Zydus Cadila likely to get emergency use approval for its COVID-19 vaccine this week: Report

While there is yet a covid-19 vaccine to roll out for kids, Zydus Cadila is likely to get emergency use authorisation (EUA) from the Centre this week states a India Today report. If approved, Zudus Cadilla's ZyCoV-D would be the first vaccine in India for the 12-18 years age group.

Zydus Cadila applied for the EUA status for its Covid vaccine ZyCoV-D on July 1. The company has conducted the largest clinical trial for its Covid-19 vaccine in India, including on the adolescent population in the 12-18 years age group.

ZyCoV-D is a three-dose, intradermal vaccine, which is applied using a needle-free system, Tropis, which can also lead to a significant reduction in any kind of side effects.

In July, the the Centre had told the Delhi High Court that Zydus Cadila's COVID-19 vaccine may be available in the near future for children in the age group of 12 to 18 years, however there has been no specific date announced yet.

Lav Agarwal, Jointt Secretary, Health Ministry while addressing the media had said that as soon as the Centre gets robust enough results of these trials, it'll decide on vaccination for children, based on expert decision.

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Few weeks ago, the Centre had informed that Zydus Cadila has concluded its trial for children between the age group of 12 to 18 and is subject to statutory permissions. The Ahmedabad-based pharmaceutical firm had on July 1, requested emergency use approval for ZyCoV-D, its three-dose Covid shot - the world's first Plasmid DNA vaccine.

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.

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 authorisation (EUA) with the Indian Drug regulator for its three-dose COVID-19 vaccine ZyCoV-D, and plans to manufacture 10-12 crore doses annually.

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