The Drug Regulatory Authority of Pakistan (DRAP) awarded approval to the National institute of Health (NIH) to embrace CanSino Biologics’ Ad5-nCoV COVID-19 vaccine for immediate Phase 3 clinical trials in the world’s fifth most populated nation. A Recombinant Novel Coronavirus Vaccine Adenovirus Type 5 vector, the vaccine was made in partnership with the Beijing Institute of Biotechnology (BIB). Pakistan joins China (military use), Russia, Chile, Argentina and soon Saudi Arabia as countries that will host the Phase 3 clinical trials. Canada was on the list but has been in an extended delay due more than likely to politics.
High Level Approvals
This research approval was afforded high level authority attention as the clinical trial will be overseen by NIH Executive Director Major General Aamer Ikram in partnership with a local Pakistani pharmaceutical company called AJM Pharma Pvt Ltd. The latter’s CEO, Adnan Hussain executed the collaboration agreement as well. The national coordinator for this pivotal study is Professor Hasan Abbas Zaheer with AJM Pharma who will serve a clinical trials coordinator while Major General Ikram serves as the study principal investigator. The sponsors have selected a nationally prominent clinical research organization called Dimension Research CRO & SMO to monitor the study as well as coordinate with a global CRO appointed by CanSino Biologics: the goal would be to ensure quality and harmonization of this large scale trial across sites and operations. Additionally, Pakistan’s National Bioethics Committee (NBC), part of the Pakistan Health Research Council (PHRC) signed off on the study.
According to The News International the following trial sites have been selected:
· Aga Khan University Hospital (AKUH)
· The Indus Hospital
· Lahore’s Shaukat
· Khanum Memorial Cancer Center Hospital & Research Centre (SKMCH&RC)
· University of Health Sciences (UHS)
· Shifa International Hospital
CanSino Biologics faced competition for the country’s participation due to intense competition but the company has managed to secure strategically important locations for their trials and now moves forward. In China, the military has access to the vaccine for at least a year.
About the Drug Regulatory Authority of Pakistan (DRAP)
Drug Regulatory Authority of Pakistan (DRAP) was established in 2012, enacted under DRAP ACT 2012. The Authority is mandated for effective coordination and enforcement of the Drugs Act, 1976 to regulate manufacture, import, export, storage and sale of therapeutic goods in the country.
Dimension Research CRO & SMO
Dimension Research CRO & SMO (Dimension) is a nationally-focused CRO in the nation of Pakistan. One of the more sophisticated CROs operating in the country, it has 10 years’ experience running every kind of trial. The company positions itself as a “full-service CRO and site management organization handling Phase II-IV clinical trials and BE/BA/PK/PD studies. The company also supports Proteomic and Genomic research in collaboration with U.S. and UK-based companies. This CRO is active not only in Pakistan but also UAE and in various African nations.
Educated in London, Dr. Ikram served the Pakistani military health care and medical research as well as academia. He then moved into government and now leads the National Institutes of Health. He is serving as the ultimate authority for this Phase 3 clinical trial of Ad5-nCoV.