African newborns' controversial US-backed vaccine trial halted after backlash over consent and funding concerns

Trial Will Not Proceed

The US-backed hepatitis B vaccine trial in Guinea-Bissau will not move forward, the lead researcher said Wednesday. The proposal had drawn global backlash. Health minister Quinhin Nantote had previously denied the project would proceed. “This is not even remotely true,” Nantote told the Guardian in Portuguese last week.

Calls for Newborn Vaccination

Paul Offit, a vaccines expert at the Children’s Hospital of Philadelphia, sharply criticized the proposed study as unethical. He said Guinea-Bissau should be supported in giving immunizations to all newborns as soon as possible.

Guinea-Bissau currently plans to offer a universal hepatitis B birth dose in 2028. Offit said the vaccine’s proposed immune-system concern was “fanciful,” describing hepatitis B vaccine as one protein among billions encountered each day.

Questions Over Consent and Funding

Experts said families who declined the study would not have received the vaccines, making genuine informed consent impossible. Støvring questioned whether participation could be considered non-coercive when children had a 50% chance of receiving the vaccine in the trial and no chance outside it.

Experts Cite Vaccine Benefits

Offit said there was a clear benefit to hepatitis B vaccination at birth and warned that not receiving it could create lifelong danger. He said there was no evidence the birth dose was problematic and pointed to the United States’ elimination of hepatitis B in children after the program began. Offit said Guinea-Bissau has a high incidence of chronic hepatitis B and argued that the country particularly needs to launch a birth-dose program.