By Express News Service
NEW DELHI: Pune-based Gennova Biopharmaceuticals, a subsidiary of Emcure Pharmaceuticals, whose mRNA Covid-19 vaccine GEMCOVAC-19 got the nod from the Drug Controller General of India (DCGI), said they are working on a booster dose that would be effective against the Omicron variant also.
The DCGI on Tuesday granted Emergency Use Authorization (EUA) to GEMCOVAC-19, which is India’s first indigenously developed mRNA vaccine. It is only the third mRNA vaccine approved for Covid-19 in the world.
Gennova Chief Operating Officer Samit Mehta said the clinical trial protocol for the booster shot had been submitted using the Omicron variant. “We have made minor tweaks in the current formulation, and we have already submitted that protocol for clinical trials for boosters,” he said.
The company said they aim to produce around 4-5 million doses per month, and this capacity can be doubled. On the plans for the roll-out of the vaccine, Mehta said, “It depends upon what stand the government takes whether they would like to procure and then deploy or they would prefer it if we are ones to reach out to the private market. Discussions are underway.”
Mehta said the extensive trials saw minor side effects. “We injected our product in at least 4,000 healthy volunteers, and we haven’t noticed events like myocarditis or any other cardiac issues among the trial volunteers. Though adverse events have been reported in other mRNA vaccines, we didn’t witness anything like that in our trials.”
