Trial halted in Guinea-Bissau

A US-backed hepatitis B vaccine trial on African newborns has been stopped. Lead researcher Frederik Schaltz-Buchholzer said it is now clear the study will not move forward in Guinea-Bissau.

“it was "now clear" that the study "will not move forward in Guinea-Bissau"”

Government denied approval

Guinea-Bissau's health minister Quinhin Nantote previously told the Guardian the project would not move forward. Schaltz-Buchholzer cited lack of necessary governmental approval as the reason.

“"This is not even remotely true," Nantote told the Guardian in Portuguese”

Funding sources identified

The study was to be funded with one point six million dollars from the US Centers for Disease Control and Prevention, plus another one point six million dollars from private partners including the Pershing Square…

The disputed hypothesis

Danish researchers led by Frederik Schaltz-Buchholzer, Christine Stabell Benn and Peter Aaby hypothesized that live vaccines like BCG might have overall mortality benefits, but hepatitis B could dampen that effect.

Expert calls hypothesis fanciful

Paul Offit, a vaccines expert at the Children's Hospital of Philadelphia, criticized the study as unethical.

“"There's no evidence for that, and it doesn't make biological sense,"”

Informed consent concerns

Those who declined participation would not have received vaccines, making true informed consent impossible. Danish researcher Henrik Støvring asked how mothers could give non-coercive consent when participation offered a fifty percent chance of vaccination but…

“"If they decide to participate in the trial, they have a 50% chance of getting the vaccine for their children. But if they stay out, they have a 0% chance of getting the vaccine."”

Government seizes vaccine supplies

Guinea-Bissau's government now has control over the researchers' vaccines after apprehending them during a search of the Bandim Health Project offices on Monday.

Offit's recommended path forward

Paul Offit said the solution is clear: take the money and vaccinate as many children as possible. Guinea-Bissau currently plans to offer the universal birth dose in twenty twenty-eight.

“"The solution is clear here: take the money and vaccinate as many kids as you can,"”

Vaccine benefits established

Offit emphasized Guinea-Bissau has high hepatitis B rates and needs the vaccine program urgently. The United States eliminated hepatitis B in children within years of starting its birth dose program, demonstrating clear benefits.

“"All newborns should be given a birth dose of hepatitis B vaccine,"”