In a small West African nation where hepatitis B takes a heavy toll and transmission at birth is the most common path to lifelong infection, a proposed American-funded trial has run into the blunt objection of the World Health Organization. The agency holds that a proven, decades-old protection for newborns should not be withheld from some infants for the sake of a comparison study, and Guinea-Bissau, governed by a junta, has paused the work while technical reviews proceed. The episode sits within a wider and more fraught quarrel over vaccines, public health authority, and the United States' s
WHO Raises Scientific and Ethical Objections to US-Funded Hepatitis B Vaccine Trial in Guinea-Bissau
Newborns in the proposed trial could be exposed to potentially irreversible harm from being denied a proven life-saving vaccine, according to WHO.
"Neither condition appears to be met"
Mark
Why did the WHO come out so strongly on this one?
Mimi
Because of the design. Some newborns would get a vaccine with a proven record and others wouldn't. The WHO says that exposes babies to potentially irreversible harm.
Mark
And the US side says what?
Mimi
Kennedy's department says the study aims to answer questions about the vaccine's broader health effects and fill evidence gaps.
Luke
Worth noting that's the department's stated aim. We don't have the trial protocol in this reporting, and the WHO itself says its concerns rest on what it knew of the proposal.
Mark
So the WHO may not have seen everything?
Luke
That's the fair reading. Its criticism is of the proposed design as described to it, not of a finalized document we can check.
Mimi
Still, the WHO is specific: placebo trials are acceptable only when no proven intervention exists, and it says that condition isn't met.
Mark
Where does Guinea-Bissau fit?
Mimi
It has high hepatitis B prevalence and planned to add the birth dose nationally by 2028. The trial has been suspended pending technical reviews.
Luke
Suspended isn't cancelled. And the reporting doesn't say who ordered the pause or what would reverse it.
Mark
And the US-WHO tension?
Luke
It's real context, with the withdrawal notice and Kennedy's remarks, but it doesn't tell us whether the WHO's scientific points are right. Those stand or fall separately.
Il Polso
- The WHO has called a US-funded placebo trial on newborns in Guinea-Bissau scientifically questionable and ethically unjustified, with its chief labelling it unethical.
- Guinea-Bissau, a high-prevalence country, has suspended the study, leaving a planned national birth-dose rollout by 2028 caught in the dispute.
- Washington frames the trial as filling evidence gaps, while critics point to a US health department led by a long-time vaccine sceptic and a recent move to drop universal newborn hepatitis B vaccination at home.
- The trajectory hangs on two open questions: whether the United States presses ahead despite opposition from an agency it is leaving, and whether Guinea-Bissau lifts its suspension after technical review.
In a small West African nation where hepatitis B takes a heavy toll and transmission at birth is the most common path to lifelong infection, a proposed American-funded trial has run into the blunt objection of the World Health Organization. The agency holds that a proven, decades-old protection for newborns should not be withheld from some infants for the sake of a comparison study, and Guinea-Bissau, governed by a junta, has paused the work while technical reviews proceed. The episode sits within a wider and more fraught quarrel over vaccines, public health authority, and the United States' strained relationship with the agency that has long coordinated global immunisation.
On Friday the World Health Organization set its objections down in writing. A planned US-funded hepatitis B vaccine trial on newborns in Guinea-Bissau, it said, raises serious questions on both scientific and ethical grounds. The West African country, which is run by a junta, has since suspended the study pending further technical reviews.
The agency's position rests on what the existing birth dose already does. It calls the vaccine effective and essential, a proven intervention used for more than three decades and included in the national schedules of over 115 countries. It prevents mother-to-child transmission at birth, which the WHO says cuts those infections by 70 to 95 percent, and it protects children from life-threatening liver disease. To give the shot to some babies and withhold it from others, the agency argues, would expose newborns to potentially irreversible harm. Placebo designs are acceptable only when no proven intervention exists, and the WHO says neither condition applies here. Its chief had earlier called the trial unethical.
