<2>Statement on the Planned Hepatitis B Birth Dose Vaccine Trial in Guinea-Bissau
<3>Introduction
The World Health Organization (WHO) has been made aware of a planned trial to evaluate the effectiveness of a hepatitis B birth dose vaccine in Guinea-Bissau. This statement aims to provide an update on the planned trial and address any concerns that may arise.
<3>The Trial Background
The trial, which is being conducted by a team of researchers from various institutions, aims to evaluate the effectiveness of a hepatitis B birth dose vaccine in preventing the transmission of hepatitis B virus (HBV) from mother to child. The trial will involve a cohort of pregnant women who will receive the vaccine at birth, and their infants will be followed up for a period of 12 months to assess the vaccine’s efficacy.
<3>WHO’s Role
WHO has been informed about the planned trial and has provided guidance to the researchers on the trial’s design, conduct, and reporting. WHO has also ensured that the trial is conducted in accordance with the principles of Good Clinical Practice (GCP) and the International Conference on Harmonisation (ICH) guidelines.
<3>Concerns and Controversies
There have been concerns raised about the trial’s potential impact on the