Danish researchers were poised to begin a controversial trial of a United States-funded vaccine on newborns in the West African nation of Guinea-Bissau last month when a public outcry derailed their plans.
Scientists wanted to evaluate the effects of hepatitis B vaccination on 14,000 babies at two different times. Half of the randomly selected sample group will receive the vaccine at birth – as recommended – while the other half will receive it six weeks later. Researchers will then compare health outcomes over five years.
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Soon after the case was announced, there was an international outcry The health expert community on ethical grounds for experimentation. This resulted in such widespread scrutiny that the Bissau-Guinea government suspended the research pending a review on January 22.
“I was disappointed, to say the least, that my country would have approved such a study,” former Guinea-Bissau health minister Magda Robalo told Al Jazeera in a video call from the capital, Bissau.
While a small ethics committee in the health ministry was aware of the study, the country’s national public health agency, which would approve such an important experiment, was not informed, she said.
“(Researchers) took advantage of the fact that Guinea-Bissau does not have a very strong research capacity … a very strong critical mass of public health professionals, very vested in understanding what the politics are around global health,” she added with a pained expression.
Because of their weakened immune systems, babies are at the highest risk of prolonged infection. Hepatitis B virus (HBV), which is spread through body fluids and can cause chronic liver damage and cancer. In most cases, carrier mothers transmit the virus to their infants during birth or through breastfeeding. According to the World Health Organization (WHO), HBV will cause 1.1 million deaths worldwide in 2022.
There is no cure for the disease, but the WHO advises that babies receive a dose of the approved hepatitis B vaccine at birth and a booster a few weeks later. WHO-approved According to several independent studies, the vaccine provides protection, possibly for life.
Guinea-Bissau, a small country of 2.2 million people, has one of the highest rates of HBV infection in the world – one in five people. Officials usually give babies the vaccine six weeks after birth because there aren’t enough doses to go around. However, starting in 2028, Guinea-Bissau is planning a budget that supports vaccines at birth.
Danish researchers who planned the vaccine trial to argue The study is timely, as Guinea-Bissau will take advantage of the remaining time before switching to the new schedule to recruit participants. They also point out that half of all babies in Guinea-Bissau will receive shots at birth for the first time.
But critics like Roballo say the trial is unethical because it withholds the vaccine at a critical time for another 7,000 babies, even if they would have gotten the shots at six weeks under the current schedule.
“You don’t run research like that,” insisted Roballo, who served as a senior WHO official for many years.
“Works that we know will contribute to improving their lives and protect them from diseases that they are likely to contract,” she said.
Under scrutiny
Not only is the ethics of the experiment under scrutiny, but so are the researchers willing to lead it.
It was conducted by scientists from the Guinea-Bissau-based Bandim Health Project, part of the University of Southern Denmark. A study of thousands of Bissau-Guinea Women and Children since 1978. The project’s chairperson, Christine Stabel Bain, and founder, Peter Eby, are both leading scientists in Denmark.
The pair, who are married, say their work aims to reveal the unintended consequences of vaccines, good or bad. One of their studies, for example, found vaccines against diphtheria, tetanus (lockjaw) and pertussis (DTP). was associated with higher infant mortalityEspecially in girls.
After reviewing the results in 2014, WHO concluded Key studies and others with similar findings were inconsistent but worthy of further review. WHO recommends that countries continue to vaccinate against DTP.
Danish scientists have repeatedly accused Bain and AB of claiming without evidence that inactivated vaccines such as DTP and HBV vaccines can cause adverse reactions, including death.
Critics say the pair downplay important results from their own randomized controlled trials (RCTs). RCTs, like the one proposed in Guinea-Bissau, are the gold standard of experiments in medical research because they significantly reduce the risk of bias.
Last February, an investigation by the Danish publication Weekendavisen Revealed They have not published the results of an RCT conducted 14 years ago, see DTP vaccine results.
The result of the study, which hypothesized that the vaccine increased infant mortality rates, especially among girls, was null, meaning no significant effects were reported. However, the pair continued with the study and pushed back on public statements that the vaccine needed to be tested, the newspaper alleges.
Months after investigation, study was published.
In a response to Al Jazeera, Bain pushed back against accusations that he hid test results.
“Allegations raised in Danish newspapers were investigated by our institution’s committee for research integrity in February 2025. That review did not find grounds for sanctions or other actions,” she said.
Still, critics say there is a disconnect between the researchers’ claims and the findings in general.
“They couldn’t really present solid evidence to confirm these hypotheses,” Anders Peter Hvid, a researcher at the Danish State Serum Institute, told Al Jazeera, questioning why researchers would be willing to give a vaccine they thought was harmful in the first place.
