Ahmedabad-based Zydus Cadila's ZyCoV-D plasmid DNA vaccine against Covid-19 has received approval for emergency use authorisation from the Drug Controller General of India and it will be administered to people 12 years and above, the Department of Biotechnology said on Friday. ZyCoV-D is the world's first and India's indigenously developed DNA-based vaccine for Covid-19, and is developed with the Department of Biotechnology, Government of India, under 'Mission Covid Suraksha’.
“This three-dose vaccine which when injected produces the spike protein of the SARS-CoV-2 virus and elicits an immune response, which plays a vital role in protection from disease as well as viral clearance. 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,” the company statement said.
This is significant, considering the Union Health Ministry’s own disclosure in reply to a RTI query that over 3.86 crore people failed to get the second dose of the anti-Covid 19 vaccine (Covishield and Covaxin) within the stipulated time of the inoculation.
Interim results from Phase-III clinical trials, in over 28,000 volunteers, showed primary efficacy of 66.6% for symptomatic RT-PCR positive cases. “This has been the largest Covid-19 vaccine trial in India. 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,” said the ministry.
Dr Renu Swarup, secretary, DBT, and chairperson, BIRAC, said, “It is a matter of great pride that we have the emergency use authorization for the world’s first DNA-based 19 vaccine by Zydus, developed in partnership with the Department of Biotechnology and supported through Mission Covid Suraksha. We are confident that this will be an important vaccine for India and the entire world. This is an important milestone in our indigenous vaccine development mission and positions India on the global map for novel vaccine development.”
Zydus Group chairman Pankaj Patel said that he and his entire group are “extremely happy that our efforts to put out a safe, well-tolerated and efficacious vaccine to fight Covid has become a reality with ZyCoV-D”.