New Delhi: Over 3,500 volunteers have registered themselves for the trial at the All India Institute of Medical Sciences (AIIMS) in the last about one week for the first phase of human clinical trial of India’s first indigenously-developed vaccine “Covaxin” against Covid-19.
Of these, screening of 22 persons is underway. The human clinical trial has begun at AIIMS with the first dose of the injection given to a man in his 30s, a resident of Delhi. AIIMS sources said the man was screened earlier this week and all his parameters were found to be within the normal range. No immediate side effect was observed after the injection was given. Few more participants would be given the vaccine in the days to come. AIIMS-Delhi is one of the 12 sites/hospitals selected by the Indian Council for Medical Research (ICMR) for conducting phase I and II randomised, double-blind, placebo-controlled clinical trials of Covaxin.
In the first phase, Covaxin will be tested on 375 volunteers and the maximum of 100 of them would be from the AIIMS. Covaxin trials have already begun in Hyderabad, Patna, Kancheepuram, Rohtak, and now Delhi, and are yet to be carried out in Nagpur, Bhubaneshwar, Belgaum, Gorakhpur, Kanpur, Goa and Visakhapatnam.
The second phase will include around 750 volunteers from all 12 sites together. Phase I of the vaccine trial will be done on healthy people aged between 18-55 years who do not have co-morbid conditions. Women with no pregnancy will also be selected for the trial in the first phase. In the second phase, 750 people will be recruited for which around 1,800 volunteers have registered themselves for the trial at AIIMS.
Covid-19 vaccine candidate Covaxin is being developed by the Hyderabad-based Bharat Biotech in collaboration with the ICMR and the National Institute of Virology (NIV). It got the nod for human clinical trials from the Drugs Controller General of India (DCGI). In yet another development, Department of Biotechnology in association with Biotechnology Industry Research Assistance Council (BIRAC) has facilitated the establishment of “first-of-its-kind” mRNA- (messenger RNA) based vaccine manufacturing platform in India. DBT has provided seed funding for the development of Gennova’s novel self-amplifying mRNA-based vaccine candidate for Covid-19.