Pakistan Struggles to Recruit Volunteers for Phase 3 CanSino Biologics Vaccine Trial: Military Involved

Pakistan Struggles to Recruit Volunteers for Phase 3 CanSino Biologics Vaccine Trial Military Involved.

Pakistan, the fifth most populous nation in the world, recently geared up to support a Phase 3 COVID-19 vaccine clinical trial sponsored by a Chinese company. With the greenlight from the nation’s top drug regulatory body last month to allow Phase 3 clinical trials involving CanSino Biologics’ Ad5-nCoV (a COVID-19 vaccine candidate), five tertiary-care health care centers accepted the offer to conduct the pivotal, nationwide COVID-19 vaccine trials sponsored by CanSino Biologics and their local pharmaceutical company partner AJM: the nation’s National Institute of Health (NIH) would also support this endeavor. Trial site organizations included Shifa International Hospital, Islamabad, the University of Health Sciences (UHS) and Shaukat Khanum Memorial Cancer Hospital and Research Centre (SKMCH&RC), Lahore, and the Aga Khan Hospital as well as the Indus Hospital in Karachi. Collectively the sites are targeting 10,000 volunteers. However, despite the participation of nationally prominent health institutions and increasing military command and control involvement,  investigators continue to struggle to recruit sufficient levels of volunteers.

COVID-19 in Pakistan

Although the Pakistani population has experienced significant COVID-19 spikes given this nation’s size in population, its total number of cases and deaths make it less impacted than say its neighbor, India and many others.  The fifth most populous nation in the world–just below the United States—yet, Pakistan ranks  28th when it comes to the total number of COVID cases. The country also ranks 28th in total number of deaths associated with the novel coronavirus at 6,835. How accurate the reporting here is TrialSite cannot be certain.

Clinical Trial Launch

CanSino Biologics in collaboration with its partner Beijing Institute of Biotechnology, sponsored the first Phase 3 COVID-19 vaccine clinical trial launched in September reported Reuters. A global multicenter, randomized, double-blind, placebo-controlled, adaptive designed Phase 3 clinical trial (NCT04526990) with a total of 40,000 volunteers are targeted, 10,000 of them from Pakistan. See the link for a detailed overview of the study.

The study team would evaluate the investigational vaccine product called Ad5-nCoV. For more on Ad5-nCoV, follow the link to Precision Vaccinations

The country’s lead principal investigator is Aamer Ikram SI, PhD with Shaukat Khanum Memorial Cancer Hospital and Research Centre. As will be discussed later, the Pakistani military became a nexus of pandemic response command and control including this strategic nationwide clinical trial: Asad Umar serves as the overseer of the entire nation representing the military.

The study includes local pharmaceutical partner AJM, led by Hassan Abbas Zaheer as well as Pakistani National Institutes of Health.

Volunteer Recruitment Challenges

 Published recently in The News International, a Pakistani English language newspaper, healthcare professionals are concerned about the lack of willingness to participate in the studies. One principal investigator was quoted about the situation, “Yes, there are roadblocks in convincing people to volunteer for the vaccine trials. There are misconceptions in the minds of the people as if they are being used as guinea pigs due to conspiracy theories about COVID-19 on the social media. But we are steadily heading towards achieving the target of 10,000 volunteers in Islamabad, Lahore and Karachi.”

Social & Political Tensions

A bigger challenge, frankly in Pakistan could be  the social, economic and political implications as a result of this pandemic. Like many other nations, COVID-19 impacts Pakistan in deeper and more profound ways but it’s mobilization of the military raised concern for democracy advocates.  

The global upheaval caused by the pandemic has adversely impacted this already fragile economy, and dangerously, a risk to its fledgling democracy writes Madiha Afzal, a David M. Rubenstein Fellow with the prominent thinktank Brookings. 

The country became divided as to how to respond and manage to the pandemic. The civilian leadership response was labeled weak and the military moved in to fill the power void, at least provisionally during the pandemic. However, that central command and control response has made its way into other facets of society such as the repression of dissent.  

Central State beats out Laissez-faire Approach for Response

Much like accusations in the United States, Ms. Afzal educates that according to some factions in that nation, Imran Khan, President, failed to respond to COVID-19 with a sufficiently strong, nationally unified plan: rather deferring to a regional, fragmented  approach, and thereby leading to reactionary, heterogenous policies and responses ultimately influencing regional spikes and a general disarray. 

The military in Pakistan, known to be powerful and influential in that nation, stepped in to fill the void. And Ms. Afzal reports that the military’s various efforts including the enforcement of “smart” lockdowns as well as the deployment of intelligence agencies to lead contact tracing actually resulted in a more contained situation. But will there be a long term price for a fledgling democracy?

Pakistani Principal Investigator Point of View

The News International shared quotes from two principal investigators including Dr. Salma Abbas with Shaukat Khanum Hospital and Dr. Faisal Mehmood from the Aga Khan Hospital in Karachi both shared that there is still an intense hesitance but they remained optimistic that conditions would improve. Dr. Mehmood commented, “Yes and no, every day we are getting more and more. It takes time to get the news out to people. You can help in spreading the news.” He of course is referring to educating the public about the importance of clinical trials and that this particular Chinese vaccine had already undergone extensive Phase 1 and 2 testing.

Challenge to Opportunity

M Waqar Bhatti, writer for the News International shares that CanSino Biologics negotiated a deal with the nation of Pakistan where the latter would receive vaccine sufficient for 20% of its population or up to 200 million doses in exchange for participation in the pivotal Phase 3 clinical trial, according to that nation’s NIH executive director Prof Dr. Aamer Ikram. Dr. Ikram articulated during an online webinar sponsored by the Medical Microbiology and Infectious Diseases Society of Pakistan (MMIDSP) that collectively the people must seize the moment and convert what is deemed as a challenge into an opportunity.

Lead Research/Investigator

Aamer Ikram SI, PhD with Shaukat Khanum Memorial Cancer Hospital and Research Centre

Salma Abbas, MPH, Shaukat Khanum Hospital

Faisal Mehmood, MBBS, Associate Professor, Aga Kahn University Hospital