Zydus Cadila on Friday received an approval for the Emergency Use Authorization (EUA) from the Drug Controller General of India (DCGI) for its COVID-19 vaccine ZyCoV-D.
It is the world’s first and India’s indigenously developed DNA-based vaccine for COVID-19 to be administered for all above 12 years of age, said the Ministry of Science an Technology.
The company said it plans to manufacture 100 million to 120 million doses of ZyCoV-D annually and has started to stockpile the vaccine.
The generic drugmaker, listed as Cadila Healthcare Ltd, applied for the authorisation of ZyCoV-D on July 1, based on an efficacy rate of 66.6 per cent in a late-stage trial of over 28,000 volunteers nationwide.
ZyCoV-D is the world’s first plasmid DNA vaccine against the coronavirus. This three-dose vaccine, which when injected produces the spike protein of the SARS-CoV-2 virus and elicits an immune response, plays a vital role in protection from the infection 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.
“Developed in partnership with the Department of Biotechnology, Government of India under the ‘Mission COVID Suraksha’ and implemented by BIRAC, ZyCoV-D has been supported under COVID-19 Research Consortia through National Biopharma Mission for Preclinical studies, Phase I and Phase II Clinical Trials and under the Mission COVID Suraksha for Phase III Clinical Trial,” a government press release stated.
According to the government release, 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).
Vaccine Technology Centre (VTC), vaccine research centre of the Zydus group, Translational Health Science and Technology Institute (THSTI), an autonomous institute of the Department of Biotechnology (DBT and Interactive Research School for Health Affairs (IRSHA), Pune, GCLP Lab set up under the Department of Biotechnology – National Biopharma Mission (NBM) also played a vital role in this success story.
Speaking on the development, the Chairman of the Zydus Group, 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.”
ZyCoV-D will be India’s second indigenous coronavirus vaccine after Covaxin, and the sixth vaccine to be approved in the country so far, joining the leagues of Serum Institute’s Covishield, Bharat Biotech’s Covaxin, Russia’s Sputnik V and the US-made Moderna and Johnson & Johnson.
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Published on: Friday,August 20, 2021, 08:15 PM IST
