A controversial U.S.-funded study in Guinea-Bissau examining hepatitis B vaccines among newborns has been cancelled, according to Yap Boum, a senior official at the Africa Centres for Disease Control and Prevention (CDC). Boum announced the cancellation at a press conference Thursday morning, citing ethical concerns surrounding the study's design.
The $1.6 million project, funded under the purview of Robert F. Kennedy Jr., a known vaccine skeptic, and the U.S. Department of Health and Human Services (HHS), sparked outrage due to its methodology, which involved withholding proven hepatitis B vaccines from a segment of the newborn population 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 most commonly spread from mother to child during birth and delivery, as well as through contact with infected blood or other body fluids.
The ethical dilemma stemmed from the established efficacy of hepatitis B vaccines in preventing infection and subsequent liver damage, including cirrhosis and liver cancer. The standard of care globally, and particularly in regions with high HBV prevalence, is to administer the vaccine shortly after birth. Critics argued that withholding the vaccine, even for research purposes, placed newborns at unnecessary risk.
"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," Boum stated, emphasizing the need for ethical research practices. The specific details of the study's design that led to the ethical concerns were not immediately disclosed.
The cancellation raises questions about the oversight of U.S.-funded research projects in developing countries and the role of individuals with known biases in shaping public health initiatives. It also highlights the importance of adhering to established ethical guidelines and ensuring that research protocols prioritize the well-being of participants, particularly vulnerable populations like newborns. The Africa CDC is expected to release further details regarding the reasons for the cancellation and any potential implications for future research collaborations.
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