Zydus Cadila anticipates emergency use approval for its COVID-19 vaccine

INDIA – In what will be the first COVID-19 jab for the adolescent population in India, the Zydus Cadila vaccine expects to get a nod from the Indian regulatory centre this week.

Zydus Cadila’s jab will be the sixth COVID-19 vaccine to get approved in India after Covishield, Covaxin, Sputnik V, Moderna and J&J, which was the latest to get DGCI approval.

ZyCoV-D is a three-dose, intradermal vaccine which is applied using the PharmaJet needle-free system. It can be stored at 2-8 degree Celsius but has shown good stability at temperatures of 25 degree Celsius for at least three months.

Zydus Cadila had said last month 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 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,” Union Health Minister Mansukh Mandaviya had said last week.

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.

Meanwhile, India logged 28,204 new coronavirus infections, the lowest in 147 days, taking the total tally of cases to 3,19,98,158, while the active cases fell to 3,88,508, the lowest in 139 days, according to the Union Health Ministry data.

The national COVID-19 recovery rate has increased to 97.45 percent, which is the highest ever recovery rate achieved, the ministry said.

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