AIIMS in Delhi Monday began the process to recruit volunteers for human clinical trials of the indigenously developed Covid-19 vaccine candidate Covaxin. Addressing a press conference, AIIMS director Dr Randeep Guleria said around 1,800 people registered for the trial at the institute.
The country’s top medical institute is among 12 sites selected by the ICMR for conducting phase I and II randomised, double-blind and placebo-controlled clinical trials of Covaxin. In the first phase, the vaccine would be tested on 375 volunteers — 100 of them would be from AIIMS. The second phase would include around 750 volunteers from the 12 sites.
“In the first phase, we see the safety of the vaccine which is of primary importance and the dose range is also calculated. In the second phase, we will see how immunogenic it is and that is subsequently followed by phase III, which involves a larger population to assess its efficacy and therapeutic benefit. Phase I of the vaccine trial will be done on healthy people, aged between 18 and 55 years and having no comorbid conditions. Women who are not pregnant will also be selected to be a part of the trial in the first phase. In the second phase, 750 people will be recruited and they will be between 12 and 65 years of age,” Dr Guleria said.
Covaxin, which is being developed by Hyderabad-based Bharat Biotech in collaboration with the ICMR and the National Institute of Virology (NIV), had recently got approval for human clinical trials from the Drugs Controller General of India.
“…If everything works out ideally, then by the end of the year or early next year, we should be in a position to say that we can start manufacturing. But there are lots of ifs and buts involved,” Dr Guleria said.