Officials in Guinea-Bissau have halted a contentious clinical trial funded by the US government that aimed to investigate the side effects of the hepatitis B vaccine. The trial, which was supported by a $1.6 million grant from the Centers for Disease Control and Prevention (CDC) in December, faced significant pushback from researchers and members of the US Congress, leading to its termination.
Foreign Minister Joao Bernardo Vieira emphasized the decision, stating, “It’s not going to happen, period.” The trial was met with ethical concerns, as it proposed to withhold the vaccine from half of the 14,000 participating infants at birth, instead delaying the administration until they reached six weeks. This approach contradicts recommendations from the World Health Organization (WHO), which advocates for the immediate vaccination of newborns to prevent mother-to-child transmission of hepatitis B.
In Guinea-Bissau, nearly 20% of the population is chronically infected with hepatitis B. Without vaccination, it is estimated that up to 90% of infants born to infected mothers could contract the virus, with 15% to 25% facing premature death from liver cancer or liver failure. The country plans to implement a birth dose of the vaccine by 2028 to combat this pressing health issue.
Critics have raised additional concerns about the study’s protocols and the CDC’s decision to grant funding without the standard competitive review process. The WHO expressed profound apprehension regarding the ethical considerations and scientific basis of the study, stating that delaying vaccination could subject newborns to “serious and potentially irreversible harm.”
Frederik Schaltz-Buchholzer, MD, PhD, from the Bandim Health Project, which was to conduct the trial, expressed hope for a revised trial proposal in the future. This development underscores the importance of ethical standards in clinical research and the need for rigorous scrutiny to protect vulnerable populations, particularly in regions with high disease prevalence.