New Delhi: Corona vaccine trials are underway in all countries around the world. Similarly, the All India Institute of Medical Sciences, which is testing the Covid-19 vaccine in India, is scheduled to launch a Phase III clinical trial for Bharat Biotech’s Anti-Coronavirus (Covid-19) vaccine candidate before the Ethics Committee early next week Can submit a proposal. Bharat Biotech received approval from the Drugs Controller General of India last week to conduct Phase III clinical trials of its Anti-covid-19 vaccine candidate CoVaccine in India and AIIMS is one of the sites to be organized for trials.
Dr. Sanjay Rai, Professor, Department of Community Medicine, AIIMS Delhi, confirms, “The proposal is being prepared for 3 phase trials, and within a few days we will submit it to the Institute’s Ethics Committee for approval.”
Dr. Rai is also the lead investigator for CoVaccine tests at the hospital. It is necessary to get permission from any sites before starting the troll. As per the rules laid down by the country’s biomedical research regulator – the Indian Council of Medical Research (ICMR), an ethical committee has to oversee clinical research and thoroughly review the proposal on any site before being allowed to start testing Necessary. The Ethics Committee of AIIMS has 15 members and is expected to take approximately 10–14 days to provide the necessary approvals.
Sanjay Rai said, “The proposal is about 200 to 300 pages which takes time to read properly. It is important to read it carefully so that the concerns found in it can be considered.”
For Phase 1 and 2 trials, Dr. Rai’s team submitted the proposal to the committee on 30 June, and approval came on 18 July. AIIMS plans to recruit anywhere between 2000 and 3000 participants as soon as it is approved. Bharat Biotech submitted the Phase 3 trial for India to the National Drug Controller on 2 October, and received its approval on 22 October, suggesting minor procedural changes to the testing plan. The company plans to recruit at least 26,000 participants for Phase 3 trials at 25 to 30 hospital sites in 13–14 states.
Bharat Biotech has completed Phase I testing, and results have been submitted to DCGI. Who has not shown any major security concerns? For Phase 2, safety testing has been completed, and immunogenicity testing is currently underway to determine the body’s immune response to the vaccine. CoVaccine is India’s first vaccine candidate against Covid-19. Bharat Biotech has developed vaccine candidates in association with ICMR- National Institute of Virology (NIV).