New details are leading experts to fear that an “unethical” vaccine trial in Guinea-Bissau is the “prototype” of studies led by Robert F Kennedy Jr, secretary of the US Department of Health and Human Services (HHS) and a long-time vaccine critic.
At the center of US vaccine policy is an unlikely group of Danish researchers whose work on the health effects of vaccines has been questioned. The study in Guinea-Bissau would have looked at the overall health effects of administering hepatitis B vaccines by vaccinating only half of the newborns in the study at birth, despite an 18% prevalence rate of the disease in adults, which can have serious and sometimes fatal health consequences.
Stand Up for Science, a science and health nonprofit in the US, sent a researcher to Guinea-Bissau to examine public records and interview experts. The organization met with members of Congress on February 19 to share these results in an unpublished report, obtained by The Guardian, that raises concerns about how deeply the Bandim Health Project is involved in public health in Guinea-Bissau and the challenges of conducting ethical research in this environment, with immense implications for how US research will be conducted under Kennedy.
“We fear this is a prototype for other studies,” said Colette Delawalla, founder of Stand Up for Science. The United States could fund global studies with ethical concerns similar to those of the Tuskegee experiment five, 10 or 100 times a year, he said. “It could be extraordinarily deadly.” Stand Up for Science held nationwide rallies on Saturday to protest movements like this.
The Danish researchers behind the now-suspended hepatitis B vaccine trial have run Bandim in Guinea-Bissau for 48 years, but now face new questions about their previous work; the most recent, a study published in Vaccine that details several cases in which researchers appeared to conduct studies and then publish partial results or none at all.
The group has deep ties to the current US administration; Kennedy has cited Peter Aaby, one of the researchers, as shaping some of his own views on vaccines. Christine Stabell Benn, another of the researchers, was included in the hepatitis B working group of the advisory committee on immunization practices, meaning she helped determine the evidence behind the committee’s decision to end the universal delivery recommendation. Stabell Benn also hosted a podcast with Tracy Beth Høeg, a sports doctor turned top official at the US Food and Drug Administration (FDA), who said she wants to end “unnecessary” vaccines.
The researchers are “deeply connected in Guinea-Bissau,” said Magda Robalo, former health minister and president of the Guinea-Bissau Institute for Global Health and Development. “They’re built into the system.”
Bandim “is the government,” a source told the Stand Up for Science researcher. The Guinea-Bissau ethics committee is seen as “a club of friends,” the researcher noted.
The ethics committee charges a fee for each study review, which is “problematic” because it could influence members to approve the protocols, Robalo said. And the committee is not prepared to review investigations like this, he added.
Obtaining informed consent is extremely difficult in Guinea-Bissau due to low literacy rates and language barriers, Robalo said. The local Creole phrase for hepatitis B and any other disease that causes jaundice is “febri amarelu,” or “yellow fever,” which is also the name of a separate disease. “How can there be informed consent if there isn’t even good language to describe to people what they are protecting against by getting vaccinated or not?” -Delawala asked.
“Guinea-Bissau does not have a single credible institution in public health research at the moment,” Robalo said. That also means that many local researchers work with Bandim on studies, creating potential conflicts of interest. For example, Armando Sifna, the current public health director of Guinea-Bissau, was affiliated with Bandim for more than a decade; In December, he was identified as working simultaneously with Bandim and the national public health institute of Guinea-Bissau.
This is “very common,” Robalo said. However, local researchers have little power to influence what is studied and how, he said. While Danish researchers argue that Bissau Guineans want this trial to continue, “there is a symbolic nature here,” Robalo said. “Those people don’t have the power to make decisions.”
Following public outcry over the trial, the University of Southern Denmark stopped “all work related to the study” while it is reviewed, said Ole Skøtt, dean of health sciences at the university. It said it had contacted the WHO’s research ethics review committee to conduct an independent ethical assessment.
The Guardian’s questions to Health Minister Quinhin Nantote were not answered as of press time. Stabell Benn requested questions via email but did not respond by press time.
The U.S. House Energy and Commerce Committee detailed its concerns about the hepatitis B trial in a Feb. 6 letter to Jim O’Neill, then acting director of the U.S. Centers for Disease Control and Prevention (CDC), calling the trial “ethically troubling and scientifically unsound” and requesting the release of documents related to the CDC’s role in the study.
The fact that the CDC funneled federal funds to Kennedy associates without transparency or meaningful review “suggests that the agency’s grantmaking process may be seriously degraded in service of an anti-vaccine ideological agenda,” the letter said.
Tedros Adhanom Ghebreyesus, director-general of the World Health Organization (WHO), said at a press conference on February 11 that “it was unethical to continue this study,” and the organization issued a statement on February 13 outlining its “important concerns” about the study’s “scientific justification, ethical safeguards and overall alignment with established principles for research involving human participants.”
“That’s not going to happen, period,” Guinea-Bissau Foreign Minister Joao Bernardo Vieira told Reuters on February 18.
Yap Boum II, a senior official at the African Center for Disease Control (CDC), told reporters on Thursday that the African CDC is providing support to Guinea-Bissau in reviewing the suspended trial, but the most important issue should be to deploy hepatitis B vaccine doses for newborns as soon as possible, and the discussion should “move to a comprehensive response,” Boum said. The evidence is clear and recommending the vaccine to all babies at birth is “a high priority” for the Africa CDC, said Landry Dongmo Tsague, director of primary health care at the Africa CDC.
Previously, Kennedy, citing Aaby’s work on vaccines in Guinea-Bissau, withdrew support for Gavi, the Vaccine Alliance, which supported a planned rollout in 2027. Nantote recently said the birth dose campaign would be delayed until 2028. But African officials, including in Guinea-Bissau, are exploring making the hepatitis B vaccine available to all newborns by 2027, Tsague said.
The United States allocated $1.6 million to the hepatitis B trial, with matching funding from the Pershing Square Foundation and the Bluebell Foundation. “In fact, they could just take this money and vaccinate every newborn for the next 10 years,” Delawalla said.
“The study is on hold for review,” an HHS spokesperson said. “CDC will continue to work with its partners to determine if the study can be approved by the relevant authorities in the country of origin.”
Details of the trial have resonated across Africa. “Countries across the continent have been alerted to this,” Robalo said. They are working to enhance their own research capabilities outside of the “asymmetric relationship between research institutions in the Global North and the Global South,” he said.
