The subject expert committee (SEC) of India’s drug regulatory authority has approved the application of Reliance Life Sciences seeking to conduct clinical trials of its COVID-19 vaccine. Reliance Life Sciences will soon be conducting trials of its recombinant protein-based vaccine candidate against coronavirus.
According to an official report, Reliance had approached the drug regulator for a phase 1 trial of its proposed two-dose vaccine. Phase 1 clinical trials are meant to obtain information on safety, tolerability, pharmacokinetics, and mechanism of action of drugs with the objective of determining the maximum tolerated dose.
The official stated that the phase 1 trials are usually conducted for 58 days to check the tolerated dose strength. Once it’s done, the company can apply for conducting phase 2/3 trials. Two of the six vaccines to have got emergency use authorization in India so far are indigenously developed and produced. They are Bharat Biotech’s Covaxin and Zydus Cadila’s Zycov-D. The others are Serum Institute of India’s AstraZeneca-developed Covishield, Russia’s Sputnik V, US-developed Moderna and Johnson & Johnson vaccines.
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