A U.S.-backed trial of a hepatitis B vaccine in African newborns that sparked a global backlash has been halted, the lead researcher said 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 have not received the necessary government approval.”
Guinea-Bissau Health Minister Quinhin Nantote previously denied the project could go ahead. “It’s not even remotely true,” Nantote told the Guardian in Portuguese last week.
The study was to be funded with $1.6 million from the U.S. Centers for Disease Control and Prevention (CDC), as well as an additional $1.6 million from private partners such as the Bill Ackman-backed Pershing Square Foundation and the Bluebell Foundation.
“The solution here is clear: Take the money and vaccinate as many children as possible,” said Paul Offit, a vaccine expert at Children’s Hospital of Philadelphia, who sharply criticized the proposed study as unethical.
The government of Guinea-Bissau now controls the vaccines of the researchers, whom they apprehended on Monday during their search of the offices of the Bandim Health Project.
It is essential to help Guinea-Bissau expand vaccination to all newborns as soon as possible, Offit said. Guinea-Bissau currently plans to offer the universal dose at birth in 2028.
The Danish researchers, led by Schaltz-Buchholzer, Christine Stabell Benn and Peter Aaby, hypothesized that administering live vaccines, such as Bacillus Calmette-Guérin (BCG), could have an overall mortality benefit beyond just preventing diseases like tuberculosis – but that concurrent administration of another vaccine like hepatitis B could blunt this effect.
Such a hypothesis was “fanciful” because the hepatitis B vaccine is a single protein among billions that the immune system encounters every day, Offit said.
“There is no evidence of this, and it makes no biological sense,” he continued. He also added that there was a very clear benefit to giving the vaccine to babies as early as possible, due to the high rates of hepatitis B in the country and the risk of lifelong illness and death from infection.
The Danish researchers did not respond at the time of publication to questions about the study or these criticisms. The CDC did not respond at press time to questions about whether the funding, which was allocated as part of 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 hepatitis B vaccine as soon as possible after birth – preferably within 24 hours – followed by at least two additional doses,” said Tarik Jašarević, WHO spokesperson. “WHO remains committed to working with national authorities, researchers and partners to ensure that all newborns – in Guinea-Bissau and around the world – receive timely, evidence-based protection against hepatitis B. »
Those who refused to participate in the study would not have received the vaccines, making true informed consent impossible, experts say.
“Imagine you are a mother. You want to do the best for your child,” said Henrik Støvring, a Danish researcher who co-published research raising questions about the Bandim Project’s previous research.
“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 this is non-coercive informed consent?” » asked Støvring.
The proposed trial sparked distrust among Bissau-Guineans, who questioned whether the vaccine — whose safety and effectiveness have been recognized for decades — was being tested on Africans because it was dangerous, Schaltz-Buchholzer said in his message.
It “should be clear” that both birth vaccination schedules – with or without hepatitis B – are “not dangerous for anyone,” he wrote. Experts say there is a clear benefit to giving the hepatitis B vaccine at birth, but failure to do so can result in lifelong danger.
Conducting a study like this “demonstrates that there is something worth studying that they have no evidence for,” Offit said.
“We have millions and millions, probably hundreds of millions, of children in this world who have received this vaccine at birth or not. If there was any evidence that this is a problem, you would know about it by now,” Offit added. “We eliminated hepatitis B among children in the United States virtually within a few years of starting this program, so the benefits are clear.”
Schaltz-Buchholzer also questioned the effectiveness and safety of the hepatitis B vaccine at birth, noting that he believes the study was canceled because it challenges “prevailing medical assumptions, such as that HBV0 has no nonspecific effects.” The study, in addition to looking at mortality, also reportedly looked at side effects such as skin conditions and neurodevelopmental disorders. Dozens of studies have shown no link between vaccination and autism.
“All newborns should receive a dose of hepatitis B vaccine at birth,” Offit said. “Guinea-Bissau is a country that suffers from a high incidence of chronic hepatitis B. This country, more than any other country, probably needs to launch this program. »
Gn Health
