In a positive development, Zydus Cadila received Emergency Use Authorization (EUA) by the Drugs Controller General of India (DCGI) for its COVID vaccine ZyCoV-D on Friday. The vaccine from Ahmadabad-based pharmaceutical company is now the world’s first and India’s indigenously developed DNA-based vaccine for humans including children and adults 12 years and above.
Zydus Cadila’s vaccine gets DCGI nod for EUA
“Zydus Cadila receives approval for Emergency Use Authorization from DCGI for ZyCoV-D today. World’s first amd India’s indigenously developed DNA based vaccine for COVID-19 to be administered in humans including children and adults 12 yrs and above,” the Ministry of Science & Technology announced.
Developed in partnership with the Centre’s Department of Biotechnology under the ‘Mission COVID Suraksha’, ZyCoV-D has been supported under COVID-19 Research Consortia through National Biopharma Mission for Preclinical studies.
This 3-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 Ministry said. 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% for symptomatic RT-PCR positive cases. This has been the largest vaccine trial so far for Coronavirus India. This vaccine had already exhibited robust immunogenicity and tolerability and safety profile in the adaptive Phase I/II clinical trials carried out earlier.
‘Proud moment for India’
Dr. Renu Swarup, Secretary, DBT, and Chairperson, BIRAC said that “It is a matter of great pride that today we have the EUA for the world’s first DNA COVID-19 vaccine ZyCoV-D. We are confident that this will be an important vaccine for both India and the world. This is an important milestone in our Indigenous Vaccine Development Mission and positions India on the Global Map for Novel Vaccine Development”
Speaking on the development, 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.”