The subject expert committee of the Central Drugs Standard Organisation (CDSCO) has recommended that Zydus Cadila's COVID-19 vaccine ZyCoV-D be granted emergency use authorisation (EUA), sources told CNBC-TV18 on August 20.
The three-dose vaccine has shown a 66.6 percent efficacy against positive cases in an interim analysis, the Ahmedabad-based pharma firm had submitted in its application for EUA.
ZyCoV-D is a plasmid-based vaccine and the three doses are going to offer sustained immunity with a longer antibody response memory. The cycle will be 0-28-56-days. It is an intra-dermal vaccine and it will be administered without a syringe. The vaccine can be stored at a normal refrigeration temperature of 2 to 8 degrees.
Meanwhile, the SEC, which met on August 19, is of the view that Zydus Cadila needs to submit additional data for its two-dose vaccine.
The expert panel has sent the recommendation to the Drug Controller General of India (DCGI).
If approved by the DCGI, ZyCoV-D will be the fifth vaccine authorised for use in India after Serum Institute’s Covishield, Covaxin from Bharat Biotech, Russia’s Sputnik V, and Moderna product, which recently got the nod for emergency use in the country.
The vaccine, ZyCoV-D, is also India’s second indigenously developed coronavirus vaccine after Covaxin.
Zydus Cadila plans to manufacture 120 million doses annually.