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.
AIIMS has also set up a dedicated email and phone number for the volunteers to register themselves for this project. The volunteers will have to undergo tests, which include Covid-19 test and also tests for other comorbidities. If found healthy, they will be administered the vaccine.
"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.
"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.
The volunteers will be kept under observation for a period of nearly 150 days. Covaxin is developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV).
According to Bharat Biotech, The Phase 1 clinical trial for Covaxin has been initiated across the country from July 15 onwards, and this is a randomised, double-blind, placebo-controlled clinical trial on 375 volunteers across the country.
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.
The SARS-CoV-2 strain was isolated in NIV, Pune, and transferred to Bharat Biotech. The indigenous, inactivated vaccine was developed and manufactured in Bharat Biotech's BSL-3A (Bio-Safety Level 3) High Containment facility located in Genome Valley, Hyderabad.
The Drug Controller General of India, Central Drugs Standard Control Organisation (CDSCO), and the Ministry of Health & Family Welfare granted permission to initiate Phase-I and II human clinical trials after the company submitted results generated from pre-clinical studies, demonstrating safety and immune response.
