According to official updates from ICMR, the human clinical trials of the indigenously developed Covaxin have commenced at Jeevan Rekha Hospital in Karnataka's Belgavi, earlier this month. 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. Simultaneous trials have also started at AIIMS Delhi and PGIMS Rohtak.
Jeevan Rekha Hospital shall conduct the trial on 200 volunteers, aged between 18 and 65 years. Amit Bhate, director of the hospital, informed media that the four candidates- two men and two women who were administered the vaccine on July 31st are doing well and have demonstrated absolutely no side-effects or reactions of the vaccine.
The four candidates who were administered the vaccine on July 31 are doing well and have demonstrated absolutely no side-effects or reactions of the vaccine.Bhate added that the second dose will be administered to them on the 14th day, while antibody tests will commence from the 28th day. After this, immunogenicity tests shall be conducted on a monthly basis for a few months. The trial centre is conducting physical and laboratory tests in accordance with the ICMR protocols and is counseling the volunteers (who meet all criteria) about the possible risks.
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. 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 at Bharat Biotech's BSL-3 (Bio-Safety Level 3) High Containment facility located in Genome Valley, Hyderabad.
Incidentally, Bharat Biotech is the same company which has developed vaccines against polio, rotavirus, Japanese encephalitis and Zika. The Phase 1 trials for the potential vaccine had started on July 15th.