The Drug Controller General of India recently granted permission to initiate Phase I & II human clinical trials for COVID-19 Vaccine COVAXIN.
The much-anticipated process of conducting clinical trials for a possible coronavirus vaccine, COVAXIN, began on Tuesday at the Nizams Institute of Medical Sciences (NIMS). ICMR’s National Institute of Virology and Bharat Biotech are jointly developing a vaccine against SARS-CoV-2, the virus that causes COVID-19.
"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 Dr 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 audiovisual 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 & II human clinical trials for COVID-19 Vaccine COVAXIN.
ICMR had earlier announced that it aims to launch COVAXIN by August 15. "It is envisaged to launch the vaccine for public health use latest by 15th August 2020 after completion of all clinical trials. BBIL is working expeditiously to meet the target, however, the final outcome will depend on the cooperation of all clinical trial sites involved in this project," ICMR had said.
(With PTI inputs)Click here for Moneycontrol's full coverage of the coronavirus pandemic