Bharat Biotech to move to phase II trials for Covaxin
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.
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.
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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