Covaxin, India’s first developed vaccine against the coronavirus, started its first phase of human trial. The human trial began at Delhi’s AIIMS. The first dose of the injection was given to a 30-year-old man.
Dr Sanjay Rai, Professor at the Centre for Community Medicine at AIIMS and the principal investigator of the study said that since Saturday around 3,500 people have volunteered for the trial at AIIMS. Till now at least 22 people screening is on its way, he added.
He said, “The first volunteer, a resident of Delhi, was screened two days ago and all his health parameters were found to be within the normal range. He also does not have any co-morbid conditions. The first dose of 0.5 ml intramuscular injection was given to him around 1.30 pm. No immediate side-effects have been observed so far. He was under observation for two hours and will be monitored for the next seven days.”
ICMR chose 12 sites for the first and second phase of the clinical trials of the Covaxin. One of the 12 sites is AIIMS in Delhi.
375 volunteers would be tested by the vaccine’s phase 1 and 100 volunteers would be from AIIMS. In phase 2, the vaccine will be injected to 750 volunteers from all 12 sites.
Vaccine’s phase 1 will be done on people who are healthy and ranging between aged 18-55 years. In the trial of the vaccine’s first phase, non-pregnant women will also be selected.
The second phase of the clinical trial of the vaccine, people ageing 12-65 years will be recruited.
Around 1,800 volunteers have already registered themselves for the trial at AIIMS.
Rai said that the first phase of the vaccine will be done to check the safety of the vaccine which is most important. Adding, he said that the range of the vaccine’s dosage will also be determined in the first phase.
According to Rai, the vaccine has three formulations, and each volunteer will be injected with any 1 of the formulation in 2 doses, 2 weeks apart.
The first 50 subjects will be provided with the lowest strength of the vaccine. Rai further said that if all 50 subjects show the positive result after the dosage then it will be given to another 50 patients with high doses.