AIIMS Delhi administered its first dose of Bharat Biotech’s ‘Covaxin’ to a 30-year-old man on Friday. The development comes days after the ethics committee gave approval to AIIMS Delhi to begin the human trials of the potential Covid-19 vaccine.
The second dose will be given to the subject after a period of two weeks in which he will be monitored, states a report by the Indian Express. AIIMS, Delhi is one of the 12 sites selected by ICMR for conducting Phase I and II randomised, double-blind and placebo-controlled clinical trials of Covaxin, the report adds.
Dr Sanjay Rai, Principal Investigator Covid-19 vaccine trial at AIIMS told IE that the first dose of 0.5 ml of the intramuscular vaccine was given to the subject on Friday, who was observed for two hours.
Rai said that a diary had also been given to him to constantly monitor his condition, and that the team would coordinate with him daily for a week to understand if he encounters any medical issues.
The phase I and II clinical trials of the vaccine for SARS-CoV-2 by Bharat Biotech have been approved by the Indian drug regulator after pre-clinical studies demonstrated safety and immune response.
The company has developed the vaccine in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV).
The phase I of the vaccine would see it being tested of 375 volunteers and 100 of them would be from AIIMS. A total of 750 volunteers from all 12 sites would be included in the second phase. AIIMS, Delhi has now received over 3,500 applications of those who want to participate in the trials.
Dr Rai said 20 volunteers had been shortlisted to participated in the trial, after several tests were conducted on them, and that the results were awaited, stated the report.