Zydus Cadila to seek emergency authorization for ZyCoV-D vaccine next week


Zydus Cadila, the Ahmedabad-based pharmaceutical firm on June 18, 2021, is likely to apply to the Drug Controller General of India (DCGI) seeking emergency use authorization for its COVID-19 vaccine ZyCoV-D next week.

Once approved, ZyCoV-D will be the world’s first DNA plasmid-based vaccine against COVID-19 and the fourth vaccine in India in addition to three vaccines COVAXIN, COVISHIELD, and SPUTNIK V currently being administered.

“The analysis of the phase-three data is almost ready and the company has informed the government that it could apply for emergency use license for its COVID-19 vaccine next week,” said an official source from the company.

The company’s official source further informed that by next week, Zydus would have enough data on whether the vaccine can be administered to children aged 12 to 18 years.

Zydus Cadila has enrolled more than 28,000 volunteers for their phase three study, said Dr VK Paul, NITI Aayog Member (Health).

About ZyCoV-D vaccine

ZyCoV-D will be the world’s first DNA plasmid-based vaccine against COVID-19. The vaccine contains the genetic code that instructs human cells to make COVID—19 antigen.

ZyCoV-D vaccine, the second indigenous vaccine is also the first vaccine with a three-dose regimen that will be administered intradermally through a needle-free device. The vaccine can be stored at 2 to 4 degrees Celsius and does not cold chain storage.

ZyCoV-D COVID-19 vaccine is being developed with support from the Centre’s National Biopharma Mission (NBM) as part of the Biotechnology Industry Research Assistance Council, Department of Biotechnology.

ZyCoV-D: Clinical Trials

The phase-1 and phase-2 trials on over 1,000 healthy humans by Zydus were found to be safe and immunogenic.

The company has enrolled more than 28,000 volunteers for their phase-3 trials. The results are expected.

ZyCoV-D: Production

Zydus Cadila kickstarted the production of the ZyCoV-D vaccine in April 2021. The company aims to produce up to 240 million doses per year.

Source link

Author: admin

Like it? Share with your friends!


Corona Update

Live Update

%d bloggers like this: