Why Are Ethical Concerns Blocking the Progress of COVID-19 Vaccine Efforts?

Photo of a vaccine.

Akpabio Akpabio and Utibe Effiong

 

While the COVID-19 pandemic rages on, racial disparities in outcomes have become obvious. As scientists race to find effective therapies, vaccines are increasingly considered a potential solution to the crisis.

But comments made by some Westerners about vaccine trials in Africa threaten the success of such efforts.

Recently, a senior medical correspondent for the BBC suggested that, should the vaccine trial not achieve “early, quick results” in the UK, trials in Kenya would be the next option. Naturally, the comments caused a considerable backlash among Kenyans and other Africans on social media. Before that, comments made by two leading French doctors rightly sparked international outrage. During a live television interview, Jean-Paul Mira and Camille Locht suggested that a potential vaccine for COVID-19 be tested in Africa, where “they have no masks, no treatment, no intensive care.”

In response to such comments, the Director-General of the World Health Organization (WHO), Dr. Tedros Adhanom Ghebreyesus, declared that “Africa can’t and won’t be a testing ground for any vaccine.” African leaders have spoken up in support of this position.

A vaccine is a biological product that is administered to induce immunity to a particular disease—a process called vaccination or immunization. This process is inherently beneficial, but it can result in harm if not properly conducted. Human trials are essential in determining the safety of any vaccine. But how do we select candidates for vaccine tests?

Fallout from unethical experiments is persistent and includes distrust of public health officials and poor participation in research studies by members of vulnerable populations.

When properly analyzed, the comments made by Mira and Locht reveal the underlying link between poverty and disease. Globally, poor populations tend to be underrepresented in major scientific studies. Recently, the WHO, currently led by an African, expressed fear that the coronavirus pandemic could spread to countries with “weaker health systems,” many of which are in Africa. A weak health system is closely tied to a struggling economy. This narrative of poverty and disease in vulnerable populations fuels questionable ideas about unethical vaccine trials.

Public outcry against the infamous Tuskegee syphilis study and similar human experiments resulted in formal ethical documents such as the Nuremberg Code and the Declaration of Helsinki. Those instruments aimed to protect research subjects from harm by ensuring informed consent and voluntary participation. Fallout from unethical experiments is persistent and includes distrust of public health officials and poor participation in research studies by members of vulnerable populations.

In Nigeria, the US pharmaceutical giant Pfizer carried out an unauthorized clinical trial of the antibiotic trovafloxacin (Trovan). The experiment compared Trovan with the standard treatment (ceftriaxone) during a meningitis epidemic affecting the northern part of Nigeria in 1996. Five of 100 children given Trovan died, and six of 100 who received a substantially reduced dose of the standard drug died. A $75 million out-of-court settlement was agreed to in 2009 after the company was found guilty.

Even in the US, concerns are being raised that ethical standards for conducting human clinical trials—and the usual standards of evidence for determining whether interventions are safe and effective—might be loosened. The US Food and Drug Administration (FDA) gave the National Institutes of Allergy and Infectious Diseases permission to test an experimental vaccine in healthy participants despite having no data on the vaccine’s safety even in preclinical animal studies.

While vaccine trials for endemic diseases like malaria and HIV are beneficial, especially for populations ravaged by disease, proper regulation and supervision are necessary to prevent exploitation and harm. Key ethical principles should be followed, including scientific validity, social value, independent review, fair subject selection, favorable risk-to-benefit ratio, and informed consent, as well as respect for participants and communities. The role of collaborative partnerships must also be emphasized. 

Clinical trials still represent the gold standard in testing the safety and efficacy of new and existing treatments. However, developing regions, including sub-Saharan Africa, remain underrepresented in trials sponsored by the pharmaceutical industry for several reasons, including fear of corruption and unethical behavior. Corruption, whether actual or perceived, is one of many issues that have precluded implementation of more industry-sponsored clinical trials in this region.

According to a list of vaccine candidates compiled for the scientific journal Nature Reviews Drug Discovery, as of the first week of April 2020, only five COVID-19 vaccine candidates were in the clinical trial phase. All five trials are in the US or China. There is no COVID-19 vaccine clinical trial currently underway anywhere in Africa.

Africans, and indeed other vulnerable populations, must be recognized as partners rather than pawns. The second-most populous continent deserves better representation in key epidemiological studies.

COVID-19 vaccines are best studied in populations that are affected worst by the outbreak. The British correspondent and French doctors in question should publicly apologize, retract their offensive statements, and consider more ethical and medically accurate appraisals of the vaccine landscape. The future of vaccine testing in vulnerable populations—its success or failure—is entirely up to us all.

About the Authors

Dr. Akpabio Akpabio is a rheumatologist and internal medicine physician at the University of Uyo teaching hospital in Nigeria. He is certified by the European League Against Rheumatism and volunteers with the Global Image Foundation.

Dr. Utibe Effiong, MPH '14, is an internal medicine physician with MidMichigan Health and a clinical assistant professor of medicine at Central Michigan University. He is also a senior fellow of global health and development at the Aspen Institute.


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