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The Indian government said on Tuesday that after the vaccine was found to be safe and effective in an early study, India has approved its first mRNA-based indigenous COVID-19 vaccine developed by Gennova Biopharmaceuticals Ltd for further clinical trials.
Gennova is one of the few pharmaceutical companies in the world that uses mRNA technology in their coronavirus injections, including Moderna Inc (MRNA.O) and Pfizer Inc (PFE.N). These vaccines do not use live viruses to generate an immune response, but instead prompt the body to produce a protein that triggers the immune response.
The company said on Tuesday that it plans to start mid-term trials of its candidate vaccine HGCO19 in about 10 to 15 locations in India in early September, and to start late-stage trials in 22 to 27 locations in India.
The clinical trials of Gennova vaccine candidates started in December last year, with part of the funding provided by the Biotechnology Department of the Ministry of Science and Technology of India.
“It’s too early to be excited about this vaccine because the Phase 3 trials have not yet been completed. When this vaccine is available, India will receive at least one dose of the vaccine,” said Prashant Khadayate, a pharmaceutical analyst at GlobalData.
However, the development of mRNA vaccines will help India “show its scientific innovations on a global scale,” Khadayate added.
So far, India has authorized the emergency use of two domestically developed COVID-19 vaccines produced by Bharat Biotech and Zydus Cadila (CADI.NS), but before the potential third wave of coronavirus outbreak, its immunization plan has not yet been based on mRNA vaccine.
Moderna’s vaccine received emergency use approval from the Indian government in June, but the company is still resolving compensation and import issues.
A government statement said that Gennova’s parent company Emcure Pharmaceuticals Ltd applied for an initial public offering last week and the company is also expanding its vaccine production capacity.
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