Bharat Biotech has received the drug regulator’s clearance to move its vaccine candidate against Covid-19, Covaxin, to the second phase of human testing, The Sunday Express has learnt. The trials are expected to begin in the coming week, following ethics committee approvals, said sources close to the development.
A subject expert committee (SEC) studying its request to begin the phase II trial recommended that the trial be conducted on 380 participants, stated Joint Drugs Controller Dr S Eswara Reddy in a letter to the Hyderabad-based firm dated September 3.
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The Sunday Express has reviewed a copy of this letter.
A candidate that raked up controversy in early July following an Indian Council of Medical Research (ICMR) letter pushing for an August 15 launch, Covaxin is an “inactivated” vaccine — it works by injecting doses of the virus that have been killed aiming to prompt the body to build antibodies against it without the virus posing a threat.
Each stage of a vaccine’s clinical trial tests its safety and ability to develop an effective immune response. While the first phase focuses on safety in healthy participants, the second phase looks at the effectiveness. The third phase looks into these aspects in a much larger population that would represent a wider demographic.
In the first phase of the Covaxin trial, around 375 participants were studied across 12 sites. Covaxin is one of the frontrunners in the race for a Covid-19 vaccine in India. Starting its phase II trials will put it right behind Zydus Cadila and Serum Institute of India, which are already conducting phase II trials for their vaccine candidates in India.
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