New Delhi: The Drugs Controller General of India (DCGI) on Friday granted the Emergency Use Authorisation (EAU) to Zydus Cadila’s three-dose Covid-19 vaccine ZyCoV-D. It is also the first approved Covid-19 vaccine in India which can be administered to children aged between 12-18.
Earlier in the day, the Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) had recommended that the vaccine be granted EAU.
After this, the proposal was sent to the DCGI for the final nod.
ZyCoV-D is the world’s first DNA based Covid-19 vaccine. The vaccine injects genetically engineered plasmids which trigger the immune system of the body to start generating spike protein against Covid-19.
In addition, the plug-and-play technology on which the plasmid DNA platform is based can be easily adapted to deal with mutations in the virus, such as those already occurring.
“Interim results from Phase-III Clinical Trials, in over 28,000 volunteers, showed primary efficacy of 66.6 per cent for symptomatic RT-PCR positive cases,” said the Ministry of Science and Technology in a statement.
This is the largest vaccine trial in India so far.
Both the Phase I/II and Phase III clinical trials have been monitored by an independent Data Safety Monitoring Board (DSMB), the ministry added.
After being granted the approval by the DCGI, Chairman of the Zydus Group, Mr. Pankaj R. Patel said, “We are extremely happy that our efforts to put out a safe, well tolerated and efficacious vaccine to fight COVID-19 has become a reality with ZyCoV-D. 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.”