US-funded hepatitis B vaccine trial cancelled in Guinea-Bissau

A proposed hepatitis B vaccine trial in Guinea-Bissau has been cancelled following opposition from the Guinea-Bissau government and international criticism regarding the study's ethics.

The Proposed Study

The study was planned by the Bandim Health Project, a research center operating in Guinea-Bissau since 1978. The trial was designed to involve 14,000 newborns, with half receiving a hepatitis B vaccine shortly after birth and the other half receiving a saline-injection placebo. According to the Bandim investigators, the trial aimed to investigate "non-specific effects" (NSEs)—health impacts caused by a vaccine that go beyond its primary mechanism of action, such as mortality, eczema, and neurodevelopmental conditions like autism.

The project was set to receive $1.6 million in grant funding from the US Centers for Disease Control and Prevention (CDC). The University of Southern Denmark (SDU) Research Ethics Committee granted the study approval based on an updated methodology, which included offering mothers maternal hepatitis B testing and voluntary HIV testing.

Government and International Response

The government of Guinea-Bissau has denied that the trial had authorization. Quinhin Nantote, the minister of public health in Guinea-Bissau, stated, “We were […] surprised that the Guinea-Bissau government had already authorized widespread [vaccine] administration,” and added, “We were angered because neither I, as minister, nor those responsible, had been informed.”

International health officials expressed significant ethical concerns regarding the study design. Walter Kazadi Mulombo, the WHO representative in Guinea-Bissau, stated, “A study that will withhold that intervention from other newborns is unethical.” The WHO further noted that the hepatitis B birth dose vaccine is a "proven lifesaving intervention" and that withholding it could expose newborns to serious harm, including chronic infection, cirrhosis, and liver cancer.

Dr. Gavin Yamey, a professor of global health and public policy at Duke University, criticized the proposal, stating, "The proposed trial reeks of neocolonialism."

Police Action and Investigation

On October 19, the Judicial Police (PJ) of Guinea-Bissau conducted a raid on the Bandim Health Project's offices and seized a batch of hepatitis B vaccines. In a translated statement, the PJ said, "the seizure constitutes an investigative measure and does not, by itself, allow for the conclusion that there are irregularities in the quality, safety, or efficacy of the vaccines."

In Denmark, the Danish Medical Agency (DKMA) determined that the trial was not notifiable in Denmark because it was being conducted abroad. SDU dean Jakob Grauslund stated that the trial had never started, no babies had been enrolled, and no vaccinations had been administered as part of the research.

Why it matters

The cancellation follows a period of intense scrutiny regarding the ethics of conducting clinical trials in developing nations. While Bandim investigators argued that media scrutiny could contribute to vaccine mistrust, critics and health experts have questioned the ethics of withholding a recommended vaccine from vulnerable populations.

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Sources

• bioxconomy.com: HBV trial will not go ahead following police raid
• yahoo.com: Why a US-funded vaccine trial on babies was cancelled in Guinea-Bissau
• bbc.com: US-funded vaccine trial on babies cancelled in Guinea-Bissau after uproar

This article was drafted with AI assistance and checked against the sources above. Company claims are reported as claims. Cover image is AI-generated.