Danish Researchers Target Newborns in Guinea-Bissau
In Bissau, capital of the West African nation of Guinea-Bissau, a controversial clinical trial designed to test non-specific effects of the hepatitis B vaccine on newborns was brought to a halt after a police raid on the offices of Danish researchers, defector.com reported. The study, backed by a $1.6 million grant from the Centers for Disease Control and Prevention awarded on December 18, 2025, aims to enroll thousands of infants to examine health outcomes when the standard birth dose is withheld.
The proposed research targets 14,000 newborns, splitting them evenly between those who receive the vaccine at birth and those who have the immunization delayed until six weeks of age. Guinea-Bissau currently administers the vaccine at six weeks due to infrastructure constraints, though national plans target universal birth doses by 2027 in alignment with World Health Organization guidelines. Nearly one in five individuals in the country live with chronic hepatitis B, a virus that leads to cirrhosis and liver cancer.
University of Southern Denmark Researchers Face Ethics Backlash
The study was designed by Christine Stabell Benn and Peter Aaby of the Bandim Health Project. Robert F. Kennedy Jr. has frequently praised the Danish researchers’ work on non-specific vaccine effects, citing their studies when announcing U.S. funding cuts to the international vaccine agency Gavi. However, the trial design drew sharp criticism from infectious disease specialists who pointed to significant ethical and methodological flaws.
David Boulware, an infectious disease physician at the University of Minnesota, noted that the protocol failed to screen mothers for hepatitis B prior to delivery. Because transmission rates from infected mothers are high, withholding the vaccine from infants born to positive mothers carries severe health risks. Following a protocol leak in January, the Africa Centers for Disease Control and Prevention announced the study’s cancellation, and World Health Organization Director-General Tedros Adhanom Ghebreyesus called the project unethical.
University Ethics Committee Reopens Controversial Trial Protocol
The revised protocol includes mandatory pre-natal screening for mothers, excluding infants born to positive mothers from the study while enrolling newborns of negative mothers into the randomized delay group. Four members of the university ethics committee resigned in protest of the decision.
Critics maintain that the revised trial remains hazardous. The test used to screen mothers carries a five percent false-negative rate, and withholding immediate protection from thousands of newborns leaves infants vulnerable to transmission.
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