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The CDC awarded an unsolicited, no-bid $1.6 million grant for a five-year randomized study of hepatitis B vaccination in about 14,000 newborns in Guinea-Bissau. The proposed design would give some babies a birth dose and delay the first dose for others, prompting WHO leaders and public-health experts to question whether vulnerable infants were being denied a proven intervention.
What the CDC funded
The Associated Press reported in December 2025 that the CDC awarded an unsolicited, no-bid $1.6 million grant to a University of Southern Denmark team for a five-year newborn trial in Guinea-Bissau. The project was associated with the Bandim Health Project and researchers Christine Stabell Benn and Peter Aaby.
| Element | Reported detail |
|---|---|
| Federal funding | $1.6 million |
| Award route | Unsolicited and no-bid |
| Recipient | University of Southern Denmark research team |
| Planned duration | Five years |
| Planned enrollment | About 14,000 newborns; STAT described the target as about 14,500 |
| CDC review concern | AP reported that the award did not receive customary CDC ethics review, citing an agency official |
Public Citizen, an advocacy organization, separately reported that the Pershing Square Foundation provided additional funding. That account should be understood as an attributed advocacy-source report rather than an official CDC funding statement.
The researchers included Benn, who AP reported had been praised by U.S. Health Secretary Robert F. Kennedy Jr. and had served as a consultant to a Kennedy-appointed vaccine committee.
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How the proposed trial would work
Randomizing the timing of the first dose
The study, referred to as HBV0-NSE, was designed to compare two schedules. One group would receive a hepatitis B vaccine dose at birth. The comparison group would receive its first hepatitis B dose later, following Guinea-Bissau’s policy at the time the proposal was developed.
That distinction matters because the study was not simply comparing two vaccine products. It was comparing immediate protection with delayed vaccination among newborns.
Outcomes beyond hepatitis B infection
STAT reported that the CDC grant’s stated objective was to assess the birth dose’s effects on “early-life mortality, morbidity, and long-term developmental outcomes.” AP described follow-up for death, illness and developmental outcomes.
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Critics noted that the protocol did not appear designed primarily to measure hepatitis B infection rates or the direct protective benefit of vaccination. The trial therefore raised a broader question: whether a study of possible effects on overall child health justified delaying a vaccine that is specifically intended to prevent hepatitis B transmission.
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The investigators’ defense
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.” The researchers argued that the design tested an additional intervention against the country’s existing schedule rather than removing a dose already provided under local policy.
Why WHO and other experts objected
WHO’s ethical objection
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.”
WHO immunization director Kate O’Brien told STAT that hepatitis B vaccine is “safe” and “extremely effective.” STAT reported that at least 150 countries follow WHO advice to vaccinate at birth. From that perspective, using a delayed schedule as the randomized comparison can look like withholding an established preventive measure, even when the delayed schedule reflects current national practice.
The consequences of missing early protection
STAT reported that babies 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, citing the evidence underlying those figures.
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Those risks explain why critics treated the ethical issue differently from an ordinary comparison of vaccine schedules. Emory infectious-diseases physician Boghuma K. Titanji called the proposal “unconscionable” and said, “There’s so much potential for this to be a harmful study,” according to AP.
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.” The comparison reflects concern about research involving a disadvantaged population, not a claim that the hepatitis B project was the same kind of study as Tuskegee.
Questions about scientific relevance
Critics also questioned whether results from Guinea-Bissau could guide U.S. policy. STAT noted that the country’s infant schedule includes BCG and oral polio vaccines, creating a different immunization context from that of American newborns. A result associated with those conditions might not apply to U.S. infants without additional evidence.
Why Guinea-Bissau was chosen
The country’s vaccination policy
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, while later reporting suggested the change might move to 2028.
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The investigators described the period before a policy change as a limited “window of opportunity” to compare schedules. Critics responded that a country’s current standard of care does not automatically make it ethically acceptable to randomize children away from a globally recommended intervention.
Hepatitis B prevalence
Public Citizen reported chronic hepatitis B prevalence of about 20% in Guinea-Bissau. STAT cited a study that found nearly 19% adult hepatitis B positivity. These are reported estimates from the cited sources, not results from a new prevalence survey conducted for this trial.
Independent reader supportYour contribution helps us test, update, and keep practical guides available for everyone.Was the study cancelled?
Public reporting did not establish a single final status. Guinea-Bissau and Africa CDC officials described the project as cancelled, suspended or subject to additional ethical review. HHS said the trial would proceed as planned, and the investigators said Guinea-Bissau’s ethics committee had reviewed their protocol.
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|---|---|
| Guinea-Bissau and Africa CDC officials | Cancellation, suspension or further ethical review |
| HHS | Trial would proceed as planned and meet high ethical standards |
| Investigators | Protocol reviewed by Guinea-Bissau’s ethics committee; registration promised before launch |
STAT reported in its February 2026 update that the trial had not begun and was not listed on ClinicalTrials.gov at that time. The investigators said they would register it before initiation. Because the public accounts conflict, the project’s final disposition remains unresolved without a later authoritative notice.
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What the funding dispute reveals
Unsolicited funding versus competitive review
An unsolicited, no-bid award means the proposal was not selected through an open competition among submitted applications. AP’s report that customary CDC ethics review did not occur before the award intensified concern because the study involved newborns, a contested intervention and a research setting with limited resources.
Local authority and global standards
Guinea-Bissau is a sovereign country and can set its own immunization policy. The dispute is whether local policy alone is enough to establish an ethical baseline for research when WHO recommends a birth dose and the disease burden is substantial.
Evidence generation versus immediate prevention
HHS and the investigators presented the project as evidence generation about mortality, illness and development. WHO and other critics focused on the immediate duty to prevent hepatitis B infection. Those positions address different endpoints, which is why arguments about the study’s potential scientific value did not resolve the ethical objection.
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Quick Recap
What is established—and what is not
- The CDC made an unsolicited, no-bid $1.6 million award for a five-year newborn study.
- The planned randomization concerned a hepatitis B birth dose versus a later first dose under Guinea-Bissau’s existing policy.
- WHO’s director-general publicly called the study unethical.
- The trial’s enrollment was reported as about 14,000 to 14,500 infants, depending on the publication.
- HHS and the investigators said the project would proceed, while African officials described a halt or review.
- As of STAT’s February 2026 report, enrollment had not started and the final status was unsettled.
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