A scientific and ethical fight has reignited over a U.S.-funded study of the hepatitis B vaccine in newborns in Guinea-Bissau, after a Danish university gave researchers approval this week to proceed with a revised version of the previously canceled trial.
The study, supported through the Centers for Disease Control and Prevention, is designed to examine whether the birth dose of the hepatitis B vaccine has unintended health effects. The vaccine has been used safely for decades, and when the trial first surfaced late last year, infectious-disease experts around the world denounced it as unethical — arguing that withholding a proven intervention from newborns violates the principles governing human research. The trial was canceled after an on-the-ground investigation raised major concerns about its protocol.
This week, the University of Southern Denmark said an independent ethical assessment had cleared the revised study to proceed, noting that an ethics panel in Guinea-Bissau had approved it and that national authorities there must still grant final authorization before any enrollment begins. Critics, including a U.S. science-advocacy organization, vowed to stop the study again, calling it a gross violation of human rights directed at some of the world’s most vulnerable people.
Inside the CDC, supporters of the trial had been waiting on the Danish review to revive the project, according to agency sources. For now, the study exists in a narrow space between an ethics approval in Copenhagen and an authorization decision in Bissau — with the health of newborns, and the standards of global research, at the center of the argument.
Related reading: Updated Flu Shots Target the H3N2 'Super Flu' as Officials Urge October Vaccination · FDA Closes the Largest Cyclospora Outbreak on Record, Tied to Imported Iceberg Lettuce · FDA Flags Four Deaths in Evenamide Studies as U.S. Trial Hold Stays in Place
