Guinea-Bissau has suspended a US-funded study on vaccines for hepatitis B, citing concerns over the ethics of the trial's design.
In a move that has sparked controversy, the West African nation has effectively cancelled the study led by Danish researchers, which aimed to investigate the health effects of administering vaccines alongside other shots. The decision was made by Quinhin Nantote, Guinea-Bissau's newly appointed minister of health, who confirmed that the trial had been suspended due to issues with its methodology.
Experts have raised concerns over the ethics of the study, arguing that withholding treatment from some infants could put them at risk of severe illness and death. "This is not acceptable," said medical doctor and global health researcher Abdulhammad Babatunde. "To prevent things like the Tuskegee study, the control group has to get the standard of care, and the intervention group should get potentially better care."
The World Health Organization recommends administering hepatitis B vaccines to all newborns within 24 hours of birth, but in Guinea-Bissau, infants currently receive the shot at six weeks of age. The trial's design was seen as problematic due to its potential to compromise efforts to increase vaccine coverage.
The US Department of Health and Human Services has called into question the credibility of the Africa Centers for Disease Control and Prevention (Africa CDC), which oversaw the study, labeling it a "powerless, fake organization attempting to manufacture credibility by repeating its claims publicly." However, Jean Kaseya, director-general of the Africa CDC, said that the decision to suspend the trial was made by Guinea-Bissau's ministry of health, and he supports the country's sovereignty in this matter.
"This is not our problem," Kaseya said. "It's the sovereignty of the country. I don't know what will be the decision, but I will support the decision that the minister will make."
As a result of the controversy surrounding the study, officials from Denmark and the US have been invited to review the trial's design and methodology in Guinea-Bissau. A team of research experts from the Africa CDC has also been dispatched to help the country's ministry of health review the study.
The decision highlights the challenges faced by many African countries in conducting research that meets international standards, particularly when it comes to issues like vaccine trials. The situation underscores the need for increased transparency and accountability in medical research, as well as support for countries struggling to improve their healthcare systems.
In a move that has sparked controversy, the West African nation has effectively cancelled the study led by Danish researchers, which aimed to investigate the health effects of administering vaccines alongside other shots. The decision was made by Quinhin Nantote, Guinea-Bissau's newly appointed minister of health, who confirmed that the trial had been suspended due to issues with its methodology.
Experts have raised concerns over the ethics of the study, arguing that withholding treatment from some infants could put them at risk of severe illness and death. "This is not acceptable," said medical doctor and global health researcher Abdulhammad Babatunde. "To prevent things like the Tuskegee study, the control group has to get the standard of care, and the intervention group should get potentially better care."
The World Health Organization recommends administering hepatitis B vaccines to all newborns within 24 hours of birth, but in Guinea-Bissau, infants currently receive the shot at six weeks of age. The trial's design was seen as problematic due to its potential to compromise efforts to increase vaccine coverage.
The US Department of Health and Human Services has called into question the credibility of the Africa Centers for Disease Control and Prevention (Africa CDC), which oversaw the study, labeling it a "powerless, fake organization attempting to manufacture credibility by repeating its claims publicly." However, Jean Kaseya, director-general of the Africa CDC, said that the decision to suspend the trial was made by Guinea-Bissau's ministry of health, and he supports the country's sovereignty in this matter.
"This is not our problem," Kaseya said. "It's the sovereignty of the country. I don't know what will be the decision, but I will support the decision that the minister will make."
As a result of the controversy surrounding the study, officials from Denmark and the US have been invited to review the trial's design and methodology in Guinea-Bissau. A team of research experts from the Africa CDC has also been dispatched to help the country's ministry of health review the study.
The decision highlights the challenges faced by many African countries in conducting research that meets international standards, particularly when it comes to issues like vaccine trials. The situation underscores the need for increased transparency and accountability in medical research, as well as support for countries struggling to improve their healthcare systems.