Guinea-Bissau Birth-Dose Trial Serves a US Policy Fight

A University of Southern Denmark ethics panel voted on October 7, 2026, to let researchers enroll 14,000 newborns in a hepatitis B vaccine trial in Guinea-Bissau. Four members resigned, including a reviewer who had presented the study.

Dean Jakob Grauslund told Christine Stabell Benn the same day that her group may proceed with a revised protocol. He also said the study cannot begin until Guinea-Bissau issues national authorization, a step still outstanding after health minister Quinhin Nantote suspended the work on January 22, 2026.

A Danish Committee Votes, Then Four Members Walk Out

The panel that voted sits at the researchers’ home campus. It had not reviewed medical studies before this file, and it changed its rules so that it could. Denmark’s regional and national health-research boards did not take the case, Grauslund said, because a foreign ethics panel had already signed off and Danish law then blocked a second look.

The university asked the World Health Organization Research Ethics Review Committee and the European Network of Research Ethics Committees to step in. Both said they could not. That left a campus body to bless a trial that will not enroll a single Danish infant.

Stig Børsen Hansen, a founding member and one of two reviewers who presented the protocol, resigned on October 9, 2026. Three other members left with him.

You are now enrolling newborns in a lottery to test a hypothesis.

Stig Børsen Hansen, founding member, University of Southern Denmark research ethics committee

Hansen said infants randomly assigned to miss the birth dose, the ones who “lost the lottery,” can contract hepatitis B in their first days, and that those infections would happen, in effect, by design. Paul Offit, an infectious disease physician at Children’s Hospital of Philadelphia, put the US stake in one line: Robert F. Kennedy Jr., the health secretary, “wants to make it so we don’t use a birth dose here in this country.”

THE PATH TO THE OCTOBER VOTE

1. 2024: Guinea-Bissau decides to add a hepatitis B birth dose to the national schedule, with introduction planned for 2028.
2. November 2025: The Guinean National Ethics Committee approves the protocol.
3. December 5, 2025: The US Advisory Committee on Immunization Practices votes 8-3 to drop a universal newborn hepatitis B shot.
4. December 16, 2025: CDC adopts that advice and confirms a $1.6 million award to the Bandim group.
5. January 22, 2026: Nantote suspends the trial, saying coordination for a final decision was not sufficient.
6. March 2026: The University of Southern Denmark places the study on a full hold and cites possible conflicts around the local ethics approval.
7. Late September 2026: Staff in the CDC director’s office tell the budget office to set aside $1.6 million from global health security funds.
8. October 7, 2026: Grauslund clears the revised protocol. Guinea-Bissau’s government authorization remains the last gate.

Africa CDC, which has opposed the design, said in early October 2026 that talks between the United States and Guinea-Bissau were still going. Colette Delawalla, founder of Stand Up for Science, said her group stopped the study once and intends to do it again.

The 2028 Delay Is What Makes the Design Possible

Guinea-Bissau does not now give every newborn a hepatitis B shot in the first day of life. The first dose rides with routine infant vaccines at about six weeks. Officials had talked about moving the first dose to birth in 2027, then set the national start for 2028.

Bandim Health Project, the Danish-run research unit that has worked in the country since the late 1970s, calls that gap a unique window of opportunity until 2028. Until the ministry rolls out a universal birth dose, the team can randomize newborns to a WHO-approved shot at birth, the future policy, or to no birth dose, the current policy, and watch what happens to deaths, hospital stays, skin disease, and development.

That framing treats the delay as a natural experiment. It is also the only reason a no-birth-dose arm can be described as usual care. Once 2028 arrives, that claim expires. Offit said Kennedy and the Danish team were using the postponement to put children at risk they did not need to face. “What a horribly unethical and cruel thing to do,” he said.

The project sits inside the country’s health system, not beside it. Bandim has trained dozens of scientists from a demographic surveillance site in Bissau, and at least one senior official, the director of public health, held a dual appointment with the project as recently as December 2025. In March 2026, then-dean Ole Skøtt said there may be conflicts of interest in the local ethics approval. Those ties are why a campus vote in Odense does not close the file in Bissau.

Washington Already Dropped the Universal Birth Dose

The US fight is no longer theoretical. On December 16, 2025, CDC adopted ACIP’s December 5 vote and moved to shared decision-making for hepatitis B birth doses when a mother tests negative. Infants born to mothers who test positive, or whose status is unknown, should still get the vaccine within 12 hours of birth, with hepatitis B immune globulin. If the birth dose is deferred, CDC says the series should begin no earlier than 2 months of age.

