Islamabad: Pakistan’s National Institute of Health (NIH) has received formal approval from the drug regulatory authority to conduct phase three clinical trials of a COVID-19 vaccine in the country.
Drug Regulatory Authority of Pakistan (DRAP) has approved the trial of the vaccine developed by CanSinoBio, a China-based vaccine developer, and the Beijing Institute of Biotechnology.
The first trial in Pakistan would likely be conducted at Indus Hospital, Karachi, for which 200 volunteers, both male and female, have registered. The trial will take 56 days during which three injections of inactivated virus will be administered to the volunteers.
Almost 93 per cent of those infected with coronavirus in Pakistan have recovered.
Clinical trials to be held across Pakistan
Pakistan’s NIH and AJM Pharma are collaborating with CanSinoBio for the trial of potential COVID-19 vaccine, known as recombinant novel coronavirus vaccine adenovirus type 5 vector (Ad5-nCoV). Dr. Aamer Ikram, the NIH executive director, would be the principal investigator of the clinical trial.
The trials would be conducted in country’s top health institutes, including the Aga Khan Medical University and Indus Hospital in Karachi, Shaukat Khanum Memorial Hospital and the University of Health Sciences in Lahore and Shifa International Hospital in Islamabad. Ethical approval for the study has also been obtained from the National Bioethics Committee of Pakistan Health Research Council.
The paid clinical trials would enroll people of different ages, gender and ethnic backgrounds as a more diverse study population helps ensure safety and effectiveness. The global scientific community will keenly follow the progress of the clinical trial, officials said. The trials would speed up the availability of vaccines at reasonable prices in Pakistan and also enhance the country’s ability to develop vaccines locally, the statement said.
China leading the vaccine race
CanSino Biologics is the first COVID-19 vaccine patent granted by China that will conduct multi-country phase three trials in Saudi Arabia, Russia, Brazil and Chile. CanSino was the first company in the world to move to human trials in March. At the same time, China’s state-owned Sinopharm is collaborating with Pakistan’s Karachi University’s International Center for Chemical and Biological Sciences to supply coronavirus vaccines to Pakistan. Sinopharm also initiated phase three clinical trials of COVID-19 vaccine in Abu Dhabi, UAE, with up to 15,000 volunteers.
Stages of vaccine development and testing
• Exploratory stage
• Pre-clinical stage
• Clinical development
• Regulatory review and approval
• Quality control
Clinical trial phases
Clinical development is a three-phase process:
Phase one: During phase one, only a few people receive the trial vaccine to test safety.
Phase two: In the second phase, the vaccine is given to several hundred people split into different groups such as by age and physical health.
Phase three: The study is extended in phase three and the vaccine is given to thousands of people and tested for efficacy and safety.
Phase four trial are optional studies that may be conducted after a vaccine is approved and released for further safety, efficacy, and potential uses.