Officials in Guinea-Bissau and an ethics committee at the University of Southern Denmark have approved a US-backed hepatitis B trial involving 14,000 newborns. Supported by HHS Secretary Robert F. Kennedy Jr. and $1.6 million in CDC global health funding, the study randomizes infants to receive or withhold birth doses despite an 18% adult infection rate in Guinea-Bissau. Four Danish committee members resigned in protest over ethical violations.
Guinea-bissau trial authorization
- ▪University of Southern Denmark Faculty of Health Sciences Dean Jakob Grauslund stated that final national government authorization in Guinea-Bissau is required before the trial can begin.
- ▪The University of Southern Denmark ethics committee and Guinea-Bissau officials approved a controversial US-backed hepatitis B birth-dose vaccine trial in Guinea-Bissau.
Trial design and protocol
- ▪The revised trial protocol screens mothers for hepatitis B prior to birth and excludes infants of positive mothers, while enrolling infants of mothers who test negative.
- ▪The Guinea-Bissau hepatitis B trial will enroll 14,000 newborns, giving half the newborn dose at birth and withholding it from the other half for six weeks.
Bandim Health Project researchers
- ▪The Bandim Health Project, which operates the trial, is led by University of Southern Denmark researchers Peter Aaby and Christine Stabell Benn.
- ▪Danish authorities are investigating Bandim Health Project researchers Peter Aaby and Christine Stabell Benn over allegations of falsification and scientific misconduct in prior vaccine research.
Funding for the trial
- ▪The Centers for Disease Control and Prevention set aside $1.6 million in global health security funds for the Guinea-Bissau hepatitis B trial led by Danish researchers.
- ▪The CDC funding for the Guinea-Bissau hepatitis B vaccine trial will be matched by private funding from the Pershing Square Foundation and the Bluebell Foundation.
Political involvement and vaccine agenda
- ▪Children's Hospital of Philadelphia physician Paul Offit stated that U.S. Health Secretary Robert F. Kennedy Jr. aims to eliminate the newborn hepatitis B birth dose in the United States.
- ▪U.S. Health and Human Services Secretary Robert F. Kennedy Jr. promoted the Danish researchers' hepatitis B study as exemplifying the Trump administration's vaccine agenda.
Ethics committee resignations and rule changes
- ▪Resigning ethics reviewer Stig Børsen Hansen stated that randomizing newborns in Guinea-Bissau to withhold the hepatitis B birth dose subjects them to infection by design.
- ▪Stig Børsen Hansen and three other members resigned in protest from the University of Southern Denmark ethics committee over the approval of the Guinea-Bissau vaccine study.
- ▪Aarhus University professor Henrik Støvring noted that the University of Southern Denmark institutional ethics committee altered its rules to vote on the international study.
International research ethics guidance
- ▪In February 2026, the World Health Organization stated that resource constraints cannot be used to justify withholding proven medical care in research studies involving people.
- ▪World Health Organization guidelines and the Declaration of Helsinki require medical trials to provide the best proven intervention regardless of a host country's baseline care.
Hepatitis B transmission and health risks
- ▪Approximately 18 percent of adults in Guinea-Bissau carry hepatitis B, putting unimmunized newborns at risk of chronic infection, liver cirrhosis, and liver cancer.
- ▪Infectious disease physician Paul Offit noted that maternal hepatitis B tests have a 5 percent false negative rate and that the virus can transmit casually in community settings.
Guinea-bissau vaccine implementation
- ▪Guinea-Bissau experienced a coup in November 2025 and currently lacks the resources and infrastructure to provide routine newborn vaccinations.
- ▪Guinea-Bissau authorities intend to begin universal newborn administration of the hepatitis B birth dose in 2028, after pushing back a planned 2027 rollout.
Debatable claims
- ▪Maternal screening is insufficient to protect newborns from hepatitis B transmission in the trial
- ▪Withholding the hepatitis B birth dose in the Guinea-Bissau trial violates international ethical standards
- ▪The CDC should withhold funding from the Guinea-Bissau hepatitis B vaccine study
Story comments
Loading comments…