AIIMS Delhi has administered the first dose of Bharat Biotech’s Covaxin to a 30-year-old male Friday, days after the medical institute received approval from the ethics committee to start the human trials. The subject will be monitored for two weeks after which he will be given the second dose.
The country’s top medical institute is among the 12 sites selected by the Indian Council for Medical Research (ICMR) for conducting Phase I and II randomised, double-blind and placebo-controlled clinical trials of Covaxin.
“A first dose of 0.5 ml of the intramuscular vaccine was administered to him on Friday. He was kept under observation for two hours. A diary has been handed over to him for continuous monitoring of the conditions. We will also coordinate with him daily for atleast a week to understand if he is facing any kind of medical issues,” said Dr Sanjay Rai, Principal Investigator Covid-19 vaccine trial at AIIMS told.
Covaxin, which is being developed by Hyderabad-based Bharat Biotech in collaboration with the ICMR and the National Institute of Virology (NIV), had recently got the nod 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 all 12 sites put together. The medical institute has received over 3,500 applications so far to participate in the human trials.
“We have shortlisted 20 volunteers who have undergone several tests to participate in the trial. The results are awaited,” added Dr Rai.