Africa-Press. The World Health Organization (WHO) criticized a now-halted plan to run a hepatitis B vaccine trial on thousands of newborns in Guinea-Bissau, calling it “unethical.”
The US-funded study aimed to give one group of children the vaccine at birth, while another group would have been scheduled to receive it only at six weeks of age.
The WHO said it had “serious concerns” about the plan and described the birth dose as an “effective and essential public health intervention with a strong track record of success.”
The US Department of Health, led by Robert F. Kennedy Jr—who has questioned vaccine effectiveness—had sought to use the trial to address questions about the vaccine’s broader health effects.
The WHO said its concerns relate to the study’s scientific rationale, ethical safeguards, and compliance with accepted standards for research involving human participants. It stressed that the vaccine has been used for more than three decades in over 115 countries.
The organization warned that giving a proven, life-saving vaccine to some newborns but not others would expose those deprived of it to “potentially irreversible harm.”
A large share of Guinea-Bissau’s population is believed to be infected with hepatitis B, and the WHO says vaccination at birth prevents mother-to-child transmission in 70–95% of cases.
The WHO noted that trials involving a placebo or withholding treatment are only acceptable when no proven intervention exists—something it said did not apply to the hepatitis B birth dose.
The WHO recommends vaccinating all newborns against hepatitis B within 24 hours of birth, noting that infection at birth is the most common route to lifelong infection, with 90% of infected newborns becoming chronic carriers.
In Guinea-Bissau, the dose is currently given at six weeks, although authorities plan to introduce the birth dose nationwide by 2028 in line with global standards—an effort the WHO said it would help accelerate.
Around 14,000 infants in the West African country were expected to take part in the US-funded study led by Danish researchers, but public backlash prompted the government to suspend it last month. Critics questioned why infants in Guinea-Bissau were being proposed for such a trial.
Two months ago, a committee of senior advisers voted to stop recommending hepatitis B vaccination for all newborns in the United States.
The committee was appointed by US health secretary Kennedy, who had earlier dismissed all members of the Advisory Committee on Immunization Practices (ACIP) and replaced them with others who criticize vaccines.
Kennedy has repeatedly denied being anti-vaccine and has said he and his children are vaccinated, while also repeating claims about vaccine harms that have been widely debunked.
One of the most prominent opponents of the project in Guinea-Bissau is former health minister Magda Robalo, who told the scientific journal Nature last month: “This is unacceptable and should not continue. The people of Guinea-Bissau are not guinea pigs.”
According to the WHO, more than 12% of the country’s adult population has chronic hepatitis B, and smaller studies by other researchers have suggested the rate could be as high as one in five. Most infected people have no symptoms or only very mild ones, though some may experience jaundice, dark urine, severe fatigue, nausea, vomiting, and abdominal pain.
The WHO says patients with chronic hepatitis face a high risk of developing cirrhosis and liver cancer.
