Guinea-Bissau Health Ministry Denies Approval of Controversial Hepatitis B Trial

Key points

• Guinea-Bissau Health Minister Quinhin Nantote stated the government has not approved the hepatitis B trial, calling media reports of authorization 'surprising.'
• The trial would enroll 14,000 newborns, withholding the hepatitis B birth dose from half of them to study potential harms, a design widely condemned as unethical.
• The US CDC allocated $1.6 million from global health security funds to support the trial, which is linked to HHS Secretary Robert F. Kennedy Jr.
• Danish researchers Peter Aaby and Christine Stabell Benn, who are under investigation for scientific misconduct, claim local ethics committees approved the study, but the Guinean government disputes this.
• The trial remains suspended pending final government authorization, with the WHO and advocacy groups urging Guinea-Bissau to prioritize universal vaccination instead.

Background

The trial was first announced in late 2025 and suspended in January 2026 after international outcry over its ethical design. The WHO and other experts argued that withholding a proven vaccine from infants in a country with high hepatitis B prevalence violates medical ethics. The study has been linked to HHS Secretary Robert F. Kennedy Jr., a known anti-vaccine advocate, and Danish researchers who have faced allegations of data falsification in previous vaccine studies.

How outlets are covering it

The Guardian and Rolling Stone report that Guinea-Bissau’s health ministry explicitly denied approving the trial, contradicting claims by Danish researchers that local ethics committees had signed off. Ars Technica and Rolling Stone highlight the CDC’s decision to allocate $1.6 million from global health security funds, drawing criticism from experts who argue the money should be used for urgent outbreaks like Ebola in the Democratic Republic of Congo. Stand Up for Science, a non-profit advocacy group, condemned the trial as a 'gross violation of human rights' and vowed to block it, while the WHO emphasized the need to provide the birth dose to all newborns in Guinea-Bissau. Danish researchers, including Peter Aaby and Christine Stabell Benn, defended the trial by arguing it aligns with the current standard of care in Guinea-Bissau, where the birth dose is not yet routinely provided, but critics argue this violates ethical guidelines requiring the use of the best proven intervention.

Why it matters

The dispute highlights tensions between US health policy and international ethical standards for clinical trials, particularly in developing nations. If the trial proceeds, it could expose thousands of infants to preventable hepatitis B infection, with potential lifelong health consequences. The case also raises questions about the influence of anti-vaccine advocates on public health funding and the role of global health organizations in protecting vulnerable populations from unethical research.

What to watch

The trial remains suspended pending final authorization from the Guinean government. The CDC and HHS have not confirmed whether they will proceed with funding the study, while advocacy groups and the WHO continue to pressure Guinea-Bissau to prioritize universal hepatitis B vaccination. Danish authorities are investigating allegations of scientific misconduct against the researchers involved, which could further impact the trial’s viability.