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Guinea‑Bissau Halts U.S.-Funded Hepatitis B Vaccine Trial for Babies

The West African nation stopped a controversial study that would have withheld hepatitis B shots from half of the enrolled infants.

By Neutral EchoSource: aljazeera.com2 min read
Guinea‑Bissau Halts U.S.-Funded Hepatitis B Vaccine Trial for Babies
Image via aljazeera.com

In brief

Guinea‑Bissau suspended a $1.6 million trial, organized by a Danish team, that intended to compare birth‑dose and six‑week hepatitis B vaccine schedules. The program, funded by the U.S. CDC and led by the Bandim Health Project, faced global criticism for potential ethical violations. Authorities have raided the research facilities and seized vaccine batches as investigations proceed.

Guinea‑Bissau announced on August 30 that it had ended a U.S. CDC‑funded hepatitis B (HBV) vaccine trial that would have withheld a life‑saving shot from half of the babies enrolled in the study.

The trial, designed by a Danish research group based in Bissau, aimed to compare a birth‑dose schedule with a six‑week‑dose schedule for the HBV vaccine, a method recommended by the World Health Organization (WHO).

The study would have involved around 14,000 infants and planned to follow them for five years to assess long‑term health outcomes.

Al Jazeera reports that the project received $1.6 million from the U.S. Centers for Disease Control and Prevention (CDC) under the administration of Health Secretary Robert F. Kennedy, who is known for his anti‑vaccine stance.

The announcement in December of the previous year drew widespread anger from health experts worldwide, who contended that withholding a protection‑providing vaccine from half the participants posed serious ethical concerns.

The Danish team, led by Christine Stabell Benn and Peter Aaby of the Bandim Health Project, which has operated in Bissau since 1978, had stated that the trial would focus on the unintended impacts of vaccines that contain inactivated viruses, including the HBV vaccine.

Benn and Aaby have previously suggested that such vaccines might be harmful, a claim that many biologists and clinicians find unsubstantiated.

Al Jazeera noted that the Guinea‑Bissau government paused the project in January and began a review of the trial’s procedures and compliance with national safety standards.

The judicial police of Guinea‑Bissau said in mid‑October that it had raided the research group’s facilities in the capital, Bissau, and seized vaccine batches, indicating a possible breach of local regulations.

Investigators are still determining whether the trial met the country’s safety guidelines, while the research team maintains that it had followed all required protocols.

Officials have not yet commented publicly on the specifics of the alleged violations, but the seizure of vaccine supply has stalled any further progress in the study.

Al Jazeera notes that the halted trial represents a significant setback for African science, according to a statement from one of the researchers involved, although the researcher’s name has not been disclosed in the report.

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