India begins human trials of Coviaxin, hoping for Covid-19 vaccine success

Private and state-owned hospitals will test the potential vaccine on volunteers, aged between 18 and 55

Human trials for Covaxin, one of the first potential vaccines developed in India in the fight against Covid-19, is underway in 12 centres across the country.

Covaxin is derived from a strain of the SARS-CoV-2, the virus that causes Covid-19, and it was isolated at the Pune-based National Institute of Virology (NIV).
The Indian Council of Medical Research (ICMR) and Bharat Biotech are jointly working for the preclinical as well as clinical development of this vaccine. It has already received approval for phase-I and phase- II human trials by the Drug Controller General of India (DGCI).

The ICMR had identified 12 clinical trial sites such as medical institutions and hospitals like AIIMS, NIMS, and others.

All India Institute of Medical Science (AIIMS)-Delhi on Monday began recruiting volunteers for conducting human clinical trials of Covaxin, the premier medical institute's director Dr Randeep Guleria said.

He also said that there is not much evidence of community transmission of Covid-19 happening at the national level.

AIIMS-Delhi is among the 12 sites selected by ICMR for conducting Phase I and II randomised, double-blind and placebo-controlled clinical trials of Covaxin.

In phase I, the vaccine would be tested on 375 volunteers and 100 of them, the highest, would be at AIIMS. The second phase, would include around 750 volunteers from all 12 sites put together, Guleria said while addressing reporters.

Phase I of the vaccine trial will be done on healthy people, aged between 18 and 55 years, having no co-morbid conditions. Women with no pregnancy will also be selected to be a part of the trial in the first phase, he said.