Science & health
Guinea-Bissau says controversial newborn hepatitis B study was never approved
Guinea-Bissau’s health minister says the country has not approved a proposed study that would enroll 14,000 newborns and delay hepatitis B vaccination for half of them for six weeks. The research would track broader outcomes such as mortality and neurodevelopment rather than vaccine safety or effectiveness. The denial follows confusion over claims that local approval had been granted and criticism of the study’s ethics, funding and researchers’ methods. The US HHS also said the study has not been approved.
Editorial summary · Publisher article
What matters
- The proposed trial would withhold the birth dose from half the enrolled newborns in a country where hepatitis B is widespread.
- Danish ethics committee members reportedly fast-tracked approval after being told Guinea-Bissau had authorized the study.
- Researchers’ prior work has been challenged by another Danish study that found little significant evidence across 24 of 25 papers.
- The CDC reportedly set aside $1.6 million, with additional private funding, although future US support is unclear.
Context & caveats
- The study’s approval and future remain unresolved.
- Several criticisms come from researchers and advocacy groups quoted by the Guardian, while the study team did not answer the supplied questions.
Why this made the edition
The report documents an official denial, the study’s design and funding, ethics concerns and the unresolved approval process affecting newborns.
Source material