WHO slams US-funded newborn vaccine trial as “unethical”

The World Health Organization (WHO) has issued a strong condemnation of a vaccine trial funded by the United States, labeling it as "unethical" due to its decision to withhold a safe and effective hepatitis B vaccine from certain newborns in Guinea-Bissau, Africa. In a statement released on Friday, the WHO asserted that the trial, in its current design, violates established ethical and scientific standards, outlining several reasons why the study could be detrimental and of poor quality. Concerns about the trial have been mounting among health professionals since the announcement of US funding appeared in the Federal Register last December. This disclosure revealed that the Centers for Disease Control and Prevention (CDC), under the leadership of Health Secretary Robert F. Kennedy Jr., allocated $1.6 million to a group of Danish researchers for their unsolicited proposal to undertake the study. The research team, led by Christine Stabell Benn and her husband Peter Aaby from the Bandim Health Project at the University of Southern Denmark, has faced scrutiny in the past for their controversial research practices related to vaccine safety. Kennedy has referenced their work as justification for reducing global vaccine funding. The CDC's backing of Benn's hepatitis B vaccine trial coincided with a decision by the agency's advisors—appointed by Kennedy—to retract a longstanding recommendation for a birth dose of the hepatitis B vaccine, a move that drew criticism from various health experts. In the Guinea-Bissau study, Benn's team plans to assign 14,000 newborns to receive their first dose of the hepatitis B vaccine either at birth or at six weeks, aiming to analyze differences in safety outcomes. Notably, Guinea-Bissau currently administers the first dose at six weeks but anticipates transitioning to a birth dose by 2028, hindered only by resource limitations.