Judicial police in Guinea-Bissau seized doses of the hepatitis B vaccine from the offices of the controversial researchers linked to a proposed clinical trial – the Bandim Health Project – that would affect thousands of newborns in the country, reports The Guardian.
According to a Facebook post by the officials and translated from Portuguese, the police search involved “investigative procedures aimed at clarifying the circumstances related to the said batch of vaccines”. The announcement noted that seizing the immunisations did not point to “irregularities in the quality, safety, or effectiveness of the vaccines”.
Guinea-Bissau has flatly denied having approved the controversial hepatitis B study in newborns that would be funded by the US Government and private partners, with the country's Minister saying last week that it has never agreed to the research – which would not investigate the safety or effectiveness of vaccines but would instead track “non-specific” health outcomes like overall mortality or neuro-developmental conditions.
The trial has been championed by anti-vaccine activist Robert F Kennedy Jr, secretary of the US Department of Health and Human Services (HHS).
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 had definitely not authorised the trial, said Minister Quinhin Nantote, referring to the study as “tests”.
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, after convening an emergency meeting a week ago in Guinea-Bissau with the Bandim Health Project, the local ethics committee, the National Institute of Public Health (Inasa) and the Expanded Vaccination Programme (PAV).
The Bandim Health Project had posted a letter of approval for the trial from Guinea-Bissau’s national ethics committee at the ministry of public health, dated 14 July and signed by the committee’s president, Mouhammed Djicó Ould Ahmed. A Danish research ethics committee, which had to change its rules to consider a clinical trial, had also approved the study earlier this month.
The study was redesigned over the summer, but it would still deny hepatitis B vaccines to 7 000 newborns in the first six weeks of life, in a country where about one in five adults have the virus. Hepatitis B kills 15% to 25% of people with chronic infections, causing cancer and liver failure, and newborns are particularly vulnerable – but vaccination within 24 hours of birth is safe and highly effective at preventing illness.
The Bandim Health Project is run by 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 rigour, 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.
Unethical
Any study that would deny the vaccine to participants was “unethical and exposes newborns to serious and potentially irreversible harm”, said Tarik Jašarević, a spokesperson for the World Health Organisation (WHO), calling hepatitis B vaccination at birth an “essential public health intervention”.
Through its country office in Guinea-Bissau, the WHO and its partners have been advising the ministry of health on the planned introduction of the hepatitis B vaccine and the potential impact of this study, Jašarević added.
The Bandim Health Project was founded by anthropologist Peter Aaby in 1978, and is now co-led by his wife, Stabell Benn, an epidemiologist.
Stabell Benn was a member of the hepatitis B working group of the Advisory Committee on Immunisation Practices (ACIP), helping present evidence to the US committee that voted to end the universal birth recommendation before such decisions on vaccines were stayed by a federal judge. Stabell Benn also hosted a podcast with Tracy Beth Høeg, a former top official with the US Food and Drug Administration (FDA) who said she wanted to end “unnecessary” vaccines.
The Bandim organisation is deeply enmeshed in Guinea-Bissau but has done little to improve the country’s health and research capacities in five decades of operation, according to a report from the non-profit Stand Up for Science (SUFS). The organisation is now fundraising to help roll out the vaccines at birth to all newborns in the country.
Experts have decried the African experiment as “horribly unethical and cruel”, “neocolonialist” 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 Stand Up for Science. “We absolutely must respect their sovereignty as a nation.”
It would cost around $13 200 to buy enough vaccines through Unicef and Gavi, the Vaccine Alliance, to immunise all newborns in Guinea-Bissau each year, Delawalla pointed out.
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 randomised controlled trials were outside its purview. When committee members requested more information about the Guinea-Bissau approval, no further details were provided.
Guinea-Bissau, which currently has a transitional military government after a coup in November, in January had asked a team of experts from the Africa Centres for Disease Control and Prevention (Africa CDC) to help evaluate the study.
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.
The WHO has offered support in rolling out the hepatitis B vaccine at birth to all newborns in Guinea-Bissau.
“WHO stands ready to support Guinea‑Bissau as it considers its way forward and in accelerating the introduction of the birth dose and strengthening implementation,” the organisation said in a statement on the clinical trial.
See more from MedicalBrief archives:
‘Unethical’ hepatitis B jab study to go ahead in Guinea-Bissau
WHO slams US-funded baby vaccine trial in Guinea-Bissau
Controversial study will delay life-saving vaccine for Guinea-Bissau babies