The Trump administration has directly awarded a $1.6 million contract to a Danish research team to study the effects of withholding the hepatitis B vaccine from newborns in Africa, a move that has ignited a fierce ethical debate within the global public health community.
Controversial Study Design and Ethical Alarms
According to a federal notice, the US Centers for Disease Control and Prevention (CDC) granted the no-bid contract to a team at the University of Southern Denmark. The study, set to begin in early 2026, will involve 14,000 newborns in Guinea-Bissau, a West African nation with high rates of hepatitis B infection.
The research is designed as a randomised controlled trial. Some infants will receive the hepatitis B vaccine at birth, while others will not. All children will be monitored for death, illness, and long-term developmental outcomes. The protocol states there is no placebo involved.
This design has provoked outrage among leading medical experts. They argue it is unethical to withhold a vaccine with a decades-long proven safety record from infants at significant risk of a dangerous, lifelong infection. Dr. Boghuma K. Titanji, an infectious diseases specialist at Emory University, labelled the study "unconscionable," warning it could exacerbate vaccine hesitancy in Africa.
Links to Vaccine Sceptics and Bypassed Reviews
The Danish research team is led by Christine Stabell Benn, a consultant for a committee appointed by US Health Secretary Robert F. Kennedy Jr., a prominent figure in vaccine-sceptic circles. The committee recently voted to stop recommending a routine hepatitis B vaccine dose for all American newborns.
A CDC official, speaking anonymously, revealed the contract was highly unusual. The proposal was unsolicited and did not go through the agency's customary competitive or ethical review process. Instead, officials from the Department of Health and Human Services (HHS) instructed the CDC to approve it, with HHS providing special funding.
Internally, some CDC scientists have compared the study's premise to the infamous Tuskegee syphilis study, where treatment was withheld from Black men. Dr. Titanji agreed the comparison was apt, stating it involves "researchers watching people grow ill when a medical intervention could have kept them healthy."
Scientific Scrutiny and Defence
The research practices of Benn and her husband, Peter Aaby, have been questioned before. Earlier this year, former CDC Director Dr. Tom Frieden called a 2017 study they co-authored "fundamentally flawed."
In a statement, the Danish research team defended the trial, calling it a unique "window of opportunity" because Guinea-Bissau does not currently recommend a birth dose of the hepatitis B vaccine but plans to introduce universal newborn vaccination in 2027. They also stated the trial was approved by a national ethics committee in Guinea-Bissau.
However, HHS spokesman Andrew Nixon said only that the department "will ensure the highest scientific and ethical standards are met." The study is funded for five years, with the first 500 children enrolled to be followed for that duration to monitor behaviour and brain development.
