Hepatitis B Vaccine Trial in Guinea-Bissau Halted Amid Controversy
A US-supported hepatitis B vaccine trial involving newborns in Africa has been stopped, as announced by the lead researcher on Wednesday.
Frederik Schaltz-Buchholzer, a researcher from Denmark, stated that it became “clear” the study “will not move forward in Guinea-Bissau,” highlighting the lack of necessary governmental approval on LinkedIn.
The health minister of Guinea-Bissau, Quinhin Nantote, had previously denied any plans to proceed with the project. In a statement to the Guardian last week, he firmly said, “This is not even remotely true,” in Portuguese.
The study was supposed to receive funding of $1.6 million from the US Centers for Disease Control and Prevention (CDC), complemented by another $1.6 million from private entities like the Pershing Square Foundation and the Bluebell Foundation.
Paul Offit, a vaccination expert from the Children’s Hospital of Philadelphia, criticized the trial as unethical, suggesting that the clear solution would be to utilize the funds to vaccinate as many children as possible.
Following a search of the Bandim Health Project’s offices on Monday, the Guinea-Bissau government now has control over the researchers’ vaccines.
Offit emphasized the urgency of rolling out immunizations to all newborns in the country, as Guinea-Bissau plans to provide the universal birth dose in 2028.
The Danish team, led by Schaltz-Buchholzer, Christine Stabell Benn, and Peter Aaby, had proposed that administering live vaccines, like the Bacillus Calmette-Guérin (BCG), could lead to a mortality benefit beyond just preventing specific illnesses. However, introducing another vaccine like hepatitis B alongside it could potentially undermine this benefit.
Offit dismissed this hypothesis as “fanciful,” arguing that the hepatitis B vaccine is a single protein among the billions the immune system interacts with daily, and there’s no foundational evidence supporting the researchers’ claims. He reiterated the clear health benefits of administering the vaccine to infants without delay, especially considering the high rates of hepatitis B in Guinea-Bissau which can lead to serious long-term health issues.
The Danish researchers didn’t respond to inquiries about the study or the mounting criticism, while the CDC also remained silent regarding whether the funding would now be redirected towards vaccinating all newborns in Guinea-Bissau as recommended by the World Health Organization (WHO).
According to Tarik Jašarević, a spokesperson for WHO, the organization urges that all infants should receive their first hepatitis B vaccine dose swiftly after birth, ideally within 24 hours, along with at least two more doses. WHO aims to collaborate with various stakeholders to ensure all newborns globally receive timely immunizations against hepatitis B.
Experts have voiced concerns that those who opted out of the trial wouldn’t have received any vaccines, raising questions about whether true informed consent could ever be achieved. Henrik Støvring, a Danish researcher who has co-authored studies questioning previous research linked to the Bandim project, expressed the dilemma faced by mothers wishing to do right by their children. If they choose to participate in the trial, they face a 50% chance of vaccinating their child, whereas opting out provides a 0% chance. That’s hardly informed consent, he argued.
The proposed trial raised distrust among the local population, with many Bissau-Guineans concerned that testing a usually safe and effective vaccine on Africans meant it might be dangerous, as Schaltz-Buchholzer noted in his post.
He insisted that vaccination schedules, whether including hepatitis B or not, are not harmful and that the immediate benefits of vaccinating against hepatitis B at birth are significant. Not vaccinating can lead to serious, long-lasting risks, according to experts.
Offit stated that conducting such a study implies a need to investigate something for which there is no evidence. Given that millions of children worldwide have received this vaccine at birth, any substantial issues would likely have been recognized by this point. The success in virtually eliminating hepatitis B among children in the United States since the program’s inception highlights these benefits.
Schaltz-Buchholzer expressed skepticism about the vaccine’s safety and efficacy at birth, arguing this study was halted since it challenges prevailing medical beliefs, such as those regarding the non-specific effects of hepatitis B vaccination. Besides mortality, the study would have examined potential side effects, including skin conditions and neurodevelopmental issues, although various studies have concluded no link to autism.
Offit reiterated that all newborns must receive a hepatitis B vaccine at birth, underscoring the need for urgency in Guinea-Bissau, which faces a high incidence of chronic hepatitis B.