Acting CDC director Jim O’Neill said the change restores informed consent “to parents whose newborns face little risk of contracting hepatitis B.” ACIP first endorsed a universal birth dose in 1991, 34 years before the 8-3 rollback. Kennedy had replaced the previous 17-member panel after taking office.

In September 2026 he praised Aaby and Stabell Benn at an anti-vaccine conference as “the deities of vaccine research,” and held up US-supported hepatitis B work in newborns as a model for his vaccine agenda. The Guinea-Bissau protocol’s primary questions, overall mortality and hospital care, plus eczema and neurodevelopment, are the questions that agenda wants answered. They are not the questions WHO treats as open.

FOUR RULES FOR THE FIRST HEPATITIS B SHOT

The US rule and the trial arm are not the same clock. American infants who skip the birth dose are told to wait until at least 2 months. The Bissau delayed arm waits about six weeks, which is today’s national schedule, in a country where adult carriage is far higher than in the United States.

What the New Protocol Still Leaves Uncovered

The protocol posted earlier in 2026 has been rewritten. Researchers will test mothers for hepatitis B before birth. Babies of mothers who test positive will be vaccinated and kept out of the trial. Babies of mothers who test negative may be enrolled, then randomized to a birth dose or a six-week wait. The new text has not been released to the public.

That screen cuts the highest perinatal risk. It does not close the file. Offit notes that hepatitis B can live on surfaces for up to seven days and can pass through washcloths, toothbrushes, and nail clippers, and that in earlier work about half of infected children acquired the virus after birth from household or community contact. He also cites a 5% false-negative rate on the maternal test, which would enroll some infants whose mothers carry the virus.

GAPS THE SCREEN DOES NOT CLOSE

• Community spread: Relatives, siblings, and caregivers can still infect a newborn in a high-carriage setting during the six-week wait.
• False-negative tests: A negative result is not a guarantee the birthing parent is uninfected.
• Known disease versus speculative harm: The delayed arm forgoes a shot that prevents most mother-to-child infections in order to hunt skin and developmental signals.
• Unpublished protocol: Independent reviewers cannot check the new consent language, stopping rules, or how many mothers will actually be tested.

Henrik Støvring, a professor of statistics and pharmacometrics at Aarhus University, said decades of data already show the vaccine helps, so it is unfair to assign some children to miss it. “The main problem of this trial is that you have some very well-known bad diseases that you can protect with this vaccine,” he said. “And what they then want to study is something highly speculative.”

WHERE EXPERTS DISAGREE

• WHO and Africa CDC: Withholding a proven birth dose from some newborns is unethical, even where the national schedule has not yet moved, because the benefit is established and the harm is foreseeable.
• Bandim and HHS: Randomizing to birth dose versus current six-week care is usual-care research in a country that has not introduced the shot, and HHS has called the work a gold-standard study of broader health effects.
• Danish critics, including Støvring: The cleaner site would be Denmark, where the birth dose is already selective, pregnant people are screened, and community transmission is rare.

Jake Scott, an infectious disease physician at Stanford, put the design problem without jargon: you do not test whether a proven vaccine is safe by delaying it in the babies most likely to be infected. If the hypothesis is about non-specific immune effects in a low-risk infant, Denmark already runs that schedule. Running the same contrast in Bissau loads a known viral risk onto children who will never sit in an American pediatric clinic.

Bandim’s Four-Decade Bet on Non-Specific Effects

Peter Aaby began following families in the Bandim district of Bissau in December 1978. With Stabell Benn he built a research program around a claim that vaccines do more than block their target germs. Live shots such as measles, BCG, and oral polio, they argue, lower deaths from other infections. Non-live shots such as diphtheria-tetanus-pertussis, they argue, can raise deaths, especially in girls.

WHO withdrew a high-titer measles vaccine in 1992 after Bandim and other sites found higher female mortality. That episode still anchors the group’s story about itself. Later papers from the same unit reported that higher mortality after DTP introduction in children aged 6 to 35 months, with a hazard ratio of 2.14 against unvaccinated peers. Those findings have been argued over for years and have not rewritten WHO’s core infant schedule.

A 2025 review in the journal Vaccine, led by Støvring, pooled 13 of the group’s randomized trials across 26 papers and more than 1,400 statistical tests. Only one of the 13 trials showed the effect it was designed to detect. In 23 of 25 papers the authors leaned on secondary findings; in 22 of those, the signal vanished after the analyses were handled for multiple testing. In February 2026 a campus committee referred separate questions about unpublished DTP trial data to the Danish Committee on Research Misconduct, which is still weighing whether findings that would have undercut the DTP-harm claim were held back.