“They have a lot of null findings that they’re ignoring themselves time and time again … and they’re ignoring these ethical issues and basically having tests that are negative over and over again on African children,” he said.
Other critics point out that hepatitis B infection in newborns can manifest as late as five years later – meaning the full effects of not being vaccinated at birth may never be known. They also fault researchers’ plans to conduct “open-label” trials, where organizers would know which participants received the vaccine. Usually, such experiments are done “blind” to avoid bias. It is not clear why the Bandim Health Project chose to conduct an open-label trial.
Both Ben and Abby have pushed back against the backlash against the Guinea-Bissau project and what they called a “moral outrage”. long statement, Blaming his critics for not having a “curious and humble” mindset.
The pair say they don’t question the vaccine’s effectiveness, but “the issue is whether prevention comes at a cost of prevention,” such as death.
“Academic Celebrities’ Moral Outcry Seems Unnecessary,” The statement Read on
“Contrary to the claims of some critics, we will not prevent the vaccination of any other (wise) children. It’s gotten … as a result of the trial, more kids who wouldn’t have gotten it are actually being vaccinated.”
Funding from Trump’s White House
Despite facing controversy at home, the Bandim Health Project found an audience with the US Centers for Disease Control (CDC), led by Health Secretary Robert F. Kennedy Jr. (RFK), a vaccine skeptic whose anti-vaccine advocacy group praised Aaby. 2019 article.
By the researchers $1.6m secured in funding Studies that involve human subjects and require close monitoring by the CDC will be the norm in December, without going through a competitive, rigorous process. Earlier, RFK Jr Disintegrate It appointed a team of scientists at the helm of the agency and a non-scientist as its acting head.
RFK has long pushed the narrative that vaccines are linked to autism. Details first Leaked online A study from Guinea-Bissau showed that HBV vaccination at birth is associated with skin disorders and neurodevelopmental conditions – such as autism – by age five.
WHO, in December, Confirmed There is no link between vaccines and autism.
After news of the research caught the attention of researchers in Denmark and the US in early January, Guinea-Bissau contacted the Africa Centers for Disease Control and Prevention, which declared that the trial needed to be reviewed. Representatives of the US Department of Health, however, repeatedly told reporters that the experiment would go ahead, sparking confusion before a decisive suspension by the Guinea-Bissau government last week.
Al Jazeera has reached out to the US CDC for comment. CDC officials told news organizations that the experiment was important to test for “non-specific effects” of the hepatitis B vaccine.
A military coup in Guinea-Bissau in late November replaced the entire government. In a media statement last week, the new health minister, Quinnhine Nantote, confirmed that his government was not involved in discussions about the study.
Under RFK, the US has suspended funding to Gavi, the vaccine alliance that helped distribute critical doses to less-wealthy nations during the COVID-19 pandemic. In a statement justifying Gavi’s cuts, RFK cited the work of the Bandim Health Project.
The US has reduced the number of vaccines recommended for newborns from 17 to 11. In December, the Department of Health overturned a decade-old recommendation to give infants the HBV vaccine at birth, and now says parents and doctors should make their own decisions.
A painful history of trials gone wrong
For many, the controversial trial is reminiscent of Western-led health practices that have proven deadly for minority communities and poor countries in the past.
During a severe outbreak of meningitis in the northern state of Kano, Nigeria in 1996, Pfizer administered the experimental antibiotic Trovan to 200 children. Drugs not approved by the US Food and Drug Administration caused severe reactions in children. At least 11 of them died and others suffered injuries ranging from paralysis to blindness.
This case contributes to the high level of vaccine mistrust in northern Nigeria. In 2003, many boycotted the national polio vaccination campaign, leading to a An explosion in polio cases A year later, Nigeria carried 80 percent of the world’s cargo at that time. The Covid-19 vaccine campaign similarly faced major setbacks in the region.
Much earlier, between 1932 and 1972, US health officials studying the effects of untreated syphilis on about 400 black men in Tuskegee, Alabama, observed that they died even when effective treatments such as penicillin were already available. More than 100 men died in the trial.
Back in Bissau, former health minister Robalo told Al Jazeera that the country’s priority was not to retest the hepatitis B vaccine, but to provide enough so that babies could receive the birth dose immediately.
The Bandim Health Project, she said, has been operating in Guinea-Bissau for decades and should know which agencies to turn to, especially after a military coup. Over the years, researchers should train enough Bissau-Guinea in clinical research to boost local capacity, she added.
“We are not second-class citizens,” Robalo said. “We are not a population to be used for anything you can’t do in the Global North. We demand respect despite the fact that we don’t have the necessary capabilities. We don’t tolerate it.”