Guinea-Bissau Judicial Police Search Bandim Health Project Offices, Seize Hepatitis B Vaccine Doses

Since reports surfaced this month that the CDC director's office set aside $1.6 million for a newborn hepatitis B trial in Guinea-Bissau, the dispute has moved from paperwork to police action. Judicial police searched the offices of the Bandim Health Project and seized doses of hepatitis B vaccine, according to a Facebook post from the police.

The post, translated from Portuguese, said the search took place on Monday and involved "investigative procedures aimed at clarifying the circumstances related to the said batch of vaccines." It also said the seizure did not point to "irregularities in the quality, safety, or effectiveness of the vaccines."

No charges have been announced. The police have not said what circumstances they are trying to clarify.

What the trial would do

The study is backed by $1.6 million from the U.S. Centers for Disease Control and Prevention. The Pershing Square Foundation and the Bluebell Foundation matched that amount, for $3.2 million in total.

The design was reworked over the summer. It would still withhold hepatitis B vaccine from 7,000 newborns during their first six weeks of life.

About one in five adults in Guinea-Bissau has the virus. Hepatitis B kills 15% to 25% of people with chronic infections, through cancer and liver failure. Vaccination within 24 hours of birth is safe and highly effective at preventing illness.

Who approved what

The Bandim Health Project says the trial is cleared. It recently posted a letter of approval from Guinea-Bissau's national ethics committee at the Ministry of Public Health, dated July 14 and signed by the committee's president, Mouhammed Djicó Ould Ahmed. A Danish research ethics committee, which had to change its rules in order to consider a clinical trial, also approved the study earlier this month.

The government says otherwise. Quinhin Nantote, health minister of the transitional government, rejected reports that the trial would move forward. "This is not even remotely true," he told The Guardian in Portuguese last Thursday.

So one side holds a signed approval letter and the other says the trial is not going ahead. Neither side has publicly explained how the ethics committee letter squares with the minister's statement.

The WHO position

World Health Organization spokesperson Tarik Jašarević said any study that denies the vaccine to participants is "unethical and exposes newborns to serious and potentially irreversible harm." He called birth-dose vaccination an "essential public health intervention."

Jašarević said the WHO country office and its partners have been advising the health ministry on introducing the hepatitis B vaccine and on the potential impact of the study.

The researchers and Kennedy

The Bandim Health Project was founded in 1978 by anthropologist Peter Aaby. It is now co-led by his wife, epidemiologist Christine Stabell Benn. Aaby, Stabell Benn and lead researcher Frederik Schaltz-Buchholzer did not respond to questions from The Guardian about the trial or the police search.

Kennedy has repeatedly praised the pair. He called them "the deities of vaccine research" at a recent anti-vaccine conference and has cited their earlier work on the diphtheria-tetanus-pertussis vaccine. Stabell Benn also served on the hepatitis B working group of the CDC's Advisory Committee on Immunization Practices.

The Guardian reported that the same researchers later repeated their DTP study and found completely different results. Kennedy has kept citing the first one.

What is at stake

This is American taxpayer money going to a trial design that the WHO calls unethical. The host government says it has not signed off on that design, and the researchers hold a letter that says a government committee did. Someone has to be wrong about the paperwork, and that is a question of record that can be checked.

The police said the seizure points to no problem with the vaccines themselves. The open questions are what the investigation is actually examining, whether the trial proceeds, and whether the CDC keeps the $1.6 million committed while the host country's own officials say the study is not authorized.