The US health department, led by Robert F. Kennedy Jr, describes the research differently, as a way to answer questions about the vaccine's broader effects and to fill evidence gaps. Kennedy is a longtime vaccine sceptic, and the trial arrives amid a contested stretch of American vaccine policy, including a recent advisory vote to stop recommending universal newborn hepatitis B shots.
For Guinea-Bissau the stakes are close to home. Transmission at birth is the most common route to lifelong hepatitis B infection, and the country has a high prevalence of the disease. It had already resolved in 2024 to add the birth dose to its national schedule by 2028. The WHO says it stands ready to help the country weigh its next steps on the trial and to speed a routine rollout.
The relationship between Washington and the agency is also strained, since the United States has begun the process of withdrawing. What comes next depends on whether the US pushes forward despite the objections, and whether Guinea-Bissau lifts its pause once the reviews are complete.
On Friday the World Health Organization put its objections in writing: a planned US-funded hepatitis B vaccine trial on newborn babies in Guinea-Bissau, it said, is open to question on both scientific and ethical grounds. The West African country is run by a junta, and it has since suspended the study pending further technical reviews, according to the WHO.
The agency's statement was direct about what is at stake. The existing hepatitis B birth dose, it said, is an "effective and essential" public health intervention with a proven record. It prevents life-threatening liver disease by stopping mother-to-child transmission at birth, and it has been in use for more than three decades. More than 115 countries include it in their national schedules. The WHO also said the vaccine prevents 70 to 95 percent of cases of mother-to-child transmission, and that protecting newborns matters for national and global elimination efforts.
The WHO's reasoning rests on the design of the trial. A study that gives a proven, life-saving intervention to some babies and withholds it from others, the agency said, exposes newborns to "potentially irreversible harm." It added that placebo or no-treatment vaccine trials are acceptable only when no proven intervention exists, or when that design is "indispensable" for other reasons. "Neither condition appears to be met," it said. The WHO also found insufficient scientific justification for the study and said its design raises a significant likelihood of substantial risk of bias. It stressed that its concerns were based on what it knew of the proposed trial.
The statement followed sharper words earlier in the week. On Wednesday, WHO chief Tedros Adhanom Ghebreyesus called the planned trial "unethical." The agency said that day it knew of "no underpinning evidence" to suggest any concern about the vaccine, which has been used for more than 40 years.
The US health department, led by Robert F. Kennedy Jr, describes the study differently. It says the research seeks to "answer questions about the broader health effects" of the vaccine and to "fill existing evidence gaps." Kennedy has long been a vocal sceptic of vaccines.
The trial lands in a charged context. Two months ago, an advisory panel appointed by Kennedy voted to stop recommending that all newborns in the United States receive a hepatitis B vaccine, ending a decades-old recommendation. The panel's move was the latest contentious about-face on vaccines. Since President Donald Trump appointed Kennedy, the US government has begun a major overhaul of vaccine policy, which has prompted growing concern in the medical community.
For Guinea-Bissau the stakes are local. Hepatitis B causes hundreds of thousands of deaths worldwide each year, and transmission at birth is the most common route to lifelong infection. Guinea-Bissau has a high prevalence of the disease. In 2024 it decided to add the hepatitis B birth dose to its national vaccine schedule, with introduction planned by 2028.
The US-WHO relationship is also strained. In January 2025 the United States gave the WHO its one-year withdrawal notice, and Kennedy said last month that the Geneva-based organisation had "trashed everything that America has done for it." The WHO said it stands ready to support Guinea-Bissau as it weighs the way forward on the trial, and to help speed the vaccine's eventual routine rollout.
What to watch is whether Washington presses ahead despite the WHO's opposition, and whether Guinea-Bissau lifts its suspension once the technical reviews are done.
Citazioni salienti
WHO has significant concerns regarding the study's scientific justification, ethical safeguards, and overall alignment with established principles for research involving human participants.— World Health Organization statement
The study seeks to answer questions about the broader health effects of the vaccine and fill existing evidence gaps.— US health department
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