Covaxin: First part of phase-1 of human trials concludes at PGI Rohtak; results encouraging

The first part of phase-1 of Covaxin human trial completed on Saturday at Post-Graduate Institute (PGI) of Medical Sciences, Rohtak, said Dr Savita Verma, principal investigator of the vaccine trial team.

Speaking to ANI, Dr Verma said that six people were administered the vaccine on Saturday under the second part of phase-1.

"First part of phase-1 of vaccine trial (Covaxin) has been completed. 50 people across India were administered the vaccine and the results were encouraging. Six people were administered vaccine on Saturday under second part of phase-1," she said.

Human trials of Covaxin, India's first vaccine candidate against coronavirus, began at PGI Rohtak on July 17. Three volunteers were administered Covaxin on that day.

Covaxin has been developed by Bharat Biotech, a pharmaceutical company based in Hyderabad.

AIIMS Delhi has also been conducting human trials of Covaxin. A total of 12 medical institutes have been selected by the Indian Council for Medical Research (ICMR) for conducting two phases of randomised clinical trials of the potential COVID-19 vaccine.

ICMR has informed that institutions in India are developing the vaccine prototypes only after complying with every necessary rules and regulation stratified by international customs since no compromises are being made in the attempt to ahead in the race for coronavirus vaccine.

Phase I trials which test primarily for safety and preliminary dosing in a few dozen healthy subjects.

Phase II trials, following the success of Phase I trials, evaluate immunogenicity, dose levels (efficacy based on biomarkers), and adverse effects of the candidate vaccine, typically in hundreds of people. Phase III trials typically involve more participants, including a control group, and test effectiveness of the vaccine to prevent the disease (an "interventional" trial), while monitoring for adverse effects at the optimal dose.

Only after every step has been ratified by the medical community can a vaccine prototype be allowed to be released to commercial use in markets.

(WIth agency inputs)