Controversial US-backed vaccine trial in African newborns halted

A woman stands in a shared room at a residential care facility for pregnant mothers in Gabu, Guinea Bissau, on . Photograph: Rebecca Blackwell/AP View image in fullscreen A woman stands in a shared room at a residential care facility for pregnant mothers in Gabu, Guinea Bissau, on . Photograph: Rebecca Blackwell/AP Controversial US-backed vaccine trial in African newborns halted Hepatitis B study in Guinea-Bissau that was to be funded ‘will not move forward’ The US-backed hepatitis B vaccine trial in African newborns that drew global backlash was halted, the lead researcher said on Wednesday. It was “now clear” that the study “will not move forward in Guinea-Bissau”, Frederik Schaltz-Buchholzer, a Danish researcher, wrote on LinkedIn, adding, “we were not given the necessary governmental approval.” The minister of health in Guinea-Bissau, Quinhin Nantote, previously denied that the project would move forward. “This is not even remotely true,” Nantote told the Guardian in Portuguese last week. The study was to be funded with $1.6m from the US Centers for Disease Control and Prevention (CDC), along with another $1.6m from private partners like the Bill Ackman-backed Pershing Square Foundation and the Bluebell Foundation. “The solution is clear here: take the money and vaccinate as many kids as you can,” said Paul Offit, a vaccines expert at the Children’s Hospital of Philadelphia, who sharply criticized the proposed study as unethical. The government of Guinea-Bissau now has control over the researchers’ vaccines, which they apprehended when they searched the offices of the Bandim Health Project on Monday. It was vital to support Guinea-Bissau in rolling the immunizations out to all newborns as soon as possible, Offit said. Guinea-Bissau currently plans to offer the universal birth dose in 2028. The Danish researchers, led by Schaltz-Buchholzer, Christine Stabell Benn and Peter Aaby, hypothesized giving live vaccines, like the Bacillus Calmette-Guérin (BCG), may have an overall mortality benefit beyond simply preventing illnesses like tuberculosis – but giving another vaccine like hepatitis B alongside it could dampen that effect. View image in fullscreen The Minister of health, Quinhin Nantote, at the presidential palace in Guinea-Bissau on . Photograph: Patrick Meinhardt/AFP/Getty ImagesSuch a hypothesis was “fanciful” because the hepatitis B vaccine is a single protein among billions encountered , Offit said. “There’s no evidence for that, and it doesn’t make biological sense,” he continued. He also added that there was a very clear benefit to giving the vaccine to babies as soon as possible, because of high rates of hepatitis B in the country and the possibility of lifelong illness and death from infection.