The Drugs Controller General of India (DCGI) on Friday gave approval for emergency-use authorization of Zydus Cadila's ZyCoV-D vaccine, the Union Ministry of Science and Technology said. The world’s first and India’s indigenously developed DNA-based vaccine for COVID-19 will be administered in humans including children and adults 12 years and above, the ministry said.
Interim results from Phase-III Clinical Trials, in over 28,000 volunteers, showed primary efficacy of 66.6 percent for symptomatic RT-PCR positive cases. This has been the largest vaccine trial so far in India for COVID-19. This vaccine had already exhibited robust immunogenicity and tolerability and safety profile in the adaptive Phase I/II clinical trials carried out earlier. Both the Phase I/II and Phase III clinical trials have been monitored by an independent Data Safety Monitoring Board (DSMB).
On July 1, the Ahmedabad-based pharma major had applied for emergency use authorisation (EUA) with the DCGI for the vaccine. The company said it has conducted the largest clinical trial for the vaccine in India in over 50 centres so far.
ZyCoV-D is now the sixth vaccine that has been approved for use in the country after Serum Institute's Covishield, Bharat Biotech's Covaxin, Russia's Sputnik V and the US-made Moderna and Johnson and Johnson. Plasmid DNA-based ZyCoV-D is to be administered intradermally using a needle-free injector.
Pankaj R Patel, the Chairman of the Zydus Group, expressed happiness on being able to put out a "safe, well-tolerated and efficacious" vaccine.
"To create the world’s first DNA vaccine at such a crucial juncture and despite all the challenges, is a tribute to the Indian research scientists and their spirit of innovation. I’d like to thank the Department of Biotechnology, Government of India for their support in this mission of Atma Nirbhar Bharat and Indian Vaccine Mission COVID Suraksha," he said.