By Shalini Bhardwaj

New Delhi [India], August 20 (ANI): Zydus Cadila‘s wait for a regulatory nod for its ZyCoV-D plasmid DNA vaccine against Covid is over. The Ahmedabad-based pharma company has received approval from the Drugs Controller General of India (DCGI). According to a press release of the Department of Biotechnology under the Ministry of Science and Technology, “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.” “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 preclinical studies, Phase I and Phase II clinical trials and under the Mission COVID Suraksha for Phase III clinical trial,” it said.

“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.

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 by Zydus developed in partnership with the Department of Biotechnology and supported through Mission COVID Suraksha. 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.”

Speaking on the development, Chairperson 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 under the Government of India for their support in this mission of Atma Nirbhar Bharat and Indian Vaccine Mission COVID Suraksha.”

Union Health Minister Mansukh Mandaviya during monsoon session during the question hour in the Rajya Sabha had said, “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. 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 authorisation 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 centres.

Approval for world’s first DNA-based ‘ZyCov-D’ vaccine is testimony to innovative zeal of India’s scientists: PM Modi

Prime Minister Narendra Modi on Friday said that the approval for the world’s first DNA-based ‘ZyCov-D’ vaccine of Zydus Cadila group is a testimony to the innovative zeal of India’s scientists. In a tweet, the Prime Minister wrote, “India is fighting COVID-19 with full vigour. The approval for 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.”

This comment by the Prime Minister came in response to a tweet by the Central Drugs Standard Control Organisation (CDSCO) under the Ministry of Health and Family Welfare. 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 emergency situation in India for 12 years and above.”

Following this, Union Health Minister Mansukh Mandaviya applauded Prime Minister Narendra Modi‘s vision of Aatmanirbhar Bharat and added that ‘Make in India’ delivered another significant accomplishment.
“Double good news for the nation! @CDSCO_INDIA_INF approves the 1st DNA-based, needle-free #COVID19 vaccine in the world – ‘ZyCov-D’ of @ZydusUniverse Making children of India COVID-safe, this vaccine can be used for individuals aged 12 and above,” tweeted the Health Minister. He further added, “‘ZyCov-D’ is the 6th approved #COVID19 vaccine in India, and the 2nd indigenously developed one. PM @NarendraModi ji’s vision of #AatmanirbharBharat and Make in India delivers another significant accomplishment!”

Zydus Cadila received approval for Emergency Use Authorization (EUA) from the Drug Controller General of India (DCGI) for ZyCoV-D today, the world’s first and India’s indigenously developed DNA based vaccine for COVID-19 to be administered in humans including children and adults 12 years and above. Union Minister of Commerce and Industry, Piyush Goyal also congratulated the Zydus Group especially scientists involved in this success under Mission COVID Suraksha. Taking to Twitter, Goyal wrote, “Make In India’s milestone moment – World’s first DNA based COVID-19 vaccine, ZyCoV-D gets Emergency Use Authorization for 12 years and above. Congratulations to Zydus Group esp. all scientists involved in this success under Mission COVID Suraksha.” Zydus Cadila in a tweet also had informed that ZyCoV-D is the only needle-free COVID vaccine in the world. “Zydus receives EUA from DCGI for ZyCoV-D, the only needle-free COVID vaccine in the world,” tweeted the healthcare company. (ANI)

Adolescents likely to get ZyCoV-D COVID vaccine after four weeks

The Drugs Controller General of India (DCGI) on Friday approved Zydus Cadila’s DNA vaccine for emergency use in adults and children aged 12 years and above. It is considered a timely move amid warnings of an upcoming third wave in the country. Recently, a committee of experts under the National Institute of Disaster Management (NIDM) warned of the third COVID-19 wave that could peak around October and sought better preparedness for children.

Dr Renu Swarup, Secretary, Department of Biotechnology, Government of India, while speaking exclusively to ANI on vaccines for children in India and use of Zydus Cadila’s ZyCoV-D for above 12 years adolescents, said, “So far the vaccines which were in the market were those which were for above 18 years. This is the DNA vaccine that has just received emergency use authorization is for 12 to 18 years and above. For the younger children, maybe 5 to 12 years, and even below there are different stages of the research which is still going on, and mostly all the vaccine manufacturers on different platforms are doing their trials.”

Dr Swarup added, “We know that Bharat biotech has already got permission for the trial of a vaccine which is again for younger children five years and above. Similarly, the biological E is still in their phase three trials. Currently, it’s now doing its phase 2, phase 3 for which it got approval for the trials on children.”
“So, most of the vaccine developers are working but that’s going to take a little while it’s very difficult to say when. But they are already working on it, but this is for 12 and above. It is a good development, and we hope that this is going to make a major difference,” she further said.

When asking about the administering of ZyCoV-D to Children she said, “DNA vaccine which has just received emergency use authorization. we’ve just been informed that this was going to take about four weeks before they can bring out the doses for the immunisation programme, which children will get immunised. It will be taken by the entire NTAGI Working Group on COVID because they will have to decide, considering how much volume is going to be available. Knowing this, that this is a new technology, a new platform, it does take time for the scale-up of this vaccine.” “The schedule of the dosing for which category of children will be guided by the NTAGI the working group based on a number of parameters that they will consider, and that’s how the decision will be taken,” she added. (ANI)