A controversial US-funded trial that would have withheld the hepatitis B birth-dose vaccine from newborns in Guinea-Bissau is dead, as the Guardian’s Melody Schreiber reports. Lead researcher Frederik Schaltz-Buchholzer, a Danish scientist with the Bandim Health Project, conceded on LinkedIn that “we were not given the necessary governmental approval.”
The study was set to receive $1.6 million from the US Centers for Disease Control and Prevention (CDC), matched by private backers including the Pershing Square Foundation. Guinea-Bissau’s health minister, Quinhin Nantote, had already denied it would proceed, and authorities seized the researchers’ vaccines during a search of Bandim’s offices.
The Danish team hypothesized that live vaccines like BCG offer survival benefits beyond preventing tuberculosis — and that giving hepatitis B alongside could blunt that effect. Paul Offit, a vaccine expert at the Children’s Hospital of Philadelphia, called the idea “fanciful,” noting the vaccine is a single protein among billions the immune system meets daily. “There’s no evidence for that, and it doesn’t make biological sense,” he said.
Critics also questioned the trial’s ethics, since families who declined to enroll would have gotten no vaccine at all. “If they stay out, they have a 0% chance of getting the vaccine. So how can you say that’s a non-coercive informed consent?” asked Henrik Støvring, a Danish researcher whose published research has raised questions about earlier Bandim studies.
The World Health Organization (WHO) recommends a hepatitis B dose within 24 hours of birth, and Guinea-Bissau, which carries a high burden of chronic infection, plans to roll out a universal birth dose in 2028. Offit wants it sooner, urging funders to “take the money and vaccinate as many kids as you can.”
“We eliminated hepatitis B in the United States in children virtually within years of starting that program, so the benefits are clear,” Offit said.
