The CDC awarded an unsolicited, no-bid $1.6 million grant to a University of Southern Denmark team for a five-year randomized trial involving about 14,000 newborns in Guinea-Bissau. The proposed study would compare a hepatitis B vaccine dose given at birth with the later first dose used under the country’s current policy, while tracking deaths, illness and developmental outcomes.
The funding and design drew unusually sharp criticism. WHO Director-General Tedros Adhanom Ghebreyesus called the study unethical, while HHS and the investigators defended it as research into broader health effects and vaccine policy. Reports from African officials and HHS later disagreed about whether the trial had been halted. Its final status remained unresolved in the latest reporting.
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What the CDC funded
In December 2025, the Associated Press reported that the CDC gave the University of Southern Denmark an unsolicited, no-bid award worth $1.6 million. The project was planned to run for five years and involve roughly 14,000 newborns in Guinea-Bissau. STAT described a planned enrollment of about 14,500 infants, so the safest general description is “about 14,000.”
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|---|---|
| Funder | U.S. Centers for Disease Control and Prevention |
| Recipient | University of Southern Denmark researchers associated with the Bandim Health Project |
| Amount | $1.6 million |
| Procurement | Unsolicited and no-bid, according to the Associated Press |
| Planned duration | Five years |
| Planned population | About 14,000 newborns; STAT reported approximately 14,500 |
| Comparison | Hepatitis B vaccine at birth versus the later first dose under Guinea-Bissau’s current schedule |
| Outcomes named in the grant description | Early-life mortality, morbidity and long-term developmental outcomes |
The researchers included Christine Stabell Benn and Peter Aaby. AP reported that Benn had been praised by U.S. Health Secretary Robert F. Kennedy Jr. and had served as a consultant to a Kennedy-appointed vaccine committee. Public Citizen, an advocacy organization, separately reported additional support from the Pershing Square Foundation; that account should be understood as an advocacy-source description rather than a CDC funding announcement.
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How the funding process became part of the controversy
An unsolicited award does not automatically establish that a study is invalid, but it differs from the normal competitive grant process in which multiple proposals are evaluated against published criteria. AP cited a CDC official who said the award did not receive the agency’s customary ethics review. That reported omission intensified questions about whether the project had received the level of independent scrutiny expected for research involving newborns.
The dispute therefore concerns both the scientific question and the route used to finance it. Critics have asked why a study that could influence an established infant-immunization policy was funded without a conventional competition and without the customary CDC ethics process described by AP. HHS and the investigators have maintained that the protocol received ethical review in Guinea-Bissau and that the work would meet applicable standards.
What the proposed trial would do
Randomized vaccine timing
Under the plan described by AP and STAT, newborns would be assigned to one of two schedules: a hepatitis B dose at birth or the later first dose that Guinea-Bissau’s policy used when the proposal was developed. Researchers would then follow the children for death, illness and longer-term developmental outcomes.
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The investigators’ defense is that the comparison does not remove any vaccine required by the existing national schedule. Benn told STAT: “No child in the study receives fewer vaccines than under current national policy. All children receive routine vaccines; half receive an additional hepatitis B birth dose that they would not otherwise receive.” In that framing, the birth-dose group receives an extra intervention, while the comparison group receives the local standard schedule.
What the protocol was designed to measure
STAT reported that the grant’s stated goal was to assess the birth dose’s effects on “early-life mortality, morbidity, and long-term developmental outcomes.” Critics noted that the design did not appear aimed primarily at measuring hepatitis B infection rates or the direct protective benefit of vaccination against infection. That distinction matters because a study can investigate broader effects of an intervention without directly answering how well it prevents the disease it targets.
Why WHO and other experts objected
The ethical baseline
WHO recommends hepatitis B vaccination at birth, and STAT reported that at least 150 countries follow that advice. WHO immunization director Kate O’Brien described the vaccine as “safe” and “extremely effective.” WHO Director-General Tedros Adhanom Ghebreyesus said: “Of course, a sovereign country can decide whatever they want, but as far as WHO’s position is concerned, it’s unethical to proceed with this study.”
