Srinagar: The All India Institute of Medical Sciences (AIIMS) Ethics Committee has given its approval for conducting the human clinical trial of the indigenously developed Covid-19 vaccine candidate Covaxin.
According to a report by a Delhi based news agency ANI, Dr Sanjay Rai, Professor at the Centre for Community Medicine at AIIMS has said 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 AIIMS Ethics Committee of the institute had earlier given 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).
“Any healthy individual who wishes to participate in the trial can send in an email on [email protected] or send an SMS or call on 7428847499,” the report quoted Dr Rai as saying.
The report added that the institute has already registered a few volunteers for the trial and from Monday onwards, the team will start their health screening before giving them vaccination. Out of the 375 volunteers only 100 volunteers would be chosen and remaining will participate at other sites, the report added.
According to the Indian Council for Medical Research (ICMR), there are 12 places where the trial for Covaxin is taking place.
Earlier, the news agency quoted Director General of Indian Council of Medical Research (ICMR) Dr Balram Bhargava saying: “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,” Dr Balram had said.
Pertinently, Drugs Controller General of India (DCGI) has given its permission to 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.
Earlier on Wednesday, Indian pharmaceutical company Zydus said that it has started human studies for its potential COVID vaccine. The company said that its plasmid DNA vaccine, was found to be safe, immunogenic and well-tolerated in the pre-clinical toxicity studies.
On Sunday, with nearly 39,000 new COVID cases reported in the past 24 hours, the total number of infections rose to over 10.7 lakh. With the 543 fresh deaths, the total number of casualties have mounted to 26,816. According to the Health Ministry of India, 3,73,379 cases are active and as many as 6.7 lakh patients have recovered so far.
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