Guinea-Bissau suspends US-funded hepatitis B vaccine trial amid concerns over ethics.
The West African nation has put its foot down on a contentious study aimed at investigating the health effects of delayed vaccination, with officials insisting it is a matter of national sovereignty. The decision comes as US health officials have questioned the credibility of Africa's leading disease control organization, claiming that it is conducting a "public-relations campaign" to shape public perception.
The trial, led by Danish researchers and backed by the US Department of Health and Human Services, aimed to give 7,000 infants hepatitis B vaccines at birth and withhold them for another 7,000 until six weeks old. Critics argue that this design is unethical, as it puts some children at risk of severe illness and death.
Guinea-Bissau's Minister of Health, Quinhin Nantote, confirmed to journalists that the trial had been "cancelled or suspended" due to concerns over the science behind the study. A team of researchers from the Africa Centers for Disease Control and Prevention (CDC) will travel to Guinea-Bissau to review the study, along with officials from Denmark and the US.
However, African health leaders have disputed this claim, arguing that it was actually the US CDC's decision to halt the trial due to concerns over ethics. The Director-General of the Africa CDC, Jean Kaseya, has insisted that decisions on the trial must be made by Guinea-Bissau itself, citing issues of sovereignty.
"This is not about international organizations or foreign countries telling us what to do," said Kaseya. "It's the sovereignty of the country."
Critics argue that the US and Danish researchers ignored key ethical considerations in their design, such as ensuring that all participants receive standard care while only some are given experimental vaccines.
"The current reason why the vaccine is not achieving coverage in Guinea-Bissau is because there's no funding, and the funding should try to promote the vaccine, not use children as lab rats," said a medical doctor from Nigeria.
The World Health Organization recommends giving the hepatitis B vaccine to all newborns within 24 hours of birth. The trial's design has raised concerns about the exploitation of vulnerable populations in low-income countries.
Guinea-Bissau faces significant challenges in providing healthcare to its population, with less than a quarter of citizens having access to basic services like water and sanitation. Poverty and food insecurity are also persistent issues.
As the situation unfolds, it remains unclear whether the revised trial will move forward or if Guinea-Bissau's decision stands.
The West African nation has put its foot down on a contentious study aimed at investigating the health effects of delayed vaccination, with officials insisting it is a matter of national sovereignty. The decision comes as US health officials have questioned the credibility of Africa's leading disease control organization, claiming that it is conducting a "public-relations campaign" to shape public perception.
The trial, led by Danish researchers and backed by the US Department of Health and Human Services, aimed to give 7,000 infants hepatitis B vaccines at birth and withhold them for another 7,000 until six weeks old. Critics argue that this design is unethical, as it puts some children at risk of severe illness and death.
Guinea-Bissau's Minister of Health, Quinhin Nantote, confirmed to journalists that the trial had been "cancelled or suspended" due to concerns over the science behind the study. A team of researchers from the Africa Centers for Disease Control and Prevention (CDC) will travel to Guinea-Bissau to review the study, along with officials from Denmark and the US.
However, African health leaders have disputed this claim, arguing that it was actually the US CDC's decision to halt the trial due to concerns over ethics. The Director-General of the Africa CDC, Jean Kaseya, has insisted that decisions on the trial must be made by Guinea-Bissau itself, citing issues of sovereignty.
"This is not about international organizations or foreign countries telling us what to do," said Kaseya. "It's the sovereignty of the country."
Critics argue that the US and Danish researchers ignored key ethical considerations in their design, such as ensuring that all participants receive standard care while only some are given experimental vaccines.
"The current reason why the vaccine is not achieving coverage in Guinea-Bissau is because there's no funding, and the funding should try to promote the vaccine, not use children as lab rats," said a medical doctor from Nigeria.
The World Health Organization recommends giving the hepatitis B vaccine to all newborns within 24 hours of birth. The trial's design has raised concerns about the exploitation of vulnerable populations in low-income countries.
Guinea-Bissau faces significant challenges in providing healthcare to its population, with less than a quarter of citizens having access to basic services like water and sanitation. Poverty and food insecurity are also persistent issues.
As the situation unfolds, it remains unclear whether the revised trial will move forward or if Guinea-Bissau's decision stands.