New Delhi: Pharmaceutical major Zydus Cadila applied for Emergency Use Authorisation (EUA) on Thursday looking for the approval from the Drugs Controller General of India (DCGI) for the launch of their ZyCoV-D COVID-19 vaccine for 12 years and above, sources said today.
The coronavirus vaccine has completed the third phase trial, they added. The shot is also “needle-free” and “safe for children”, the company says.
ZyCoV-D is a DNA coronavirus vaccine, which carries the genetic code for that part of a virus that triggers the immune system of the body.
This will also be the second indigenous coronavirus vaccine to apply for such authorisation as well as the world’s first DNA vaccine against coronavirus.
Previously, 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.”
On July 18, Niti Aayog Member (Health) Dr VK Paul had said that Zydus Cadila has enrolled early 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.
Speaking about the vaccine candidate last month, AIIMS Delhi Director Dr Randeep Guleria had said: “Zydus Cadila is DNA vaccine. It’s a new platform that is being used. It’s something that we should be proud of. A platform for which research isn’t done in past in our country and now making this new type of vaccine.”
The above-mentioned 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.
India has approved three vaccines against COVID-19 — Covishield (Serum Institute), Covaxin (Bharat Biotech) and the Russian Sputnik V. Covishield has been developed by AstraZeneca and Oxford University.