Zydus Cadila submits additional data to DCGI for its COVID-19 vaccine: Sources
Jul 27, 2021
New Delhi [India], July 27 : Ahmedabad-based Zydus Cadila has submitted additional data related to immunogenicity and safety, on its three-dose COVID-19 vaccine ZyCoV-D, to India's drug regulator Drugs Controller General of India (DCGI), sources said on Tuesday.
The drug regulator had asked the pharma major to return with more data, sources had informed ANI earlier.
DCGI will consider giving emergency use authorisation (EUA) after review of data recommended in the meeting of the regulator's Subject Expert Committee (SEC). If data is found to be satisfactory then final approval from DCGI for the vaccine may be granted in August.
Previously, the sources had told ANI that a continuous and rolling review of data for ZyCoV-D was being undertaken and final approval would take a few more days.
Zydus Cadila had on July 1, requested emergency use approval for ZyCoV-D, its three-dose COVID shot - the world's first plasmid DNA vaccine for human use. If approved it will be the country's second indigenous vaccine after Bharat Biotech's Covaxin.
