The government of Guinea-Bissau has halted a controversial United States-backed study that planned to investigate the effects of administering the hepatitis B vaccine to newborns, following international criticism over its ethics.
The lead researcher, Danish scientist Frederik Schaltz-Buchholzer, confirmed the development on Wednesday, saying the project would no longer proceed in the West African country because the necessary government approval had not been granted.
According to The Guardian UK, which reported the development, the proposed study was expected to receive $1.6m from the United States Centres for Disease Control and Prevention, alongside another $1.6m from private donors, including the Pershing Square Foundation and the Bluebell Foundation.
Schaltz-Buchholzer announced the decision in a LinkedIn post, saying it was “now clear” that the study “will not move forward in Guinea-Bissau”.
The country’s Health Minister, Quinhin Nantote, had earlier denied that the project would proceed, telling The Guardian in Portuguese that the claim was “not even remotely true”.
The proposed trial drew criticism from vaccine experts who questioned its scientific basis and the ethics of withholding an established vaccine from some newborns.
Paul Offit, a vaccine expert at the Children’s Hospital of Philadelphia, criticised the study and argued that the funding should instead be used to protect children against hepatitis B.
“The solution is clear here: take the money and vaccinate as many kids as you can,” Offit said.
The government has taken control of the researchers’ vaccines after officials searched the offices of the Bandim Health Project on Monday, The Guardian reported.
The study was designed by Danish researchers, including Schaltz-Buchholzer, Christine Stabell Benn and Peter Aaby. They wanted to investigate whether administering the hepatitis B vaccine alongside the Bacillus Calmette-Guérin vaccine, commonly known as BCG, could affect the broader impact of vaccination on childhood mortality.
The researchers’ hypothesis was that live vaccines such as BCG might offer benefits beyond protection against their target diseases, and that administering hepatitis B vaccine alongside them could potentially reduce those effects.
However, Offit rejected the scientific basis of the proposal, describing the hypothesis as “fanciful”.
“There’s no evidence for that, and it doesn’t make biological sense,” he said, arguing that the benefits of administering hepatitis B vaccine at birth were well established.
Critics also raised concerns about informed consent, warning that parents could feel pressured to enrol their children if participation offered a chance to receive the vaccine while those who declined would not receive it through the study.
Henrik Støvring, a Danish researcher who has co-published work questioning previous research from the Bandim project, said the arrangement could undermine voluntary participation.
“If they decide to participate in the trial, they have a 50% chance of getting the vaccine for their children. But if they stay out, they have a 0% chance of getting the vaccine. So how can you say that’s a non-coercive informed consent?” he asked.
The controversy also fuelled public distrust in Guinea-Bissau, with some residents questioning why the vaccine was being studied in African newborns despite its longstanding use internationally.
The World Health Organisation recommends that all infants receive their first dose of hepatitis B vaccine as soon as possible after birth, preferably within 24 hours, followed by at least two additional doses.
WHO spokesperson Tarik Jašarević said the organisation remained committed to working with governments, researchers and partners to ensure newborns received timely protection against the disease.
“All newborns should be given a birth dose of hepatitis B vaccine,” Offit said, adding that Guinea-Bissau urgently needed to expand access to the immunisation because of the country’s high burden of chronic hepatitis B.
According to The Guardian, Guinea-Bissau currently plans to introduce universal hepatitis B vaccination at birth in 2028.
The CDC did not respond to The Guardian’s questions about whether the funding initially earmarked for the trial would instead support the rollout of the vaccine to newborns in the country.