Hyderabad: Hyderabad-based vaccine manufacturer Bharat Biotech has been approved to conduct Phase 3 clinical trials in 19 institutions and sites across 10 states for Covaxin-the Covid-19 vaccine candidate-developed by the pharmaceutical giant along with ICMR in collaboration with NIV. In Hyderabad, the Nizam Institute of Medical Sciences (NIMS), Panjagutta, is projected to be one of the 19 institutions to be selected for the successful Phase 1 and 2 human trials. The NIMS sources said that immediately after the Hospital Ethics Committee would review it and take a call, they were awaiting a written correspondence for Phase-3 trials. Although the Phase-1 and Phase-2 trials were limited to double-digit figures, only around 50 each, but now 300 to 350 volunteers will undergo the third phase trials.
While the first two stages were limited to safe young and middle-aged people, this time the option of volunteers would be between the ages of 18 and 65, leaving out children and young teenagers. Patients with cancer or persons with significant health conditions will be left out of these trials. The first two phases of trials did not see health problems in volunteers, according to NIMS sources, which paved the way for the critical Phase 3 trials. After reviewing the safety and immunogenicity data of the phase 1 and 2 clinical trials, the Drugs Controller General of India (DCGI) allowed Phase 3 trials, they pointed out.
Phase 3 experiments will be performed on about 28,500 participants in 19 locations across 10 states. Two doses of the experimental vaccine with a gap of 28 days will be given to them. It will take almost two and a half months to complete the two doses once the Phase-3 trials at the NIMS begin, as the sample size of the volunteers is very high. A dose can be delivered to approximately 15 to 20 volunteers per day, meaning that the process of completing a single dose on all volunteers itself takes 15 to 20 days if delivered.