Zydus Cadila likely to get emergency use approval

Ahmedabad-based Zydus Cadila’s three-dose COVID-19 vaccine ZyCoV-D is expected to get an emergency-use nod from the expert committee this week, sources said.

New Delhi [India], August 9 : Union Health Minister Mansukh Mandaviya last week during the question hour in the Rajya Sabha had said, “The government expects that in October-November, four more Indian pharmaceutical companies will start production of indigenous vaccines that will help to meet the domestic demand, Biological E and Novartis vaccines will also be available in the market in the coming days, while Zydus Cadila will soon get an emergency use nod from Expert Committee.” Zydus Cadila last month had said that it has applied for emergency use authorization (EUA) with the Indian Drug regulator for its three-dose COVID-19 vaccine ZyCoV-D, and plans to manufacture 10-12 crore doses annually.
The company has conducted the largest clinical trial for its COVID-19 vaccine in India so far in over 50 centers.
The EUA is expected to be given for adults first, though the Drug Controller General of India (DCGI) had earlier asked the Ahmedabad-based firm to return with more data on its ZyCoV-D.
Earlier, during a press briefing, a Member of NITI Aayog Dr V K Paul had said that the DCGI is examining Zydus Cadila’s COVID vaccine for children.
“ZuCoV-D is the first-ever plasmid DNA vaccine for human use, it has proven its safety and efficacy profile in our fight against COVID-19,” MD of Cadila Healthcare Dr Sharvil Patel said.

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