The $1.6 million study, funded under the purview of Robert F. Kennedy Jr., a known vaccine skeptic and the secretary of the US Department of Health and Human Services (HHS), had sparked considerable outrage due to ethical concerns. Critics argued that the study involved withholding proven hepatitis B vaccines in a country with a high prevalence of the disease.
Hepatitis B is a viral infection that attacks the liver and can cause both acute and chronic disease. According to the World Health Organization (WHO), it is a major global health problem, particularly in Africa and Asia. The hepatitis B vaccine is highly effective in preventing infection, especially when administered shortly after birth.
The core ethical concern revolved around the potential harm to newborns who were not vaccinated as part of the study's design. Experts argued that withholding a life-saving vaccine in a region where hepatitis B is endemic was unacceptable, regardless of the study's potential benefits.
"It's of importance for Africa CDC to have evidence that can be translated in policy, but this has to be done within the norm. So we are," Boum stated, implying that the study did not meet ethical standards.
The cancellation raises questions about the oversight of US-funded research projects in developing countries, particularly those involving vulnerable populations. It also highlights the ongoing debate about the role of vaccine skepticism in public health policy. The Africa CDC's decision to halt the study underscores the importance of adhering to ethical guidelines and prioritizing the well-being of participants in research. Further details regarding the specific ethical violations and the future of hepatitis B prevention efforts in Guinea-Bissau were not immediately available.
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