The Subject Expert Committee (SEC) has recommended Phase 1 clinical trials of Reliance’s recombinant COVID-19 vaccine candidate.
Earlier, Mukesh Ambani-owned Reliance Life Sciences had sought approval for the Phase I trial of its proposed two-dose COVID-19 vaccine.
The company has received approval during the meeting of the SEC on Friday.
After recommendations from SEC, the company is required to get approval from the Drug Controller General of India (DCGI), following which the Reliance Life Sciences can commence Phase 1 trials of the COVID-19 vaccine.
The trials will be done at 10 sites in India, including centres in Tamil Nadu, Andhra Pradesh, Maharashtra and Delhi.
Phase 1 of the trial usually lasts for 58 days to detect the highest dose that most patients can tolerate.
In India, six vaccines have so far received Emergency Use Authorisation (EUA), which includes Serum Institute of India’s Covishield, Bharat Biotech’s Covaxin, Zydus Cadila’s vaccine, Russia’s Sputnik V, Moderna and Johnson and Johnson.
