Gennova mRNA-based vaccine awaits nod

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India’s first mRNA-based Covid-19 vaccine, from Gennova Biopharma, a subsidiary of Pune-based Emcure Pharmaceuticals, is in its final stages. Soumya Swaminathan, chief scientist at the World Health Organization (WHO), visited Gennova’s vaccine manufacturing facility at Hinjewadi in Pune on Monday. The company is awaiting regulatory approvals for its mRNA vaccine for Covid-19.

The company declined to comment further on Swaminathan’s visit. Prime Minister Narendra Modi recently highlighted the country’s progress in vaccine production and spoke about Gennova’s mRNA vaccine during his address at the UN General Assembly’s 76th session. Prime Minister Modi said the m-RNA vaccine was in the final stages of development. The country would be sourcing 60 million doses of Gennova’s mRNA vaccine.

The Drug Controller General of India (DCGI) had approved Phase II and Phase III studies of the vaccine in August. Gennova had submitted the interim clinical data of the Phase I study to the Central Drugs Standard Control Organisation. The Vaccine Subject Expert Committee reviewed the interim Phase I data and found the vaccine to be safe, tolerable and immunogenic. Trials are going on across the country at 10-15 sites in Phase II and 22-27 sites in Phase III. Gennova is using the Department of Biotechnology’s and Indian Council of Medical Research’s clinical trial network sites for this study.

After completing the clinical trials, the company will apply for approval for the sale of the Covid-19 vaccine. Once approved, the mRNA vaccine production can be scaled up rapidly and the company would be delivering the committed 60 million doses by December. As the company has worked on backward integration such as enzymes and reagents, it does not expect any raw material challenges. Emcure has capacity to make 200 million doses and the installed capacity can be further scaled up to one billion doses.

Around Rs 500-crore investments have been made by the company in developing the vaccine, with around `100 crore coming from the government as seed capital and for conducting clinical trials.

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