The Centre has given approval to Hyderabad-based Bharat Biotech’s coronavirus vaccine Covaxin to conduct phase 2 of clinical trials from September 7.

The trials will be conducted on 380 volunteers, according to a letter issued to Bharat Biotech International by Dr S Eswara Reddy, the Joint Drugs Controller of India. In the first phase of the Covaxin trial, around 375 participants were studied across 12 sites.

“This is to inform you that the subject proposal was examined in consultation with SEC (Covid-19) experts held through virtual meeting on September 3, wherein the committee recommended for the conduct of Phase II part of clinical trials with 380 participants subject to the condition that time for screening the participants should be revised in 4 days,” the Directorate General of Health Service said in a statement.

In the first phase trial of the vaccine, the blood samples collected from the volunteers who received the vaccine were monitored for side effects. According to Dr E Venkata Rao, Principal Investigator of the trial at Institute of Medical Sciences (IMS) and SUM Hospital, faculty of medical sciences, there were no side effects.

IMS and SUM Hospital is one of the 12 medical centres in the country chosen by the Indian Council for Medical Research (ICMR) for conducting the human trial of the vaccine developed by Hyderabad-based Bharat Biotech.

Covaxin is one of the frontrunners in the race for a Covid-19 vaccine in India. It is an “inactivated” vaccine — it works by injecting doses of the virus that have been killed aiming to prompt the body to build antibodies against it without the virus posing a threat.

Each stage of a vaccine’s clinical trial tests its safety and ability to develop an effective immune response. Phase 1 focuses on determining safety and dosage in a small group of healthy participants, while the second phase looks at the vaccine’s effectiveness. The third phase looks into these aspects in a much larger population that would represent a wider demographic.

(with agency inputs)