India Approves Further Trials for First Homegrown mRNA COVID-19 Shot

By Reuters Staff

August 25, 2021

BENGALURU (Reuters) - India on Tuesday approved further clinical trials for its first homegrown mRNA-based COVID-19 vaccine, being developed by Gennova Biopharmaceuticals, after the shot was found to be safe and effective in an early-stage study.

The country has authorised emergency use for two domestically developed COVID-19 shots, made by Bharat Biotech and Zydus Cadila, but does not have mRNA-based vaccines yet in its immunisation programme ahead of a potential third coronavirus wave.

Gennova plans to conduct a mid-stage study at about 10 to 15 sites and a late-stage trial at 22 to 27 sites in India, the government said in a statement.

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.

The company did not immediately respond to a Reuters request for comment.

"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 already," 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.

The technology behind Gennova's vaccine, mRNA enclosed in a lipid nanoparticle, is also used in shots made by U.S. drugmakers Moderna Inc and Pfizer Inc that prompt the human body to make a viral protein to trigger an immune response. Unlike currently approved mRNA vaccines, Gennova's uses self-amplifying mRNA, which also makes copies of itself inside the body, thus requiring smaller vaccine doses.

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 filed for an initial public offering last week, is also scaling up its vaccine manufacturing capacity, the government statement added.