Controversial US-backed vaccine trial in African newborns halted

Hepatitis B study in Guinea-Bissau that was to be funded by CDC and that drew global backlash ‘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.

Such a hypothesis was “fanciful” because the hepatitis B vaccine is a single protein among billions encountered by the immune system each day, 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.

The Danish researchers did not respond by press time to questions about the study or to this criticism. The CDC did not respond by press time to questions about whether the funding, which was appropriated through its global health work, would now be used to roll out the vaccine to all newborns in Guinea-Bissau, as recommended by the World Health Organization (WHO).

“WHO recommends that all infants receive a first dose of the hepatitis B vaccine as soon as possible after birth – preferably within 24 hours – followed by at least two additional doses,” said Tarik Jašarević, a WHO spokesperson. “WHO remains committed to working with national authorities, researchers, and partners to ensure that all newborns – in Guinea‑Bissau and worldwide – receive timely, evidence‑based protection against hepatitis B.”