Por Shivani Singh
BENGALURU, Aug 24 (Reuters) – India has approved further clinical trials for its first local mRNA-based COVID-19 vaccine developed by Gennova Biopharmaceuticals Ltd, the government said on Tuesday, after the injection was found to be safe and effective in an early stage study.
Gennova is one of the few pharmaceutical companies worldwide – including Moderna Inc and Pfizer Inc – that use mRNA technology in their coronavirus vaccine.
These vaccines do not use a live virus to generate an immune response, but instead induce the human body to produce a protein that triggers it.
The company said Tuesday that it plans to begin mid-stage testing of its candidate vaccine, HGCO19, in early September at 10 to 15 sites, and late-stage testing at 22 to 27 sites in India.
Clinical trials of Gennova’s vaccine candidate began in December and are funded in part by the biotechnology department of India’s Ministry of Science and Technology.
“It is too early to get excited about this vaccine as phase 3 trials have not yet been completed. By the time this vaccine hits the market, India will have already vaccinated the majority of its population with at least one dose,” said Prashant Khadayate. , GlobalData Pharmaceutical Analyst.
India has so far authorized emergency use for two domestically developed COVID-19 vaccines, manufactured by Bharat Biotech and Zydus Cadila, but does not yet have mRNA-based vaccines in its immunization schedule ahead of a possible third wave of coronavirus.
Moderna’s vaccine won emergency use approval from the Indian government in June, but the company is still resolving issues over compensation and imports.