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The central criticism is that a country’s current practice is not necessarily an adequate ethical control when a proven intervention is globally recommended. Scientific American reported that a leaked protocol prompted comparisons with the Tuskegee syphilis study. Wilbur H. Chen of the University of Maryland told the magazine: “The protocol provides no ethical justification to withhold from vulnerable infants a lifesaving vaccine.” Emory infectious-diseases physician Boghuma K. Titanji called the study “unconscionable” and warned, “There’s so much potential for this to be a harmful study,” according to AP.
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STAT reported that newborns infected with hepatitis B have about a 90% chance of developing chronic infection. It also reported that roughly one-quarter of people with chronic infection die prematurely from liver disease. Those figures were presented by STAT with reference to the evidence it cited; they are not a new CDC estimate.
Guinea-Bissau was reported to have substantial hepatitis B circulation. Public Citizen cited chronic hepatitis B prevalence of about 20%, while STAT cited a study finding nearly 19% adult positivity. These are reported estimates from the named sources, not the result of a new prevalence survey described here.
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Why Guinea-Bissau’s policy context matters
When the proposal was developed, Guinea-Bissau did not routinely provide a hepatitis B birth dose. The country had announced plans for universal newborn vaccination in 2027, with later reporting suggesting the change could move to 2028. Investigators described the period before that policy change as a limited “window of opportunity” to compare schedules.
Critics responded that a temporary local standard does not automatically make randomization away from a globally recommended birth dose acceptable. They also questioned whether results from Guinea-Bissau could be transferred to U.S. policy. The country’s infant schedule includes BCG and oral polio vaccines, and those co-administered vaccines, along with local disease patterns and health conditions, could affect mortality or development outcomes independently of hepatitis B vaccination.
Was the trial cancelled?
No definitive public resolution had emerged in the reports reviewed for this article. Statements from Guinea-Bissau and Africa CDC officials described the project as cancelled, suspended or requiring additional ethical review. HHS, by contrast, said the trial would proceed as planned, and the investigators said Guinea-Bissau’s ethics committee had reviewed their protocol.
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| Question | What the reporting established |
|---|---|
| Had enrollment started? | STAT reported that the trial had not begun as of its February 2026 update. |
| Was it registered? | STAT said it was not listed on ClinicalTrials.gov at that time; investigators said they would register it before initiation. |
| What did African officials say? | Reports characterized the study as cancelled, suspended or subject to further ethical review. |
| What did HHS say? | HHS said the trial would proceed and that appropriate standards would be met. |
| What did investigators say? | They defended the comparison as adding a birth dose for half the infants and said Guinea-Bissau’s ethics committee had reviewed the protocol. |
Because these accounts conflict, it is not accurate to describe the study as definitively cancelled or definitively underway. A registration record, formal suspension notice or later statement from the relevant authorities would be needed to settle its disposition.
What the dispute is really about
The controversy combines five separate questions that are often blurred together:
- Funding: whether an unsolicited, no-bid CDC award and the reported absence of customary CDC ethics review provided adequate oversight.
- Ethics: whether the local schedule can serve as a control when WHO recommends a hepatitis B birth dose.
- Scientific aim: whether measuring mortality, illness and development justifies a design that is not primarily powered to measure hepatitis B infection prevention.
- Generalizability: whether findings from Guinea-Bissau’s epidemiology and vaccine schedule would apply to U.S. infants.
- Governance: which review and authorization claims prevail among Guinea-Bissau officials, Africa CDC, HHS and the investigators.
The established facts are the CDC’s reported $1.6 million award, the proposed randomized timing comparison, WHO’s public ethical objection and the conflicting accounts of the project’s status. Whether the trial can ethically and scientifically proceed remains the unresolved issue.
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