WHO slams US-funded newborn vaccine trial as "unethical"

The World Health Organization (WHO) has condemned a US-funded vaccine trial in Guinea-Bissau as “unethical” for withholding a proven, safe, and potentially lifesaving hepatitis B vaccine from some newborns. The trial, led by Danish researchers at the University of Southern Denmark and funded by the US Centers for Disease Control and Prevention (CDC), plans to randomize 14,000 newborns to receive their first hepatitis B vaccine dose either at birth or at six weeks. The WHO criticized the trial for failing to meet established ethical and scientific standards, highlighting that withholding the birth dose vaccine exposes infants to significant health risks. The hepatitis B vaccine birth dose is a well-established intervention that prevents mother-to-child transmission of the virus, which can lead to chronic infection, cirrhosis, and liver cancer. More than 115 countries have included the birth dose in their immunization schedules for over three decades. Guinea-Bissau currently administers the first dose at six weeks but plans to implement the birth dose by 2028, delayed due to resource constraints. The WHO emphasized that exploiting such scarcity for research purposes is unethical and that the trial protocol lacks adequate harm reduction measures, such as screening pregnant women or vaccinating newborns exposed to hepatitis B. The trial has drawn widespread criticism, particularly because it was funded under the leadership of CDC Director Robert F. Kennedy Jr., who has been associated with anti-vaccine positions and has reduced global vaccine funding. The Danish research team, led by Peter Aaby and Christine Benn, has a controversial history regarding vaccine safety research, which has fueled further opposition. The CDC’s recent decision to abandon a universal recommendation for the hepatitis B birth dose, influenced by advisors appointed by Kennedy, has also been widely condemned by public health experts. The WHO’s statement underscores that withholding a proven, lifesaving vaccine in a clinical trial setting lacks scientific justification and poses serious ethical concerns. The agency warns that the trial could cause irreversible harm to newborns and undermine decades of progress in hepatitis B prevention globally.