The process of conducting clinical trials for Covaxin, a vaccine candidate for COVID-19, began on Tuesday at the Nizam’s Institute of Medical Sciences (NIMS) here, a top official of the state-run medical facility said.
“We will select healthy individuals and draw blood and send the blood samples to designated labs in New Delhi. They will give the green signal. Then the medicine people will examine and the first shot of the vaccine will be given due observation,” NIMS director K. Manohar told PTI.
The Indian Council of Medical Research (ICMR) has identified 12 clinical trial sites such as medical institutions and hospitals, including NIMS, and has asked their principal investigators to ensure that the subject enrolment is initiated no later than July 7. “Everything will be sent to ICMR, where data is analysed. We have already started the screening of individuals. We will first take audio-visual consent of the individual,” the medical officer added.
Asked about the total number of individuals required for the clinical trial, Manohar said at least 30 are needed.
The clinical trials proposal was already placed before the NIMS hospital ethics committee.
The Drug Controller General of India recently granted permission to initiate Phase I and II human clinical trials for COVID-19 vaccine Covaxin being developed by Bharat Biotech, in collaboration with ICMR and National Institute of Virology.
