Experts fear ‘unethical’ vaccine trial in Africa is ‘prototype’ for US studies under RFK Jr

## Summary
Photograph: Nature Picture Library/Alamy Experts fear ‘unethical’ vaccine trial in Africa is ‘prototype’ for US studies under RFK Jr Danish researchers whose work on effects of vaccines has been called into question are at center of US vaccine policy New details are leading experts to fear that an “unethical” vaccine trial in Guinea-Bissau is the “prototype” for studies under Robert F Kennedy Jr , secretary of the US department of health and human services (HHS) and longtime vaccine critic. Danish researchers behind the now-suspended hepatitis B vaccine trial have run Bandim in Guinea-Bissau for 48 years, but they are now facing new questions about their previous work – most recently, a study published in Vaccine detailing several instances where the researchers appeared to conduct studies and then release partial results or none at all. The phrase in the local creole for hepatitis B and any other illness causing 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 the people what they’re protecting themselves against by getting or not getting the vaccine?” Delawalla asked. “Guinea-Bissau does not have a single credible institution in public health research at this point in time,” Robalo said. Yap Boum II, a senior official at the Africa Center for Disease Control (CDC), told journalists on Thursday that Africa CDC is providing support to Guinea-Bissau in reviewing the suspended trial – but the bigger issue should be rolling out birth doses of hepatitis B vaccine as soon as possible, and the discussion should “move to the comprehensive response”, Boum said.

## Article Content
Baby receiving oral vaccine against polio, at infant medical centre in Canogo Island, Guinea-Bissau, December 2013.
Photograph: Nature Picture Library/Alamy
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Baby receiving oral vaccine against polio, at infant medical centre in Canogo Island, Guinea-Bissau, December 2013.
Photograph: Nature Picture Library/Alamy
Experts fear ‘unethical’ vaccine trial in Africa is ‘prototype’ for US studies under RFK Jr
Danish researchers whose work on effects of vaccines has been called into question are at center of US vaccine policy
New details are leading experts to fear that an “unethical” vaccine trial in Guinea-Bissau is the “prototype” for studies under
Robert F Kennedy Jr
, secretary of the US department of health and human services (HHS) and longtime vaccine critic.
At the center of US vaccine policy is an unlikely set of Danish researchers whose work on the health effects of vaccines has been called into question. The study in
Guinea-Bissau
would have looked at the overall health effects of giving hepatitis B vaccines by only vaccinating half of the newborns in the study at birth despite an 18% prevalence rate in adults of the illness, which can lead to serious and sometimes fatal health consequences.
RFK Jr’s pick to review Covid vaccines authored misleading research, experts say
Read more
Stand Up for Science, a science and health nonprofit in the US, sent an investigator to Guinea-Bissau to look at public records and interview experts. The organization met with members of Congress on 19 February to share these results in an unreleased report, obtained by the Guardian, that raises concerns about how deeply the Bandim Health Project is enmeshed in public health in Guinea-Bissau and the challenges to conducting ethical research in this setting – with immense repercussions for how US research will be carried out under Kennedy.
“We are fearful that this is a prototype for other studies,” said Colette Delawalla, founder of Stand Up for Science. The US could fund global studies with the similar ethical concerns as the Tuskegee experiment five or 10 or 100 times a year, she said. “It could be extraordinarily deadly.” Stand Up for Science held nationwide rallies on Saturday to protest moves like these.
Danish researchers behind the now-suspended hepatitis B vaccine trial have run Bandim in Guinea-Bissau for 48 years, but they are now facing new questions about their previous work – most recently, a
study
published in Vaccine detailing several instances where the researchers appeared to conduct studies and then release partial results or none at all.
The group has deep ties with the current US administration; Kennedy has
cited
Peter Aaby, one of the researchers, as formative to some of his own views on vaccines. Christine Stabell Benn, another of the researchers, was
included
on the hepatitis B working group of the advisory committee on immunization practices, which means she helped determine the evidence behind the committee’s decision to end the universal birth recommendation. Stabell Benn also hosted a podcast with Tracy Beth Høeg, a sports physician turned top official with the US Food and Drug Administration (FDA) who
said
she wants to end “unnecessary” vaccines.
The researchers are “deeply, deeply connected in Guinea-Bissau,” said Magda Robalo, former minister of health and president of the Institute for Global Health and Development in Guinea-Bissau. “They are embedded in the system.”
Bandim “is the government”, one source told the Stand Up for Science investigator. The Guinea-Bissau ethics committee is seen as “a friends club”, the investigator found.
The ethics committee charges a fee for each study review, which is “problematic” because it could influence the members to approve the protocols, Robalo said. And the committee is not equipped to review research like this, she added.
Informed consent is extremely challenging to obtain in Guinea-Bissau because of low literacy rates and language barriers, Robalo said. The phrase in the local creole for hepatitis B and any other illness causing 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 the people what they’re protecting themselves against by getting or not getting the vaccine?” Delawalla asked.
“Guinea-Bissau does not have a single credible institution in public health research at this point in time,” Robalo said. That also means many local researchers work with Bandim on studies, which creates potential conflicts of interest. For example, Armando Sifna, the current director of public health in Guinea-Bissau, was affiliated with Bandim for more than a decade – as recently as December, when he was
identified
as working with Bandim and the national public health institute in Guinea-Bissau simultaneously.
That’s “very common”, Robalo said. Yet the local researchers have little power to influence what is studied and

