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), sparked widespread criticism for its approach of withholding proven hepatitis B vaccines in a region with a high prevalence of the disease. The ethical concerns centered on the potential harm to newborns who were not immediately vaccinated against hepatitis B, a potentially life-threatening viral infection that attacks the liver.
Hepatitis B is transmitted through contact with infected blood or bodily fluids, and newborns can contract the virus from their mothers during birth. Without vaccination, infants who contract hepatitis B have a high risk of developing chronic infection, which can lead to cirrhosis, liver cancer, and death. The World Health Organization (WHO) recommends that all newborns receive a hepatitis B vaccine within 24 hours of birth, followed by subsequent doses to ensure long-term protection.
"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, but the decision to withhold a proven vaccine in a high-risk population was a major point of contention.
The cancellation of the study raises questions about the oversight and ethical review processes for US-funded research conducted in developing countries. It also highlights the importance of ensuring that research protocols align with international ethical guidelines and prioritize the well-being of participants. The Africa CDC's decision to halt the study reflects a commitment to upholding ethical standards in research and protecting vulnerable populations from potential harm. Further details regarding the study's cancellation and any potential investigations are expected to be released in the coming weeks.
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