Government officials reject hepatitis B vaccine trial proposal

Government officials in Guinea-Bissau have rejected a clinical trial designed by Danish researchers and funded by the US to investigate potential side effects of the hepatitis B vaccine given to newborns. The proposed study aimed to identify alleged nonspecific harms from the widely used vaccine dose that is currently recommended for all newborns worldwide.

The trial's lead researcher, Christine Stabell Benn of Bandim Health Project and the University of Southern Denmark, confirmed in an email that Guinea-Bissau's Council of Ministers formally rejected the study on October 16th. This move comes after weeks of controversy surrounding the trial.

A recent development in this saga is the raid by judicial police in Guinea-Bissau on Bandim Health's offices, where they seized vaccines. Stabell Benn pointed out that the police action took place shortly after the government rejected the study proposal.

The researcher expressed regret over the decision to reject the study, stating that it was deemed scientifically and ethically justified by her team. However, she acknowledged the authority of the government in deciding whether research can proceed within their country's borders.

Experts from various fields have questioned the trial's justification and design, labeling it as "unethical due to its plan to withhold the newborn dose of hepatitis B vaccine from half of the participants.

The trial's cancellation comes as a relief for thousands of babies in Guinea-Bissau who would have been at risk of developing chronic hepatitis B infections if the study had proceeded.

The country has struggled with high rates of hepatitis B infections, which can lead to severe health consequences such as liver cirrhosis and cancer. In light of this, experts argue that there is no scientific justification for a trial that would withhold the newborn dose of the vaccine from half of the participants.

The researchers behind the study, Bandim Health's Stabell Benn and her husband Peter Aaby, have been at the center of controversy in the past. Their work on nonspecific harms from vaccines has been lauded by anti-vaccine advocates, but criticized by their peers for its quality.

Aaby and Stabell Benn are currently under investigation by Danish authorities for alleged scientific misconduct in their previous studies. The investigation adds to concerns about the ethics of the hepatitis B vaccine trial that was planned to take place in Guinea-Bissau.

The US CDC's decision to award an unsolicited grant of $1.6 million to Bandim Health has also sparked outrage, with some questioning the motivations behind the funding.

The controversy surrounding the hepatitis B vaccine trial on newborns in Guinea-Bissau continues to escalate, with outside experts questioning the ethics of withholding proven care from participants.

In response to criticism, Stabell Benn and colleagues have maintained that their approach is justified because Guinea-Bissau does not currently offer routine hepatitis B vaccinations at birth. They argue that without the trial, these newborns would not have received the vaccine anyway, as it is only planned for introduction in 2028 due to a lack of resources and infrastructure.

However, experts point out that this reasoning contradicts established guidelines such as the Declaration of Helsinki, which requires trials to provide participants with the best proven intervention available. In the case of hepatitis B prevention, this means administering the newborn dose within the first 24 hours of life, as recommended globally.

The World Health Organization has explicitly stated that resource constraints cannot be used to justify withholding proven care in a research study involving people. This stance is at odds with Stabell Benn and colleagues' approach, which appears to prioritize cost-effectiveness over the well-being of trial participants.

A Bandim Health researcher involved in the trial, Frederik Schaltz-Buchholzer, has tried to deflect criticism by blaming the Anglophone media" for framing the trial as dangerous due to its control group.

The controversy surrounding the US-backed vaccine trial on babies in Guinea-Bissau has led to a breakdown in trust between local officials and researchers involved in the project.

Rumors have been circulating on social media that the trial was actually testing a novel vaccine, with some speculating that the hepatitis B vaccine is dangerous and that Guinea-Bissau newborns are being used as test subjects. These concerns were fueled by negative media coverage of the trial.

Despite claims from researchers that the media controversy has led to misplaced fears about the safety of the hepatitis B vaccine in Guinea-Bissau, local distrust towards the researchers may have played a role in the rejection of the trial and subsequent police operation.

The Council of Ministers had instructed authorities to investigate the origin and handling of vaccines intended for the proposed study, leading to a search of the Bandim Health Project premises on October 19. The Judicial Police sealed a fridge containing a batch of hepatitis B vaccines meant for the trial.

No vaccines were administered during the trial as it had not yet begun, but local officials seem unconvinced by the researchers' claims that they cooperated fully with authorities during the investigation.

The US-backed vaccine trial for babies has been canceled due to international outcry. The decision was made by Stabell Benn, who stated that any future proposal would have to undergo thorough scientific, ethical, and governmental reviews.

Bandim has ruled out moving the trial to a different location. According to Benn, the underlying scientific question remains important but must be addressed in an appropriate local context with proper partnership and regulatory oversight. The cancellation marks a conclusion to this contentious issue.