Mumbai: Gennova Biopharmaceuticals, subsidiary of Pune-based drug maker Emcure on Tuesday said its mRNA Covid-19 booster vaccine – Gemcovac-OM against the Omicron variant of SARS-CoV-2 received emergency use authorization (EUA) from 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, including XBB subvariant. The company said 12 lakh booster doses have already been approved by Central Drugs Laboratory (CDL), Kasauli, and the vaccine is expected to be rolled out soon. Gennova declined to give the price of the booster dose, but said it will be announced at the time of the official launch. The company said its booster shot has demonstrated robust immune responses in the phase-3 clinical trial conducted at 20 centers across 13 cities in India on 3,000 individuals. The vaccine was safe and well tolerated. It comes in a lyophilized (freeze dried) vaccine, stable at 2- 8 °C. The vaccine is a needle-free device delivered intradermally using a special device called Tropis, developed by US-based PharmaJet.

The currently approved vaccines used as precautionary/ booster doses are designed against the ancestral (Wuhan) 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.

“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,” said Sanjay Singh, CEO, Gennova.

“The mRNA platform, which was developed in association with the Department of Biotechnology (DBT), Government of India, provides an opportunity for a quick turnaround for vaccine development for any variants of concern in future,” Singh added.