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Hepatitis B vaccine trial in Guinea-Bissau receives approval to proceed

Researchers plan to withhold doses from thousands of infants, according to The Guardian.

The short version

  • Officials in Guinea-Bissau and an ethics panel at the University of Southern Denmark approved a trial enrolling 14,000 infants.[The Guardian]
  • Danish researchers plan to provide the hepatitis B shot to half the infants at birth while withholding it from others for six weeks.[The Guardian]
  • The project is budgeted to receive $1.6m from the CDC alongside matching private funding from the Pershing Square and Bluebell foundations.[The Guardian]
  • Four members of the Danish ethics committee resigned in protest, citing major ethical concerns with the study's protocol.[The Guardian]

Key facts

  • Authorities in Guinea-Bissau and a University of Southern Denmark ethics panel approved a pediatric hepatitis B vaccine study.[The Guardian]
  • Under the trial design, 14,000 babies will be enrolled, with half receiving the hepatitis B vaccine at birth and half having it delayed for six weeks.[The Guardian]
  • The US CDC budgeted $1.6m for the study, paired with private funding from the Pershing Square Foundation and Bluebell Foundation.[The Guardian]
  • Four members of the Danish ethics board, including reviewer Stig Børsen Hansen, resigned in protest over ethical issues.[The Guardian]

What remains uncertain

  • Guinea-Bissau's health minister previously indicated the study was suspended, leaving the full operational timeline and implementation status unconfirmed.[The Guardian]

Sources

Outlet counts describe coverage, not independent confirmation. Reports may share a wire service or original source.