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## Expert Analysis

### Merits
- Tedros Adhanom Ghebreyesus, director-general of the World Health Organization (WHO), said at a news conference on 11 February that it was “unethical to proceed with this study”, and the organization released a statement on 13 February outlining its “significant concerns” over the study’s “scientific justification, ethical safeguards, and overall alignment with established principles for research involving human participants”. “It’s not going to happen, period,” Guinea-Bissau’s foreign minister Joao Bernardo Vieira told Reuters on 18 February.
- Yap Boum II, a senior official at the Africa Center for Disease Control (CDC), told journalists on Thursday that Africa CDC is providing support to Guinea-Bissau in reviewing the suspended trial – but the bigger issue should be rolling out birth doses of hepatitis B vaccine as soon as possible, and the discussion should “move to the comprehensive response”, Boum said.

### Areas for Consideration
- Yap Boum II, a senior official at the Africa Center for Disease Control (CDC), told journalists on Thursday that Africa CDC is providing support to Guinea-Bissau in reviewing the suspended trial – but the bigger issue should be rolling out birth doses of hepatitis B vaccine as soon as possible, and the discussion should “move to the comprehensive response”, Boum said.

### Implications
- Photograph: Nature Picture Library/Alamy Experts fear ‘unethical’ vaccine trial in Africa is ‘prototype’ for US studies under RFK Jr Danish researchers whose work on effects of vaccines has been called into question are at center of US vaccine policy New details are leading experts to fear that an “unethical” vaccine trial in Guinea-Bissau is the “prototype” for studies under Robert F Kennedy Jr , secretary of the US department of health and human services (HHS) and longtime vaccine critic.
- At the center of US vaccine policy is an unlikely set of Danish researchers whose work on the health effects of vaccines has been called into question.
- The study in Guinea-Bissau would have looked at the overall health effects of giving hepatitis B vaccines by only vaccinating half of the newborns in the study at birth despite an 18% prevalence rate in adults of the illness, which can lead to serious and sometimes fatal health consequences.
- The organization met with members of Congress on 19 February to share these results in an unreleased report, obtained by the Guardian, that raises concerns about how deeply the Bandim Health Project is enmeshed in public health in Guinea-Bissau and the challenges to conducting ethical research in this setting – with immense repercussions for how US research will be carried out under Kennedy. “We are fearful that this is a prototype for other studies,” said Colette Delawalla, founder of Stand Up for Science.

### Expert Commentary
This article covers bissau, guinea, health topics. Notable strengths include discussion of bissau. Areas of concern are also raised. Readability: Flesch-Kincaid grade 0.0. Word count: 1361.