Guinea-Bissau has not approved the controversial study of hepatitis B in newborns that would be funded by the US government and private partners, the African country’s health minister said on Tuesday.
The study, which would not examine the safety or effectiveness of vaccines but rather track “non-specific” health outcomes like overall mortality or neurodevelopmental problems, was championed by Robert F Kennedy Jr, secretary of the US Department of Health and Human Services (HHS) and longtime anti-vaccine campaigner.
Members of a Danish research ethics committee were told that Guinea-Bissau officials had approved an updated study design, influencing some committee members’ vote to continue the trial last week.
But the Health Ministry never accepted or authorized the trial, Quinhin Nantote said in Portuguese during a press briefing, where he called the study “tests.”
“The ministry did not authorize the tests under the conditions presented in the publications currently in circulation,” indicated the Minister of Health. He said Guinea-Bissau officials were “surprised” to see media reports that the country had given approval to the study.
“Any scientific research initiative involving human beings, especially children, must strictly comply with applicable national legislation, international ethical principles and relevant evaluation and approval mechanisms,” Nantote said.
He spoke after calling 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 led by Danish researchers Peter Aaby and Christine Stabell Benn, whose decades of research were called into question last year.
The claims in almost all of their papers are “highly misleading,” said Charlotte Strøm, a Danish researcher who co-authored a study showing that Aaby, Stabell Benn and their co-authors did not have significant results in 24 of 25 studies and that they chose not to publish research that might not support their views.
“When researchers do this and abandon appropriate methodological rigor, they literally decide the results themselves, and that is not science,” Strøm said, calling it “problematic, questionable (and) unethical.”
She added: “I think there are serious reasons for concern. »
Kennedy has repeatedly praised their work, which he said shows that after vaccination, “you can have massive injuries and catastrophic injuries, and they’re hiding in plain sight.”
Aaby, Stabell Benn and Frederik Schaltz-Buchholzer did not respond at the time of publication to questions from the Guardian about why members of the Danish ethics committee were informed that the trial had been approved by local authorities and why it could not take place in Denmark.
In Denmark, infants born to hepatitis B negative parents do not receive the vaccine, testing for the virus is widespread and low incidence of the virus is widespread, and the robust healthcare system can track health outcomes and provide comprehensive and timely medical care – making it an ideal place for such a study.
“It is completely unethical that this trial is even being proposed,” because a safe and effective vaccine has been available for decades, said BK Titanji, a researcher at Emory University.
It is “reassuring” to see Guinea-Bissau objecting to the trial, Titanji said, adding: “A study like this requires the highest level of ethical scrutiny.” You will conduct a study on the most vulnerable population, namely newborns, in a country with limited resources. »
When Titanji recently sought approval for a collaborative study in Cameroon, she had to include detailed documentation in her application — and this is an investigation, not medical research on human subjects, she said. “I can’t come to Emory’s IRB (institutional review board) and just say, ‘I got permission from Cameroon.’ I must provide the document.
Researchers are expected to release those documents along with an updated protocol showing how the study would be conducted, she said.
Experts have called the African experiment “horribly unethical and cruel,” “neocolonialist” and “damaging.”
“For the government of Guinea-Bissau to speak out against the exploitation of its children by the United States and Denmark is no small statement,” said Colette Delawalla, researcher and founder and CEO of the nonprofit Stand Up for Science. “We absolutely must respect their sovereignty as a nation.”
It would cost about $13,200 to purchase enough vaccines through Unicef and Gavi, the Vaccine Alliance, to vaccinate all newborns in Guinea-Bissau each year, Delawalla noted.
Everyone involved must work together to ensure that every baby in Guinea-Bissau receives the dose of hepatitis B vaccination at birth, she added. “It’s not muddy water: we can use black babies to advance pseudoscience or we can save children’s lives with a 20-cent bullet.”
It’s unclear whether the U.S. plans to move forward with the study, even after reports that the U.S. Centers for Disease Control and Prevention (CDC) has again set aside $1.6 million in funding for the trial this year, which will be supplemented by private funding from the Pershing Square Foundation and the Bluebell Foundation.
“The study has not been approved,” HHS told Reuters in a statement. The agency did not respond to the Guardian’s questions about the lawsuit.
At least four members of the Danish committee resigned after approval of the trial was fast-tracked. The committee’s rules had to be changed because randomized controlled trials did not fall within its remit. When committee members asked for more information on Guinea-Bissau’s approval, no further details were provided.
The study would involve 14,000 newborns in Guinea-Bissau, half of whom would be vaccinated at birth and the other half would be denied vaccination for the first six weeks of life. Hepatitis B is widespread in the country and infection in children can have serious lifelong consequences.
Guinea-Bissau, which currently has a transitional military government following the November coup, in January asked a team of experts from the Africa Centers for Disease Control and Prevention (Africa CDC) to help evaluate the study. In the meantime, Nantote said at the time, the project had been “cancelled or suspended.”
Other officials in Guinea-Bissau have also given up on this research. “It will not happen, period,” Foreign Minister João Bernardo Vieira said in February.
The World Health Organization (WHO) has offered support to roll out the hepatitis B vaccine at birth to all newborns in Guinea-Bissau. “WHO stands ready to support Guinea-Bissau in considering the way forward and in accelerating the introduction of the birth dose and strengthening its implementation,” the organization said in a February statement pushing back against the trial.
Gn Health
