Guinea-Bissau has reportedly halted a controversial US-funded hepatitis B virus (HBV) vaccine trial that attracted global attention when experts said it involved denying life-saving injections to thousands of babies.
The trial failed to gain necessary government approval, a researcher involved in the project said in a statement, adding that the end of the trial was a “significant setback” for African science.
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Officials have not commented.
The West African country’s judicial police said in mid-October they had searched the facilities of the research group leading the project in the capital, Bissau, and seized batches of vaccines.
Authorities said investigations were continuing to determine whether the trial complied with the country’s safety standards.
Here’s what we know:
What was the trial about?
The trial was designed to evaluate the effects of HBV vaccines recommended by the World Health Organization (WHO) on two groups of babies. One group would receive the vaccine at birth and another, randomly selected, would receive it six weeks later.
Some 14,000 babies are expected to take part in the trial. The researchers planned to evaluate health outcomes over five years for both sets.
The project secured $1.6 million from the U.S. Centers for Disease Control and Prevention (CDC), led by Health Secretary Robert F. Kennedy, who has previously made his anti-vaccine views known.
However, news of the trial in December last year sparked widespread anger over the refusal to vaccinate a group of babies. In January, the Guinea-Bissau government suspended the project and launched a review.
Who was leading the trial?
The Danish research group Bandim Health Project, based in Bissau and part of the University of Southern Denmark, planned the trial.
It is chaired by the eminent scientists Christine Stabell Benn and Peter Aaby, a married couple. Since 1978, they have run the Bandim health project in Bissau and have conducted studies on thousands of Bissau-Guineans.
The two researchers primarily study the unintended impacts of vaccines and hypothesized that vaccines containing inactivated viruses can cause death, including the HBV vaccine they planned to test in Bissau.
Their Danish counterparts, however, have repeatedly accused them of minimizing the results of the trials or of concealing evidence that does not correspond to their discourse.
One of the studies conducted by the two partners found that WHO-approved diphtheria, tetanus and pertussis (DPT) vaccines led to higher child mortality, particularly among girls. The WHO said the two men’s study was inconsistent but merited further review, and advised countries to continue vaccinating babies.
Last February, an investigation by the Danish publication Weekendavisen revealed that researchers had not made public the null results of one of their randomized controlled trials (RCTs) on the DPT vaccine, carried out 14 years ago. The study was published after the exhibition.
Why is the hepatitis B trial controversial?
In this case, health experts questioned the morality of withholding a highly effective vaccine from thousands of babies for research purposes. The WHO called it “unethical.”
Infants are at greatest risk of becoming chronically infected with hepatitis B – which is usually passed to them by their mothers. The disease has no cure and can lead to long-term liver damage and cancer. The WHO recommends the HBV vaccine at birth for all babies, along with booster shots, which are known to provide years of protection.
Guinea-Bissau has one of the highest numbers of people living with hepatitis B – a fifth of the 2.2 million population. Due to lack of access to enough doses, the government authorizes the vaccine up to six weeks after birth. However, it is working to start hepatitis B vaccination at birth for all babies starting in 2028.
The researchers argued that the period from now to 2028 provides a “unique window of opportunity” to assess the impact of the vaccine on babies who receive it at birth compared to those who receive it after six weeks. They noted that the research would allow thousands of babies to receive the vaccine at birth before the official schedule comes into effect.
But health experts pushed back, saying the study would essentially withhold vaccines from the other half who would have had access to them if the Bissau government could have afforded them. They said the effects, if some babies developed hepatitis B, could last a lifetime.
“(The researchers) took advantage of the fact that Guinea-Bissau does not have a very strong research capacity… a very strong critical mass of public health professionals, very well invested in understanding the policies that surround global health,” Magda Robalo, Guinea-Bissau’s former health minister, told Al Jazeera.
“It is unethical to deny children an intervention that we know works, that will help improve their lives and save them from a disease that we know they will be susceptible to,” she added.
Some also questioned why researchers planned to make the trial “open-label,” meaning they would know which participants received the vaccines and when. Such randomized trials are generally conducted “blindly.”
Others have pointed out that the trial is reminiscent of one in Tuskegee in Alabama, US, in which health authorities studied the effects of untreated syphilis in black men between 1932 and 1972, even though penicillin treatments were available at the time. More than 100 men died.
What did the researchers say?
Benn denied any wrongdoing in the group’s work in an email to Al Jazeera in February this year.
In a joint statement, Benn and Aaby further clarified that they were not testing whether the HBV vaccine prevents disease, but “whether prevention (of disease) has a prohibitive price,” such as death and other health problems.
They accused their critics of lacking curiosity and a “humble” mindset, and said the research would add to a body of science on the subject.
How did Guinea-Bissau react?
Guinea-Bissau launched an investigation into the trial in collaboration with the Africa Centers for Disease Control and Prevention (Africa CDC) and the WHO in January.
Officials also said the country’s transitional government, which took power following a coup in November, was not involved in the approval process.
A Danish ethics committee separately investigating the matter reportedly received information that Guinea-Bissau had approved an updated proposal, leading its members to vote in favor of continuing the project.
However, Health Minister Quinhin Nantote denied this in a media statement in mid-October, following a meeting with researchers and local health agencies.
On October 19, police raided and seized batches of vaccines at the Bandim facility. The authorities also appear to have called off the trial.
“It is now clear that the Hepatitis B-NSE trial will not move forward in Guinea-Bissau – we have not received the necessary government approval,” Bandim researcher Frederik Schaltz-Buchholzer said in a LinkedIn post a few days later.
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