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WHO slams Guinea-Bissau vaccine trial as unethical
The World Health Organization has sharply criticized a suspended U.S.-funded study in Guinea-Bissau that planned to delay hepatitis B vaccinations for thousands of newborns, calling the approach "unethical" and potentially harmful.
Study design and WHO objections
The trial, backed by the U.S. Department of Health under Robert F. Kennedy Jr., aimed to compare two groups of infants: one receiving the vaccine at birth and another at six weeks old. The WHO condemned the plan, emphasizing that the birth-dose vaccine is a "proven and essential" public health tool used globally for over 30 years.
In a statement released Friday, the WHO raised concerns about the study's scientific rationale, ethical safeguards, and compliance with human research standards. The organization warned that withholding a life-saving intervention from some infants could cause "potentially irreversible harm."
Global vaccination standards
The WHO recommends administering the hepatitis B vaccine within 24 hours of birth, citing its 70-95% effectiveness in preventing mother-to-child transmission. Chronic infection, which develops in 90% of untreated newborns, heightens risks of cirrhosis and liver cancer later in life.
Guinea-Bissau currently delays the vaccine until six weeks but plans to align with global guidelines by 2028. The WHO pledged support to accelerate this transition.
Public backlash and suspension
The trial, involving 14,000 infants and led by Danish researchers, faced fierce opposition in Guinea-Bissau, prompting the government to halt it last month. Critics, including former Health Minister Magda Robalo, denounced the study as exploitative.
"Guinea-Bissauans are not guinea pigs."
Magda Robalo, former Health Minister of Guinea-Bissau
U.S. context and broader controversy
The trial's funding source drew scrutiny: Kennedy, a vocal vaccine skeptic, had overhauled the U.S. Advisory Committee on Immunization Practices (ACIP) months earlier, replacing members with critics of vaccines. While Kennedy denies opposing vaccinations, he has repeatedly promoted debunked claims about their risks.
Two months prior, the revamped ACIP voted to stop recommending universal hepatitis B vaccination for U.S. newborns, further fueling debate.
Hepatitis B burden in Guinea-Bissau
The WHO estimates over 12% of Guinea-Bissau's adult population has chronic hepatitis B, with some studies suggesting rates as high as 20%. While many carriers remain asymptomatic, the virus can cause jaundice, fatigue, and severe liver damage.
