Zydus Cadila get DCGI nod for Phase-3 clinical trials for Covid-19 vaccine

New Delhi [India]: The drug regulatory body Drugs Controller General of India (DCGI) has approved Ahmedabad based drug firm Zydus Cadila to initiate Phase III clinical trials of its Covid-19 vaccine ZyCoV-D.

“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 the conduct of the Phase III clinical trials,” Ministry of Science and Technology said in a release on Sunday.

 

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

“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 Ministry said.

According to Ministry, the candidate has been supported by the National Biopharma Mission (NBM) under the aegis of Biotechnology Industry Research Assistance Council (BIRAC) and the Department of Biotechnology, Ministry of Science and Technology, Government of India.

Dr. Renu Swarup, Secretary, DBT and Chairperson, BIRAC expressed happiness and hoped that the candidate vaccine continues to show positive outcomes. Speaking on the occasion, she said, “The establishment of the Nation’s first DNA vaccine platform is an important milestone for Atma Nirbhar Bharat and a big leap forward for Indian scientific research.”

The DCGI had on Sunday said that COVID-19 vaccines of Serum Institute of India’s Covishield and Bharat Biotech’s COVAXIN have been granted permission for restricted use in an emergency situation.