Kennedy told that September conference that a prior Bandim study showed mass injuries hiding in plain sight. He did not mention a follow-up from the same researchers that found no such effects. The hepatitis B protocol now on the table is the same research bet with a new antigen: take a non-live shot given at birth, delay it for half the infants, and look for deaths, hospital care, eczema, and developmental scores.

Who Pays for a Trial Denmark Would Not Host

Money and venue are the same story. CDC announced an unsolicited $1.6 million grant in December 2025, then told its budget office in late September 2026 to park that sum again, drawing on global health security funds. Stabell Benn wrote to Lyn Redwood, a Kennedy adviser at HHS and former Children’s Health Defense president, on October 3, 2025, describing a $1.8 million pledge from the Pershing Square Foundation, co-founded by Bill Ackman, if matching funds could be raised that month. The Bluebell Foundation is the third named donor on Bandim’s own trial page.

Redwood replied that the secretary had followed Aaby and Stabell Benn’s work for years. The grant path did not run through a standard CDC request for proposals. It arrived as an unsolicited award after that political introduction, then stalled when Nantote paused the fieldwork, then revived once the campus panel voted.

Støvring’s point about Denmark is the one the October vote never answered. Pregnant people there are already tested. The birth dose is already reserved for infants whose mothers are positive. Community carriage is low. A randomized delay in that setting would still be contested, but it would not place 7,000 infants in a country where WHO estimates more than 12% of adults lived with chronic hepatitis B in 2022, and where Bandim’s own work has put adult carriage near 18%. Offit’s question sits on that contrast: would this protocol have been allowed in Odense, and if not, why is Bissau the place it runs?

The Helsinki framework asks for ethics review in both the host country and the sponsor country. Guinea-Bissau’s committee approved the plan in November 2025. Denmark’s national medical boards never sat. A campus committee that had to rewrite its own remit did.

Africa’s Birth-Dose Gap Is Why WHO Objected

WHO’s February 2026 statement on the planned trial was blunt. The birth dose has a decades-long safety record and is effective at preventing 70 to 95 percent of mother-to-child cases. A study that gives that shot to some newborns and withholds it from others, WHO said, exposes infants to chronic infection, cirrhosis, and liver cancer. About 90% of newborns infected at birth become chronic carriers. Tedros Adhanom Ghebreyesus, WHO’s director-general, said a sovereign country can decide what it wants, “but as far as WHO’s position is concerned, it’s unethical to proceed with this study.”

The same office that condemned the design is trying to close Africa’s birth-dose gap, not study it. The birth-dose coverage in the African Region was only 17% in 2024. In 2025, 20 of 47 countries in that region still had not introduced the shot. Gavi lists Guinea-Bissau among countries aiming at a 2028 start through a national immunization-strategy pilot.

THE NUMBERS WHO IS TRYING TO MOVE

• New chronic infections, 2024: 0.9 million worldwide, 68% of them in the WHO African Region.
• People living with chronic HBV: 240 million in 2024, about 2.9% of the world.
• HBV deaths, 2024: about 1.1 million, up 17% since 2015.
• Children under five in Guinea-Bissau: about 2% infected in 2020, against a global target of 0.1%.

WHO also offered to help Guinea-Bissau speed the birth dose, strengthen screening in pregnancy, and watch safety after introduction. That is the opposite of a six-week randomized wait. The trial’s defenders say the country will not launch universal birth dosing until 2028 either way, so the control arm loses nothing the ministry was about to give. The counter is simpler, and it is the reason the campus vote did not end the argument: a delay in a national program is not the same as assigning a newborn to miss a shot inside a study.

Grauslund’s letter left the last move with Bissau. Until that authorization is signed, the 14,000 slots are a protocol, not a ward list. The US schedule fight that made the protocol valuable is already over in Washington. The infants who would carry it live in a city where the virus is common and the national birth dose is still two years away.

Disclaimer: This article is news reporting and analysis of a planned clinical trial and of hepatitis B immunization policy. It is informational only and is not medical advice, a recommendation to give or withhold any vaccine, or guidance on any child’s care. Readers making decisions about hepatitis B shots should consult a physician or pediatrician who knows the patient and the local schedule. Enrollment figures, ethics votes, funding amounts, and authorization status come from the public statements and documents named above and can change if Guinea-Bissau, the University of Southern Denmark, CDC, or WHO issue new decisions.