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.
Dr Sanjay Rai, Professor at the Centre for Community Medicine at AIIMS told ANI 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 ANI.
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.firstname.lastname@example.org 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.
“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.
It may be noted that there are 12 places where the trial for Covaxin is taking place as per the Indian Council for Medical Research (ICMR).
Trials have started at AIIMS, Patna and few other places.
ANI had cited Director General of Indian Council of Medical Research (ICMR) Dr Balram Bhargava as saying on July 14 that as far as coronavirus pandemic is concerned the country has two indigenous candidate vaccines which scientists are trying best efforts to fast-track as their moral duty so that there should not be a delay of a single day for regulatory clearances for these vaccines to break the transmission of the virus as soon as possible.
“There are two Indian indigenous candidate vaccines and they have gone successful toxicity studies in rats, mice and rabbits. The data was submitted to the Drugs Controller General of India (DCGI) following which both these candidate vaccines got clearance to start the early phase of human trials,” he had said.
ANI had also reported that DCGI has given its permission to pharma giant Zydus Cadila besides Bharat Biotech International Limited (BBIL), which had partnered with ICMR to conduct phase I/II clinical trials on humans for COVId -19 vaccine.