memory immune responses specific to the Omicron variant would reduce the probability of infection and hospitalization and prevent future waves of the pandemic. The Made-in-India GEMCOVAC-OM specifically addresses this gap.
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