US-Backed Newborn Hepatitis B Vaccine Trial Cancelled in Guinea-Bissau

A controversial US-backed hepatitis B vaccine study involving newborns in Guinea-Bissau will not proceed after failing to receive government authorization, according to the project's lead researcher.

Danish researcher Frederik Schaltz-Buchholzer announced on LinkedIn that the study would not move forward in the West African nation due to a lack of required governmental approval. Guinea-Bissau's Minister of Health, Quinhin Nantote, had previously refuted claims that the trial would proceed. On Monday, local authorities searched the offices of the Bandim Health Project and took control of the trial's vaccine supply.

Funding and Ethics Concerns

The proposed trial was slated to receive $1.6 million from the US Centers for Disease Control and Prevention (CDC), along with an additional $1.6 million from private entities, including the Bluebell Foundation and the Bill Ackman-backed Pershing Square Foundation.

Medical experts strongly criticized the trial's ethics. The study's design meant infants whose parents opted out of participation would receive no vaccine, creating a scenario where informed consent was compromised. Henrik Støvring, a Danish researcher, noted that mothers opting into the trial had a 50% chance of their child receiving the vaccine, whereas those opting out had a 0% chance, undermining voluntary consent.

Paul Offit, a vaccine expert at the Children's Hospital of Philadelphia, described the research as unethical, emphasizing that available funds should instead be utilized to vaccinate as many infants as possible. Offit noted that the safety and efficacy of the hepatitis B birth dose have been proven through hundreds of millions of administrations globally.

Study Hypothesis and WHO Guidelines

The research team, led by Schaltz-Buchholzer, Christine Stabell Benn, and Peter Aaby, suggested that live vaccines such as Bacillus Calmette-Guérin (BCG) might offer overall mortality benefits beyond preventing tuberculosis, and hypothesized that administering a hepatitis B vaccine simultaneously might blunt that effect. Offit dismissed this hypothesis as biologically unfounded.

Schaltz-Buchholzer acknowledged that the proposed trial created public distrust in Guinea-Bissau, with residents questioning the safety of the long-established vaccine. He maintained that neither vaccination schedule presented danger, though he questioned existing medical assumptions regarding non-specific effects. The planned study also intended to evaluate potential side effects, including skin and neurodevelopmental conditions.

The World Health Organization (WHO) recommends that all infants receive their first dose of the hepatitis B vaccine as soon as possible after birth, ideally within 24 hours, followed by at least two subsequent doses. Spokesperson Tarik Jašarević stated that the WHO remains committed to helping national authorities ensure infants receive timely, evidence-based protection. Guinea-Bissau currently plans to implement universal birth-dose vaccinations in 2028. Neither the CDC nor the Danish researchers responded to inquiries by publication time.