Greenlight for Zydus Cadila's ZyCoV-D! India gets First Covid-19 vaccine for children above 12 years
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New Delhi, August 21: A major landmark in India's war against the COVID-19, as the Drug Controller General of India has given Emergency Use Authorization approval to world's first DNA-based, Made In India Covid vaccine ZyCoV-D.
Zydus-Cadila’s ZyCoV-D becomes the sixth vaccine to receive EUA in India. The Zydus-Cadila vaccine can be administered in children as well and is applicable for use for ages 12 years and above.
With that approval, India becomes the first country to develop a DNA vaccine as ZyCov-D gets emergency use authorization. The vaccine, jointly developed in partnership with the Department of Biotechnology, had demonstrated a primary efficacy of 66.66 percent in phase 3 clinical trials.
Developed in partnership with the Department of Biotechnology (DBT), Government of India under the ‘Mission COVID Suraksha’. It had demonstrated a primary efficacy of 66.66 percent in phase 3 clinical trials. The Department of Biotechnology under the Ministry of Science and Technology reads, "The Zydus Cadila has received approval for Emergency Use Authorization (EUA) from the Drug Controller General of India (DCGI) for ZyCoV-D today i.e 20/08/2021, the world's first and India's indigenously developed DNA-based vaccine for COVID-19 to be administered in humans including adults and children 12 years and above."
"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 statement says. The vaccine is to be administered at days 0, 28, and, 56, the regulator said.
Dr. Renu Swarup, Secretary, DBT said "This is an important milestone in our Indigenous Vaccine Development Mission and positions India on the Global Map for Novel Vaccine Development."
In a tweet, CDSCO wrote, "After evaluation of interim Phase III clinical trial results in consultation with Subject Expert Committee, CDSCO has approved DNA COVID-19 vaccine (ZyCoV-D) of M/s Cadila Healthcare for restricted use in an emergency in India for 12 years and above."
In a tweet, the Prime Minister wrote, "India is fighting COVID-19 with full vigour. The approval for the world's first DNA-based 'ZyCov-D' vaccine of @ZydusUniverse is a testimony to the innovative zeal of India's scientists. A momentous feat indeed."
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