The World Health Organization (WHO) emphasizes that the hepatitis B birth dose vaccine is a proven, essential public health intervention, preventing life-threatening liver disease by blocking mother-to-child transmission at birth. Used for over three decades in more than 115 countries, the vaccine protects individual newborns and is central to national and global hepatitis B elimination efforts. Timely administration provides both immediate and long-term health benefits, reducing chronic infections, cirrhosis, and liver cancer.
WHO has expressed serious concerns regarding the proposed randomized controlled trial (RCT) of the hepatitis B birth dose in Guinea-Bissau. The organization questions the study’s scientific justification, ethical safeguards, and alignment with established principles for research involving human participants. Withholding a vaccine with a decades-long record of efficacy and safety poses a foreseeable risk of irreversible harm to newborns. WHO notes that placebo or no-treatment arms are only ethically acceptable when no proven intervention exists or when critical efficacy questions require such a design—conditions that do not appear to apply in this study.
The publicly described trial design also raises concerns about scientific validity and policy relevance. A single-blind, no-treatment-controlled trial introduces high risk of bias and limited interpretability. Using scarce resources as a rationale to withhold established care is ethically unacceptable, as research must minimize harm and ensure participant benefit. WHO states that, based on available information, the trial is inconsistent with accepted ethical and scientific standards.
Guinea-Bissau has suspended the trial pending further technical review. WHO stands ready to assist the country in accelerating birth dose implementation, including strategies for home and facility births, antenatal hepatitis B screening, linkage to care, neonatal prophylaxis, cold-chain logistics, healthcare worker training, and monitoring coverage and safety. WHO remains committed to ensuring that all newborns in Guinea-Bissau and globally receive timely, evidence-based protection against hepatitis B while upholding the highest ethical and scientific standards in research.
Hepatitis B remains a significant global health challenge, causing hundreds of thousands of deaths annually. Transmission at birth is the most common route to chronic infection, with around 90% of newborns infected during delivery becoming lifelong carriers at high risk of severe liver disease. In Guinea-Bissau, more than 12% of adults live with chronic hepatitis B, and infection rates in children under five remain far above the global target. The country formally decided in 2024 to introduce the birth dose into its national schedule by 2028, underscoring both the vaccine’s value and the ethical imperative to protect newborns without delay.
