AIIMS to start clinical trial of indigenous COVID-19 vaccine Covaxin from today
Bharat Biotech (India)
The All India Institute of Medical Sciences (AIIMS) Ethics Committee on Saturday gave its approval for conducting the human clinical trial of the indigenously developed COVID-19 vaccine candidate Covaxin starting today, July 20.
Dr Sanjay Rai, Professor at the Centre for Community Medicine at AIIMS told that the hospital will start enrolling healthy individuals from Monday onwards.
"Today, we got approval from AIIMS Ethics Committee for starting the human clinical trial of the indigenously developed Covaxin. We are launching the enrollment process from Monday. We are going to select healthy participants with no comorbidities and without a history of COVID-19. The age group of the study population is 18 to 55 years. This would be a randomised, double-blind, placebo-controlled clinical trial," Dr Rai told.
The country`s top drug regulator had recently gave a green signal for human clinical trials for COVID-19 vaccine candidate Covaxin, which has been developed by the Hyderabad-based Bharat Biotech in collaboration with the ICMR and the National Institute of Virology (NIV).
Asked about the concerns raised by AIIMS Ethics Committee a few days back regarding the trial, Dr Rai said that those concerns were addressed in the Ethics Committee meeting and the panel gave green signal to initiate the trial.
"Any healthy individual who wishes to participate in the trial can send in an email on Ctaiims.covid19@gmail.com or send an SMS or call on 7428847499," he said, adding that in the first and second phase AIIMS (Delhi) will choose only 100 participants out of 375 volunteers and the remaining will participate at other sites.
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"We have already registered a few volunteers for the trial. From Monday onwards, our team will start their health screening before giving them vaccination," he said.
(With inputs from ANI)