In brief
Guinea‑Bissau discontinued a $1.6 million hepatitis B vaccine study that compared birth‑dose and six‑week‑dose schedules for 14,000 babies. The Danish‑led Bandim Health Project faced backlash for withholding shots from a random half of participants, leading to a government pause, a police raid, and ongoing investigations into safety compliance.
Guinea‑Bissau has stopped a U.S.‑funded hepatitis B virus (HBV) vaccine trial that would have withheld lifesaving shots from half the babies enrolled in the study. The decision came after a judicial police raid seized vaccine batches from the country’s Bandim Health Project facility, and after mounting criticism from health experts and regulatory bodies over the potential ethical breach.
The study was a four‑year clinical trial designed to assess outcomes for infants receiving the WHO‑recommended HBV vaccine at birth versus those who would start the schedule six weeks later. It planned to enroll roughly 14,000 babies in Bissau and follow their health for five years to capture any long‑term effects.
Its lead team, the Bandim Health Project of the University of Southern Denmark, was chaired by Christine Stabell Benn and Peter Aaby. The investigators, whose research has focused on unintended vaccine impacts, proposed testing the vaccine’s safety in a setting where one half of the cohort would receive no shot until week six. The project received $1.6 million in funding from the U.S. Centers for Disease Control and Prevention (CDC) under the direction of Health Secretary Robert F. Kennedy.
Because half of the children were ostensibly denied an immediate protection against hepatitis B, a serious chronic liver disease, the trial drew widespread condemnation. Critics argued that the design “offered the virus a chance to take advantage of a population that was left vulnerable.” The backlash was amplified by the fact that the two chairs had previously suggested that vaccines containing inactivated viruses could increase mortality, a claim that many scientists find controversial.
In January, unaffected by the emergency review that followed, the Guinea‑Bissau government paused the trial and launched a formal investigation into its ethical and safety protocols. One researcher involved in the project said in a statement that the ending of the trial was a “significant setback” for African science.
On 14 October, the judicial police entered the Bandim Health Project’s premises in Bissau and confiscated vaccine vials and related documentation. The authorities said they were continuing to determine whether the trial had complied with national safety standards and whether it met the regulations required for such a study. No official comment has yet been released from the Ministry of Health, and the research team has not yet released a public statement.
The raid underscores a broader tension between international research collaborations and local regulatory oversight. While WHO’s guidelines affirm that a birth‑dose schedule is most effective for preventing mother‑to‑child transmission, the trial’s comparison with a delayed schedule raised questions about the ethics of withholding immediate protection from a random group, especially in a country with high hepatitis B prevalence.
As of now, the investigation is still in progress. The police are looking into whether the study adhered to Guinea‑Bissau’s national safety and consent requirements, with a particular focus on the 14,000 babies expected to take part. The international scientific community will watch closely, as this incident may influence future vaccine trials in comparable settings.
