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India approves world’s first plasmid DNA Covid vaccine

New Delhi, Aug 20 (IANS) Zydus Cadila on Friday announced that it has received Emergency Use Authorisation from the Drug Controller General of India for ZyCoV-D – the world’s first plasmid DNA vaccine for Covid-19.

ZyCoV-D is a three-dose vaccine which will be administered first on day zero, the 28th and then on the 56th day.

With this approval, India now has its first Covid-19 vaccine for the adolescents in the 12-18 age group, besides the adult population, the company said in a statement.

“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 immunisation drive,” Cadila Healthcare Chairman Pankaj R. Patel said in a statement.

“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 added.

ZyCoV-D is a needle-free vaccine administered using the PharmaJet — a needle free applicator, which ensures painless intra-dermal vaccine delivery.

The company plans to manufacture 10-12 crore doses of ZyCoV-D annually.

It also plans to seek approval for the two-dose regimen of the vaccine.

ZyCoV-D is a Plasmid DNA vaccine which, when administered, produces the spike protein of the SARS-CoV-2 virus and elicits an immune response mediated by the cellular and humoral arms of the human immune system, which play a vital role in protection from disease as well as viral clearance.

The Covid-19 vaccine was also tested in the adolescent population in the 12-18 years age group in India and was found to be safe and very well tolerated.

ZyCoV-D had already exhibited a robust immunogenicity and tolerability and safety profile in the adaptive Phase 1/2 clinical trials carried out earlier. Both the Phase 1/2 and Phase 3 clinical trials have been monitored by an independent Data Safety Monitoring Board.

The vaccine is stored at 2-8 degrees Celsius but has shown good stability at temperatures of 25 degrees Celsius for at least three months.

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