News Analysis India

Tag: emergency use authorisation

  • WHO’s emergency use authorisation for Covaxin further delayed: Sources

    All the relevant trial data has been submitted to WHO, and all clarifications by the UN health agency have been responded to Bharat Biotech.

  • Zydus Cadila seeks emergency authorisation for ZyCoV-D COVID-19 vaccine for 12 years, above

    By ANI
    NEW DELHI: Pharmaceutical major Zydus Cadila on Thursday applied for Emergency Use Authorisation (EUA) seeking approval from the Drugs Controller General of India (DCGI) for the launch of their ZyCoV-D vaccine for 12 years and above, sources said on Thursday.

    The vaccine has completed the third phase trial, they added.

    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 will be the second indigenous COVID-19 vaccine to apply for such authorisation as well as 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.

    India has so far approved four vaccines against COVID-19 — Covaxin (Bharat Biotech), Covishield (Serum Institute), Russian Sputnik V and US-made Moderna vaccine.

    Covishield has been developed by AstraZeneca and Oxford University.

    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.