Guinea-Bissau cancels controversial US-funded hepatitis B vaccine trial

Guinea-Bissau has cancelled a controversial United States-funded hepatitis B vaccine trial involving newborn babies, following international criticism over its ethical implications.

The decision ends a research proposal that attracted scrutiny from public health experts and raised questions about the protection of children participating in medical studies, according to Africanews and Agence France-Presse (AFP).

The proposed trial was designed to involve approximately 14,000 newborns over five years. lResearchers planned to divide the babies into two groups: one would receive the hepatitis B vaccine shortly after birth, while the other would receive it at six weeks, in line with Guinea-Bissau's existing vaccination schedule. The researchers intended to compare health outcomes, including illnesses, deaths and possible developmental effects.

The United States funded the project through a $1.6 million grant from the US Centers for Disease Control and Prevention (CDC). The research was associated with the Bandim Health Project and Danish researchers, including Christine Stabell Benn and Peter Aaby.
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Health experts criticised the proposed design, arguing that withholding an established preventive vaccine exposed newborns to avoidable risks. The WHO also raised concerns about the trial's scientific justification and ethical safeguards.

The debate attracted further criticism because Guinea-Bissau has a substantial hepatitis B burden. Critics questioned whether vulnerable African children were being exposed to risks that would not be acceptable in wealthier countries. The dispute also raised concerns about informed consent, research oversight and the influence of foreign-funded projects on African health priorities.

The Africa Centres for Disease Control and Prevention (Africa CDC), led by Jean Kaseya, supported Guinea-Bissau's right to determine whether the research should proceed. Kaseya publicly stressed that the decision belonged to the country, rather than foreign governments or international organisations.

The researchers also defended their proposal. In a joint statement reported by Al Jazeera, Benn and Aaby said they were not testing whether the vaccine prevented hepatitis B, but investigating whether vaccination had wider effects on children's health.

The final cancellation was publicly confirmed by Danish researcher Frederik Schaltz-Buchholzer, who said the project would not proceed because researchers had not received the necessary government approval. Africanews reported the cancellation on November 6.

The decision highlights the importance of national oversight, informed consent and ethical standards in international medical research, particularly where newborns and vulnerable communities are involved