ISLAMABAD/KARACHI: The Drug Regulatory Authority of Pakistan (DRAP) on Monday gave its approval to the National Institute of Health (NIH) to conduct the Phase III clinical trial of a coronavirus vaccine, making it the first one ever in the country.
According to a statement from the NIH, the medical facility 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]”.
The Chinese bio pharmaceutical, CanSino Biologics Inc, has already been conducting the trial in various countries, including China, Russia, Chile, Argentina, and shortly in Saudi Arabia and Pakistan.
The Phase III clinical trial of CanSinoBIO Ad5-nCoV, the coronavirus vaccine, in Pakistan would be carried out under NIH Executive Director Maj Gen Aamer Ikram after AJM Pharma Pvt Ltd CEO Adnan Hussain signed an agreement to collaborate with the Islamabad-based facility.
AJM Pharma’s Prof Hasan Abbas Zaheer would be the trials’ national coordinator, with Maj Gen Ikram the principal investigator.
According to the NIH’s statement, the trials would be carried out in Karachi’s Aga Khan University Hospital (AKUH) and The Indus Hospital, Lahore’s Shaukat Khanum Memorial Cancer Hospital and Research Centre (SKMCH&RC) and University of Health Sciences (UHS), and Shifa International Hospital in Islamabad.
“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,” the statement added.
“The NBC of PHRC has given the ethical approval for the study,” it said further, noting that the trials were already approved by the US registry of worldwide clinical trials, the ClinicalTrials.gov.
The NIH, in this regard, underlined that the trials’ progress would be monitored by the global scientific community, “can open the door towards public-private partnership”, and “will help to enhance indigenous vaccine manufacturing capabilities of Pakistan to achieve self-reliance and sufficiency”.
CanSinoBIO has over the past few months made rapid advances in developing a recombinant novel coronavirus vaccine, using technology from Canada and China. It also became the first company in the world to initiate human trials.
The results of the pharmaceutical’s Phase I and II trials were published in May and July 2020, respectively, in the peer-reviewed journal, The Lancet.
Source: The News