AIIMS panel allows human trial of India’s first Covid-19 vaccine candidate ‘Covaxin’
PTI, Jul 19, 2020, 11:21 AM IST
New Delhi: The AIIMS Ethics Committee on Saturday gave its nod for a human clinical trial of the indigenously developed COVID-19 vaccine candidate Covaxin following which 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 a maximum of 100 of them would be from AIIMS.
“The AIIMS Ethics Committee gave its approval for starting the human clinical trial of the indigenously developed Covaxin today. 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 randomized, 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 [email protected] or an SMS to or call on 7428847499, he said. The institute may also put up these contact details on its website.
According to Rai, the Ethics Committee had raised few concerns in the protocol submitted for carrying out of the trial.
“Those concerns were addressed to the following which the EC gave its approval to begin the trial by the premier institute,” he said.
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 Zydas Cadila Healthcare Ltd to go in for phase I and II human clinical trials.
Dr Balram Bhargava had said these two vaccine candidates have undergone successful toxicity studies in rats, mice, and rabbits, and these data were 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,” he said.
“Since India is one of the largest vaccine producers in the world, it is the country’s “moral responsibility” to fast-track the vaccine development process to break the chain of coronavirus transmission,” he added.
Udayavani is now on Telegram. Click here to join our channel and stay updated with the latest news.
Kumaraswamy accuses Amit Shah of ignoring Kannada
Indian economy may contract 25% in current fiscal: Economist Arun Kumar
IFFI apologises after mixing up Satyajit Ray’s ‘Sonar Kella’ plot with Salman Khan’s ‘Dabangg’
Related Articles More
Will poor and underprivileged get COVID-19 vaccine for free? asks Congress
Sudhakar inspects COVID-19 vaccination arrangements at Manipal Hospital
Bachchan hails COVID-19 vaccination drive, hopes to eradicate COVID like polio from India
62% of designated beneficiaries vaccinated on day one in Karnataka
584 new COVID-19 cases in Karnataka, 4 deaths
I have not asked for a ministerial position: Halady Srinivasa Shetty
Staff nurse Shobha, first to be vaccinated against Covid at Dr. TMA Pai hospital
Ravi Katapadi, the hope of the poorest children, won 12.5 lakhs at KBC | Udayavani
Signal surges ahead of Whatsapp amid privacy concerns
What do vaccine experts say about confusion over the covid vaccine?
Bantwal: Prostitution racket busted; accused detained
Shiv Sena to contest in West Bengal Assembly election says Raut
Uganda’s opposition rejects Museveni’s reelection as fraud
Govt must issue white paper on unavailability of funds demands Parameshwara
Tens of thousands evacuated amid Indonesia floods