NEW DELHI: Covaxin, India's first COVID-19 vaccine candidate, launched a clinical trial at All India Institutes of Medical Sciences (AIIMS), Delhi on July 24th. About 2,000 volunteers have participated in the first phase of the human clinical trial of Covaxin. India's COVID-19 vaccine started a clinical trial on 15 July.
A 30-year-old man was given the first shot of vaccine of Covaxin, India’s first Covid-19 vaccine. The volunteer will be in the hospital for two hours of observation. Sources in AIIMS said that he will be sent home and monitored for the next seven days.
Dr Sanjay Rai, Professor at the Centre for Community Medicine at AIIMS said that, "The first dose of 0.5 ml intramuscular injection was given at approximately 1.30 pm. No immediate side-effects have been observed so far. He has been under observation for two hours and will be monitored for the next seven days."
Covaxin was extracted from the novel coronavirus strain isolated by the Pune National Institute of Virology. Bharat Biotech developed an "inactivated" vaccine at its high-containment facility in Genome Valley, Hyderabad.
Bharat Biotech explained that, "If the vaccine is administered into a human being, it has no ability to kill or reproduce because it is a dead virus. It just serves the immune system as a dead virus and retains an antibody response to the virus."
In Phase I, the vaccine will be tested on 375 volunteers. The second phase of the trial will be performed on 750 volunteers. For the Phase I trial, healthy individuals who are between 18 and 55 years of age who do not have any history of co-morbidity will be chosen. During the Phase II experiment, people between 12 and 65 years of age will be enrolled.
"In Phase I, the safety of the vaccine is considered to be of primary importance and the dose range is also calculated," said Dr Randeep Guleria, Director of AIIMS.
Chief Minister of Goa, Pramod Sawant tweeted as, "Human trials of Covaxin, an indigenously developed vaccine for COVID-19, has begun at Redkar Hospital in Goa. This is a testimony of India's immense potential in healthcare innovation. My best wishes to the entire team working on Covaxin."