An institutional ethics committee in Denmark has cleared a contentious clinical trial that plans to withhold the hepatitis B vaccine at birth from thousands of newborns in Guinea-Bissau, prompting immediate resignations from committee members and strong pushback from international health specialists, The Guardian reported Friday.
The study, conducted by Danish researchers Christine Stabell Benn and Peter Aaby of the University of Southern Denmark, seeks to evaluate 14,000 infants. Under the research protocol, half of the infants would receive the standard hepatitis B shot at birth, while the other half would have the dose delayed until six weeks of age. The researchers aim to track overall infant mortality alongside secondary outcomes like skin ailments and neurodevelopmental conditions.
Ethical Resignations and Health Concerns
Four members of the ethics committee at the University of Southern Denmark stepped down following the vote to approve the project. Reviewer Stig Børsen Hansen resigned in protest on Friday, telling The Guardian that the protocol placed infants into a lottery where those not selected for vaccination face avoidable infection risks “by design.”
Hepatitis B is widespread in Guinea-Bissau, where roughly 18 percent of adults carry the pathogen. While vertical transmission from mother to infant occurs during labor, the virus also spreads easily through household contact and can survive on surfaces for days. Infants infected in early life face high risks of developing lifelong complications, including cirrhosis and liver cancer.
Critics, including Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, have condemned the design as a violation of basic medical ethics. Offit told Rolling Stone that withholding care in a high-prevalence setting guarantees severe illness for some participants.
“It’s a wholly unethical trial, and it shouldn’t be allowed,” Offit told Rolling Stone.
The World Health Organization warned earlier this year that withholding proven medical interventions due to local resource limitations breaches the ethical standards set by the Declaration of Helsinki, which mandates the best proven care for research subjects.
U.S. Backing and Funding Scrutiny
The trial has received prominent support from U.S. Health and Human Services Secretary Robert F. Kennedy Jr., who has frequently highlighted Benn and Aaby’s research at anti-vaccine gatherings. Rolling Stone reported that political appointees inside the U.S. Centers for Disease Control and Prevention instructed the agency’s budget office in late September to earmark $1.6 million for the project from global health security funds. The project is also slated to receive matching private donations from the Bluebell Foundation and the Pershing Square Foundation, co-founded by financier Bill Ackman.
Benn and Aaby have defended the trial, maintaining that Guinea-Bissau does not currently administer universal hepatitis B shots on day zero. Because the government does not plan to institute a nationwide birth-dose regimen until 2028, the researchers argue that infants placed in the control group receive standard local care rather than substandard treatment.
Danish authorities are separately investigating Benn and Aaby over accusations of scientific misconduct related to earlier vaccine research, according to reporting by Rolling Stone and the Danish publication Weekendavisen. Both researchers have denied manipulating or suppressing any scientific data.
Uncertain Path to Implementation
The researchers adjusted their design earlier this year to screen pregnant mothers and exclude infants born to women testing positive for hepatitis B, though experts note rapid tests carry false-negative margins and miss community exposures. Whether the trial will immediately launch remains in question. An official with the Africa CDC indicated Thursday that talks between Guinea-Bissau and the United States remain ongoing, while government authorizations within Guinea-Bissau have faced conflicting reports following an earlier suspension ordered by the country’s health ministry.
