WHO Slams US-Funded Newborn Vaccine Trial in Guinea-Bissau as “Unethical”

In a sharp rebuke, World Health Organization (WHO) Director-General Tedros Adhanom Ghebreyesus has condemned a US-funded hepatitis B vaccine trial planned for newborns in Guinea-Bissau, calling it “unethical” for withholding a proven, safe vaccine from half the participants.[1] The controversy highlights tensions between vaccine skeptics in the US administration and global health experts, amid Guinea-Bissau’s high hepatitis B prevalence.[1]

The Trial at the Center of the Storm

The study, funded by the US Centers for Disease Control and Prevention (CDC), aims to enroll around 14,000 newborns in the West African nation.[1] It would randomize infants: some receiving the hepatitis B vaccine birth dose, others delayed until six weeks of age, which aligns with Guinea-Bissau’s current recommendation.[1][2] Proponents, including the US Department of Health and Human Services (HHS), describe it as a “gold-standard, independent study” to address “evidence gaps” on the vaccine’s broader health effects and inform global policy.[1]

This trial stems from a non-peer-reviewed paper by Danish researcher Christine Stabell Benn and Martin Kulldorff, proposing placebo-controlled trials for approved vaccines like hepatitis B.[2] The CDC recently granted Benn’s group funding for this exact study, the first of nine outlined in the paper.[2] HHS, under Secretary Robert F. Kennedy Jr.—known for vaccine-skeptic views—has pushed for such research following a policy shift.[1][2]

Two months prior, a Kennedy-appointed advisory panel voted to end routine hepatitis B vaccination for all US newborns, reversing decades of practice aimed at preventing mother-to-child transmission, even from undiagnosed carriers.[1] This has nearly eradicated young-adult infections in the US.[1]

WHO Chief’s Fiery Condemnation

Speaking at a WHO press conference in Geneva, Tedros did not mince words. “Guinea-Bissau is one of the countries with high prevalence of hepatitis B and withholding a birth dose could actually expose infants to a high chance of infection, and that means including a significant proportion of deaths,” he stated.[1] He argued the trial violates “basic protocol”: denying half the children a vaccine used safely for over 40 years is unethical when an effective treatment exists.[1]

Tedros emphasized Guinea-Bissau’s sovereignty but stressed WHO’s stance: “The country can proceed, knowing full well that it’s unethical, and the scientists can proceed, knowing full well that it’s unethical.”[1] The WHO is preparing a full statement, warning such studies could influence other nations.[1]

The trial was paused but is expected to resume after reevaluation by Guinea-Bissau’s ethics committee, per the Ministry of Health.[1][2] An HHS spokesperson expressed confidence it would proceed.[2]

Expert Backlash Echoes Tuskegee

Leading researchers have echoed WHO’s concerns, labeling the proposals “unethical” and flawed.[2] Paul Offit, co-inventor of a rotavirus vaccine and director of the Vaccine Education Center at Children’s Hospital of Philadelphia, deemed all nine trials in Benn and Kulldorff’s paper unethical for withholding standard care.[2]

Michael Osterholm, director of the University of Minnesota’s Center for Infectious Disease Research, compared it to the infamous Tuskegee Syphilis Study, where Black men were denied treatment: “Withholding vaccine from these kids to do these kinds of studies is unconscionable.”[2] Susan Ellenberg, a biostatistics expert, warned of unreliable data from underpowered studies, potentially exaggerating rare side effects.[2]

William Moss of Johns Hopkins noted the massive scale—over 100,000 children for some proposals—would cost hundreds of millions and yield questionable results for long-approved vaccines.[2]

Broader Context: Vaccine Policy Under Fire

This unfolds against the Trump administration’s “Make America Healthy Again” (MAHA) push, citing Benn and Kulldorff’s unpeer-reviewed work to justify cuts to the US childhood vaccine schedule.[2] Kennedy, heading HHS, has advocated placebo-controlled trials for new vaccines and more scrutiny of existing ones.[2] Critics argue this revives discredited skepticism, risking public health gains.[2]

Guinea-Bissau’s junta, which seized power in November after overthrowing President Umaro Sissoco Embalo, adds political volatility.[1] Hepatitis B remains a major threat there, with mother-to-child transmission a key vector without birth-dose protection.[1]

Implications for Global Health

If approved, the trial could set a precedent, challenging ethical norms in vaccine research where placebos are standard for new pathogens but not established ones.[2] WHO’s intervention underscores fears of ripple effects in high-burden regions.[1] Public health advocates urge prioritizing access over speculative studies, given the vaccine’s track record in slashing infections worldwide.[1][2]

As debates rage, the balance between scientific inquiry and child safety hangs in the balance. Will Guinea-Bissau proceed, defying WHO? Or will ethics prevail? The world watches.[1][2]

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Original source: Ars Technica – WHO slams US-funded newborn vaccine trial as “unethical”