Zydus application claims efficacy of 66.6%. SEC is of a view that Zydus needs to submit additional data for 2-dose vaccine. ZyCoV-D COVID vaccine is for all above 12 years of age and the vaccine has to be administered in three doses – the first dose, and the remaining doses after 28 and 56 days.
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.