Guinea-Bissau’s government has rejected a clinical trial that controversially would study the effects of giving hepatitis B vaccines to newborns. The declaration has sparked renewed debate globally about the ethics of conducting research, inoculating babies and governments conducting research on the developing world.
The ministry did not approve the research study in the way it was presented in media reports, Quinhin Nantote, health minister, said on October 13. The comments came after reports circulated that the study was okayed, prompting speculation over approval for the trial and if the experimental treatment has regulatory approval.
This proposed study is funded by the US government and is being conducted by researchers at the University of Southern Denmark and the Bandim Health Project. The future of the project remains unclear, as officials continue to review the scientific and ethical issues related to it.
The research is meant to investigate whether a dose of the hepatitis B vaccine given to a baby has effects apart from its known benefit of preventing infection. The investigators plan to study so-called nonspecific effects, like effects on the health, illness, and child development.
The published study protocol set out the plan for a randomised controlled trial of about 14,500 newborns. As planned, one group would be given the hepatitis B vaccine dose plus the other scheduled newborn vaccines, with another group of babies given other scheduled newborn vaccines but not the hepatitis B birth dose.
The study has met with much criticism, as some of the infants who take part would be denied a proven method of prevention. Critics say it is hard to justify subjecting newborns to preventable infection risks, given there is a proven vaccine.
There’s an important distinction here. The debate is not that hepatitis B vaccination doesn’t prevent infection. The debate is whether the proposed trial can ethically study any potential benefits that might occur when some infants would not receive the birth dose.
That row erupted recently after reports said the study had been granted the required local approval. The health minister of Guinea-Bissau yet denied that report, claiming the government has not approved the trial.
The debate has also focused on the institutional support for and nature of research, including ethics committees. The Bandim Health Project has been conducting public health research in the country for several decades, but support for a research station from the Institute is not synonymous with approval for parts of a specific trial.
The World Health Organization had earlier said that the study was put on hold by Guinea-Bissau until it could examine the proposal more closely. In the February 2026 report, the body questioned whether the proposed study was scientifically sound, whether there would be sufficient protection for patients and why the birth dose of the vaccine was being denied to some babies.
The US Department of Health and Human Services has also claimed that the study has been granted no approval. Both statements imply the project cannot be regarded as an approved trial just because researchers have a protocol or funding.
