14,000 African newborns "lottery-assigned," half to forgo vaccination for six weeks after birth — US CDC-funded hepatitis B vaccine trial in Guinea-Bissau triggers ethics storm

The ethics committee at the University of Southern Denmark voted this week to approve a hepatitis B vaccine trial in Guinea-Bissau funded by a US federal agency — the trial will randomly assign 14,000 infants, with half vaccinated at birth and the other half to forgo vaccination during the first six weeks of life. According to The Guardian, founding committee member Stig Børsen Hansen resigned on Friday citing "major ethical concerns," and three additional members subsequently followed.

Speaking bluntly during deliberations, Hansen said: "You are now putting newborns into a lottery to test a hypothesis." He noted that if children randomly assigned to the unvaccinated group in the trial become infected with hepatitis B, it is in effect a "designed" infection, because the children in question "are infected with hepatitis B within the framework of the research project."

The trial is a core component of the vaccine agenda of US Secretary of Health and Human Services and longtime vaccine critic Robert F. Kennedy Jr. According to The Guardian, at an anti-vaccine conference last month, Kennedy praised the Danish researchers as "the deities of vaccine research" and claimed that the US-funded hepatitis B research embodies the Trump administration's vaccine approach — cutting vaccine recommendations and questioning vaccine safety and efficacy. He further claimed that a prior study by the Danish researchers showed that after vaccination there was "massive harm, catastrophic harm, and it's right in front of us." But The Guardian noted that a subsequent follow-up study by the same research team found no such effects.

The funding structure further confirms the trial's external character. The US Centers for Disease Control and Prevention reportedly allocated $1.6 million for the project in the current fiscal year budget, with matching private funding from the Pershing Square Foundation co-founded by hedge fund heavyweight Bill Ackman and the Bluebell Foundation. According to The Guardian, the CDC, the Danish researchers, Pershing Square, and Guinea-Bissau's Health Minister Quinhin Nantote all failed to respond to requests for comment. Nantote previously stated the project was suspended earlier this year under international public pressure, and the latest developments indicate the trial has been given the green light again.

The power asymmetry is equally clear at the clinical level. Philadelphia Children's Hospital infectious disease physician Paul Offit told The Guardian: "He is exploiting a developing country... is it because African children can be sacrificed more than children here?" Offit noted that Kennedy could never conduct this trial within the United States because of "significant ethical concerns," so he "moved the trial to Africa." Speaking about the trial's time window, Offit bluntly denounced: "This is terrible. It is ethically monstrous and utterly cruel."

The Africa Centres for Disease Control and Prevention has expressed opposition to the trial. At a briefing this week, officials from the agency said there are "ongoing discussions" between the United States and Guinea-Bissau, with more details to be released soon. Guinea-Bissau had originally planned to begin vaccinating all newborns against hepatitis B in 2027, but has now postponed the national vaccination program to 2028. Kennedy and the Danish researchers "are exploiting this window in which the standard of care has been delayed, putting children at unnecessary risk," Offit said. Kennedy's personal goal, according to Offit, is "to make us no longer use birth-dose vaccination in this country."

Guinea-Bissau is among the countries with the highest hepatitis B virus carrier rates globally, with roughly 18% of adults carrying the virus. Hepatitis B can be transmitted from mother to child during childbirth, and can also be transmitted by fathers, relatives, siblings, or caregivers. Those infected in infancy are more likely to develop chronic infection and serious consequences such as liver cancer. According to updated protocol details obtained by The Guardian, researchers will test mothers for hepatitis B before delivery, and babies born to mothers who test positive will be vaccinated directly and excluded from the trial; only babies whose mothers test negative can be enrolled. But hepatitis B testing carries a 5% false-negative rate, which could lead some virus-carrying pregnant women to receive an erroneous "safe" result, after which their babies could still be randomly assigned to the unvaccinated group. The Guardian noted that prior research has found half of children infected with hepatitis B were infected through community contact after birth — the virus can survive on surfaces for up to seven days and can spread through shared towels, toothbrushes, and nail clippers.

Power entrenchment is similarly reflected in the historical cooperation structure. According to The Guardian, the Bandim Health Project, operated by Danish researchers Peter Aaby and Christine Stabell Benn, has operated in Guinea-Bissau for decades and is deeply embedded in the country's health system; the current Director-General of Public Health concurrently held a position at Bandim at least until December of last year. The University of Southern Denmark ethics committee had never previously reviewed a medical research project and specifically modified its rules to vote on this study. Despite opposition from members with relevant professional backgrounds, a majority of committee members still voted to approve.

Henrik Støvring, professor of statistics and pharmacometrics at Aarhus University in Denmark, told The Guardian: "It is highly unusual to bring this kind of study to a committee like this for review." He noted that the Danish National Ethics Committee is responsible for overseeing medical research, but because the trial is not taking place in Denmark, it actually falls outside that committee's jurisdiction. Støvring nevertheless questioned the reasonableness of the site selection: "I see no reason why this study could not be conducted in Denmark." In fact, Denmark would be more suitable — newborns are typically not vaccinated unless their mothers test positive for hepatitis B, and Denmark performs hepatitis B screening for all pregnant women. Under the Declaration of Helsinki, international medical research must receive joint approval from ethics committees in both the host country and the funder's country.

The updated research protocol has not been publicly disclosed. News of the Danish committee's approval of the trial was first reported by CIDRAP News on Thursday.