Particle.news
Download on the App Store

Guinea-Bissau Halts U.S.-Backed Hepatitis B Newborn Trial for Ethics Review

Officials paused the study after finding the national ethics committee had not technically vetted the protocol.

Overview

  • Health leaders said the trial is suspended pending a technical and ethical review, citing that the six-person committee did not meet and lacked required resources.
  • The randomized study would compare giving the hepatitis B vaccine at birth versus starting at six weeks, tracking about 14,000 infants for mortality, illness and development.
  • The Bandim Health Group at the University of Southern Denmark is leading the research, with partial U.S. funding totaling $1.6 million awarded during the Trump administration.
  • Africa CDC affirmed Guinea-Bissau’s decision-making authority, while a U.S. HHS spokesperson said the study was still set to proceed, underscoring ongoing disagreement over its status.
  • WHO and UNICEF officials previously raised concerns about the plan, and Guinea-Bissau still intends to introduce a routine hepatitis B birth dose nationwide in 2028.