Lead researcher says Guinea-Bissau hepatitis B trial will not proceed

WHO recommends a first dose preferably within 24 hours of birth

Lead researcher Frederik Schaltz-Buchholzer said Wednesday that the US-backed hepatitis B vaccine trial involving newborns in Guinea-Bissau will not proceed. In the same LinkedIn post, he wrote that it was “now clear” the study “will not move forward in Guinea-Bissau” and added, “we were not given the necessary governmental approval.” Guinea-Bissau health minister Quinhin Nantote had previously denied that the project would move forward. Nantote told The Guardian in Portuguese last week: “This is not even remotely true.”

The government of Guinea-Bissau now has control over the researchers’ vaccines, which it apprehended during a search of the Bandim Health Project’s offices on Monday.

The study was to be funded with $1.6 million from the US Centers for Disease Control and Prevention and another $1.6 million from private partners such as the Bill Ackman-backed Pershing Square Foundation and the Bluebell Foundation.

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

The Danish researchers, led by Schaltz-Buchholzer, Christine Stabell Benn and Peter Aaby, hypothesized that giving live vaccines such as the Bacillus Calmette-Guérin vaccine, or BCG, might provide an overall mortality benefit beyond simply preventing illnesses such as tuberculosis. They also hypothesized that giving another vaccine, such as hepatitis B vaccine, alongside BCG could dampen that effect. The proposed study would examine mortality as well as side effects including skin and neurodevelopmental conditions.

Infants whose parents declined participation would not have received the vaccines; experts said that arrangement made true informed consent impossible. Henrik Støvring, a Danish researcher who has co-published research raising questions about previous research from the Bandim project, said: “Imagine you’re a mother. You want to do the best for your child.” He added: “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. So how can you say that’s a non-coercive informed consent?”

The proposed trial generated distrust among Bissau-Guineans, who wondered whether a vaccine with a decades-long record of being safe and effective was being tested on Africans because it was dangerous, Schaltz-Buchholzer said in his post.

Schaltz-Buchholzer wrote that it “should be clear” both birth-vaccination schedules, with or without hepatitis B, were not “dangerous to anyone.” He questioned the effectiveness and safety of hepatitis B vaccination at birth and said he believed the study was canceled because it challenged “prevailing medical assumptions, such as that HBV0 does not have non-specific effects.”

Paul Offit, a vaccines expert at the Children’s Hospital of Philadelphia, sharply criticized the proposed study as unethical. “The solution is clear here: take the money and vaccinate as many kids as you can,” Offit said. He called the hypothesis “fanciful” because the hepatitis B vaccine is a single protein among billions encountered by the immune system each day. “There’s no evidence for that, and it doesn’t make biological sense,” he said.

Offit said there was a clear benefit to giving the vaccine to babies as soon as possible because Guinea-Bissau has high rates of hepatitis B and infection can cause lifelong illness and death. He said conducting a study like this “makes the case that there’s something that’s worthy of study, for which they have no evidence”. Experts said there was a clear benefit to hepatitis B vaccination at birth and that not doing so could lead to lifelong danger.

Offit said, “We have millions and millions, arguably hundreds of millions, of children in this world who have gotten that vaccine as a birth dose or haven’t. If there was any evidence that this was problematic, you would know this by now.” He added: “We eliminated hepatitis B in the United States in children virtually within years of starting that program, so the benefits are clear.” The Guardian reported that dozens of studies have shown no link between vaccination and autism.

WHO spokesperson Tarik Jašarević said, “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.” He said WHO remained committed to working with national authorities, researchers and partners so that newborns in Guinea-Bissau and worldwide receive timely, evidence-based protection against hepatitis B.

It was vital to support Guinea-Bissau in rolling immunizations out to all newborns as soon as possible, Offit said. Guinea-Bissau currently plans to offer the universal birth dose in 2028. “All newborns should be given a birth dose of hepatitis B vaccine,” Offit said. “Guinea-Bissau is a country that suffers a high incidence of chronic hepatitis B. That country, more than any other country, arguably, needs to launch this program.”