Human clinical trials for Covaxin finally begin at NIMS Hyderabad

Human clinical trials for Covaxin, the indigenously developed COVID-19 vaccine candidate, kicked off at the Nizam Institute of Medical (NIMS) Sciences in Hyderabad, with two healthy volunteers being administered the first dose.

Hyderabad (Telangana): Human clinical trials of COVID-19 vaccine candidate Covaxin finally began at Hyderabad's Nizam Institute of Medical (NIMS) Sciences on Monday.

The first vaccine dose was given to two two healthy volunteers in the first phase in NIMS.

NIMS Hyderabad is among the 12 sites selected by the Indian Council for Medical Research (ICMR) for conducting phase I and II human trials of Covaxin, the indigenously developed COVID-19 vaccine candidate.

In phase I, the vaccine would be tested on 375 volunteers and the maximum of 100 of them would be from AIIMS Delhi.

COVID-19 vaccine candidate Covaxin, developed by the Hyderabad-based Bharat Biotech in collaboration with the ICMR and the National Institute of Virology (NIV), had recently got the nod for human clinical trials from the Drugs Controller General of India (DCGI).

Read:WATCH: Bharat Biotech developed India's first COVID-19 vaccine candidate

The indigenous, inactivated vaccine has been developed and manufactured in Bharat Biotech's BSL-3 (Bio-Safety Level 3) high containment facility.

Noting that this was the first indigenous vaccine being developed by India, ICMR Director General Dr Balram Bhargava in a letter to principal investigators of the 12 sites recently had asked them to fast-track the human clinical trial approvals stating it is one of the "top priority projects which is being monitored at the top-most level of the government."

Read:COVID-19: AIIMS to start clinical trial of indigenous vaccine Covaxin from Monday

The trials have so far started in AIIMS, Patna and some more sites.

The DCGI has permitted two vaccines -- one developed by the Bharat Biotech International Limited in collaboration with the ICMR and another one by Zydas Cadila Healthcare Ltd to go in for phase I and II human clinical trials.

(With inputs from PTI)