DCGI gives EUA for mRNA-based Omicron-specific booster vaccine from Gennova

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.