NEWS & POLITICS
WHO criticizes U.S.-Funded Hepatitis B vaccine trial in Guinea-Bissau over ethical concerns
The World Health Organization (WHO) has strongly criticized a United States-funded hepatitis B vaccine trial planned in Guinea-Bissau, warning that it raises serious ethical concerns by delaying a proven life-saving birth-dose vaccine for some newborns.
Noluthando Buthelezi
BISSAU, Guinea-Bissau —The proposed study would give one group of infants the hepatitis B vaccine at birth, while another group would receive it at six weeks of age — the country’s current schedule. WHO says this design is unethical because the birth-dose vaccine is a well-established public health intervention used safely in more than 115 countries for over 30 years.
Health experts estimate that administering the hepatitis B vaccine within 24 hours of birth prevents 70–95% of mother-to-child transmission cases. Infection at birth is the leading cause of chronic hepatitis B, which can result in lifelong liver disease or cancer.
Guinea-Bissau, where hepatitis B prevalence remains high, currently administers the vaccine at six weeks. However, authorities formally approved the introduction of the birth dose into the national immunization program in 2024, with nationwide rollout planned for 2028 to align with global standards.
The U.S. Department of Health and Human Services, led by Robert F. Kennedy Jr., is backing the trial, which would involve 14,000 newborns and is being led by Danish researchers. U.S. officials say the study aims to examine broader health effects of the vaccine.
The proposal has triggered public backlash. Former health minister Magda Robalo criticized the trial, stating, “Guinea-Bissauans are not guinea pigs.” Amid mounting outrage, the government has suspended the study pending further review.
The controversy has intensified debate over ethics in global health research, particularly when studies involve delaying access to interventions already considered standard care worldwide.