The Hyderabad-based firm, while applying for phase-three trial, stated that the vaccine was well-tolerated in all dose groups and no serious adverse events have been reported.
He had offered to be the first volunteer for the third phase trial of Covaxin, which started in the state today.
Bharat Biotech had on Monday said the Phase 3 trial of Covaxin will involve 26,000 volunteers across 25 centres in India and is being conducted in partnership with the ICMR.
The phase III trials will involve 26,000 volunteers across 25 centres in India, being conducted in partnership with ICMR
IMS and SUM Hospital is among the 21 medical institutes selected across the country by the Indian Council for Medical Research (ICMR) where the third phase trial would be conducted.
The SARS-CoV-2 strain was isolated in NIV, Pune and transferred to Bharat Biotech. The indigenous, inactivated vaccine is developed and manufactured in Bharat Biotech’s BSL-3 (Bio-Safety Level 3)
Hyderabad-headquartered company is currently conducting Phase II human trials of Covaxin after receiving Drug Controller General of India nod
Among several hospitals across the country, the city-based NIMS was also selected to take part in phase I clinical trials of Covaxin, which concluded recently.
The blood samples collected from the volunteers who received the vaccine were to ascertain how effective the vaccine was in terms of the level of antibodies developed.
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Twelve clinical trial sites have been identified at present and the apex health research body has asked the medical institutions and principal investigators to ensure that the subject enrolment is initiated no later than July 7.
Having completed pre-clinical studies, human clinical trials are scheduled to start across India in July