Results in three months, mass production soon
The All India Institute of Medical Sciences (AIIMS) in Delhi initiated phase I/II of human clinical trials of the indigenously developed Covid-19 vaccine Covaxin on Monday, AIIMS-Delhi Director Dr Randeep Guleria said, adding that it would take at least three months for researchers to arrive at the first set of data about its efficacy. AIIMS Delhi is among the 12 sites where human trials for Covaxin will be conducted.
“It (starting trials) is heartening because it’s an indigenous vaccine; making a new vaccine is an achievement. Even if a vaccine is first developed somewhere else in the world, India will be mass producing it. We are good at it,” he said.
“We have already registered a few volunteers and more are in the process of joining for the trial,” said Dr Sanjay Rai, Professor at the Centre for Community Medicine at AIIMS.
These volunteers will be undergoing health screening on Monday before they are administered Covaxin, developed by the Hyderabad-based Bharat Biotech in collaboration with the Indian Council for Medical Research (ICMR) and the National Institute of Virology (NIV).
Overall, total 375 volunteers were listed for human clinical trials out of which AIIMS (Delhi) will be choosing only 100 participants for the first and second phase of the trials. Rest of the volunteers will undergo trials at a different site.
The ICMR has notified 12 sites where the trial for Covaxin will be taking place. On July 17, human trials of Covaxin began at Post-Graduate Institute (PGI) of Medical Sciences in Rohtak where three volunteers were administered Covaxin. Also, trials have started at AIIMS, Patna and few other places as well.
Another facility which will be starting the process of human trials for Covaxin is Redkar Hospital in North Goa’s Pernem taluka. The North Goa-based private hospital is also amongst the 12 listed facilities.
Redkar Hospital will be selecting ten volunteers from Goa and instead of randomizing, the facility will select volunteers on basis of eligibility. The reports for prospective volunteers have been sent to Delhi to ascertain their eligibility following which those who clear the selection criterion will be administered Covaxin.
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.
Anybody willing to participate in the trial can send an email to Ctaiims.covid19@gmail.com or an SMS to or call on 7428847499, said a senior doctor from the hospital.
Approximately 1,000 human volunteers would be participating in the exercise for each of the two indigenously developed vaccine candidates.