Why US-funded vaccine trial plan for babies in Guinea-Bissau caused outrage | Health News
Danish Vaccine Trial in Guinea-Bissau Stalled Amid Ethical Concerns
Danish researchers aiming to conduct a U.S.-funded vaccine trial on newborns in Guinea-Bissau faced significant public backlash last month, resulting in the suspension of their study by the local government. The planned trial aimed to evaluate the effects of administering hepatitis B vaccines at two different intervals to 14,000 infants. Half of the participants were to receive the vaccine at birth, consistent with standard recommendations, while the other half would receive it six weeks later. The researchers intended to compare health outcomes over a five-year period.
However, the announcement of the trial sparked outrage within the international health community over its ethical implications. Following intense scrutiny, the Bissau-Guinean government suspended the research on January 22 pending a comprehensive review.
Magda Robalo, a former health minister of Guinea-Bissau, expressed disappointment regarding the study’s approval. She stated that while a small ethics committee within the health ministry was aware of the trial, the national public health institute, which has the ultimate authority to approve such research, was not consulted.
Robalo criticized the researchers for capitalizing on the country’s limited research capacity, asserting that Guinea-Bissau lacks a sufficient number of well-versed public health professionals to navigate the complexities surrounding global health policies.
Babies are particularly vulnerable to chronic hepatitis B virus (HBV) infections due to their developing immune systems. The World Health Organization (WHO) reports that HBV can lead to severe long-term liver damage and cancer, with maternal transmission being a significant concern during birth or breastfeeding. In 2022, HBV was responsible for approximately 1.1 million deaths worldwide.
The WHO recommends that infants receive hepatitis B vaccinations at birth, along with booster doses in subsequent weeks, as these vaccines can provide long-lasting protection.
Guinea-Bissau, with a population of approximately 2.2 million, has one of the highest rates of HBV infection globally, affecting about one in five residents. Typically, newborns in the country are vaccinated six weeks after birth due to a shortage of available vaccines, although authorities plan to implement at-birth vaccinations starting in 2028.
The Danish researchers assert that the study is timely, capitalizing on the interim period before Guinea-Bissau’s planned vaccination schedule changes. They contend that the trial would allow half of the infants to receive at-birth vaccinations for the first time. Critics like Robalo, however, argue that withholding vaccinations, even temporarily, poses ethical concerns, as it may endanger the health of the 7,000 infants in the delayed group.
Amid growing ethical scrutiny, the researchers are also facing challenges regarding their credibility. They are affiliated with the Bandim Health Project, linked to the University of Southern Denmark, which has conducted various studies on Bissau-Guinean populations since 1978. The project’s leadership, Christine Stabell Benn and Peter Aaby, both prominent Danish scientists, emphasize examining the broader implications of vaccines, despite facing accusations of underreporting adverse outcomes of their studies.
In response to the backlash, Benn highlighted that a review by their institution found no basis for allegations of misconduct regarding their research findings.
Compounding these issues is the context of the trial’s funding, which is connected to the U.S. Centers for Disease Control (CDC) during the tenure of Health Secretary Robert F. Kennedy Jr., a known vaccine skeptic. The project received $1.6 million in funding without undergoing a conventional competitive process.
Amid these controversies, Guinea-Bissau’s new health minister, Quinhin Nantote, affirmed that his government had not been involved in any discussions about the study prior to the coup that reshaped the country’s leadership in late November.
The historical context of unethical medical trials in developing countries continues to linger in public consciousness. Incidents such as the Tuskegee Syphilis Study and Pfizer’s controversial meningitis trial in Nigeria serve as reminders of the potential consequences of exploitative research practices.
Robalo emphasized that Guinea-Bissau’s priorities lie not in repeating hepatitis B vaccine trials but in ensuring timely vaccinations for all newborns. She stressed the importance of respecting the nation’s sovereignty and the capabilities of its population in the global health landscape.
