India’s initially 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 organization is awaiting regulatory approvals for its mRNA vaccine for Covid-19.
The organization declined to comment additional on Swaminathan’s pay a visit to. Prime Minister Narendra Modi lately highlighted the country’s progress in vaccine production and spoke about Gennova’s mRNA vaccine in the course of his address at the UN General Assembly’s 76th session. Prime Minister Modi stated the m-RNA vaccine was in the final stages of development. The nation would be sourcing 60 million doses of Gennova’s mRNA vaccine.
The Drug Controller General of India (DCGI) had authorized Phase II and Phase III research of the vaccine in August. Gennova had submitted the interim clinical information of the Phase I study to the Central Drugs Standard Control Organisation. The Vaccine Subject Expert Committee reviewed the interim Phase I information and discovered the vaccine to be secure, tolerable and immunogenic. Trials are going on across the nation at 10-15 web-sites in Phase II and 22-27 web-sites in Phase III. Gennova is working with the Department of Biotechnology’s and Indian Council of Medical Research’s clinical trial network web-sites for this study.
After finishing the clinical trials, the organization will apply for approval for the sale of the Covid-19 vaccine. Once authorized, the mRNA vaccine production can be scaled up quickly and the organization would be delivering the committed 60 million doses by December. As the organization has worked on backward integration such as enzymes and reagents, it does not anticipate any raw material challenges. Emcure has capacity to make 200 million doses and the installed capacity can be additional scaled up to one billion doses.
Around Rs 500-crore investments have been made by the organization in establishing the vaccine, with about `100 crore coming from the government as seed capital and for conducting clinical trials.