Vaccine made by Mukesh Ambani's company approved for clinical trial

Reliance Life Sciences has developed a two-dose corona vaccine

This vaccine is a candidate recombinant protein-based vaccine, the vaccine has been approved in India so far.

New Delhi: The Drugs Regulatory Authority of India has given approval to Mukesh Ambani's company Reliance Life Sciences for clinical trials of a two-dose corona vaccine. Reliance Life Sciences' Covid 19 vaccine is a candidate recombinant protein-based vaccine.

Reliance Life Sciences is part of Reliance Industries. Reliance Life Sciences' application was reviewed and approved at a meeting of the Special Expert Committee (SEC) on Thursday. Reliance had approached the drug regulator for a phase-1 trial of its proposed two-dose vaccine, sources said.

The purpose of Phase-1 clinical trials to determine the maximum tolerated dose (MTD) is to obtain reliable information on vaccine safety, tolerability, pharmacokinetics (PK) and mechanism of action of drugs.

One phase-1 trial is usually performed for 58 days to check the strength of the tolerated dose, one person said. Upon its completion the company may apply for Phase 2/3 trials. There are 6 Covid 19 vaccines in India so far, which have received Emergency Use Authorization (EMA).

The Zydus Cadillac vaccine became the sixth coronavirus vaccine to be obtained in India last week, after the Covishield of the Serum Institute of India, the Covacin vaccine of Bharat Biotech, the Sputnik V of Russia and the vaccines of American companies Modern and Johnson & Johnson. The Reliance Life Sciences vaccine will be a recombinant protein vaccine, as is being developed by Biological E.