Science & health
Guinea-Bissau greenlights disputed trial withholding hepatitis B vaccine from newborns
A Guinea-Bissau trial plans to give 14,000 newborns the hepatitis B vaccine at birth or withhold it for six weeks, after a Danish university ethics committee voted to proceed and Guinea-Bissau officials greenlit the project. Critics argue the design exposes infants to preventable infection, especially in a country with high hepatitis B prevalence, and say the protocol tests speculative outcomes despite established vaccine benefits. The updated plan excludes babies whose mothers test positive, but the protocol has not been made public and several Danish reviewers resigned.
Editorial summary · Publisher article
What matters
- The study would randomize newborns to receive the vaccine at birth or wait six weeks.
- Researchers changed the protocol to test mothers and exclude babies of those who test positive, but the test has a reported false-negative rate.
- The article reports that the CDC set aside $1.6 million and that private foundation funding would match it.
Context & caveats
- The article reports claims from critics and funders’ alleged commitments; several organizations and officials did not respond to requests for comment.
Why this made the edition
Extensive reporting details the trial design, approvals, ethical objections, protocol changes, funding and the medical risks raised by experts and regulators.
Source material