The company will now be initiating Phase III clinical trials in around 30,000 volunteers. ZyCoV-D was found to be safe, well tolerated and immunogenic in the Phase I/II clinical trials, the company said in a BSE filing.
Following the development, the stock rose 3.01 per cent to hit a high of Rs 492.95 on BSE.
Pankaj R Patel, Chairman of the Zydus Group said, “We are reaching a critical milestone in our vaccine development programme and towards our goal of helping people fight the pandemic with an indigenously discovered, safe and efficacious vaccine. The launch of the Phase 3 trial will determine the efficacy of our vaccine in preventing COVID-19 which continues to pose a major threat, the world over.
The Ministry of Science and Technology 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.
“The Nation’s first indigenously developed DNA vaccine candidate against Covid-19, ZyCoV-D, by Zydus Cadila has been approved by Drugs Controller General of India (DCGI), for the conduct of the Phase III clinical trials,” said in a release on Sunday.
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.