AIIMS panel nod to human clinical trial of indigenous Covaxin
The indegenously developed COVID-19 vaccine, COVID got a green signal from the AIIMS Ethics Committee on Saturday (July 18) for carrying out the clinical trial on humans. The premier hospital is likely to begin the exercise by enrolling healthy volunteers from Monday.
AIIMS-Delhi is among the 12 sites selected by the Indian Council for Medical Research (ICMR) for conducting phase I and II human trials of Covaxin. In phase I, the vaccine would be tested on 375 volunteers and the maximum of 100 of them would be from AIIMS.
“Healthy volunteers having no comorbid conditions and without a history of COVID-19, aged more than 18 years and less than 55 years, would be eligible to participate in the randomised, double-blind, placebo-controlled clinical trial,” Dr. Sanjay Rai, Professor at the Centre for Community Medicine at AIIMS said.
“Few volunteers have already registered for the trial. We would start the screening of the individuals and evaluate their health condition from Monday onwards before vaccinating them,” Rai, who is also the principal investigator of the study, said.
Anybody willing to participate in the trial can send an email to ctaiims.covid19@gmail.com or an SMS to or call on 7428847499, he said. The institute may also put up these contact details on its website.
COVID-19 vaccine candidate Covaxin, developed by the Hyderabad-based Bharat Biotech in collaboration with the ICMR and the National Institute of Virology (NIV), had recently got the nod for human clinical trials from the Drugs Controller General of India (DCGI).
Noting that this was the first indigenous vaccine being developed by India, ICMR Director General Dr. Balram Bhargava in a letter to principal investigators of the 12 sites recently had asked them to fast-track the human clinical trial approvals stating it is one of the “top priority projects which is being monitored at the top-most level of the government”.
The trials have so far started in AIIMS, Patna and some more sites.
The DCGI has permitted two vaccines — one developed by the Bharat Biotech International Limited in collaboration with the ICMR and another one by Zydus Cadila Healthcare Ltd to go in for phase I and II human clinical trials.
Earlier in the week Zydus initiated phase 1 and 2 of human trials of its COVID-19 vaccine candidate ZyCoV-D. It was the second firm after Bharat Biotech to receive approval from domestic authorities to start human trials in the country. The company’s chairman said on Friday that they were looking to complete the trials in seven months.
The two vaccine candidates have undergone successful toxicity studies in rats, mice and rabbits and these data was submitted to DCGI following which both got clearance to start the early phase human trials early this month.
They have got their sites ready and approximately 1,000 human volunteers would be participating in the exercise for each of the two indigenously developed vaccine candidates, Bhargava had said.
Since India is one of the largest vaccine producers in the world, it is the country’s “moral responsibility” to fast-track vaccine development process to break the chain of coronavirus transmission, he had said.
India reached the 1-million mark after a record single-day spike of 34,956 COVID 19 cases on Friday (July 17). It took merely 20 days to reach 1 million from five lakh cases. India has the third-highest caseload in the world after the US (35.76 lakh cases) and Brazil (20.12 lakh cases).
Meanwhile, the country has increased its testing capacity over the last two months to approximately 3 lakh tests per day.
