Nantote disputes reports of hepatitis B trial involving 7,000 newborns
Officials said on Facebook that Guinea-Bissau’s judicial police searched Bandim Health Project offices on Monday and seized doses of hepatitis B vaccine. The researchers are involved in a redesigned study approved by ethics committees in Guinea-Bissau and Denmark, even as health minister Quinhin Nantote disputed reports that it would move forward.
Authorization conflict
The search took place Monday, according to a social media post translated from Portuguese. It involved “investigative procedures aimed at clarifying the circumstances related to the said batch of vaccines.” The same announcement said the seizure did not point to “irregularities in the quality, safety, or effectiveness of the vaccines.”
Bandim recently posted a letter of approval from Guinea-Bissau’s national ethics committee at the ministry of public health. The letter was dated July 14 and signed by committee president Mouhammed Djicó Ould Ahmed. A Danish research ethics committee also approved the study earlier this month after changing its rules to consider a clinical trial.
Quinhin Nantote, the health minister of Guinea-Bissau’s transitional government, disputed reports that the trial would move forward. “This is not even remotely true,” Nantote told The Guardian in Portuguese on Thursday.
Study design and WHO response
The study was redesigned over the summer, but it would still withhold hepatitis B vaccines from 7,000 newborns in their first six weeks of life. Guinea-Bissau is a country where about one in five adults have the virus.
The Guardian reported that hepatitis B kills 15% to 25% of people with chronic infections and can cause cancer and liver failure. Newborns are particularly vulnerable, but vaccination within 24 hours of birth is safe and highly effective at preventing illness, the newspaper said.
Any study that would deny the vaccine to participants was “unethical and exposes newborns to serious and potentially irreversible harm,” World Health Organization spokesperson Tarik Jašarević said. Jašarević called hepatitis B vaccination at birth an “essential public health intervention.” Through its country office in Guinea-Bissau, the WHO and its partners have advised the ministry of health on the vaccine’s planned introduction and the potential impact of the study.
Funding and institutional roles
U.S. Department of Health and Human Services Secretary Robert F. Kennedy Jr. has repeatedly praised the researchers, calling them “the deities of vaccine research” at a recent anti-vaccine conference. He has also cited the results of a diphtheria-tetanus-pertussis study by the researchers; the same researchers later conducted the study again and found completely different results. On Joe Rogan’s podcast in 2023, Kennedy called Peter Aaby a “very famous” researcher. Kennedy also cited Aaby’s research when he halted U.S. funding to Gavi, the Vaccine Alliance.
The Guardian described an ongoing dispute involving the researchers’ work on African newborns. The U.S. Centers for Disease Control and Prevention supplied $1.6 million, which the Pershing Square Foundation and the Bluebell Foundation matched, bringing total support to $3.2 million.
Christine Stabell Benn was a member of the hepatitis B working group of the U.S. Advisory Committee on Immunization Practices. She helped present evidence to the committee that voted to end the universal birth recommendation before a federal judge stayed such vaccine decisions. Stabell Benn also hosted a podcast with Tracy Beth Høeg, a former top official with the U.S. Food and Drug Administration who said she wanted to end “unnecessary” vaccines.
The Bandim Health Project was founded by anthropologist Peter Aaby in 1978 and is now co-led by his wife, Christine Stabell Benn, an epidemiologist. Frederik Schaltz-Buchholzer is the project’s lead researcher. Aaby, Stabell Benn and Schaltz-Buchholzer did not respond to The Guardian’s questions about the trial and the police search.
Stand Up for Science assessment
A report from the nonprofit Stand Up for Science said Bandim had done little to improve Guinea-Bissau’s health and research capacities in five decades of operation. Bandim is now fundraising to help provide birth vaccines to all newborns in the country.
Colette Delawalla, an American health researcher and founder of Stand Up for Science, said, “Our investigator encountered significant distrust of Bandim by the citizenry of Guinea-Bissau.” She said a lack of public health infrastructure meant Bandim was often the only option for people desperate to access medical care of any kind.
Delawalla said the police search highlighted Guinea-Bissau’s status as a “fragile” nation. She said the country experienced a military coup less than a year ago and lacks the stability needed for clinical trials.
“Guinea-Bissau is in the difficult situation of trying to protect their youth, their future, from exploitation by two powerful western nations and they are using what leverage they have to do so,” Delawalla said.