The World Health Organization has raised serious ethical and scientific concerns over a proposed hepatitis B birth-dose vaccine trial in Guinea-Bissau, warning that the study could expose newborn babies to preventable health risks.
In a statement released on February 13, 2026, WHO questioned the justification and design of the planned randomized trial, which would reportedly withhold the hepatitis B birth-dose vaccine from some infants.
Why This Matters
Hepatitis B is a potentially life-threatening viral infection that attacks the liver and can lead to chronic disease, cirrhosis, or liver cancer. When babies are infected at birth, the risk of developing lifelong infection is extremely high.
For more than three decades, the hepatitis B birth-dose vaccine has been used safely in over 115 countries. Health authorities worldwide recognize it as a proven and lifesaving intervention that significantly reduces mother-to-child transmission.
WHO’s Core Concerns
WHO highlighted three major issues with the proposed study:
1. Ethical Violations
Withholding a proven vaccine from newborns, WHO argues, exposes them to foreseeable harm. Ethical standards in medical research generally do not permit denying participants an established effective intervention, especially when dealing with vulnerable populations like infants.
2. Scientific Weaknesses
The agency noted that the vaccine’s safety and effectiveness are already well established. The proposed single-blind design, with a no-treatment control group, could produce biased or inconclusive results.
3. Misuse of Scarcity
WHO also emphasized that vaccine supply limitations should not be used as a basis to justify withholding standard care within a clinical trial.
Trial Suspended Pending Review
Following concerns raised by global health authorities, the government of Guinea-Bissau has reportedly suspended the trial pending further review.
WHO reaffirmed its commitment to supporting the country in strengthening routine immunisation systems, including improving timely birth-dose delivery and expanding national hepatitis B prevention strategies.
The Bigger Picture
This development highlights a broader global debate about medical ethics, equity, and the protection of vulnerable populations in research settings. While scientific inquiry is essential for public health advancement, it must always be guided by strict ethical safeguards, especially when the lives of newborns are involved.
As hepatitis B continues to affect millions worldwide, global health experts maintain that expanding access to proven prevention tools remains the safest and most responsible path forward.
Source: World Health Organization (WHO) , “Statement on the Planned Hepatitis B Birth Dose Vaccine Trial in Guinea-Bissau,” February 13, 2026.
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