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The short version

  • Judicial police in Guinea-Bissau raided offices linked to the Bandim Health Project, seizing hepatitis B vaccine doses while stating the action did not indicate quality or safety issues with the immunizations.
  • The raid occurs amid intense controversy over a redesigned clinical trial that would withhold hepatitis B vaccines from 7,000 newborns in a country where one in five adults carries the virus and chronic infection carries high mortality rates.
  • While ethics committees in Guinea-Bissau and Denmark have approved the study, the World Health Organization condemns withholding birth doses as unethical, and local health officials dispute claims that the trial will proceed as planned.

Judicial police in Guinea-Bissau conducted a raid on Monday targeting offices associated with researchers who have drawn significant praise from Robert F. Kennedy Jr., the United States Secretary of Health and Human Services. Authorities seized doses of hepatitis B vaccine during the operation, which officials described as an investigative procedure aimed at clarifying circumstances surrounding the specific batch of immunizations. In a statement posted to social media and translated from Portuguese, authorities emphasized that the seizure did not suggest any irregularities regarding the quality, safety, or effectiveness of the vaccines themselves.

The targeted researchers are central figures in a long-standing dispute concerning clinical trials on African newborns. The Bandim Health Project, co-led by epidemiologist Christine Stabell Benn and founded by her husband, anthropologist Peter Aaby, has received substantial financial backing for its work. The United States Centers for Disease Control and Prevention contributed $1.6 million to the research, a sum matched by the Pershing Square Foundation and the Bluebell Foundation, bringing the total funding to $3.2 million. Kennedy has frequently lauded these researchers, referring to them as deities of vaccine research during recent anti-vaccine conferences and citing their earlier work on diphtheria-tetanus-pertussis vaccines when he halted US funding to Gavi, the Vaccine Alliance.

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The immediate controversy centers on a redesigned study that plans to deny hepatitis B vaccines to 7,000 newborns within their first six weeks of life. This approach stands in stark contrast to established medical consensus, which holds that vaccination within 24 hours of birth is both safe and highly effective at preventing illness. In Guinea-Bissau, approximately one in five adults is infected with the hepatitis B virus. Chronic infections resulting from early exposure can lead to liver failure and cancer, killing between 15% and 25% of those affected. Newborns are particularly vulnerable to severe outcomes if left unprotected during this critical window.

International health bodies have strongly criticized the methodology of the proposed trial. Tarik Jašarević, a spokesperson for the World Health Organization, described any study denying vaccines to participants as unethical and exposing infants to serious, potentially irreversible harm. He characterized hepatitis B vaccination at birth as an essential public health intervention. Through its country office in Guinea-Bissau, the WHO and its partners have been advising the local ministry of health on the planned introduction of the vaccine and assessing the potential negative impacts of proceeding with this specific study design.

Despite the international criticism, formal approvals for the trial exist. The Bandim Health Project recently published a letter of approval from Guinea-Bissau’s national ethics committee at the ministry of public health, dated July 14 and signed by committee president Mouhammed Djicó Ould Ahmed. Additionally, a Danish research ethics committee approved the study earlier this month after modifying its rules to consider the clinical trial. However, Quinhin Nantote, the health minister of Guinea-Bissau’s transitional government, disputed reports that the trial would move forward, stating in an interview that such claims were not remotely true.

The political and social context of Guinea-Bissau adds complexity to the situation. The nation remains fragile following a military coup less than a year ago, raising questions about its stability for conducting complex clinical trials. Colette Delawalla, founder of the non-profit Stand Up for Science, noted that the Bandim organization has operated in the country for five decades with limited success in improving local health and research capacities. She highlighted significant distrust of the organization among the citizenry, though she acknowledged that due to a lack of public health infrastructure, Bandim often remains the only option for desperate individuals seeking medical care.

The researchers involved have not responded to inquiries regarding the police search or the status of the trial. Stabell Benn previously served on the hepatitis B working group of the Advisory Committee on Immunization Practices, where she helped present evidence that influenced votes to end universal birth recommendations before a federal judge stayed such decisions. She has also collaborated with former FDA officials who advocate for reducing vaccine schedules. The Bandim organization is currently fundraising to roll out vaccines at birth to all newborns in the country, a move that contrasts sharply with the exclusionary design of the controversial trial.

The raid underscores the tension between external research interests and local sovereignty in a nation struggling with political instability. Delawalla suggested that Guinea-Bissau is attempting to protect its youth from exploitation by powerful Western entities, using available leverage to assert control over health initiatives. As the transitional government navigates these pressures, the outcome of the investigation into the seized vaccines and the ultimate fate of the clinical trial remain uncertain, with conflicting signals from ethics committees, health ministers, and international organizations.

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