By Shivani Singh, Reuters in Bengaluru, August 25 :
India has approved further clinical trials for its first homegrown mRNA-based COVID-19 vaccine developed by Gennova Biopharmaceuticals Ltd, the government said on Tuesday, after the shot was found to be safe and effective in an early-stage study.
Gennova is among a few pharmaceutical firms worldwide, including Moderna Inc (MRNA.O) and Pfizer Inc (PFE.N), to use mRNA technology in its coronavirus shot. These vaccines do not use a live virus to generate an immune response but prompt the human body to make a protein that triggers one.
The company said on Tuesday it plans to start mid-stage trials of its vaccine candidate, HGCO19, in early September at about 10 to 15 sites and a late-stage trial at 22 to 27 sites in India.
Clinical trials of Gennova’s vaccine candidate began in December last year and are partly funded by the biotechnology department of India’s Ministry of Science and Technology.
“It’s too early to get excited about this vaccine as phase-3 trials are yet to be completed. By the time this vaccine reaches the market, India would have vaccinated a majority of its population with at least one dose,” said Prashant Khadayate, a pharma analyst at GlobalData.
Developing an mRNA vaccine would however help India “display its scientific innovation at a global level”, Khadayate added.
India has so far authorised emergency use for two domestically developed COVID-19 shots, made by Bharat Biotech and Zydus Cadila (CADI.NS), but does not have mRNA-based vaccines yet in its immunisation programme ahead of a potential third coronavirus wave.
Moderna’s vaccine won an emergency use approval from the Indian government in June, but the company is still sorting out issues over indemnity and imports.
Gennova, whose parent firm Emcure Pharmaceuticals Ltd filed for an initial public offering last week, is also scaling up its vaccine manufacturing capacity, a government statement said.