Guinea-Bissau suspends U.S.-funded infant hepatitis B vaccine study after ethics outcry

Guinea-Bissau has suspended a U.S.-funded study of a hepatitis B vaccine in infants after public health researchers raised ethical objections, the country’s health minister said. The Centers for Disease Control and Prevention had approved a $1.6 million grant for the study last month, days after Health Secretary Robert F.

Kennedy Jr. lifted the agency’s longstanding recommendation to give the vaccine to all infants at birth. The trial, led by Danish researchers, planned to enroll 14,000 infants and compare children given a birth dose with children who would not receive the vaccine until six weeks of age.

Researchers were not going to screen pregnant women for hepatitis B, a step that would protect the babies of infected mothers. The World Health Organization recommends a birth dose to prevent mother-to-child transmission, and health officials say infants infected at birth face much higher risks of chronic liver disease.

Public health leaders in Africa and the United States said the design violated international ethical standards that require offering the globally accepted standard of care to trial participants. Critics noted the question the study sought to answer has been broadly addressed by existing science; others raised concerns that the trial would look for effects on neurological development and atopic dermatitis but not whether delayed vaccination increased hepatitis B carriage.

Key Topics

Health, Guinea-bissau, Hepatitis B Vaccine, Cdc, Who, Gavi