NIH obtains formal approval from regulatory body for Phase III clinical trial of Covid-19 vaccine
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The National Institute of Health (NIH) said on Monday that it had obtained formal approval from the Drug Regulatory Authority of Pakistan (Drap) for the Phase III clinical trial of a Covid-19 vaccine developed by CanSinoBio, a China-based vaccine developer, and the Beijing Institute of Biotechnology.
In a statement, NIH said that this will be the first ever phase III clinical trial for any vaccine in Pakistan. "It is a multi-country, multi-centre clinical trial being conducted by CanSinoBio already in China, Russia, Chile, Argentina and shortly in Saudi Arabia."
The statement added that the principal investigator of the clinical trial would be Major General Aamer Ikram, who is the NIH executive director, adding that the AJM Pharma chief executive officer, Adnan Hussain, had signed an agreement with the institute last month for collaborating on the clinical trial of the vaccine, known as recombinant novel coronavirus vaccine adenovirus type 5 vector (Ad5-nCoV).
"It is a tripartite activity between NIH, CanSinoBio and AJM Pharma. The study will be conducted in prestigious medical centres in the country, including the Aga Khan Medical University and the Indus Hospital in Karachi, the Shaukat Khanum Memorial Hospital and the University of Health Sciences in Lahore and the Shifa International Hospital in Islamabad."
The National Bioethics Committee (NBC) of the Pakistan Health Research Council (PHRC) has given ethical approval for the study while the clinical trial has also been approved by the highest global regulatory body, it said.
"The progress of the clinical trial will be keenly followed by the global scientific community as well as people all over the world.
"This initiative can open the door towards public-private partnership to involve the private sector and will help to enhance indigenous vaccine manufacturing capabilities to achieve self-reliance," the statement said, adding that it will project a positive image of the country.
"Being a part of this activity, Pakistan will be among the priority countries to have early access for the Covid-19 vaccine through NIH."
The statement added that in the last few months, CanSinoBIO had made rapid advances in developing a Covid-19 vaccine, employing technology from China and Canada. "It was the first company in the world to move to Phase II of clinical trials and initiate human trials."
