Guinea-Bissau rejects trial withholding hepatitis B vaccine from newborns
Guinea-Bissau’s Council of Ministers has formally rejected a US-funded trial that would have withheld the hepatitis B vaccine birth dose from half of participating newborns. The decision matters because the vaccine is recommended worldwide and experts say the proposed study could expose babies to preventable, lifelong infection.
The trial was to be run by Danish researchers and backed by a $1.6 million US grant. Researchers say Guinea-Bissau does not routinely vaccinate newborns against hepatitis B and plans to introduce a birth dose in 2028, but the WHO and other experts argue research must provide the best proven care regardless of local resources. Police seized vaccine doses after the government’s rejection; the researchers said they respected the decision while disputing criticism of the study.
In short
- Guinea-Bissau formally rejected the newborn vaccine trial.
- The study would have withheld hepatitis B vaccine from half the babies.
- The WHO and other experts challenged its ethical and scientific basis.
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The strongest fair case each way — we don't pick a winner.
The case for
Supporters of the trial could argue that, because Guinea-Bissau does not currently give newborns the vaccine and plans to introduce it only in 2028, a carefully designed study could provide locally relevant evidence about its benefits and inform future policy. They may also argue that research can be ethical when risks are independently reviewed, families give informed consent and the study addresses an important unanswered question.
The case against
Opponents could argue that withholding a recommended vaccine from some newborns exposes them to a preventable risk of lifelong infection, even if routine vaccination is not yet available locally. They may hold that research should offer participants the best proven care and that limited resources or local practice do not justify testing a question by denying babies an established intervention.
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Originally published by Ars Technica as “US-backed vaccine trial on babies canceled after international outcry”.