Hyderabad: The human trials of the first indigenously developed Covid-19 vaccine, Covaxin, got underway at the Nizam’s Institute of Medical Sciences (NIMS) here on Monday. The Covaxin human trials are the result of the collaboration between the Indian Council of Medical Research (ICMR) and the Hyderabad-headquartered Bharat Biotech to develop a vaccine for Covid-19.
Two healthy volunteers were administered with the vaccine by health authorities at NIMS on Monday. The human clinical trials of the Covid vaccine at NIMS is part of a pan-Indian effort where 12 more trial sites, including the All India Institute of Medical Sciences (AIIMS), New Delhi, are participating.
According to officials familiar with vaccine trials, a total of 30 health volunteers from Telangana are participating in the human trials. The volunteers are drawn from across the State and after the vaccine administration, will remain in the ICU of NIMS for a few days before being discharged. Their health condition and interaction with the vaccine will be monitored remotely as well as through frequent physical check-ups, senior doctors familiar with the trials said.
The vaccine is being administered to human volunteers who are aged between 18 years and 55 years with a sample size of nearly 1,125 individuals across the country. In the Phase One clinical trials, variations of the vaccine with two different doses will be administered in order to test the efficacy of each dosage.
Once the efficacy is established, the Phase Two trials will be launched in which 750 healthy volunteers, between the age of 12 years and 65 years drawn from across the country, will take part.
Senior health officials from NIMS said researchers would be able to get a fair idea on the efficacy of the vaccine in the coming two to three months. However, the entire cycle of the vaccine development will conclude only after completion of Phase Three trials on humans, which will have a size of over 5,000 individuals and usually takes at least six months to 18 months to complete.