A US-backed hepatitis B study on African newborns is off the table after the government sign-off it needed never materialised.
Guinea-Bissau will not be the testing ground for a hepatitis B vaccine study on newborns. The US-backed trial, which sparked backlash around the world, has been halted, and the question of who gets to approve research on African babies is back in focus.
The lead researcher, Danish scientist Frederik Schaltz-Buchholzer, confirmed the news on Wednesday in a post on LinkedIn. He said it was now clear the study would not go ahead in the West African nation, because the team had not received the governmental approval it needed.
The study was slated to receive funding from the US Centers for Disease Control and Prevention. Once plans became public, criticism spread quickly across borders, and the trial became a flashpoint in the wider debate over how health research is designed, approved and carried out on the continent.
The outcome underlines a simple point: no study involving African newborns can proceed without the consent of the government whose citizens it affects. Whatever else comes out of this episode, the approval process was never a formality, and the trial's end shows how much weight local sign-off carries in health research ethics.
