Guinea-Bissau has not approved the controversial hepatitis B study in newborns that would be funded by the US government and private partners, the African country’s minister of health said on Tuesday.
The study, which would not investigate the safety or effectiveness of vaccines but would instead track “nonspecific” health outcomes like overall mortality or neurodevelopmental conditions, has been championed by Robert F Kennedy Jr, secretary of the US Department of Health and Human Services (HHS) and a longtime anti-vaccine activist.
Members of a Danish research ethics committee were informed that officials in Guinea-Bissau had approved an updated design of the study, which influenced some committee members’ votes to proceed with the trial last week.
But the health ministry never agreed to or authorized the trial, said Quinhin Nantote in Portuguese at a press briefing, where he referred to the study as “tests”.
“The ministry did not authorize the tests under the terms presented in the publications currently in circulation,” the health minister said. He said officials in Guinea-Bissau were “surprised” to see media reports that the country had given approval to the study.
“Any scientific research initiative involving human beings, particularly children, must strictly comply with applicable national legislation, international ethical principles, competent evaluation and approval mechanisms,” Nantote said.
He spoke after convening an emergency meeting in Guinea-Bissau with the Bandim Health Project, the local ethics committee, the National Institute of Public Health (Inasa) and the Expanded Vaccination Program (PAV).
The Bandim Health Project is run by the Danish researchers Peter Aaby and Christine Stabell Benn, whose decades of research have been called into question in the past year.
The claims made in nearly all of their papers are “highly misleading”, said Charlotte Strøm, a Danish researcher who has co-authored research showing that Aaby, Stabell Benn and their co-authors had no significant findings in 24 out of 25 studies and that they’ve chosen not to publish research that may not support their viewpoints.
“When researchers operate like this and abandon proper methodological rigor, they literally decide on the results themselves, and that is not science,” Strøm said, calling it “problematic, questionable [and] unethical”.
She added: “I believe there is serious cause for concern.”
Kennedy has repeatedly praised their work, which he says shows that after vaccination, “you can have mass injuries, and catastrophic injuries, and they’re hiding in plain sight.”
Aaby, Stabell Benn and Frederik Schaltz-Buchholzer did not respond by press time to the Guardian’s questions about why the Danish ethics committee members were told the trial had been approved by local authorities and why it could not be held in Denmark.
In Denmark, infants born to hepatitis B-negative parents do not receive the shot, there is widespread testing for and low incidence of the virus, and the robust healthcare system can track health outcomes and provide timely and comprehensive medical care – making it an ideal location for such a study.
“It’s completely unethical that this trial is even proposed,” because a safe and effective vaccine has been available for decades, said BK Titanji, a researcher at Emory University.
It’s “reassuring” to see Guinea-Bissau passing back on the trial, Titanji said, adding: “A study like this one needs the highest level of ethical scrutiny. You are going to be conducting a study on the most vulnerable population, which is newborn babies, in a country that is resource constrained.”
When Titanji recently applied for approval of a collaborative study in Cameroon, she had to include extensive documentation in her application – and it’s a survey, not medical research on human subjects, she said. “I can’t come to Emory’s IRB [instructional review board] and just be like: ‘I got permission from Cameroon.’ I have to provide the document.”
Experts have decried the African experiment as “horribly unethical and cruel”, “neo-colonialist” and “damaging”.
“For the government of Guinea-Bissau to stand up against the United States and Denmark exploiting its children is no small statement,” said Colette Delawalla, a researcher and founder and CEO of the non-profit Stand Up for Science. “We absolutely must respect their sovereignty as a nation.”
It would cost approximately $13,200 to buy enough vaccines through Unicef and Gavi, the Vaccine Alliance, to immunize all newborns in Guinea-Bissau each year, Delawalla pointed out.
Everyone involved should work together to ensure that every baby in Guinea-Bissau receives the birth dose of the hepatitis B vaccination, she added. “This is not muddy water: we can use Black babies to further pseudoscience or we can save children’s lives with a 20-cent shot.”
It is unclear whether the US plans to move forward with the study, even after reporting indicated that the US Centers for Disease Control and Prevention (CDC) has again set aside $1.6m for funding for the trial this year, to be matched by private funding from the Pershing Square Foundation and the Bluebell Foundation.
“The study has not been approved,” the HHS told Reuters in a statement. The agency has not responded to the Guardian’s questions about the trial.
At least four members of the Danish committee resigned after approval for the trial was fast-tracked. The rules of the committee had to be changed because randomized controlled trials were outside of its purview. When committee members requested more information about the Guinea-Bissau approval, no further details were provided.
The study would enroll 14,000 newborns in Guinea-Bissau, half of whom would be vaccinated at birth and half of whom would be denied the immunization for the first six weeks of life. Hepatitis B is widespread in the country, and infection in children can have serious lifelong effects.
Guinea-Bissau, which currently has a transitional military government following a coup in November, requested in January a team of experts from the Africa Centres for Disease Control and Prevention (Africa CDC) to help evaluate the study. In the meantime, Nantote said at the time, it was “cancelled or suspended.”
Other officials in Guinea-Bissau also pushed back on the research. “It’s not going to happen, period,” the foreign minister, João Bernardo Vieira, said in February.
