WHO Condemns Unethical Hepatitis B Vaccine Trial & Reaffirms Birth Dose Importance

The World Health Organization (WHO) has strongly condemned a US-funded clinical trial planned in Guinea-Bissau, Africa, deeming it “unethical” due to its design which would withhold a proven, life-saving hepatitis B vaccine from a portion of newborns. The trial, funded by the US Centers for Disease Control and Prevention (CDC) with $1.6 million, aimed to compare administering the vaccine at birth versus six weeks of age.

The WHO’s concerns, detailed in a February 13, 2026 statement, center on the fundamental ethical and scientific principles violated by the study’s design. The hepatitis B birth dose vaccine is a well-established public health intervention, preventing life-threatening liver disease by interrupting mother-to-child transmission. It has been integrated into the national immunization schedules of over 115 countries for more than three decades.

Why Withholding a Proven Vaccine Raises Ethical Concerns

The core of the WHO’s objection lies in the fact that the trial proposes deliberately denying a known benefit – protection against hepatitis B – to a group of newborns. According to the WHO, this is unethical because the vaccine has a proven safety record and is effective in preventing 70-95% of mother-to-child transmissions. Withholding the vaccine exposes these infants to the risk of chronic infection, cirrhosis, and liver cancer – potentially irreversible harms.

The WHO argues that trials involving a “no-treatment” arm (in this case, delaying the vaccine) are only justifiable when no proven intervention exists. Since an effective vaccine is already available, conducting a trial that intentionally leaves some newborns unprotected is considered scientifically unnecessary and ethically problematic.

the WHO’s assessment indicates a lack of robust scientific justification for the trial. Publicly available information suggests the study doesn’t challenge the established efficacy of the birth dose vaccine but instead explores hypothetical safety concerns without sufficient evidence to warrant exposing participants to risk. The study design, a single-blind, no-treatment-controlled trial, is also flagged as potentially biased, which could limit the reliability and practical relevance of the results.

The WHO also emphasized that resource limitations cannot justify withholding proven care in a research setting. Ethical research demands minimizing risk and ensuring a potential benefit for all participants. The proposed protocol, as described, does not appear to guarantee even a basic level of harm reduction and benefit, such as screening pregnant women and vaccinating newborns exposed to hepatitis B.

Context: US Policy Shifts and Funding Decisions

The controversy surrounding the trial is further complicated by recent policy changes within the US health system. An advisory panel appointed by US Health Secretary Robert F. Kennedy Jr. Recently voted to discontinue the universal recommendation for a hepatitis B vaccine birth dose in the United States. This decision, widely criticized by health experts, preceded the CDC’s funding of the Guinea-Bissau trial. Kennedy has publicly expressed skepticism towards vaccines and has cited the work of researchers involved in this trial in justifying cuts to global vaccine funding.

The Danish researchers leading the trial, Christine Stabell Benn and Peter Aaby of the Bandim Health Project at the University of Southern Denmark, have previously faced scrutiny for their research into vaccine safety. Their work has been controversial and has been cited by vaccine critics.

Guinea-Bissau Suspends the Trial

In response to the growing concerns, Guinea-Bissau has reportedly suspended the trial pending further technical reviews. The WHO has offered its support to Guinea-Bissau as it evaluates its next steps, including accelerating the introduction of the hepatitis B birth dose vaccine into its national immunization program. The country formally decided in 2024 to add the vaccine to its schedule, with full implementation planned by 2028.

Hepatitis B: A Global Health Challenge

Hepatitis B remains a significant global health threat, causing hundreds of thousands of deaths annually. The most common route of infection is transmission from mother to newborn during childbirth, with approximately 90% of infected newborns becoming chronic carriers, placing them at high risk for serious liver complications later in life. In Guinea-Bissau, over 12% of adults are estimated to be living with chronic hepatitis B, and the infection rate in children under five – around 2% in 2020 – is significantly higher than the global target of ≤0.1%.

The WHO emphasizes its commitment to working with national authorities, researchers, and partners to ensure all newborns worldwide receive timely, evidence-based protection against hepatitis B, and that all research in this area adheres to the highest ethical and scientific standards. Protecting newborns with the birth dose vaccine is not only beneficial for individual health but is also crucial for national and global efforts to eliminate hepatitis B.