The World Health Organization (WHO) issued a statement on Friday denouncing a U.S.-funded vaccine trial in Guinea-Bissau as 'unethical.' The trial, which involves withholding an established, safe, and potentially lifesaving hepatitis B vaccine from certain newborns, was criticized for violating established ethical and scientific standards.
According to the WHO, the trial 'in its current form, and based on publicly available information,' does not align with ethical principles, listing reasons it deemed the trial harmful and of low quality.
Health experts widely condemned the trial following its announcement in the Federal Register in December. The notice disclosed that the Centers for Disease Control and Prevention (CDC)âunder Health Secretary Robert F. Kennedy Jr., known for anti-vaccine viewsâgranted $1.6 million to Danish researchers for their unsolicited proposal to conduct the trial.
The researchers, led by Christine Stabell Benn and Peter Aaby from the Bandim Health Project at the University of Southern Denmark, have faced controversy over research practices concerning vaccine safety. Kennedy cited their work in deciding to cut global vaccine funding.
The trial's funding coincided with the CDC's advisory panelâselected by Kennedyâchoosing to withdraw a universal recommendation for hepatitis B vaccination at birth, a decision criticized by health professionals.
The trial in Guinea-Bissau involves randomizing 14,000 newborns to receive the hepatitis B vaccine either at birth or six weeks later, to analyze differences in assumed safety outcomes. Currently, Guinea-Bissau administers the first vaccine dose at six weeks, but plans to shift to a birth dose by 2028 due to resource limitations.