The National Institute of Health (NIH) attained 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. This will be the first ever phase 3 clinical trial for any vaccine in Pakistan. It is a multi-country multi-center clinical trial being conducted by CanSinoBio already in China, Russia, Chile, Argentina and shortly in Saudia Arabia.
According to the NIH spokesperson, the NBC of PHRC has given the ethical approval for the study. These Clinical Trials have also been approved by Clinical Trial Org. https://clinicaltrials.gov/ (the global clinical trial highest regulatory body).
The statement added that the progress of the Phase III Clinical Trial in Pakistan will be keenly followed by the global scientific community as well as the people all over the world. This initiative can open the door towards public private partnership to involve private sector and will help to enhance indigenous vaccine manufacturing capabilities of Pakistan to achieve self-reliance /sufficiency. These Trial will not only project a very positive image of the country but also assure Pakistan to preferential vaccine supply and pricing.
CanSino Biologics Inc. is an innovative Chinese biopharmaceutical company dedicated to exploring best solutions to the prevention of diseases through cutting edge research and development, advanced manufacturing and commercialization of innovative vaccine products for human use worldwide. In the last few months, CanSinoBIO has made rapid advances in developing a Recombinant Novel Coronavirus Vaccine employing technology from China and Canada. CanSinoBIO was the first company in the world to move to Phase II of the vaccine clinical trial and initiate human trials. They published their Phase I results in May 2020 and Phase II trial results on July 20, 2020 (The Lancet).
AJM Pharma (Pvt.) Ltd. has signed an agreement with CanSinoBIO for organizing the Phase III Clinical Trials of their vaccine in Pakistan. AJM Pharma, established in 2004, is a reputed national pharmaceutical company and specializes in multiple segments including Oncology, Thalassemia, Nephrology and Gastroenterology. Prof. Hasan Abbas Zaheer will be the National Coordinator of the Clinical Trial on behalf of AJM Pharma.
A national Clinical Research Organization, Dimension Research CRO & SMO will monitor the progress of the clinical trial and also coordinate with the global CRO appointed by CanSinoBIO to ensure uniformity of the trial in all the participating countries and centers.
