Concerns Over Guinea-Bissau Vaccine Trial

This week, a troubling plan associated with Robert F. Kennedy Jr. came to a halt as police in Guinea-Bissau raided Danish researchers’ offices. These researchers aimed to conduct a hepatitis B vaccine trial that could have put thousands of newborns in Africa at risk, potentially leading to early and painful deaths. The trial was set to be funded by a significant $1.6 million grant from the Centers for Disease Control and Prevention.

This cancellation represents a critical point in what might be considered one of the most unethical research efforts in recent times. (And there’s definitely some competition in this area, particularly with the National Institute of Justice’s recent announcement on funding research related to “gender dysphoria and violent crime.”) You might wonder why it’s important to know about a trial that has now been canceled. I’d argue it’s crucial to pay attention to the somewhat nefarious strategies RFK Jr. uses to push his anti-vaccine agenda; there’s a good chance that he may attempt something similar in the future.

A primary reason the Guinea-Bissau trial hasn’t received much mainstream attention—aside from coverage from The Guardian and Rolling Stone—is that it targeted a population in Africa, specifically children, who, despite not being in the U.S., have already been impacted by our government’s questionable uses of taxpayer money. So, here’s a breakdown of the situation. Apologies for the wordiness; it’s complex and quite troubling.

Details of the Proposed Hepatitis B Trial

In January, a CDC employee leaked details about the trial to Inside Medicine. The focus was to examine the “non-specific effects” of the hepatitis B vaccine. What kind of side effects? Skin issues like rashes and some neurodevelopmental conditions. This rings a bell, given RFK Jr.’s past promotion of unfounded links between vaccines and autism.

Currently, Guinea-Bissau recommends the hepatitis B vaccine for infants at six weeks due to access challenges but plans to implement universal vaccination at birth by 2027, aligning with World Health Organization guidelines. The proposed trial sought to administer hepatitis B vaccines to 7,000 newborns while withholding it from another 7,000 until they turned six weeks old, ostensibly to compare their health outcomes. Sound familiar? It echoes past unethical research efforts, like the Tuskegee study.

Guinea-Bissau faces one of the highest rates of hepatitis B globally, a virus notorious for attacking the liver and leading to severe complications like cirrhosis or liver cancer. Nearly one in five people there suffer from chronic hepatitis B, and about 90% of newborns exposed to the virus will develop chronic infections, with 25% facing death from related complications. Unfortunately, there’s no cure for this.

The Researchers Behind the Study

The CDC announced in December 2025 that it would award $1.6 million to researchers from the University of Southern Denmark. This decision has raised eyebrows; RFK Jr. seems to have bypassed standard review processes, which feels a bit like cronyism. The grant went to Christine Stabell Benn and Peter Aaby of the Bandim Health Project, which has been active in Guinea-Bissau since 1978 to study “non-specific effects of vaccines.” This terminology often implies a biased view against vaccines, which is concerning. They suggest that “non-live” vaccines can lead to adverse side effects, a claim RFK Jr. seems to favor.

He has praised the Danes, calling them “deities of vaccine research,” citing their work when he criticized U.S. funding for the international vaccine agency Gavi, which plays a crucial role in vaccinating children in lower-income countries. A particular paper he highlighted, published in 2017, analyzed around 1,000 children in Guinea-Bissau who received the DTP vaccine. However, the study was fraught with flaws, relying on outdated data and asserting dangerous side effects without proper investigation into the vaccine’s effectiveness.

In 2025, a separate group of researchers conducted a comprehensive review of Bandim’s research, highlighting significant methodological issues, including a lack of conclusive evidence to support the purported vaccine effects. This context emphasizes the troubling nature of Bandim’s claims, as they account for a significant portion of research on these vaccine effects.

Why Guinea-Bissau?

This raises an important question: why are the researchers focusing on Guinea-Bissau? The country was colonized by the Portuguese, not the Danes. Bandim Health Project’s activities, though, bring up uncomfortable notions of exploitation, as Western researchers conduct studies on African populations that likely wouldn’t be accepted ethically in their home countries. There’s an observable power dynamic at play, with local healthcare access and research oversight severely limited, making informed consent a major concern.

Flaws in the Proposed Trial

Many scientists, like Dr. Jeremy Faust, have pointed out a multitude of flaws in the design of the trial. Some side effects from vaccines can appear quickly, while long-term benefits might take years to be observed. By delaying vaccination for one group, the trial ignores the potential long-term protection that vaccinations provide against serious health issues. It’s akin to evaluating a chemotherapy regimen just a week after treatment.

Additionally, none of the hepatitis B vaccines slated for the trial were FDA-approved, prompting serious questions about why the CDC chose to back unapproved research.

Moreover, one major ethical issue was that the researchers had no plans to screen mothers for hepatitis B. With a substantial portion of the Guinean population carrying the virus, this oversight would have led to guaranteed infections among many infants that were denied vaccination. Dr. David Boulware described the implications as unthinkable, noting that consigning even a fraction of newborns to a near-certain risk of hepatitis B was deeply unethical.

In essence, the trial intended to deny an established, life-saving intervention to thousands of children without any valid scientific basis.

How Did This Get Approved?

How, then, did this study even receive approval? Experts contend it violates the Helsinki Declaration, which sets ethical standards ensuring participants receive the best possible care. Following public backlash after the protocol leak in January, the African CDC declared the cancellation of the study. The transitional government in Guinea-Bissau subsequently confirmed the trial’s cancellation, and the WHO condemned the continuation of the study as unethical.

Despite this, officials from the U.S. Department of Health and Human Services initially insisted the trial would proceed, questioning the authority of the African CDC. Notably, billionaire Bill Ackman’s foundation pledged additional funding to the project.

Though the trial seemed halted, things took another turn when Rolling Stone reported the study was back in motion in October. An ethics committee at the University of Southern Denmark voted to restart the study, although some members resigned in protest due to their ethical disagreements.

The newly revised trial sought to screen mothers for hepatitis B prior to childbirth, planning to vaccinate those with positive tests while enrolling infants of mothers who tested negative. This approach raises concerns, as transmission of hepatitis B can easily occur, compounded by the test’s 5% false negative rate.

Ethical Concerns Still Loom

Even with these revisions, the trial’s ethics remain questionable. It would still withhold potentially life-saving vaccines from 7,000 newborns during their first few weeks of life. Furthermore, mothers who opted out of the study would not have access to the vaccine, creating an impossible choice for families regarding their children’s health.

Recent Developments

On October 19, the Guinea-Bissau police announced on Facebook that they had raided the Bandim Health Project, confiscating hepatitis B vaccines. Shortly after, the transitional government confirmed it would not authorize the trial, hopefully putting an end to it.

What’s Next for Guinea-Bissau?

Guinea-Bissau, still recovering from a recent coup, is in dire need of resources. Experts like Faust argue that the money the CDC allocated for this flawed trial could have significantly advanced the vaccination efforts in the country, providing essential protection against disease and unnecessary deaths. The future of these resources remains uncertain, and it’s questionable whether they’ll be redirected to improve local health outcomes.

Impact on RFK Jr.’s Agenda

RFK Jr. has made it clear he wants to end the hepatitis B vaccination of newborns in the United States. Back in December 2025, his committee voted to recommend that the vaccine should only be administered after a child reaches two months, a decision that was later blocked by a judge, though ongoing lawsuits could still lead to that delay.

A recent study echoed concerns that altering vaccination practices could expose a significant portion of Americans to hepatitis B by age 20. The Guinea-Bissau trial may be over, but RFK Jr.’s push against vaccination continues unabated.