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India’s first mRNA vaccine gets emergency use nod from DCGI; Talks with govt underway on roll-out strategy

Meanwhile, Gennova’s GEMCOVAC™-19 has reached the primary endpoint of Phase III clinical trial. The clinical data were evaluated by the Central Drugs Standard Control Organisation (CDSCO). The vaccine was found to be safe, well-tolerated and immunogenic, the company claims.

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Gennova Biopharmaceuticals Ltd. is planning to produce around 40-50 lakhs of doses per month and this capacity can be quickly doubled. (File)

Gennova Biopharmaceuticals Ltd., a subsidiary of Emcure Pharmaceuticals Ltd. on Wednesday announced that its mRNA vaccine – GEMCOVAC™-19 – against COVID-19 received the Emergency Use Authorization (EUA) from the office of the Drugs Controller General of India (DCGI).

On Tuesday, DCGI approved India’s first home-grown mRNA Covid-19 vaccine by Gennova Biopharma for emergency use in 18 years and above. According to reports, while other mRNA vaccines require to be stored at sub-zero temperatures, Gennova’s mRNA vaccine can be stored at 2-8 degrees.

Developed in India, GEMCOVAC-19™ is the very first mRNA vaccine and the third mRNA vaccine to be approved for COVID-19 in the world.

“We are using a platform that is a self amplifying mRNA. Our authorisation is just for 10 microgram whereas others are using around 10 microgram. Since, we have lower dose, the side-effect profile will be lower too. The major difference is the storage requirement which makes it much easier to administer and transport,” Samit Mehta, Chief Operating Officer, Gennova Biopharmaceuticals Ltd. told Financial Express.com on Wednesday when asked about how it different from other mRNA vaccines.

According to experts, mRNA vaccines are highly efficacious due to their inherent capacity of being translated into the protein structure inside the cell cytoplasm. Moreover, the technology provides flexibility to quickly tweak the vaccine for any existing or emerging variants of the virus.

On the possibility of adverse-event like Myocarditis and Pericarditis which has been reported in Moderna’s mRNA vaccine, Mehta told Financial Express.com: “We injected our product in atleast 4,000 healthy volunteers and we haven’t noticed any such 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.”

Meanwhile, Gennova’s GEMCOVAC™-19 has reached the primary endpoint of Phase III clinical trial. The clinical data were evaluated by the Central Drugs Standard Control Organisation (CDSCO). The vaccine was found to be safe, well-tolerated and immunogenic, the company claims.

“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,” Mehta added while commenting on roll-out process for vaccination.

Gennova Biopharmaceuticals Ltd. is planning to produce around 40-50 lakhs of doses per month and this capacity can be quickly doubled. “Beyond India, Gennova aims at providing sustainable access to low-and middle-income countries around the world to the vaccine to blunt the spread of the pandemic,” it stated.

Last week, the Subject Expert Committee (SEC) in a meeting held on Friday recommended Emergency Use Authorisation (EUA) for the mRNA vaccine against COVID-19.

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