Experts raise alarm over controversial US-backed study in West Africa

New details about a hepatitis B vaccine trial in Guinea-Bissau are raising alarm among experts, who warn that the study could serve as a “prototype” for ethically questionable research under Robert F. Kennedy Jr., secretary of the US Department of Health and Human Services (HHS) and a longtime vaccine critic.

The trial, designed by Danish researchers with longstanding ties to Guinea-Bissau, would have administered the vaccine to only half of newborns at birth despite an 18% adult prevalence rate of the illness, which can lead to serious and sometimes fatal complications, the Guardian reveals.

Stand Up for Science, a US-based nonprofit focused on science and health, sent an investigator to Guinea-Bissau to review public records and interview experts. The organisation shared its findings with members of Congress on February 19 in an unreleased report obtained by The Guardian, highlighting the Bandim Health Project’s deep entanglement in Guinea-Bissau’s public health system and raising ethical concerns.

“We are fearful that this is a prototype for other studies,” said Colette Delawalla, founder of Stand Up for Science.

She warned that the US could fund global studies with “similar ethical concerns as the Tuskegee experiment five or 10 or 100 times a year… It could be extraordinarily deadly.”

The Danish researchers, who have run Bandim for 48 years, face scrutiny over previous studies, including instances of releasing partial or no results, according to a recent study published in Vaccine.

Bandim researchers, including Peter Aaby and Christine Stabell Benn, are closely linked to US vaccine policy. Kennedy has cited Aaby as formative to his views on vaccines, while Stabell Benn, a member of the US advisory committee on immunisation practices, influenced the decision to end the universal birth recommendation for hepatitis B.

She also co-hosted a podcast with Tracy Beth Høeg, an FDA official advocating against “unnecessary” vaccines.

“Bandim is deeply, deeply connected in Guinea-Bissau,” said Magda Robalo, former health minister and president of the Institute for Global Health and Development.

She described the ethics committee as “a friends club” that charges fees for study reviews, potentially compromising impartiality. Low literacy rates and language barriers make informed consent extremely challenging.

Delawalla noted, “How can there be informed consent if there isn’t even good language to describe to the people what they’re protecting themselves against by getting or not getting the vaccine?”

Following public outcry, the University of Southern Denmark paused “all work related to the study” pending review, according to Ole Skøtt, dean of health sciences.

The WHO also raised concerns, with director-general Tedros Adhanom Ghebreyesus calling it “unethical to proceed with this study.”

Guinea-Bissau’s foreign minister Joao Bernardo Vieira told Reuters on February 18, “It’s not going to happen, period.”

US lawmakers have questioned the CDC’s role, describing the trial as “ethically disturbing and scientifically unsound” in a February 6 letter, noting that federal funding to Kennedy’s associates lacked transparency and meaningful review. Africa CDC officials stressed that the focus should shift to making the birth-dose hepatitis B vaccine available to all newborns as soon as possible.

“Recommending the vaccine to all babies at birth is a high priority,” said Landry Dongmo Tsague, Africa CDC’s director of primary health care.

The US allocated $1.6 million to the trial, matched by private foundations. Delawalla criticised this approach, saying, “They could actually just take this money and vaccinate every newborn for the next 10 years.”

An HHS spokesperson said, “The study is paused for review… CDC will continue to work with its partners to determine whether the study may be approved by the relevant home-country authorities.”

The controversy has resonated across Africa, prompting efforts to strengthen local research capacity and reduce dependence on Global North institutions.

“Countries around the continent have been alerted to this,” Robalo said.

By Sabina Mammadli