Human clinical trials of Covaxin begin at Belagavi hospital

Human clinical trials of Covaxin developed by Bharat Biotech, Hyderabad in association with Indian Council of Medical Research (ICMR) for treatment of Covid-19 commenced at the Jeevan Rekha Hospital.

Jeevan Rekha is among the 12 facilities identified by ICMR for conducting clinical trials. In the first phase, vaccine has been administered to 375 persons across the country and the progress has been on expected lines, Director Dr Amit Bhate told DH.

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Four persons, two male and two female have been administered the vaccine here and they were progressing on expected lines with no reactions being witnessed after four days. The second dose will be administered to them on the 14th day after the first dose has been administered, he said.

Volunteers in the age group of 18 to 55 years had been shortlisted after thorough screening. Their blood and swab samples had been sent to the Central Laboratory of ICMR at New Delhi. After receipt of their reports, four volunteers, two male and two female were selected. Pregnancy tests were also conducted for women volunteers, he said.

Dr Bhate said, first day of the vaccine being administered is calculated as zero day and second dose would be given on 14th day to the volunteers. Antibody tests will commence on 28th day onwards and every month immunogenicity tests will be conducted for few months.

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After the first dose being administered on Friday, there have been no reactions on all four volunteers and the trials have began on expected lines. Their health was being monitored for all parameters as per the protocols, he said.

Phase-2 trials of the vaccine will commence after 20days across the country, he added.