Controversial Hepatitis B Birth-Dose Trial Approved in Guinea-Bissau

A randomized trial of 14,000 newborns in Guinea-Bissau will give the hepatitis B vaccine at birth to half of the participants and withhold it for the first six weeks for the other half. The study was cleared this week by the University of Southern Denmark’s ethics committee and green-lit by Guinea-Bissau officials. Funding of $1.6 million from the U.S. CDC will be matched by the Pershing Square Foundation and the Bluebell Foundation. The trial is promoted by U.S. Health and Human Services Secretary Robert F. Kennedy Jr. and is led by Danish researchers Peter Aaby and Christine Stabell Benn of the Bandim Health Project.

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The hepatitis B birth dose is a WHO recommendation to prevent chronic infection, liver cancer and cirrhosis. Guinea-Bissau has one of the world’s highest adult hepatitis B prevalence rates—about 18 %—and does not currently give a universal birth dose, though a national rollout is slated for 2028. The revised protocol, updated in January, screens mothers for hepatitis B and excludes infants of positive mothers, but the document has not been released publicly.

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• Sample size: 14,000 infants

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• Adult hepatitis B prevalence: ~18 %

The Guardian

• CDC allocation: $1.6 million (global-health security funds)

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• Private matching funds: Pershing Square Foundation, Bluebell Foundation

The Guardian

• Hepatitis B test false-negative rate: 5 % (per Offit)

The Guardian

• An Africa CDC official said “ongoing discussions” are taking place between the United States and Guinea-Bissau, with further details to be released.

The Guardian

• The WHO Research Ethics Review Committee and the European Network of Research Ethics Committees declined to conduct an independent review, citing procedural constraints.

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• Paul Offit, Children’s Hospital of Philadelphia, called the design “a wholly unethical trial” and warned that withholding the birth dose could lead to “cirrhosis or liver cancer.”

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• Two members of the Danish ethics panel, including Stig Børsen Hansen, resigned, labeling the enrollment process a “lottery” that deliberately exposes participants to infection.

The Guardian

• The revised protocol’s screening procedures are described only in limited terms; it is unclear how many mothers will be tested or how false-negative results will be handled.

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• While Danish and U.S. officials claim national approval, Guinea-Bissau’s final authorization has not been publicly confirmed, and the trial cannot start until that step is completed.

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• The CDC’s role in securing the grant remains opaque; agency officials have not responded to inquiries about the decision-making process.

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• “You are now enrolling newborns in a lottery to test a hypothesis,” — Stig Børsen Hansen

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• “It’s a wholly unethical trial, and it shouldn’t be allowed,” — Dr. Paul Offit

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The trial remains on hold pending formal authorization from Guinea-Bissau’s national ethics committee. If approval is granted, the study could begin later in 2026, but it is likely to face continued legal and ethical challenges from international health bodies and vaccine-expert groups.

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