Guinea-Bissau vaccine trial faces ethical scrutiny

A controversial Hepatitis B vaccine study has been cleared to proceed in Guinea-Bissau, involving approximately 14,000 newborns. The trial design involves randomizing infants so that half receive the vaccine at birth, while the other half is withheld the birth dose for the first six weeks of life.

The study is conducted by the Bandim Health Project, led by Danish researchers Peter Aaby and Christine Stabell Benn. While the project has operated in Guinea-Bissau for decades, the current trial has faced intense ethical scrutiny. Several members of the ethics committee at the University of Southern Denmark have resigned in protest, citing major ethical concerns regarding the withholding of preventative vaccines from newborns.

Guinea-Bissau faces high Hepatitis B rates, with roughly 18% of adults carrying the virus. Infection during infancy significantly increases the risk of chronic infection and liver cancer. The project has also drawn attention from Robert F. Kennedy Jr., who has publicly praised the researchers, a move that has drawn criticism from medical professionals who argue the trial's logic contradicts established health guidelines.