Drug Controller General grants emergency approval to the Zycov-D, a COVID-19 vaccine developed by Zydus Cadilla.
The Drug Controller General has granted emergency approval to the Zycov-D, a COVID-19 vaccine developed by the Ahmedabad based Zydus Cadilla group, on Friday, making it the first vaccine in India that can be administered to adults as well as those 12 and above. It’s also the only DNA-based vaccine in the world and can be administered without a needle, purportedly minimising chances of reactions.
Interim results from Phase-III Clinical Trials, in July, in over 28,000 volunteers, showed a primary efficacy of 66.6 % 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)," the Department of Biotechnology said in a statement on Friday.
The vaccine has been developed in partnership with the Department of Biotechnology under the ‘Mission COVID Suraksha’, The three-dose vaccine once administered produces the spike protein of the SARS-CoV-2 virus and elicits an immune response. "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 DBT noted. Renu Swarup, Secretary, DBT told The Hindu that with the approval, the vaccine would be available "very soon" and that stockpiling had already begun.
In previous statements, the company has said it expects to make 10-12 crore doses annually and five crore by the year-end.
“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," Pankaj Patel, Chairman, Zydus Group said in a statement.
This is the fifth vaccine, after Covishield, Covaxin, Sputnik V and Moderna to be approved for use in India. Inspite of nearly 57 crore doses administered since January, the mainstay of India’s vaccination programme continue to Covishield and Covaxin, with the former being nearly 90% of the doses administered so far. About a third of adults have been administered atleast one dose and and 10% two doses.
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