US-Backed Hepatitis B Vaccine Trial in Guinea-Bissau Halted

A US-backed Hepatitis B vaccine trial in Guinea-Bissau, intended to study 14,000 newborns, has been formally rejected by the country's Council of Ministers on October 16, 2026, leading to its cancellation[3][4][5]. Lead researcher Frederik Schaltz-Buchholzer confirmed on October 21, 2026, that the trial, known as HBV-NSE, would not proceed without the necessary governmental authorization[1][5].

The decision by Guinea-Bissau’s government to stop the trial highlights global ethical concerns about medical research in vulnerable populations. The move also draws attention to the views of US Health Secretary Robert F. Kennedy Jr., who has expressed support for the trial's researchers and is associated with efforts to change US vaccine policy[1][6].

Records Show Trial Halted

The HBV-NSE trial planned to randomize infants to receive the hepatitis B vaccine at birth or withhold it for the first six weeks[3]. The study was set to receive $1.6 million in grant funding from the US Centers for Disease Control and Prevention (CDC) and an additional $1.6 million from private entities, including the Pershing Square Foundation and the Bluebell Foundation[1][4][5]. Researchers Frederik Schaltz-Buchholzer, Christine Stabell Benn, and Peter Aaby of the Bandim Health Project led the trial's design[1][4]. However, the Council of Ministers in Guinea-Bissau reaffirmed its non-acceptance of the submitted protocol on October 16, 2026[3].

Ethical Debates and Official Rejection

The World Health Organization (WHO) condemned the trial's design as unethical, stating that withholding a proven life-saving intervention such as the hepatitis B birth dose exposes newborns to serious harm, including chronic infection, cirrhosis, and liver cancer[3]. Guinea-Bissau has a high hepatitis B prevalence, and experts emphasized the critical importance of birth-dose vaccination[3][4]. While the Bandim Health Project researchers proposed that live vaccines offer broader benefits that the hepatitis B vaccine might diminish, critics argued against knowingly withholding a treatment[1][2][5]. Guinea-Bissau currently plans to introduce a universal hepatitis B birth dose policy in 2027 or 2028[2][7].

Police Action and US Secretary's Support

Judicial police raided the offices of the Bandim Health Project in Bissau on October 19, 2026, seizing vaccine doses for investigation and sealing a refrigerator containing the vaccines intended for the study[3][6]. Meanwhile, US Health Secretary Robert F. Kennedy Jr., who took office in February 2025, has publicly praised the work of Peter Aaby and Christine Stabell Benn[1][8][9]. Kennedy spoke at the Children's Health Defense conference in September 2026, listing them among "the deities of vaccine research" and linking modern healthcare to autism[1]. Stabell Benn previously expressed optimism that Kennedy would "be a catalyst for opening Pandora's box" regarding vaccine knowledge[1].

What We Could Not Confirm

It is not confirmed what will happen to the $1.6 million in CDC funding initially earmarked for the trial, or whether it will support Guinea-Bissau's planned national hepatitis B birth dose rollout[4].