US plan for $1.6m hepatitis B vaccine study in Africa called ‘highly unethical’ | Vaccines and immunisation

The Trump administration said it would fund a $1.6 million study to vaccinate newborns for hepatitis B in the West African country of Guinea-Bissau, where nearly one in five adults live with the virus. Researchers call this “highly unethical” and “extremely risky.”

The news follows an official change from the US Centers for Disease Control and Prevention (CDC) to recommendations regarding hepatitis B vaccinations at birth. in the name Although safe and effective vaccination has been available for decades and there is no evidence of harm, receiving vaccines is an “individual” decision. It’s part of U.S. Surgeon General Robert F. Kennedy Jr.’s sweeping changes to childhood vaccines; these changes have global consequences; including cutting funding for programs that bring vaccines to countries around the world.

“He has a fixed, unwavering belief that vaccines cause harm,” said Paul Offit, director of the Vaccine Education Center and a physician at the Children’s Hospital of Philadelphia. “He’ll do whatever he can to prove it.”

The actions taken this year by Kennedy, a longtime anti-vaccine activist, have “a global impact,” said Elizabeth Jacobs, a professor emeritus at the University of Arizona and a founding member of the grassroots public health advocacy group. “It is spreading around the world like an infection in itself.”

Gavin Yamey, a professor of global health at the Duke Global Health Institute, said testing established vaccines in a country with high hepatitis B rates and a fragile health system “reeks of neo-colonial attitudes” and risks increasing global distrust of the United States and science.

Kennedy sent shockwaves through global health when he announced in June that the United States would end funding for Gavi, the Vaccine Alliance that has vaccinated more than 1.2 billion children and saved an estimated 20.6 million lives, citing an extraordinary 2018 study to justify the action.

to work made an alarming claim: Diphtheria-tetanus-pertussis (DTP) vaccine caused the death of young girls in Guinea-Bissau. It was published by a group of Danish researchers, including a married couple named Peter Aaby and Christine Stabell Benn.

But when Kennedy made his 2025 announcement, he didn’t mention 2022. paper The fact that some of the same authors found completely different results on the same topic essentially invalidates the initial study.

“As in a previous study, we did not find that early DTP was associated with increased female mortality,” the researchers wrote.

This is an example of questionable research that has come under criticism from other researchers and journalists who have examined its findings.

Now the same researchers will be the ones conducting the new study on the hepatitis B vaccine in Guinea-Bissau. US funding will go Bandırma Health ProjectLed by Aaby and Stabell Benn from the University of Southern Denmark.

Aaby and Stabell Benn did not respond to the Guardian’s questions about details of the five-year study, which is planned to start in early 2026.

Babies in the randomized, controlled trial will either receive or not receive the hepatitis B vaccine at birth. Researchers will then compare early mortality, morbidity and development between groups. award announcement From the CDC.

World Health Organization recommends We administer the vaccine to all babies at birth, but Guinea-Bissau is struggling to expand the vaccine to every newborn child. to recommend dose at six weeks of age. The country has pledged to fill this gap and plans to offer hepatitis B vaccination to all newborns in 2027.

Preventing an intervention that has proven to be safe and effective is a gross violation of scientific ethics. “Choosing to vaccinate some children and not others is highly unethical,” Offit said.

Yamey noted: “There is already an RCT [randomized, controlled trial] Better results are achieved with the birth dose, so why is there a need for another?”

The study does not appear to look at whether the vaccine is more effective at birth; Jacobs said it’s “concerning” because “nowhere in this do they say they’re going to study the effectiveness of the vaccine.”

Instead, the trial will examine whether there are “general health effects” when vaccinated at birth, rather than specific outcomes such as preventing virus infection. based on Bandırma Health Project

“This announcement set off alarm bells in the global health community,” said Martin McKee, professor of European public health at the London School of Hygiene and Tropical Medicine, who described it as symptomatic of “a policy desperately seeking evidence.”

“It’s unclear what the research question is. It seems to be about the safety of the vaccine rather than its effectiveness, but both are already well established and it seems extremely risky to conduct such a study in a population where almost a fifth of the adult population has evidence of infection,” McKee said.

He also questioned whether participants could truly give informed consent, given ethical concerns about how the study was conducted.

In a recent study, about 18% of Bissau-Guinean adults had hepatitis B, a virus that can lead to cirrhosis or liver cancer, especially in young children. If a baby is infected in the first year of life, there is a 90% chance of developing cirrhosis or liver cancer; There is a 25% chance between the ages of one and five. Approximately 5% of adults have chronic infection.

recently to work Andrew Pollard, professor of pediatric infection and immunity at the University of Oxford and director of the Oxford Vaccine Group, said about 11.2 per cent of toddlers in Guinea-Bissau already had hepatitis B infection, meaning not enough babies were vaccinated. He added that in sub-Saharan Africa, only 17 percent of babies receive the recommended birth dose.

“The priority should be to increase vaccination with the birth dose of the hepatitis B vaccine and protect more babies from the risk posed by this virus,” Pollard said.

In the U.S., vaccination is recommended at birth for all babies, not just those at risk of infection, causing rates among children to drop rapidly, from 20,000 to about 20 per year.

“We have virtually eliminated hepatitis B in children under 10,” Offit said. Children can be infected at birth, but they can also come into contact with other children and adults carrying the virus, which can remain infectious on surfaces for up to a week.

Experts expressed concerns about how the study would be carried out. They said it was unusual for such a hearing to be held in Guinea-Bissau rather than the United States or Denmark.

“Why is this study being done in a high-endemic setting where birth dose is most important?” Yamey asked.

in Denmark only three in 1000 There is a virus in humans, and vaccination is not currently recommended at birth, which means the same study can be done here. Denmark also has health registries that facilitate access to full medical records. Instead, working in a country where health care is insecure and disease rates are high could lead to “increased mistrust of global public health,” Jacobs said.

The United States canceled most of its global aid and research earlier this year, Jacobs said.

“It’s really concerning when the United States cancels all this funding for vulnerable countries and then still pays for this research to be done,” he said. “It appears that we do not value your lives sufficiently to continue providing general support, but we will not hesitate to conduct experiments on your population.”

The study is single-blind, meaning patients won’t know who got the vaccine and who didn’t, but the research team will; This can affect how data is collected and interpreted. “This means they can imprint their own biases on the results,” Yamey said. Jacobs said the endpoints, or “overall health effects,” were “very soft,” leaving the results open to manipulation.

Henrik Støvring, professor of statistics and pharmacometrics at Aarhus University, has co-authored a paper on the subject. red flags Research by the Bandim Health Project for the journal Vaccine this month noted that “broad hypotheses such as this carry a high risk of false positive findings, and in general the research group has previously been reluctant to use appropriate statistical methods to reduce such risk.”

“I think conflicts of interest are always an issue when the donor explicitly seeks out a research group and funds a study,” Støvring said.

Danish journalist Gunver Lystbæk Vestergård also written About important issues related to the research conducted by Aaby and Stabell Benn.

After the CDC sparked outrage by changing its hepatitis B vaccine recommendation without any evidence, Jacobs said: “Now they’re funding this to try to cover themselves up for doing this.”

“Because Robert F. Kennedy Jr. is an anti-vaccine fanatic, he will somehow distort this study into saying that the hepatitis B birth dose causes harm” or that it would be better to delay vaccines, Offit said.

Scientists, doctors and medical organizations have spoken out against Kennedy, he said, but “this is a political problem and requires a political solution.”

Meanwhile, Offit said that children will bear the brunt of these decisions and continued: “This breaks my heart. It really is. It is very difficult to sleep knowing that children are constantly endangered by the administration.”