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COVID-19 vaccine: SEC recommends emergency approval for Zydus Cadila's ZyCoV-D

COVID-19 vaccine: SEC recommends emergency approval for Zydus Cadila's ZyCoV-D

The committee added that Zydus needs to submit additional data for the 2-dose regimen of its vaccine

The generic drugmaker, listed as Cadila Healthcare Ltd, applied for the authorisation of the vaccine ZyCoV-D on July 1 The generic drugmaker, listed as Cadila Healthcare Ltd, applied for the authorisation of the vaccine ZyCoV-D on July 1

The Indian drug regulator's subject expert committee on Friday recommended approving ZyCoV-D, Zydus Cadila's three-dose Covid vaccine, for emergency use, CNBC-TV 18 reported on Friday, citing sources.

Zydus application claims efficacy of 66.6%. SEC is of a view that Zydus needs to submit additional data for 2-dose vaccine. The committee added that Zydus needs to submit additional data for the 2-dose regimen of its vaccine, CNBC-TV18 said in a tweet.

The generic drugmaker, listed as Cadila Healthcare Ltd, applied for the authorisation of the vaccine ZyCoV-D on July 1, based on an efficacy rate of 66.6% in a late-stage trial of more than 28,000 volunteers nationwide.

If approved, Zydus Cadila's vaccine will be the second home-grown shot to get emergency authorisation in India after Bharat Biotech's Covaxin. Zydus Cadila and India's drug regulator did not immediately respond to a Reuters request for comment.

The SEC has sent recommendations to Drugs Controller General of India (DCGI). The committee had met yesterday. "ZyCoV-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 had said.

Published on: Aug 20, 2021, 3:18 PM IST
Posted by: Mehak Agarwal, Aug 20, 2021, 3:12 PM IST