Zydus Cadila gets DCGI nod for phase III trials of its corona vaccine candidate

New Delhi, Jan 03: The Drugs Controller General of India (DCGI) has approved conducting phase III trials of the country''s first DNA vaccine candidate against COVID-19 being developed by Zydus Cadila, the Department of Biotechnology said on Sunday.

The vaccine candidate has been supported by the National Biopharma Mission (NBM) under the aegis of Biotechnology Industry Research Assistance Council (BIRAC), a PSU under the DBT.

"The nation''s first indigenously developed DNA vaccine candidate against COVID-19, ZyCoV-D, by M/s Zydus Cadila, has been approved by Drugs Controller General of India (DCGI), for conduct of the Phase III clinical trials," the DBT said.

Zydus Cadila completed Phase-I/II clinical trials of this DNA vaccine candidate in more than 1,000 participants and "interim data indicated that the vaccine is safe and immunogenic when three doses were administered intradermally", the DBT said.

"Based on the recommendations of the Subject Expert Committee, which reviewed the interim data, the DCGI has accorded permission for conducting Phase-III clinical trial in 26,000 Indian participants," the DBT added.

DBT secretary and BIRAC chairperson Renu Swarup hoped that the candidate vaccine continues to show positive outcomes.

"The Department of Biotechnology, has partnered with Zydus Cadila to address the need for accelerated development of an indigenous vaccine for COVID-19. The partnership exemplifies that such research endeavours demonstrate the government''s focus on creating an ecosystem that nurtures and encourages new product innovation with societal relevance," she said.

She noted that the establishment of the country''s first DNA vaccine platform is an important milestone for an ''Aatmanirbhar Bharat'' and a big leap forward for scientific research.

The DCGI on Sunday approved Oxford COVID-19 vaccine Covishield, manufactured by the Serum Institute, and indigenously developed Covaxin of Bharat Biotech for restricted emergency use in the country, paving the way for a massive inoculation drive.

Dr Reddy''s Laboratories is conducting phases 2 and 3 clinical trials of Russian vaccine Sputnik V, while Biological E is conducting phase 1 trials of its indigenously developed vaccine candidate.