A controversial research trial planning to withhold the hepatitis B vaccine from 14,000 newborns in Guinea-Bissau has received formal approval from a Danish university, though the study still lacks final authorization from the West African nation’s government amid widespread international condemnation and ethical scrutiny.
The University of Southern Denmark confirmed that its faculty of health sciences gave the green light to proceed with the revised protocol involving 14,000 infant participants. Backed by a 1.6 million dollar grant from the United States Centers for Disease Control and Prevention, the research project was previously put on hold following global outcry over its design.
University Approves Revised Protocol After Ethics Review
Jakob Grauslund, of the faculty of health sciences at the University of Southern Denmark, stated that he approved the study after receiving an independent ethical assessment from the institution’s research ethics committee. The revised plan also secured ethical clearance from the relevant committee in Guinea-Bissau earlier in the summer. In late September, staff within the CDC director’s office instructed the budget office to set aside $1.6 million for the project, pulling funds designated by Congress for global health security programs.
Danish researchers received institutional ethics approval this week to run a trial in Guinea-Bissau that will enroll 14,000 newborns and delay the hepatitis B birth dose for half the infants for six weeks. The protocol change says mothers will be tested before birth and infants…
Under the updated study design, researchers will screen pregnant women before delivery. Infants born to mothers who test positive for hepatitis B will receive the vaccine immediately and remain excluded from the trial, a change intended to address concerns regarding mother-to-child transmission. For other participants, half of the newborns will receive a birth dose of the vaccine, while the other half will follow Guinea-Bissau’s current national schedule, which defers hepatitis B vaccination until six weeks of age.
Critics Argue Trial Methodology Violates Ethical Standards
The trial’s core methodology has triggered intense debate among public health specialists, epidemiologists, and human rights advocates worldwide. Critics argue that withholding a proven, life-saving birth dose in a high-prevalence region violates established ethical standards. The World Health Organization recommends administering the vaccine within 24 hours of birth, noting that it reduces perinatal transmission risk by 70 to 95 percent, and previously estimated that the initial design did not adhere to recognized scientific and ethical principles.
Paul Offit criticized the timing of the first dose as the central dispute, noting that the researchers and US officials were taking advantage of a delayed national rollout to put children at risk unnecessarily. Stig Børsen Hansen, a founding member of the Danish committee who served as one of two reviewers, resigned in protest on Friday following the university vote to proceed. Other organizations have echoed those alarms. Colette Delawalla, founder and CEO of Stand Up for Science, labeled the project a gross violation of human rights and the use of bad science against some of the most vulnerable people in the world, adding that her nonprofit is exploring all available actions to halt the research.
Researchers Defend Design Against Local Vaccine Schedule
Christine Stabell Benn and Peter Aaby lead the study through the Bandim Health Project. Investigators have defended their approach by arguing that the trial evaluates the addition of a birth dose that is not yet included in the Guinea-Bissau vaccination schedule. In a statement posted to the Bandim website, the researchers maintained that no child enrolled in the study will receive fewer vaccines than under current national policy in Guinea-Bissau. The couple also categorically denied that they have deliberately withheld data or attempted to misrepresent their research amid separate investigations by Danish authorities.
I resigned from the Research Ethics Committee following its verdict on this project.
Proponents of the trial point out that the country does not currently provide universal hepatitis B vaccinations at birth, though national plans aim to launch universal coverage by 2028 after previously being scheduled for 2027.
Government Authorization Remains Pending
Despite the institutional green light from Denmark, final governmental authorization in Guinea-Bissau has, however, not yet been granted, meaning the clinical trial cannot legally commence until national authorities issue formal clearance. Health Minister Quinhin Nantote had initially suspended the research earlier in the year due to a lack of sufficient coordination.
Readers reviewing these developments should consult qualified public health professionals, pediatricians, or institutional review boards to discuss established immunization guidelines and clinical trial ethics.