A US-funded clinical trial testing the hepatitis B vaccine in newborns in Guinea-Bissau has been suspended following international criticism and intervention by local authorities. The trial, which proposed to randomize whether 14,000 infants would receive a hepatitis B vaccine birth dose, was halted pending a technical review by the World Health Organization (WHO), according to statements from the lead researcher and officials.
The study had drawn global backlash for its design, which would have withheld the vaccine from half of the newborns in a country with a high prevalence of hepatitis B. The US Centers for Disease Control and Prevention (CDC) had awarded a $1.6 million grant for the trial, which was also supported by the US Department of Health and Human Services secretary, Robert F. Kennedy Jr. His endorsement was met with skepticism from public health experts and advocacy groups.
Judicial police in Guinea-Bissau raided the offices of the researchers involved and seized vaccine doses, according to local authorities. The police said the seizure was part of an ongoing investigation to clarify the circumstances surrounding the vaccine batch and to “safeguard the public interest and protect children’s health.” The offices raided were affiliated with researchers praised by Kennedy, according to multiple reports.
The World Health Organization had previously criticized the study as “unethical,” warning that withholding the birth dose of the hepatitis B vaccine could expose infants to a high risk of infection and death. WHO Director-General Tedros Adhanom Ghebreyesus stated in February that, in a country where about one in five adults has hepatitis B, not providing the birth dose could have serious consequences for child health.
Guinea-Bissau’s government denied granting approval for the trial, and the lead researcher, Frederik Schaltz-Buchholzer, confirmed that the study “will not move forward” in the country after failing to secure the necessary governmental authorization. The trial’s suspension follows mounting pressure from both international health authorities and local officials.
The study was originally intended to investigate so-called “nonspecific” outcomes of the hepatitis B vaccine, a concept promoted by some researchers but widely disputed in the scientific community. Most health experts consider the vaccine safe and essential for preventing the transmission of hepatitis B, particularly in high-risk settings.
The controversy has highlighted tensions between international research agendas and local health priorities in Africa. Health professionals and advocacy groups have expressed concern that vulnerable populations could be exposed to unnecessary risks in trials that would not be permitted in higher-income countries.
It remains unclear whether the CDC or private funders will attempt to relocate or redesign the study. The WHO is conducting a further technical review, and Guinea-Bissau’s judicial investigation is ongoing. For now, the future of the halted trial and the fate of the seized vaccine doses remain uncertain.
The image accompanying this article is an AI-generated illustrative depiction inspired by the actual scene of the event.
