The All India Institute of Medical Sciences in New Delhi began human trials of a coronavirus vaccine on Friday, India Today reported. A shot of the Covaxin vaccine was given to a healthy 30-year-old male.
The man, after being under observation for two hours at the hospital, will be sent home and monitored for two weeks, The Indian Express reported. Following this, he will be given a second shot of Covaxin.
Initial screening and tests were conducted on several volunteers before the man was chosen to be the first human candidate to receive the vaccine.
AIIMS Delhi is among 12 sites selected by the Indian Council for Medical Research for Phase 1 and 2 randomised, double-blind and placebo-controlled clinical trials of the drug. In Phase 1, the vaccine will be tested on 375 volunteers, 100 of whom will be from AIIMS. The second phase will include 750 volunteers from all 12 sites.
Phase 1 of the trial will be conducted on healthy people, aged between 18 and 55 years, having no co-morbid conditions. Women who fit this criteria and are not pregnant will also be part of the trial. In the second phase, the volunteers will be between the ages of 12 and 65.
The ethics committee of AIIMS, Delhi had on July 18 given approval to start enrolling volunteers for the trials from July 20.
Covaxin was the first indigenous vaccine to get permission for human trials by the Drug Controller General of India, on June 29. It has been jointly developed by a Hyderabad-based private firm Bharat Biotech, the Indian Council for Medical Research and the National Institute of Virology.
Last month, ICMR had directed trial sites for Covaxin to fast-track necessary approvals and said that it planned to launch the vaccine for public use by August 15. The top medical body’s deadline was called unrealistic and unscientific by health experts. ICMR had defended its deadline, saying that it was in accordance with global norms to fast-track vaccine development.
India’s second vaccine candidate – Gujarat-based pharmaceutical giant Zydus Cadila’s ZyCoV – also entered the human trials stage earlier this month. The clinical trials of ZyCoV will be conducted across multiple sites in India with over 1,000 subjects.
Researchers working on both vaccines will need at least three months to get a reliable set of data.
India on Friday registered a record 49,310 new cases. With this, the country’s tally is now 12,87,945. The country’s toll rose to 30,601 with 740 new deaths.
The global coronavirus count is now over 1.55 crore, and the toll has crossed 6.33 lakh, according to the Johns Hopkins University. More than 88.73 lakh people have recovered so far.
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