The Drugs Controller General of India approved Zydus Cadila’s (Zycov-D)three-dose COVID-19 DNA vaccine for emergency-use authorization in adults and children aged 12 and up on Friday, making it the country’s sixth vaccination to be approved, the Union Ministry of Science and Technology said.
With the emergency use authorisation (EUA), ZyCoV-D has also become the first vaccine to be administered to those in the age group of 12-18 years in the country.
The company stated that it intends to produce 100 million to 120 million doses of ZyCoV-D each year and has begun stockpiling the vaccine.
Cadila Healthcare Ltd, a generic manufacturer, requested for ZyCoV-D approval on July 1 based on a 66.6 percent efficacy rate in a late-stage trial involving over 28,000 volunteers across the country.
The department of biotechnology (DBT) said that ZyCoV-D is the world’s first DNA-based vaccine against the coronavirus and 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 the disease as well as viral clearance.
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After Bharat Biotech’s Covaxin, Zydus Cadila’s vaccine, developed in partnership with the Department of Biotechnology, is the second home-grown shot to receive emergency approval in India.
Prime Minister Narendra Modi hailed the approval as a “momentous feat” and said the approval to the world’s first DNA-based vaccine against the coronavirus is a testimony to the innovative zeal of India’s scientists.
“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.
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“It is a matter of great pride that today we have the EUA for the world’s first DNA COVID-19 vaccine ZyCoV-D by Zydus, developed in partnership with the Department of Biotechnology and supported through Mission COVID Suraksha. The Indian Vaccine Mission COVID Suraksha was launched under the Atma Nirbhar Bharat package 3.0 being implemented by BIRAC, and is aimed at the development of safe and efficacious COVID-19 vaccines for public health. 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,” Renu Swarup, Secretary, DBT and Chairperson, BIRAC, said.
(With inputs from agencies)