What is ‘Covaxin’ and how was it developed?
Covaxin is a vaccine candidate to developed by Bharat Biotech India Ltd (BBIL) against the novel coronavirus (Covid-19) in collaboration with the Indian Council of Medical Research’s National Institute of Virology (NIV).
As a part of this collaboration, NIV isolated a strain of the virus from an asymptomatic Covid-19 patient and transferred it to BBIL early in May. The firm then used it to work on developing an “inactivated” vaccine–a vaccine that uses a dead virus–at its high containment facility in Hyderabad.
“Once the vaccine is injected into a human, it has no potential to infect or replicate, since it is a killed virus. It just serves to the immune system as a dead virus and mounts an antibody response towards the virus,” said the company, adding that inactivated vaccines usually have a better safety record.
BBIL’s Covaxin then underwent pre-clinical testing, which is when the vaccine is tested on animals like guinea pigs and mice to see if it is safe, to move on to the next stage of testing–human trials.
The AIIMS Ethics Committee on July 18 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 .i.e. July 20.
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.
“Few volunteers have already registered for the trial. We would start the screening of the individuals and evaluate their health condition from July 20 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.email@example.com 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.
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).
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 had undergone successful toxicity studies in rats, mice, and rabbits, and this 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, he had 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 had said.
*Go Corona…..Corona Go;)
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