Hyderabad : NIMS gears up for Phase-3 clinical trials for Covaxin

Hyderabad : Hyderabad-based vaccine maker Bharat Biotech has been approved to conduct Phase-3 clinical trials, for Covaxin - the vaccine candidate for Covid-19 - developed by the pharma giant along with ICMR in partnership in NIV, in 19 institutions and sites across 10 States.

The Nizam's Institute of Medical Sciences (NIMS), Panjagutta, in Hyderabad is expected to be one of the 19 institutions to be chosen for the human trials having conducted Phase-1 and 2 trials successfully. The NIMS sources said they were expecting a written communication for Phase-3 trials shortly after which the Hospital Ethics Committee would examine it and take a call.

While the Phase-1 and Phase-2 trials were restricted to double-digit figures and just about 50 each, the third phase trials will be done on 300 to 350 volunteers. While the first two phases were restricted to healthy young and middle-aged adults, this time volunteer selection will be between 18 to 65 years of age leaving out children and young adolescents. Cancer patients or people having major health issues will be left out of these trials.

According to NIMS sources, the first two phases of trials did not see health complications in volunteers which paved way for the crucial Phase-3 trials. The Drugs Controller General of India (DCGI) permitted Phase-3 trials after assessing the safety and immunogenicity data of phase 1 and 2 clinical trials, they pointed out.

Phase-3 trials would be conducted in 19 sites across 10 States on nearly 28,500 volunteers. They will be given two doses of the experimental vaccine with a gap of 28 days.

Once the Phase-3 trials commence at the NIMS, it will take nearly two-and-a-half months for completing the two doses as the volunteers' sample size is quite big. Each day nearly 15 to 20 volunteers can be administered the dose which means the process of completion of a single dose on all volunteers itself takes 15 to 20 days if given.