Controversial vaccine trial touted by RFK Jr gets go-ahead in Guinea-Bissau

KUALA LUMPUR, 10 OCTOBER 2026 —

A Danish ethics committee approved this week a trial that will withhold the birth‑dose hepatitis B vaccine from half of 14,000 newborns in Guinea‑Bissau, a study championed by U.S. Health and Human Services secretary Robert F Kennedy Jr., a long‑time vaccine sceptic.

Proponents say the trial will test whether delaying the birth‑dose vaccine affects infant mortality and other health outcomes. Critics argue the design deliberately exposes a large cohort of infants to hepatitis B infection, violating basic ethical standards and the Helsinki Declaration, which requires approval by ethics committees in both sponsor and host countries.

The study will enrol 14,000 infants, randomly assigning half to receive the hepatitis B vaccine within hours of birth and the other half to defer the dose for six weeks. Babies whose mothers test positive for hepatitis B will be excluded and given the vaccine immediately; only infants of hepatitis‑negative mothers may be randomised, according to a protocol amendment shared with the Guardian.

The revised protocol, not yet public, adds maternal screening to the original design posted in January.

Stig Børsen Hansen, a founding member of the Danish ethics panel, resigned on Friday, calling the trial “a lottery” that “makes infection happen, in effect, by design.” Three other committee members also stepped down in protest. Hansen said the children who “lost the lottery” face the risk of contracting hepatitis B, a virus that can cause irreversible lifelong damage.

The United States Centers for Disease Control and Prevention has earmarked $1.6 million for the project in its 2026 budget, to be matched by private contributions from the Pershing Square Foundation – co‑founded by billionaire activist Bill Ackman – and the Bluebell Foundation. The CDC, the Danish researchers, Pershing Square and Minister Nantote did not respond to the Guardian’s inquiries.

The trial is being run by the Bandim Health Project, a long‑standing Danish‑led research programme embedded in Guinea‑Bissau’s health system. Its senior investigators, Peter Aaby and Christine Stabell Benn, have operated in the country for decades, and at least one senior public‑health official held a dual appointment with Bandim as recently as December.

Guinea‑Bissau bears one of the world’s highest hepatitis B prevalence rates, with about 18 percent of adults carrying the virus. While mother‑to‑child transmission at birth is a known route, the virus can also spread through casual contact – surviving on surfaces for up to seven days and passing via washcloths, toothbrushes or fingernail clippers.

The hepatitis B test has a 5 percent false‑negative rate, potentially giving a false sense of security about a parent’s infection status. Children infected in the first year of life are far more likely to develop chronic infection, liver cirrhosis or cancer.

Decades of research have shown the birth‑dose vaccine to be effective in preventing these outcomes.

Henrik Støvring, a professor of statistics and pharmacometrics at Aarhus University, said “decades of research make it clear that the vaccine would be beneficial, which means it would be unfair to place some children in the vaccinated group and some children in the unvaccinated group.” He added that the trial pits “very well‑known bad diseases that you can protect with this vaccine” against a “speculative” hypothesis, contrary to World Health Organization guidance that recommends universal birth‑dose vaccination.

The Danish ethics panel, which traditionally reviews clinical studies conducted in Denmark, altered its rules to consider the Guinea‑Bissau protocol, despite the trial taking place entirely abroad. While members with relevant expertise argued against approval, a majority voted to proceed.

Støvring described the move as “very unusual” and noted that the study could have been conducted in Denmark, where hepatitis B vaccination is given at birth only to infants of hepatitis‑positive mothers, after universal maternal screening.

U.S.

officials have linked the trial to the broader vaccine agenda of Secretary Kennedy, who praised the Danish researchers at an anti‑vaccine conference last month, calling them “the deities of vaccine research.” Kennedy has advocated for eliminating the birth‑dose vaccine in the United States, a goal echoed by infectious‑disease physician Paul Offit of Children’s Hospital of Philadelphia, who said Kennedy “wants to make it so we don’t use a birth dose here in this country.” Offit warned that Kennedy could not run the trial in the United States because of its “significant ethical concerns,” adding that the researcher is “taking advantage of a developing country … Is it because children in Africa are more expendable than children here?”

The Africa Centres for Disease Control and Prevention, which has opposed the study, said on Thursday that “ongoing discussions” between the United States and Guinea‑Bissau were under way and that more details would be shared shortly.

Guinea‑Bissau had planned to roll out universal hepatitis B vaccination for newborns in 2027, but the schedule has been pushed back to 2028, a delay that Offit says Kennedy and the Danish team are exploiting to “put these children at risk unnecessarily.”

The trial will also track secondary outcomes such as skin conditions and neurodevelopmental disorders, but critics argue that the primary focus on mortality and morbidity is misplaced when a proven, low‑cost intervention is being withheld. “The main problem of this trial is that you have some very well‑known bad diseases that you can protect with this vaccine,” Støvring said.

“And what they then want to study is something speculative – in a situation where WHO and others are saying that you should give this vaccine at birth, period.”

With the ethics committee’s vote finalized, the Bandim Health Project is set to begin enrolment in the coming weeks, pending final logistical arrangements. The next step will be maternal hepatitis B screening, after which eligible infants will be randomised to receive the vaccine at birth or after six weeks.

The outcome of the trial, slated for publication several years from now, will likely shape the debate over birth‑dose vaccination policy in both the United States and low‑income settings, even as the ethical controversy continues to draw sharp criticism from global health experts.