Delhi's All India Institute of Medical Sciences (AIIMS) is likely to submit a proposal to the Institute of Ethics Committee to begin Phase 3 clinical trials of Bharat Biotech's coronavirus vaccine candidate Covaxin by early next week.
Bharat Biotech received approval for Phase 3 trials on October 22. AIIMS Delhi is one of the hospitals selected for the final-stage trials to be conducted across India.
"The proposal is being prepared for the Phase 3 trials and within a couple of days we will be submitting it to the institute of ethics committee for approval," Hindustan Times quoted Dr Sanjay Rai, professor, department of community medicine, AIIMS Delhi, as saying.
AIIMS plans to recruit between 2,000 and 5,000 participants for the trial, the report said.
Read: Covaxin update: Bharat Biotech plans to release COVID-19 vaccine by June 2021
The Indian Council of Medical Research (ICMR) rules require an ethics committee to oversee clinical research and review the proposal at any site before allowing the trial.
AIIMS ethics committee is likely to take about 10-14 days to grant the approvals.
The third phase of human trials of Covaxin is set to begin at the Indian Institute of Medical Sciences (IMS) and SUM Hospital in Odisha.
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The Central Drugs Control Organisation (CDSCO) has given the approval for the third phase trials of Covaxin, said Dr E Venkata Rao, Principal Investigator in the Covaxin human trial and a professor in the Department of Community Medicine at IMS and SUM Hospital.
Bharat Biotech had on October 2 sought the DCGI's permission to conduct phase 3 randomised double-blind placebo-controlled multicentre trial of its vaccine.
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In its application, the firm said the study would cover over 28,500 subjects, aged 18 years and above. The study would be conducted at 19 sites in 10 states.
The potential vaccine against COVID-19 is being developed by the Hyderabad-based Bharat Biotech in collaboration with ICMR and the National Institute of Virology. Two doses of the Covaxin are to be administered in a gap of 14 days.Click here for Moneycontrol’s full coverage of the COVID-19 outbreak