Pakistan is preparing to launch its first Phase 3 COVID-19 vaccine clinical trial this month, testing CanSino Biologics' Ad5-nCoV candidate despite a significant decline in the country's infection rates. The trial, expected to begin on September 20, 2020, will recruit approximately 8,000 volunteers across five major cities.
The Chinese pharmaceutical company CanSino Biologics, in partnership with Beijing Institute of Biotechnology, developed the Recombinant Novel Coronavirus Vaccine Adenovirus Type 5 Vector (Ad5-nCoV), which has successfully completed Phase 1 and Phase 2 trials. Pakistan's drug regulator approved the Phase 3 trial last month, with the National Institute of Health (NIH) and pharmaceutical company AJM leading the local implementation.
Trial Design and Recruitment Strategy
The trial will target healthcare workers and other frontline personnel who face higher exposure risks to COVID-19. "We have been strategizing with CanSino on how to make sure people who are more exposed to the virus are recruited for volunteers, so we will be targeting front-line workers who have more chances of exposure," said Aamer Ikram, Executive Director of the NIH.
Recruitment will occur over four months, with participants followed for 12 months after receiving either the vaccine or placebo. The study will be conducted at prestigious medical research centers in Karachi, Lahore, Peshawar, Quetta, and Islamabad, including Aga Khan Medical University, Indus Hospital, Shaukat Khanum Memorial Hospital, Shifa International Hospital, and University of Health Sciences.
Addressing Declining Case Numbers
Pakistan's COVID-19 cases peaked at over 6,000 daily infections in June 2020 but dropped dramatically to 426 confirmed new cases on September 8, bringing the country's total to 299,659 cases and 6,359 deaths. Despite this decline, trial organizers remain confident in the study's viability.
"We feel people are still getting infected but not getting tested, so the virus is still there," explained Hassan Abbas Zaheer, who is heading the trial for AJM. The country of more than 220 million people has been conducting 20,000 to 30,000 tests daily, suggesting potential underdetection of cases.
Global Trial Network and Regulatory Approval
CanSino is conducting parallel trials in multiple countries, including China, Russia, Chile, and Argentina, with plans to expand to Saudi Arabia. The company was the first globally to advance to Phase 2 clinical trials, publishing Phase 1 results in May 2020 and Phase 2 results in The Lancet on July 20, 2020.
Pakistan's National Bioethics Committee and Clinical Trial Org, a global regulatory body for clinical trials, have both approved the testing protocol. The Ad5-nCoV vaccine and placebo injections are scheduled to arrive in Pakistan next week.
Strategic Benefits for Pakistan
Dr. Ghazala Parveen, who heads the Biological Production Division at the National Institute of Health, emphasized the strategic advantages for Pakistan. "These trials will not only project a very positive image of Pakistan but also assure preferential vaccine supply and pricing for the country," she said.
The initiative is expected to establish a public-private partnership for local vaccine manufacturing, potentially helping Pakistan achieve self-reliance in vaccine production. "Being part of this activity, Pakistan will be among the countries that will have early access to the vaccine," Parveen noted.
The Phase 3 trial will determine the vaccine's safety and immunogenicity before mass production, with results being closely monitored by the global scientific community.
