Guinea-Bissau halts US-funded hepatitis B vaccine trial after police raid
The trial, which planned to give 14,000 babies the hepatitis B vaccine at birth or six weeks later, was denied government approval and called unethical by the WHO.
At a glance
- Guinea-Bissau has halted a hepatitis B vaccine trial that planned to involve about 14,000 babies and was funded by the US CDC with $1.6m.
- Police raided Bandim Health Project facilities in Bissau in mid-October and seized vaccine batches; researchers say approval was never granted.
- The WHO called the trial unethical because one group of babies was to receive the vaccine at six weeks rather than at birth.
Guinea-Bissau has halted a controversial hepatitis B virus (HBV) vaccine trial funded by the United States, after the project failed to secure the government approval it needed and police seized vaccine batches from the research group's facilities in the capital, Bissau.
The Bandim Health Project, a Bissau-based research group that is part of the University of Southern Denmark, planned the trial. In mid-October the country's judicial police said they had raided the group's facilities and seized vaccine batches, and authorities said inquiries were continuing into whether the trial complied with national safety standards.
Researcher Frederik Schaltz-Buchholzer said in a LinkedIn post that the trial would not move forward in Guinea-Bissau because the team "were not given the necessary governmental approval". Another researcher involved in the project called the end of the trial a "significant setback" for African science.
What the trial proposed
The study was designed to assess the effects of World Health Organization (WHO)-recommended HBV vaccines on two groups of babies. One group would receive the vaccine at birth; the other, chosen at random, would receive it six weeks later. Around 14,000 babies were expected to take part, with health outcomes tracked over five years.
The project secured $1.6m from the US Centers for Disease Control and Prevention (CDC) under Health Secretary Robert F Kennedy, who has previously made his anti-vaccine views known.
When the trial was announced in December last year, it met widespread anger over the withholding of the vaccine from one group of babies. In January, the Guinea-Bissau government paused the project and launched a review with the Africa Centres for Disease Control and Prevention (Africa CDC) and the WHO.
Ethical objections
Health experts questioned the morality of withholding a highly effective vaccine from thousands of babies for research purposes. The WHO called the trial "unethical".
Infants are at the highest risk of chronic hepatitis B infection, which is usually passed to them by their mothers. The disease has no cure and can lead to long-term liver damage and cancer. The WHO recommends HBV vaccines at birth for all babies, plus booster shots.
Guinea-Bissau has one of the highest numbers of people living with hepatitis B — one-fifth of its 2.2 million population. Because it cannot access enough doses, the government authorises the vaccine at up to six weeks after birth, although it is working to start at-birth hepatitis B vaccination for all babies from 2028.
The researchers argued that the period before 2028 offered a "unique window of opportunity" to compare babies vaccinated at birth with those vaccinated later. Critics said the study would effectively hold back vaccines from babies who would otherwise have had access to them.
"[The researchers] took advantage of the fact that Guinea-Bissau does not have a very strong research capacity," Magda Robalo, a former Guinea-Bissau health minister, told Al Jazeera. "It is unethical to deny children an intervention that we know works," she added.
Some critics also questioned the trial's "open label" design, and others compared it to the Tuskegee syphilis study in Alabama, in which health authorities studied untreated syphilis in Black men between 1932 and 1972 even though penicillin was available. More than 100 men died.
Christine Stabell Benn, who chairs the Bandim Health Project with Peter Aaby, denied any wrongdoing. In a joint statement the pair said they were not testing whether the HBV vaccine prevents the disease, but "whether the prevention [of the disease] comes at a prohibitive price", such as death and other health outcomes.
Guinea-Bissau's health minister, Quinhin Nantote, denied reports in mid-October that the government had approved an updated proposal for the trial.
Source: Al Jazeera.
Questions and answers
- Why was the hepatitis B vaccine trial in Guinea-Bissau halted?
- The trial failed to gain the necessary government approval, and in mid-October police raided the Bandim Health Project's facilities in Bissau and seized vaccine batches. Authorities said inquiries into compliance with national safety standards were continuing.
- Why did the WHO call the trial unethical?
- The study planned to give one randomly chosen group of babies the hepatitis B vaccine at six weeks instead of at birth, withholding a WHO-recommended, highly effective vaccine from thousands of infants for research purposes.
- What is hepatitis B and why is at-birth vaccination recommended?
- Hepatitis B is a liver infection with no cure that can lead to long-term liver damage and cancer. Infants are at the highest risk of chronic infection, so the WHO recommends vaccination at birth plus booster shots.
