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 can be used for people who are 18 years and above. 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.
“As far as the booster goes, we already have a candidate ready that will also address the Omicron variant in addition to Delta. We have made minor tweaks in the current formulation, and we have already submitted that protocol for clinical trials for boosters,” he said.
The pharma company said they aim to produce around 4-5 million doses per month, and this capacity can be quickly doubled. The company has 7 million doses approved and released by the Central Drug Laboratory in Kasauli.
Apart from India, Gennova aims to provide access to low-and middle-income countries around the world to blunt the spread of pandemics.
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. Currently, discussions are underway.”
When asked about the possible adverse event, 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.”
He added that prequalifying the vaccine by the World Health Organisation (WHO) was the next step for the company.
GEMCOVAC-19 is a thermostable vaccine and can be stored between temperatures of 2 to 8 C, which makes it favourable for deployment in India and other developing nations, as it can be transported to the most remote parts easily.
In contrast, mRNA vaccines made by Pfizer-BioNTech and Moderna need to be stored at sub-zero temperatures, which remains a challenge in lower and middle-income countries, officials said. On the pricing of the vaccine, he said that the government would decide on it.
mRNA vaccines are considered safe as mRNA is non-infectious, non-integrating in nature, and degraded by standard cellular mechanisms, Gennova claimed. Its technology provides flexibility to quickly tweak the vaccine for any existing or emerging virus variants.