WHO Issues Rare Public Condemnation
The World Health Organization has publicly condemned a US-funded clinical trial planned for Guinea-Bissau as "unethical," marking a sharp rebuke of research backed by the Centers for Disease Control and Prevention. WHO Director-General Tedros Adhanom Ghebreyesus stated during a news conference: "Of course, a sovereign country can decide whatever they want, but as far as WHO's position is concerned, it's unethical to proceed with this study."
The randomized controlled trial, partially funded by a $1.6 million CDC grant, would study the general health effects of giving the hepatitis B vaccine at birth to approximately 14,500 infants in the West African nation. Half would receive the birth dose, while the other half would receive their first dose at two months, the current standard of care in Guinea-Bissau.
Why WHO Considers It Unethical
The WHO's objections center on the study's design and context. The hepatitis B birth dose vaccine has been used for over three decades and is included in the national immunization schedules of more than 115 countries. Guinea-Bissau has one of the world's highest hepatitis B infection rates, with approximately one in five residents carrying the virus. An estimated 90% of newborns infected during childbirth become chronic carriers at high risk for cirrhosis and liver cancer.
WHO stated that "exploiting scarcity is not ethical: resource constraints cannot be used to justify withholding proven care in a research study involving people." The organization also noted the study protocol does not ensure basic harm reduction measures, such as screening pregnant women and vaccinating exposed newborns.
