DCGI approves Zydus Cadila’s indigenously developed DNA-based vaccine ZyCoV-D for Emergency Use Authorization
New Delhi: Zydus Cadila has received approval for Emergency Use Authorization from the Drug Controller General of India for ZyCoV-D vaccine. Ministry of Science and Technology in a statement said that it is the world’s first and India’s indigenously developed DNA-based vaccine for COVID-19 to be administered in humans including children and adults 12 years and above.
It has been developed in partnership with the Department of Biotechnology under the Mission COVID Suraksha and implemented by Biotechnology Industry Research Assistance Council, BIRAC. This three-dose vaccine, 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 Ministry said, interim results from Phase-3 Clinical Trials, in over 28 thousand volunteers, showed primary efficacy of 66.6 per cent 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 and 2 clinical trials carried out earlier. Both the Phase I, 2 and 3 clinical trials have been monitored by an independent Data Safety Monitoring Board.