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Vaccine for Children Gets DCGI Approval

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The Drugs Controller General of India has approved the new DNA based Covid-19 vaccine developed by Zydus Cadila- an Indian pharmaceutical company. The ZyCoV-D vaccine received Emergency Use Authorization (EUA) on August 20, Friday. Children above the age of 12, as well as adults, can be beneficiaries of the vaccine. 

Read further to know more.

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Manufactured by Ahmedabad based global pharmaceutical company, ZyCoV-D is the world’s first Plasmid DNA vaccine for COVID-19. It is to be administered in 3 doses using a needle-free PharmaJet technology, with a gap of 28 days between each subsequent dose. According to the official release on the Zydus Cadila website, this technology will reduce the possibility of potential side effects.

World’s First DNA Vaccine

Mr. Pankaj R. Patel- the Chairman of Cadila Healthcare Ltd spoke about the development of the vaccine in a statement, appreciating the hard work of all the researchers and the efforts of the volunteers who underwent vaccine trials.

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“This is a historic milestone with ZyCoV-D, a product of Indian innovation becoming the world’s first DNA vaccine being offered for human use and supporting the world’s largest immunization drive. We are particularly happy that our vaccine will contribute to this fight against COVID-19 and enable the country to vaccinate a larger population especially in the age group of 12-18 years”, he said.

The company is also planning to get approval for the two-dose version. After Covishield, Bharat Biotech’s Covaxin, Russia’s Sputnik V, Moderna and Johnson & Johnson, ZyCoV-D is the sixth Covid-19 vaccine to receive EUA in India.

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Efficacy and Process of Production

Zydus Cadila has developed the vaccine in partnership with the Department of Biotechnology under ‘Mission COVID Suraksha’. It has yielded successful results with more than 28,000 clinical trials. Of this, 1,000 volunteers were in the age group of 12-18 years. The company has claimed 66.6% efficacy against symptomatic COVID-19 cases and 100% for moderately symptomatic ones. The vaccine is stable at room temperature with the ideal storage range being 2 to 8 degrees Celsius.

“We have re-purposed an existing plant where we are now producing, and our new plant will be ready by the end of July. By August, we should have the capacity to make 10 million doses a month and by the end of this year, we would have made 50 million doses of ZyCoV-D,” Sharvil Patel, managing director of Zydus Cadila, had said earlier this month. (quote from the Business Standard)

How Does A Plasmid DNA Vaccine Work

DNA vaccines operate by infusing a genetically designed plasmid with the DNA sequence encoding the antigen(s) for which an immune response is desired. This prompts cells to manufacture the antigen directly, resulting in a protective immune response.

The Needle-Free Technology

The PharmaJet needle-free Tropis system will use a single-use, sterile, disposable syringe with a reusable injector. A needle-free syringe containing the vaccine will be inserted into the injector. The syringe will be simply squeezed at the injection site, following which pressure will be applied locally for 60 seconds.

Pricing and Logistics

In a virtual press conference, Zydus Group MD Sharvil Patel addressed the logistics of vaccine delivery around the country. The firm will now be working with regulatory bodies regarding pricing and delivery, with better pricing clarity within 1-2 weeks.

According to The Economic Times, the company is looking into starting vaccine supply by mid to end September. It further plans to scale up to 1 crore doses by October and 4-5 crore by end of January. The drug giant is also looking into both domestic and international partnerships for ramping up production.

PM Modi lauded the approval of the vaccine as a momentous feat in a tweet on Friday. He said:

“India is fighting covid-19 with full vigour. the approval for world’s first dna based “zycov-d” vaccine of @zydus universe is a testimony to the innovative zeal of india’s scientists. a momentous feat indeed.”

To read more on vaccines, click here.

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