Mukesh Ambani-helmed Reliance has now stepped into COVID-19 vaccine manufacturing. On Thursday, the Subject Expert Committee (SEC) has recommended phase 1 clinical trials of Reliance Life Sciences’ protein-based COVID-19 vaccine candidate against the coronavirus disease. The approval was given after the SEC reviewed its application during a meeting.
The company — run by India’s richest man Mukesh Ambani — has reportedly approached India’s drug regulator, seeking permission to start Phase-1 trials for its proposed two-dose vaccine. The proposed vaccine candidate comprises two doses, and is based on recombinant protein platform, as per reports. Reliance Life Sciences aims to obtain reliable information on safety, tolerability, how it reacts with living organisms (pharmacokinetics or PK) and mechanism of action of the drug. While Reliance Sciences itself is a testing centre for Covid-19, the exercise will be conducted at 10 sites, including those in in Delhi, Maharashtra, Tamil Nadu and Andhra Pradesh. Phase 1 lasts for nearly two months, or 58 days, and is conducted to detect the highest number of doses that most patients can tolerate. The company aims to determine the maximum tolerated dose (MTD) with these trials. Currently, there are six vaccines to have received emergency use authorisation. Serum Institute’s Covishield, Bharat Biotech’s Covaxin, Russia’s Sputnik V, Moderna’s, Johnson & Johnson’s, and Cadila’s that was approved last week.
