A US-supported study testing a hepatitis B vaccine in newborns in Guinea-Bissau was suspended after the lead researcher said the project could not proceed without government clearance. Frederik Schaltz-Buchholzer, a Danish scientist affiliated with the Bandim Health Project, announced the pause on LinkedIn, stating that the trial “will not move forward in Guinea-Bissau” because the necessary approval had not been granted. The minister of health, Quinhin Nantote, had previously denied any plans to advance the study, telling the Guardian that such claims were “not even remotely true.”

The proposed trial, funded with $1.6 million from the US Centers for Disease Control and Prevention and additional contributions from private donors including the Pershing Square Foundation and the Bluebell Foundation, aimed to evaluate whether administering a hepatitis B vaccine alongside existing infant immunizations could yield broader health benefits. Paul Offit, a vaccine expert at the Children’s Hospital of Philadelphia, criticized the design as unethical, arguing that the study lacked scientific justification and could expose infants to unnecessary risk. He emphasized that the hepatitis B vaccine is already proven to prevent serious, potentially fatal liver infections, especially in regions like Guinea-Bissau where chronic infection rates are high.

Researchers from the Bandim Health Project, led by Schaltz-Buchholzer, Christine Stabell Benn, and Peter Aaby, had hypothesized that live vaccines such as BCG might reduce overall mortality, but they proposed adding hepatitis B to explore non‑specific effects. Offit dismissed this hypothesis as “fanciful,” noting that the hepatitis B vaccine consists of a single protein and does not interact with the immune system in ways that would produce widespread health benefits. He pointed to extensive evidence showing that timely birth dosing dramatically lowers the risk of lifelong disease and death.

The Danish team did not respond to requests for comment, and the CDC declined to clarify whether the allocated funding would be redirected to a broader rollout of the vaccine in Guinea-Bissau, as recommended by the World Health Organization. WHO spokesperson Tarik Jašarević reiterated that the organization advises all infants to receive an initial hepatitis B dose within 24 hours of birth, followed by two additional doses, and remains committed to collaborating with national authorities to ensure evidence‑based protection.

Ethical concerns were raised about the consent process. Henrik Støvring, another Danish researcher involved in the project, questioned how participants could give truly informed consent when enrollment would grant a 50 % chance of receiving the vaccine, while refusal would result in a 0 % chance. This uncertainty contributed to distrust among local communities, who feared the study might be testing a vaccine on African infants because of perceived safety concerns.

The suspension follows a search of the Bandim Health Project offices by Guinean authorities, during which officials seized vaccine supplies. While the minister of health asserted that the government now controls the vaccines, Offit argued that delaying birth vaccination could jeopardize the health of newborns in a country already burdened by high hepatitis B transmission rates. He reiterated that a universal birth dose is essential and that Guinea-Bissau stands to benefit significantly from implementing the WHO‑endorsed schedule as soon as possible.