WHO Criticizes Halted US-Funded Hepatitis B Vaccine Trial in Guinea-Bissau
A halted plan to conduct a hepatitis B vaccine trial involving thousands of newborns in Guinea-Bissau has been condemned by the World Health Organization (WHO) as "unethical." The US-funded study intended to administer the vaccine at birth to one group of infants, while delaying vaccination until six weeks of age for another group.
The WHO expressed "significant concerns" about the trial, emphasizing that the birth-dose vaccine is "an effective and essential public health intervention, with a proven record."
The US Department of Health, led by Robert F. Kennedy Jr., who has publicly questioned vaccine safety, aimed to use the trial to investigate the vaccine's broader health effects.
On Friday, the WHO highlighted issues regarding the study's scientific rationale, ethical safeguards, and alignment with established standards for human research. It underscored that the hepatitis B vaccine has been in use for over 30 years across more than 115 countries.
The organization warned that withholding a proven life-saving intervention from some newborns could expose them to "potentially irreversible harm."
Guinea-Bissau has a significant portion of its population estimated to carry hepatitis B. The WHO states that vaccination at birth prevents mother-to-child transmission of the virus in 70-95% of cases.
The WHO argued that trials involving placebos or untreated groups are only acceptable when no effective treatment exists, which is not the case for the hepatitis B birth dose vaccine.
The WHO recommends administering the hepatitis B vaccine to all newborns 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.
Currently, Guinea-Bissau administers the vaccine at six weeks of age, but authorities plan to introduce the birth dose nationwide by 2028 to align with global standards. The WHO stated it would support efforts to accelerate this transition.
A total of 14,000 infants in the West African country were to participate in the study, which was funded by the US and led by Danish researchers. However, public opposition led the Guinea-Bissau government to suspend the trial last month.
'We are not guinea pigs'
Critics have questioned the rationale for selecting babies in Guinea-Bissau for the trial. Two months prior, a panel of top advisers voted to discontinue recommending hepatitis B vaccination for all newborns in the US.
This panel was appointed by US Health Secretary Robert F. Kennedy Jr., who had dismissed all members of the Advisory Committee on Immunization Practices (ACIP) months earlier and replaced them with individuals critical of vaccines.
Kennedy has denied being anti-vaccine and stated that he and his children have been vaccinated. Nonetheless, he has repeatedly made claims about vaccine harms that have been widely debunked.
Among the vocal opponents of the Guinea-Bissau project is the country's former health minister, Magda Robalo.
"It's not acceptable and it should not go on," she told the science journal Nature last month. "Guinea-Bissauans are not guinea pigs."
According to the WHO, more than 12% of Guinea-Bissau's adult population has chronic hepatitis B. Smaller studies by other researchers have estimated that the proportion could be as high as one in five.
Most individuals with the virus are asymptomatic or experience mild symptoms. However, some may develop jaundice, dark urine, fatigue, nausea, vomiting, and abdominal pain.
The WHO notes that chronic hepatitis B patients face a high risk of developing cirrhosis and liver cancer.
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