Cadila’s vaccine will be the second home-grown shot to get emergency approval in India.
The Indian drug regulator’s subject expert committee has recommended emergency use approval for Zydus Cadila’s three-dose Covid-19 vaccine, CNBC-TV18 reported on Friday, citing sources.
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 per cent 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.