According to the latest update on coronavirus vaccine, the human clinical trial of indigenously developed Covaxin has started at Jeevan Rekha Hospital in Karnataka's Belgavi. Covaxin is India's first vaccine candidate for COVID-19, developed by Bharat Biotech in collaboration with the Indian Council of Medical Research-National Institute of Virology. The Phase 1 clinical trials for the potential vaccine started on July 15.
The hospital was among the 12 facilities selected by the Indian Council of Medical Research (ICMR) to conduct human trials of the COVID-19 vaccine.
Jeevan Rekha Hospital will conduct the trial on 200 volunteers, aged between 18-65. Amit Bhate, director of the hospital, said that the progress has been on expected lines, Deccan Herald reported.As per the report, four candidates, two male and two female, were administered the vaccine on July 31. The response from the people has been extremely encouraging and all the volunteers are progressing on expected lines with no reactions being witnessed after four days.
Bhate added that the second dose will be administered to them on the 14th day, while antibody tests will commence from the 28th day onwards. After this, immunogenicity tests will be conducted monthly for a few months, he added.
The trial centre is conducting physical and laboratory tests in accordance with the ICMR protocol and is counseling the volunteers who meet all criteria about the possible risks.
Covaxin will be tested on over 1,100 people in two phases. For the first phase of clinical trials, the company plans to enroll 375 participants to test COVID-19 vaccine candidate. Based on the first trial's results, it has a plan to enroll 750 people in the second phase of trial.
Covaxin is derived from a strain of SARS-CoV-2 virus which had been isolated at National Institute of Virology (NIV), Pune, which was later transferred to Bharat Biotech to produce a vaccine candidate. The indigenous, inactivated vaccine is being developed and manufactured in Bharat Biotech's BSL-3 (Bio-Safety Level 3) High Containment facility located in Genome Valley, Hyderabad, India.
By Chitranjan Kumar