ع
Guinea-Bissau’s Council of Ministers formally reaffirmed its rejection of the hepatitis B vaccine trial on October 16, 2026, according to one of the study’s lead researchers. Judicial police raided the Bandim Health Project offices days later on October 19 and seized vaccine doses intended for the research, a move confirmed by both local authorities and the project’s investigators. Christine Stabell Benn of the University of Southern Denmark stated that the team regretted the decision but respected the government’s authority, as reported by Ars Technica. The researchers had revised their protocol earlier in 2026 and obtained ethical approval from their university, yet failed to secure necessary local governmental consent.[[1]](https://arstechnica.com/health/2026/10/unethical-vaccine-trial-on-babies-backed-by-rfk-jr-is-formally-canceled/)
The proposed five-year study, awarded a $1.6 million unsolicited grant by the US Centers for Disease Control and Prevention in December 2025, aimed to compare outcomes for newborns receiving the hepatitis B vaccine at birth versus at six weeks. An additional $1.6 million came from private partners including the Pershing Square Foundation, according to reporting by The Guardian. Only half the infants in the randomised trial would have received the birth dose, while all would get standard tuberculosis and polio vaccines, Reuters noted in its coverage of the controversy. The trial’s design drew scrutiny because Guinea-Bissau maintains high hepatitis B rates, with chronic infection affecting an estimated 12 percent or more of adults, per World Health Organization data.[[2]](https://www.theguardian.com/world/2026/oct/21/us-vaccine-trial-african-newborns-hepatitis-b)
The World Health Organization expressed significant concerns in a February 2026 statement, arguing that the trial posited hypothetical safety outcomes without credible evidence while exposing participants to foreseeable harm. WHO representative Walter Kazadi Mulombo told the BBC that officials grew worried upon discovering no publicly available protocol and highlighted the vaccine’s decades-long safe record in preventing 70 to 95 percent of mother-to-child transmissions. Africa CDC officials described the study as exploiting vaccine shortages and likened aspects of its approach to historical ethical failures, a view echoed across multiple public health bodies including in CIDRAP reporting. The organisation supported Guinea-Bissau’s request for expert evaluation of the proposal.[[3]](https://www.who.int/news/item/13-02-2026-statement-on-the-planned-hepatitis-b-birth-dose-vaccine-trial-in-guinea-bissau)
Guinea-Bissau’s government had already prohibited hepatitis B vaccine trials involving children in January 2026 and requested technical assistance from Africa CDC to assess the proposal, according to Reuters dispatches. Health Minister Quinhin Nantote and other officials repeatedly denied that the project would proceed, with the foreign minister later stating it was closed citing scientific community concerns, a position reaffirmed after the police action. The country currently administers the hepatitis B vaccine at six weeks but has committed to introducing a birth dose by 2028, though local discussions have considered accelerating that timeline in response to the controversy. Public health director Armando Sifna indicated at a press conference that the trial remained suspended pending further ethical review.[[4]](https://www.reuters.com/business/healthcare-pharmaceuticals/guinea-bissau-stops-vaccine-study-funded-by-trump-administration-2026-02-18/)
Researchers from the Bandim Health Project, including Stabell Benn, her husband Peter Aaby and Frederik Schaltz-Buchholzer, have previously published studies on potential non-specific effects of vaccines, work that US Health Secretary Robert F Kennedy Jr has cited in support of his vaccine-sceptic positions. Schaltz-Buchholzer wrote on LinkedIn that it was now clear the study would not move forward without governmental approval, as covered by The Guardian. The group defended the scientific justification, arguing it could inform optimal timing amid questions about broader health impacts, yet faced accusations that the trial reflected neocolonial attitudes by testing in Africa what would not be approved in the United States. A Science magazine article noted the funding bypassed normal competitive review processes.[[5]](https://www.science.org/content/article/cdc-funds-controversial-hepatitis-b-vaccine-trial-african-newborns)
The episode unfolded against a backdrop of US policy shifts, including the CDC’s decision to make the newborn hepatitis B dose an individual choice rather than universal, a change that drew further criticism from experts like Paul Offit of Children’s Hospital of Philadelphia. Modelling cited in AVAC analysis suggested delaying universal birth dosing could increase chronic infections, adding to worries about the trial’s implications for global policy. Guinea-Bissau’s high disease burden, where perinatal transmission often leads to lifelong risks of cirrhosis and liver cancer in up to 90 percent of infected infants, made withholding the dose particularly contentious, according to WHO assessments. The police seizure of vaccines has placed them under legal procedures, effectively ending any immediate path forward for the research.[[6]](https://avac.org/blog/global-health-watch-issue-91/)
