# Guinea-Bissau newborn Hepatitis B vaccine trial controversy

> Live situation record from CLSTR: https://clstr.news/situations/guinea-bissau-newborn-hepatitis-b-vaccine-trial-controversy
> Updated: 2026-10-19T23:58:59.000Z. Sources: 8. Developments: 3.

A controversial Hepatitis B vaccine study involving approximately 14,000 newborns in Guinea-Bissau has sparked significant ethical debate. The trial, led by the Bandim Health Project and Danish researchers Peter Aaby and Christine Stabell Benn, involves a design where half of the infants receive the vaccine at birth while the other half has the birth dose withheld for six weeks.

The study faced scrutiny after members of an ethics committee at the University of Southern Denmark resigned in protest. Critics have described the research as “horribly unethical” and “neocolonialist,” arguing that conducting such trials in resource-constrained environments exploits vulnerable populations. The protocol has also faced criticism from the World Health Organization (WHO) regarding newborn safety and parental consent.

Following reports that the study had been cleared to proceed, Guinea-Bissau’s Minister of Health, Quinhin Nantote, denied that the government had authorized the research. This denial contradicted previous reports provided to a Danish ethics committee. 

In a recent development, Guinea-Bissau’s Judicial Police seized a batch of hepatitis B vaccines from the Bandim Health Project in Bissau as part of an investigation into the trial. While authorities noted the seizure is part of an inquiry to establish the circumstances surrounding the vaccine batch, they stated the action does not inherently prove irregularities regarding the quality or safety of the vaccines. The trial, funded by the U.S. Centers for Disease Control and Prevention (CDC), cannot begin until formal national authorization is granted.

## Timeline

### 2026-10-19: Guinea-Bissau police seize vaccines amid hepatitis B trial dispute

Guinea-Bissau police have seized hepatitis B vaccines amid an investigation into a controversial $1.6 million clinical trial involving 14,000 newborns and the Bandim Health Project.

4 sources. https://clstr.news/cluster/guinea-bissau-police-seize-vaccines-amid-hepatitis-b-trial-dispute

### 2026-10-14: Guinea-Bissau denies approval for controversial newborn Hepatitis B study

Guinea-Bissau's Health Minister has denied authorizing a controversial Hepatitis B study on 14,000 newborns, following claims that the research had received local approval from a Danish ethics committee.

2 sources. https://clstr.news/cluster/guinea-bissau-denies-approval-for-controversial-newborn-hepatitis-b-study

### 2026-10-09: Guinea-Bissau vaccine trial faces ethical scrutiny

A controversial Hepatitis B vaccine trial in Guinea-Bissau will enroll 14,000 infants, with half receiving the vaccine at birth and the other half being withheld the dose for six weeks, sparking ethical outcry.

3 sources. https://clstr.news/cluster/guinea-bissau-vaccine-trial-faces-ethical-scrutiny

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Cite as: Guinea-Bissau newborn Hepatitis B vaccine trial controversy. CLSTR, https://clstr.news/situations/guinea-bissau-newborn-hepatitis-b-vaccine-trial-controversy