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India Approves Zydus Cadila’s DNA-Based Vaccine For Emergency Use For 12 And Above

The drugs regulating authority gave emergency use authorization to a three-dose vaccine ZyCov-D.

NEW DELHI — The world’s first deoxyribonucleic acid (DNA)-based Covid-19 vaccine has been cleared for use in adolescents aged 12 and above by the Indian regulator Drugs Controller General of India (DGCI).

“Zydus Cadila has received approval for Emergency Use Authorization (EUA) from the Drug Controller General of India (DCGI) for ZyCoV-D on Aug. 20, 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,” the Department of Biotechnology under the Ministry of Science and Technology said in an official release.

The vaccine is developed in partnership with the Department of Biotechnology, Government of India under the ‘Mission Covid Suraksha‘ and implemented by Biotechnology Industry Research Assistance Council (BIRAC). ZyCoV-D has been supported under Covid-19 Research Consortia through National Biopharma Mission for pre-clinical studies, Phase I and Phase II clinical trials, and under the ‘Mission Covid Suraksha’ and implemented by BIRAC.

“ZyCoV-D has been supported under Covid-19 Research Consortia through National Biopharma Mission for pre-clinical studies, Phase I and Phase II clinical trials, and under the Mission Covid-19 Suraksha for Phase III clinical trial.”

The three-dose vaccine, when injected, produces the spike protein of the Covid-19 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, according to the statement.

Renu Swarup, Secretary, Department of Biotechnology and Chairperson, Biotechnology Industry Research Assistance Council, said the team is confident the indigenously developed vaccine will go a long way towards global immunization efforts.

“It is a matter of great pride that today we have the EUA for the world’s first DNA (based) Covid-19 vaccine ZyCoV-D by Zydus developed in partnership with the Department of Biotechnology and supported through Mission Covid Suraksha,” she said.

“The Indian Vaccine Mission Covid Suraksha launched under the Atma Nirbhar Bharat package 3.0 being implemented by BIRAC, is aimed at the development of safe and efficacious Covid-19 vaccines for the 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.”

The Zydus Cadila vaccine is expected to be available for use in ages 12 and over by the end of September.

“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,” said Pankaj R. Patel, Chairperson of Zydus Group.

“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 under the Government of India for their support in this mission of Atma Nirbhar Bharat and Indian Vaccine Mission Covid-19 Suraksha.”

Union Health Minister Mansukh Mandaviya, during the parliament’s monsoon session, said more indigenous vaccines were in the works to help meet the high demand.

“The government expects that in October-November, four more Indian pharmaceutical companies will start production of indigenous vaccines that will help to meet the domestic demand,” he said.

“Biological E and Novartis vaccines will also be available in the market in the coming days, while Zydus Cadila will soon get an emergency use nod from Expert Committee.”

Zydus Cadila last month had said that it has applied for emergency use authorization with the Indian Drug regulator for its three-dose Covid-19 vaccine ZyCoV-d and planned to manufacture 10-12 crore doses annually.

The company has conducted the largest clinical trials for its Covid-19 vaccine in India so far in over 50 centers.

Meanwhile, United States’ pharma giant Johnson & Johnson’s has moved an application before the Central Drugs Standard Control Organisation (CDSCO) in India, seeking permission to conduct clinical trials of its single-dose Janssen vaccine against Covid-19 on adolescents (children of age group 12-17 years).

Earlier in August, Johnson & Johnson was given emergency use approval in India for its single-dose Covid-19 vaccine.

“On Aug. 17, 2021, we submitted an application to the Central Drugs Standard Control Organisation (CDSCO) to conduct a study of the Johnson & Johnson Covid-19 vaccine in India in adolescents aged 12-17 years,” the company said.

“To ultimately achieve herd immunity, it is imperative that Covid-19 vaccine clinical trials continue to move forward in this population, and we remain deeply committed to the critical work needed to make our Covid-19 vaccine equitably accessible for all age groups.”

The five vaccines which were granted emergency use authorization in India are Serum Institute’s Covishield, Bharat Biotech’s Covaxin, Russia’s Sputnik V, Moderna, and Now Johnson & Johnson.

(With inputs from ANI)

Edited by Amrita Das and Krishna Kakani

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