AIIMS Delhi administered the first dose of Bharat Biotech Covaxin to a 30-year-old man on Friday, days after the medical institute received approval from the ethics committee to begin human trials. The subject will be monitored for two weeks after which the second dose will be administered.
The nation's leading medical institute is among 12 sites selected by the Indian Council for Medical Research (ICMR) to conduct randomized, double-blind, placebo-controlled Phase I and II clinical trials of Covaxin.
“On Friday, he was given a first dose of 0.5 ml of the intramuscular vaccine. He was under observation for two hours. He was given a diary for continuous monitoring of conditions. We will also coordinate with him daily for at least a week to understand if he is facing any kind of medical problem, "Dr. Sanjay Rai, lead investigator for the AIIMS investigator Covid-19 vaccine trial, told The Indian Express.
Covaxin, which is being developed by Hyderabad-based Bharat Biotech in collaboration with ICMR and the National Institute of Virology (NIV), recently received the go-ahead for human clinical trials from the Drugs Controller General of India (DCGI) .
In phase I, the vaccine would be tested on 375 volunteers and 100 of them, the highest would be from AIIMS. The second phase would include around 750 volunteers from the 12 sites together. The medical institute has received more than 3,500 requests so far to participate in human trials.
“We have selected 20 volunteers who have undergone various tests to participate in the trial. Results are awaited, "added Dr. Rai
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