Zydus Cadila seeks DCGI's approval for emergency use of its DNA COVID vaccine in India
New Delhi | Jagran News Desk: Indian drug manufacturer Zyduc Cadila on Thursday informed that it has applied for the emergency use authorisation seeking approval from the Drugs Controller General of India (DCGI) for the launch of its DNA vaccine against COVID-19 in India for people above 12 years of age. The vaccine has completed the third phase of the trial and Zydus Cadila plans to manufacture up to 120 million doses of the shot annually.
The Zydus Cadila's ZyCoV-D DNA vaccine showed a 66.6 per cent efficacy against positive cases in an interim analysis. The candidate, if approved, would become India's second successful home-grown COVID-19 shot and help ease the country's severe vaccine shortage.
An approval for Zydus' vaccine, ZyCoV-D, would make it the fifth vaccine authorized for use in India, after Moderna, AstraZeneca and partner Serum Institute of India's Covishield, Bharat Biotech's Covaxin, and Sputnik V developed by Russia's Gamaleya Institute.
ZyCoV-D is a DNA Covid vaccine, which carries the genetic code for that part of a virus that triggers the immune system of the body. It is also the world's first DNA vaccine against coronavirus. Earlier, a government source had said, "Zydus Cadila has told the government that it could apply for emergency use authorisation for ZyCoV-D vaccine in the next seven-eight days."
Earlier on July 18, Niti Aayog Member (Health) Dr VK Paul had told ANI that Cydus Cadila has enrolled more than 28,000 volunteers for their phase three study.
"We are hoping that they will apply in near future. Most of their study is complete. They have enrolled more than 28,000 volunteers in their phase 3 study. We expect they will submit the results very soon. We are hopeful of this vaccine because it would be the world's first DNA vaccine. We are very proud of their work," he had said.
The vaccine is being developed with support from the Centre's National Biopharma Mission as part of the Biotechnology Industry Research Assistance Council, Department of Biotechnology.
ZyCoV-D, the second indigenous vaccine after Bharat Biotech's Covaxin, is a three-dose vaccine -- to be administered at day 0, day 28, and day 56. The company has said it is also working on a two-dose regimen of this vaccine. The stability data of the vaccine candidate showed that ZyCoV-D can be stored at 2 to 8 degrees Celsius for long-term use and 25 degrees Celsius for the short term.
Posted By: Talib Khan