Oluwatobi Adu 
ABUJA, Nigeria – Africa’s top public health agency halts a United States-funded hepatitis B vaccine trial in Guinea-Bissau after determining that the study breaches international ethical standards and risks infant health.
The Africa Centres for Disease Control and Prevention (Africa CDC) announces the cancellation of the research project targeting newborns, citing concerns that the trial design could delay access to a life-saving vaccine. Officials say such delays are unacceptable in a high-burden setting.
Speaking during a webinar update on Monday, Africa CDC deputy incident manager for mpox, Yap Boum, says the project fails to meet required ethical benchmarks for clinical research involving infants.
“The proposed methodology raises serious ethical red flags, particularly around postponing a proven hepatitis B vaccine for some newborns,” Boum says. “Africa CDC will only support research that advances public health without exposing vulnerable populations to avoidable risks.”
The trial, reportedly funded by the US Department of Health and Human Services, seeks to study alternative vaccination timing in Guinea-Bissau. However, ethicists and public health experts warn that withholding or delaying vaccination in infants increases the risk of lifelong hepatitis B infection, liver cirrhosis and cancer.
Hepatitis B remains widespread in sub-Saharan Africa, where infection during infancy significantly raises the likelihood of chronic disease. Although international guidelines recommend vaccination at birth, Guinea-Bissau typically administers the shot at six weeks due to logistical constraints.
Critics argue that the trial would not pass ethical review if conducted in the United States, raising broader concerns about double standards in global health research.
The backlash prompts parallel reviews by African and US health authorities, ultimately leading to the project’s termination. Analysts say the decision underscores growing scrutiny of foreign-funded medical trials in Africa and renewed calls for stronger ethical oversight and local leadership in research.
About the Author
Oluwafunbi Bello 
Korede Abdullah 