AIIMS to Begin Covaxin Human Trials, Invites Healthy Volunteers
The volunteers will be kept under observation for a period of nearly 150 days.
AIIMS Delhi will begin human trials of India's first indigenous COVID-19 vaccine, Covaxin, from Monday on 100 healthy volunteers aged between 18 and 55. This comes after AIIMS’s Ethics Committee gave its nod for a human clinical trial for Covaxin, on 18 July, Saturday,
Covaxin is being developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV).
According to Bharat Biotech, the Phase 1 clinical trial for Covaxin has been initiated across the country from 15 July onwards, and this is a randomised, double-blind, placebo-controlled clinical trial on 375 volunteers across the country. The volunteers will be kept under observation for a period of nearly 150 days.
Speaking to IANS, Sanjay Rai, Professor of Community Medicine and Principal Investigator of Covid-19 vaccine trial at AIIMS, said, “We will ensure that none of the volunteers have any co-morbidities.”
The SARS-CoV-2 strain was isolated in NIV, Pune, and transferred to Bharat Biotech. The indigenous, inactivated vaccine was developed and manufactured in Bharat Biotech's BSL-3A (Bio-Safety Level 3) High Containment facility located in Genome Valley, Hyderabad.
The Drug Controller General of India, Central Drugs Standard Control Organisation (CDSCO), and the Ministry of Health & Family Welfare granted permission to initiate Phase-I and II human clinical trials after the company submitted results generated from pre-clinical studies, demonstrating safety and immune response.
(With inputs from IANS)
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