A day after India’s first homegrown vaccine, COvaxin, was administered to a 30-year-old Delhi-based man, no immediate side effect has been reported. The man will be under close monitoring for the next seven days. On Saturday, a few more participants were given the vaccine at AIIMS.
The volunteer will be kept in observation for two hours in the hospital. He will then be sent home and be monitored for the next seven days, sources in the AIIMS said.
This is the first dose of the ‘Covaxin’ vaccine that has been administered to the 30-year-old healthy male who qualified after initial screening and tests that were conducted on several volunteers for the vaccine human trials.
Covaxin, being developed by the Hyderabad-based Bharat Biotech in collaboration with ICMR and the National Institute of Virology, recently got the nod for human clinical trials from the Drugs Controller General of India.
AIIMS-Delhi is among the 12 sites selected by the Indian Council for Medical Research for Phase I and II randomised, double-blind and placebo-controlled clinical trials of Covaxin.
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.
Phase I of the trial will be done on healthy people, aged between 18 and 55 years, having no 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 and they will be between 12 and 65 years of age, he said.
