Guinea-Bissau Health Minister Denies Newborn Hepatitis B Trial Is Proceeding While Ethics Approvals Stand

Since judicial police searched the Bandim Health Project's offices in Guinea-Bissau on Monday, Oct. 19, and seized hepatitis B vaccine doses, the open question is whether the newborn trial behind the raid is even going forward. Two parts of the country's own government are giving different signals.

The minister says no

Quinhin Nantote, health minister in Guinea-Bissau's transitional government, rejected reports that the study would proceed. "This is not even remotely true," Nantote told the Guardian in Portuguese last Thursday, before the raid.

The Bandim Health Project has said otherwise, in effect. It recently posted a letter approving the trial from the national ethics committee at the Ministry of Public Health. The letter is dated July 14 and signed by the committee's president, Mouhammed Djicó Ould Ahmed.

A Danish research ethics committee also approved the study earlier this month. That committee had to change its own rules to be able to consider a clinical trial.

So the project holds an approval signed inside the health ministry's own structure, and the minister who runs that ministry says the trial is not happening. Neither side has publicly explained the gap.

What the police said

The judicial police announced the search on Facebook. It described "investigative procedures aimed at clarifying the circumstances related to the said batch of vaccines." The statement said the seizure did not point to "irregularities in the quality, safety, or effectiveness of the vaccines."

The police have not said what about the batch's circumstances prompted the search. No charges against the Bandim Health Project or anyone connected to it have been announced.

The trial itself

The study has been redesigned since the summer. It would still withhold hepatitis B vaccine from 7,000 newborns during their first six weeks of life, in a country where about one in five adults has the virus.

Funding totals $3.2 million. The U.S. Centers for Disease Control and Prevention is providing $1.6 million, matched by the Pershing Square Foundation and the Bluebell Foundation.

The World Health Organization has rejected the design outright. "Unethical and exposes newborns to serious and potentially irreversible harm," WHO spokesperson Tarik Jašarević said of any study that would deny the vaccine to participants. He called hepatitis B vaccination at birth an "essential public health intervention."

The WHO's country office and its partners have been advising Guinea-Bissau's health ministry on introducing the birth dose and on the potential impact of the study, Jašarević said.

Chronic hepatitis B kills 15% to 25% of those infected, through cancer and liver failure. Newborns are particularly vulnerable. A dose within 24 hours of birth is safe and highly effective at preventing illness, according to the WHO.

The Kennedy connection

The project was founded in 1978 by anthropologist Peter Aaby. It is now co-led by his wife, Christine Stabell Benn, an epidemiologist.

Health and Human Services Secretary Robert F. Kennedy Jr. has praised the pair repeatedly. At a recent anti-vaccine conference he called them "the deities of vaccine research." He has cited their earlier work on the diphtheria-tetanus-pertussis vaccine in arguing against established vaccination policy.

That link is why a CDC grant to a West African trial has become a U.S. political issue. CDC money sits inside Kennedy's department, and the department has not been shown to have addressed the WHO's objection in the material on this dispute. Kennedy's own recent public posts have been about his son Conor's October wedding in Rio de Janeiro, not the trial.

The police search leaves two things unresolved. One is what, specifically, investigators are trying to establish about the seized batch. The other is which Guinea-Bissau authority controls the trial: the ethics committee that signed off in July, or the health minister who says it is not moving forward.

Until one of them is settled in writing, the CDC's $1.6 million and the 7,000-newborn design remain on paper only.