DRAP approves Phase III clinical trial of COVID-19 vaccine

The National Institute of Health (NIH) on Tuesday has obtained approval from the Drug Regulatory Authority of Pakistan (DRAP) for Phase III clinical trial of coronavirus vaccine.

The NIH said in a statement that it has obtained “the formal approval from DRAP for Phase III Clinical Trial of Recombinant Novel Coronavirus Vaccine Adenovirus Type 5 vector (Ad5-nCoV) developed by CanSinoBio and Beijing Institute of Biotechnology China [BIB].”

“This will be the first ever phase III clinical trial for any vaccine in Pakistan,” the statement said.

“It is a multi-country multi-centre clinical trial which CanSinoBio is already conducting in China, Russia, Chile, Argentina and will shortly start in Saudi Arabia. The principal investigator of the multi-centre clinical trial in Pakistan is NIH executive director Maj Gen Aamer Ikram.

“AJM Pharma CEO Adnan Hussain signed an agreement with the NIH last month for collaborating on the phase-III clinical trial of CanSinoBIO Ad5-nCoV in Pakistan. The study will be conducted in prestigious medical research centres in the country – Aga Khan Medical University, Karachi; Indus Hospital, Karachi; Shaukat Khanum Memorial Hospital, Lahore; Shifa International Hospital, Islamabad, and UHS Lahore.”

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