The Government of India has approved further clinical trials for its first homegrown mRNA-based COVID-19 vaccine, which was developed by Gennova Biopharmaceuticals after the shot is found to be safe and effective in an early-stage study.
Authorisations have been given for emergency use of two domestically developed COVID-19 jabs, made by the Bharat Biotech and Zydus Cadila, but does not have mRNA-based vaccines yet in its immunisation programme before a potential third coronavirus wave.
In a statement on Tuesday, the government announced that Biopharmaceutical plans to conduct a mid-stage study at 10 to 15 sites and a late-stage trial at 22 to 27 sites in India. The company did not immediately comment.
Clinical trials of Gennova’s vaccine candidate began in December 2020 and are partly funded by the biotechnology department of India’s Ministry of Science and Technology.
According to Prashant Khadayate, a pharma analyst at Global Data, “It’s too early to get excited about this vaccine as phase-three trials are yet to be completed. By the time this vaccine reaches the market, India would have vaccinated a majority of its population already”.
Khadayate believes that developing an mRNA vaccine would help India display its scientific innovation at a global level.
The technology behind Gennova’s vaccine, also used in shots made by US drugmakers, Moderna and Pfizer, prompts the human body to make a protein that is part of the virus to trigger an immune response.
Although Moderna’s vaccine won an emergency use approval from the Indian government in June, 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.