Zydus Cadila Seeks Govt Nod to Start Phase-III Clinical Trials of Covid-19 Vaccine ZyCoVD
FOLLOW US ON:
Drug firm Zydus Cadila on Thursday said its vaccine against COVID-19, ZyCoV-D , has been found to be safe and immunogenic in the Phase I/II clinical trials, and the company is seeking regulatory approval to commence Phase-III trials. The company s plasmid DNA vaccine to prevent COVID-19, ZyCoV-D, was found to be safe, well tolerated and immunogenic in the Phase I/II clinical trials. The company is now planning to initiate Phase III clinical trials in around 30,000 volunteers upon receiving necessary approvals, Zydus Cadila said in a statement.
Representational photo.
NEW DELHI: Drug firm Zydus Cadila on Thursday said its vaccine against Covid-19, ZyCoV-D , has been found to be safe and immunogenic in the Phase I/II clinical trials, and the company is seeking regulatory approval to commence Phase-III trials.
The company s plasmid DNA vaccine to prevent Covid-19, ZyCoV-D, was found to be safe, well tolerated and immunogenic in the Phase I/II clinical trials. The company is now planning to initiate Phase III clinical trials in around 30,000 volunteers upon receiving necessary approvals, Zydus Cadila said in a statement.
The Phase-II study of the vaccine, ZyCoV-D, had been conducted in over 1,000 healthy adult volunteers as part of the adaptive Phase-I and II dose escalation, multi-centric, randomised and double-blind placebo controlled study. The vaccine was found to be safe and immunogenic, he added.
India s Zydus Cadila Covid-19 vaccine found safe in clinical trials khaleejtimes.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from khaleejtimes.com Daily Mail and Mail on Sunday newspapers.
Zydus Cadila vax found safe in clinical trials
By IANS |
Published on
Thu, Dec 24 2020 20:36 IST |
0 Views
Covid vaccine.. Image Source: IANS News
Ahmedabad, Dec 24 : Zydus Cadila announced on Thursday that its plasmid DNA vaccine to prevent COVID-19 - ZyCoV-D - was found to be safe, well tolerated and immunogenic in the phase I and II clinical trials.
The company is now planning to initiate phase III clinical trial in around 30,000 volunteers upon receiving necessary approvals.
The phase II study of the vaccine ZyCoV-D had been conducted in over 1,000 healthy adult volunteers as part of the adaptive phase I/II dose escalation, multi-centric, randomised, double-blind placebo controlled study. The vaccine was found to be safe and immunogenic.
This is the second clinical hold in as many months for Cambridge, Mass.-based Voyager. In October, the
FDA placed a clinical hold on the company’s Huntington’s disease gene therapy before that asset could make its way into the clinic.
Late Tuesday, Voyager announced the latest hold. The FDA placed a hold on the RESTORE-1 clinical trial of NBIb-1817 (VY-AADC) after partner Neurocrine Biosciences submitted an Investigational New Drug Safety Report related to the observation of MRI abnormalities in some RESTORE-1 study participants. The clinical implications of this observation are currently unknown and are being evaluated, Voyager said in its announcement.