The clinical trials of the much-awaited Made in India ‘Covaxin’, the Corona vaccine of Bharat Biotech, kicked off on Friday with three volunteers being administered with the drug at the Post-Graduate Institute (PGI) of Medical Sciences in Rohtak in Haryana as part of the first phase of clinical trial on the humans. Other sites are being finalised, said the company.
Senior Professor and Head, department of Pulmonary & Critical Care Medicine, Dhruva Chaudhry, also the co-principal investigator, said that the three volunteers were short-listed out of the total eight after health checks to ensure proper liver function and absence of infection and were administered the vaccine, according to reports.
“All three tolerated it well. There were no complaints. We observed them for two hours before releasing them. The immediate component of allergic reaction has been taken care of. We will now look for any soreness at the local site over the next 24-48 hours,” said Dr Chaudhry, taking care of the clinical aspect of the process at the institute.
Dr Chaudhry said the vaccine had been tested successfully on the animals for safety and response and the process had not entered the first phase of clinical trials on humans. He said the process might take six months and the final assessment on the safety and the antibodies produced would be made by the safety board.
Covaxin has been in news since ICMR director-general Balram Bhargava shot off a letter on July 2 to 12 hospitals and research centres, asking them to enrol subjects for human trials of Covaxin, so that the vaccine is ready for public use by August 15.
Later, the ICMR sought to clarify that the letter was written with an aim to expedite the trial but in keeping with all the safety norms.