Last Updated on December 31, 2023 by The Health Master
Gennova Biopharmaceuticals announced that its mRNA COVID-19 booster vaccine – GEMCOVAC-OM – against the Omicron variant of SARS-CoV-2 received emergency use authorisation (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 Omicron variant.
Reportedly, 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.
A company statement said, “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 neutralise 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 hospitalisation and prevent future waves of the pandemic. The Made-in-India GEMCOVAC-OM specifically addresses this gap.”
GEMCOVAC-OM is a lyophilised (freeze dried) vaccine, stable at 2- 8 °C.
It is delivered intradermally using a device called Tropis, developed by PharmaJet, US.
This is a needle-free device that obviates the disadvantages of using a needle, such as a needle phobia, sharps disposal, and needle-stick injuries, to name a few, said a company statement.
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