Statement on the planned hepatitis B birth dose vaccine trial in Guinea-Bissau
WHO
February 13, 2026
AI-Generated Deep Dive Summary
The World Health Organization (WHO) has raised significant concerns about a proposed randomized controlled trial (RCT) on the hepatitis B birth dose vaccine in Guinea-Bissau. The trial, which would withhold the vaccine from some newborns, is deemed ethically and scientifically flawed by WHO experts. The hepatitis B birth dose vaccine is a proven life-saving intervention with a decades-long safety record, effectively preventing mother-to-child transmission of the virus and reducing the risk of chronic liver disease, cirrhosis, and liver cancer.
WHO argues that there is no scientific necessity for a no-treatment arm in this trial, as the vaccine has already demonstrated its efficacy and safety. The study’s design, which involves withholding a proven intervention from some participants, raises serious ethical concerns. This approach exploits resource scarcity and puts newborns at unnecessary risk of severe harm. Additionally, the protocol lacks sufficient justification, as it focuses on hypothetical safety outcomes without evidence of a genuine safety signal that would warrant such risks.
The trial’s single-blind design also introduces significant bias, potentially compromising the interpretability of its results. WHO emphasizes that ethical research must prioritize minimizing harm and ensuring participants receive proven care. In this case, the study fails to provide even basic safeguards, such as screening pregnant women or vaccinating newborns exposed to hepatitis B. These concerns have led Guinea-Bissau to suspend the trial pending further review.
WHO remains committed to supporting global efforts to eliminate hepatitis B through timely vaccination and evidence-based strategies. The organization is prepared to assist Guinea-Bissau in strengthening implementation of the birth dose vaccine, including improving delivery systems, ant
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Originally published on WHO on 2/13/2026