The World Health Organization (WHO) underscores that the hepatitis B birth dose vaccine is an effective, and essential public health intervention, with a proven record. It prevents life‑threatening liver disease by stopping mother‑to‑child transmission at birth. It has been used for over three decades, with more than 115 countries including it in their national schedules. Protecting newborns with a timely birth dose not only provides individual benefit but is also central to national and global elimination efforts.

In response to recent questions from the media, WHO would like to state the following:

WHO is aware of the proposed randomized controlled trial (RCT) on the hepatitis B birth dose vaccine in Guinea‑Bissau. Based on questions raised in publicly available information and consultation with relevant experts, WHO has significant concerns regarding the study’s scientific justification, ethical safeguards, and overall alignment with established principles for research involving human participants.