Gennova's mRNA jab gets regulator nod, 1.2 million boosters approved by CDL Kasauli

GEMCOVAC-OM is a thermostable vaccine which does not require ultra-cold chain infrastructure, making it easy for pan-India deployment. Representational image

Pune-based Gennova Pharmaceuticals on June 20 said its Omicron-specific mRNA-based Booster vaccine developed using the indigenous platform technology has been given emergency use authorisation by the Drug Controller General of India (DCGI).

"Twelve lakh doses of GEMCOVAC-OM, the booster dose of the mRNA vaccine has been cleared by Central Drugs Laboratory (CDL)," Sanjay Singh, CEO of Gennova Biopharmaceuticals told Moneycontrol.

The Department of Biotechnology (DBT) on June 20 announced that the Omicron-specific mRNA-based booster vaccine developed using the indigenous platform technology by Gennova was supported under the Mission Covid Suraksha, which is implemented by Biotechnology Industry Research Assistance Council (BIRAC).

The company said that it will be rolling out the vaccine in two weeks.

"The pricing and other details will be shared in due course of time," Singh said.

GEMCOVAC-OM is a thermostable vaccine, which does not require ultra-cold chain infrastructure, making it easy for pan-India deployment.

The mRNA vaccines by Pfizer and Moderna need to be stored in temperatures as low as -80 degree Celsius.

Noting that the threat of Covid-19 wasn't over yet, Singh said many existing vaccines were ineffective against the emerging variants like Omicron.

The vaccine was tested on 3,000 subjects across 20 centres in 13 cities across the country. It has also shown favourable results against the latest XBB variant of Covid.

Rajesh S Gokhale, Secretary, DBT, and Chairperson of BIRAC, said Gemcovac-Om was developed using the mRNA-based disease agnostic platform technology which can be used to make other vaccines in a relatively short development timeline.

India has now developed two mRNA vaccines against Covid using this rapid-disease-agnostic platform technology.

(With PTI inputs)