New Delhi (NVI): An indigenous COVID-19 vaccine ‘Covaxin’, began its Phase-I human clinical trials at All India Institute of Medical Sciences (AIIMS), Delhi, today.
The first dose of vaccine of Covaxin was given to a 30-year-old man. The volunteer will be kept in observation for two hours in the hospital.
He will later be sent home and will be monitored for the next seven days, as per the officials in AIIMS.
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.
Around 3,500 volunteers have registered themselves for the trial at AIIMS since last Saturday.
AIIMS-Delhi is among the 12 sites selected by the Indian Council for Medical Research (ICMR) 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 trial of phase I 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.
Whereas, the second phase, would include around 750 volunteers from all 12 sites. In the second phase, 750 people will be recruited and they will be between 12 and 65 years of age.
The indigenous COVID-19 vaccine has been developed and manufactured by Hyderabad-based Bharat Biotech in collaboration with ICMR and the National Institute of Virology (NIV), which recently got the nod for human clinical trials from the Drugs Controller General of India.
-RJV
