Danish University Approves CDC-Funded Trial That Would Delay Hepatitis B Shots for Half of 14,000 Newborns in Guinea-Bissau

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Different Workouts Suited Different MarkersA pooled analysis of 53 trials found that different exercise types helped different metabolic markers. Most of the evidence was low certainty. LUIS ACOSTA | AFP via Getty Images Share on Twitter Share on Facebook Share on Pocket The University of Southern Denmark has approved a disputed U.S.-funded study in Guinea-Bissau that would give the hepatitis B vaccine at birth to only half of the 14,000 newborns it plans to enroll. The university’s dean of health sciences confirmed the decision this week, according to CIDRAP News.

The study, funded with $1.6 million from the Centers for Disease Control and Prevention, still cannot begin because Guinea-Bissau’s government has not granted final authorization. The approval revives a project that health groups condemned as unethical earlier this year and puts U.S. public health dollars at the center of a global debate over research in low-income countries.

The issue is not abstract. Hepatitis B often spreads from mother to child at birth, and a vaccine dose given on the first day of life is one of the most effective tools for preventing lifelong liver infection.

Professor Jakob Grauslund, dean of the university’s faculty of health sciences, said he approved the study based on an independent ethical assessment by the school’s research ethics committee. He said a revised protocol was approved by the relevant ethics committee in Guinea-Bissau this summer. “Final governmental authorization in Guinea-Bissau has, however, not yet been granted,” Grauslund said, adding that the study cannot begin until national authorization is obtained.

The trial is led by Danish researchers Peter Aaby and Christine Stabell Benn of the Bandim Health Project. Half of enrolled babies would be randomly assigned to receive a hepatitis B birth dose along with tuberculosis and polio vaccines. The other half would follow Guinea-Bissau’s current national schedule, which starts hepatitis B vaccination at 6 weeks of age.

The researchers have defended that approach. In a statement on the group’s website, they wrote that no enrolled child “will receive fewer vaccines than under current national policy in Guinea-Bissau.” The country does not yet give a birth dose but plans to introduce one by 2028.

Earlier this year, Guinea-Bissau officials and the Danish university put the study on hold for several months after an international outcry. CIDRAP also reported that, according to Rolling Stone, CDC leaders were pushing for the study to resume. The Department of Health and Human Services did not respond to CIDRAP’s questions before publication.

The timing of the first dose is the central dispute. The World Health Organization recommends that all babies receive the hepatitis B vaccine as soon as possible after birth, ideally within 24 hours. WHO says infection in infancy and early childhood leads to chronic hepatitis in about 95% of cases.

The CDC’s guidance for clinicians says infants infected with hepatitis B have about a 90% chance of developing chronic infection. Chronic hepatitis B can lead to cirrhosis and liver cancer decades later, and it kills 15% to 25% of people with chronic infection, CIDRAP reported.

The stakes are high in Guinea-Bissau, where more than 12% of adults are estimated to be living with chronic hepatitis B, according to WHO. A baby born to an infected mother who misses the birth dose loses the best chance to block transmission, because a first shot at 6 weeks comes after the highest-risk period.

In a WHO statement on the planned trial issued in February, the agency said about 90% of newborns infected during childbirth become chronic carriers and raised significant concerns about the study’s scientific justification and ethical safeguards. WHO said resource constraints “cannot be used to justify withholding proven care in a research study.”

Randomized trials are generally considered ethical only when there is genuine uncertainty about which approach is better. Critics argue that the benefit of a hepatitis B birth dose is already well established, so assigning babies to wait is not a fair comparison.

Supporters of the design say the comparison group receives standard local care. Opponents counter that local policy reflects limited resources, not medical uncertainty, and that a study funded by a wealthy country should not lock in a lower standard.

Stand Up for Science has vowed to stop the study. Its founder and CEO, Colette Delawalla, called it “a gross violation of human rights and the use of bad science.” Wessam Mankoula of the Africa Centres for Disease Control and Prevention said discussions between the U.S. and Guinea-Bissau governments were ongoing.

The study also connects to U.S. vaccine policy. Benn has served as a consultant to a federal vaccine advisory committee that voted to stop recommending a hepatitis B birth dose for all American newborns, the Associated Press reported. That link has drawn scrutiny from public health experts who worry the trial could be used to question birth-dose policies elsewhere.

It is not publicly clear how mothers will be screened or what follow-up infants will receive under the revised protocol, and Guinea-Bissau has not said when it will decide on national authorization.

For U.S. parents, the international dispute does not change the medical evidence. Pregnant people are routinely screened for hepatitis B, and parents can ask their pediatrician or delivery team about the newborn dose before the baby is born. Families who want to check vaccination status can request records from their doctor or state immunization registry.

If Guinea-Bissau grants authorization, enrollment could begin. If it declines, the university’s approval would have little practical effect. MedicalDaily will follow the decision and any response from WHO, Africa CDC, and the CDC.

The University of Southern Denmark approved a CDC-funded study in Guinea-Bissau in which half of 14,000 newborns would receive a hepatitis B vaccine at birth and half would start at 6 weeks.

No. Guinea-Bissau has not granted final government authorization, and the university says the study cannot begin until it does.

The hepatitis B birth dose is a proven way to prevent mother-to-child transmission. WHO and other critics say delaying it for half the babies exposes them to avoidable harm.

How dangerous is hepatitis B for newborns?

WHO and the CDC say about 90% or more of babies infected at birth or in infancy develop chronic infection, which can later cause cirrhosis and liver cancer.

The U.S. Centers for Disease Control and Prevention provided $1.6 million. The research is led by the Bandim Health Project.

The Bandim Health Project says no child in the study will get fewer vaccines than Guinea-Bissau’s current national policy provides.

Does this change hepatitis B advice for U.S. families?

No. WHO recommends a birth dose within 24 hours for all babies. U.S. parents can discuss the newborn dose with their pediatrician or delivery team.