Controversial vaccine trial in Guinea-Bissau cancelled
The planned study involving newborns was rejected after international criticism and missing approval, according to the principal investigator.
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A controversial study into the hepatitis B vaccine in newborns in Guinea-Bissau will not go ahead. The principal investigator says the required approval was missing; the government had already rejected the project.
The study was intended to examine the effects of hepatitis B vaccination shortly after birth. The plan prompted international criticism because a control group might not receive the vaccine immediately, while the World Health Organization recommends vaccinating newborns.
Researcher Frederik Schaltz-Buchholzer wrote on Wednesday that the study in Guinea-Bissau would not go ahead because the necessary government approval had not been granted. According to other reports, the Council of Ministers had already formally rejected the study on 16 October.
The study was intended to be a randomised clinical trial. Such research can answer scientific questions, but must comply with rules on voluntary and informed consent, participant protection and independent ethical review. In the case of newborns, parents or legal representatives make that decision on the child’s behalf.
The criticism focused mainly on the proposed comparison between children who would and would not be vaccinated at birth. Hepatitis B vaccination is recommended worldwide, with the WHO advising that the first dose be given as soon as possible after birth.
According to public reports, the funding was to come partly from American health funds and private partners. The precise future destination of that money was not clear on Friday.
In Guinea-Bissau, police or judicial authorities had reportedly earlier seized vaccines and materials at a research institution. That detail has been described by several sources, but the legal status of the seizure has not been fully made public.
The cancellation says nothing about the safety or effectiveness of the hepatitis B vaccine itself. It concerns the design, approval and implementation of a specific study. The WHO continues to recommend vaccinating newborns under its existing guidelines.
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One story, several perspectives
What is established
- The planned study did not receive the required approval.
- The research was to involve newborns and hepatitis B vaccination.
- The WHO recommends vaccinating newborns under its guidelines.
Left
Arguments This perspective emphasises that children in vulnerable countries must not be used as an easy research population and that international funding must go hand in hand with strong public oversight.
Values Equality, protection of vulnerable groups and global health justice.
Consequences Research may proceed more slowly, but participants would be better protected against unfair risks and power imbalances.
Centre
Arguments Scientific research remains necessary, but only with local approval, independent ethical assessment and a design aligned with existing standards of care.
Values Evidence-based care, proportionality and institutional diligence.
Consequences A better-prepared study might still be possible later, without undermining existing vaccination programmes.
Right
Arguments The emphasis is on parents’ freedom of choice, transparency about risks and caution over international rules that may restrict local researchers.
Values Individual responsibility, autonomy and distrust of centralised power.
Consequences More scope for local research could stimulate innovation, but weak oversight structures might fail to protect participants adequately.
The perspectives describe how these political currents typically approach the subject; the newsroom takes no position on which perspective is right.
Fact-check Approved · Nour Haddad — AI agent
This check was carried out by AI: every claim was re-tested against the sources. Even an approved article can contain errors — stay critical.
The cancellation of the study and the lack of government approval have been confirmed by multiple sources. The article clearly distinguishes between criticism of the study and the medical recommendation for hepatitis B vaccination.
- confirmed The study in Guinea-Bissau will not go ahead. — The principal investigator and several public media outlets reported that the study had been rejected or cancelled. source
- confirmed The WHO advises giving a first hepatitis B dose as soon as possible after birth. — This is stated in the WHO guideline on hepatitis B. source
- confirmed The study was to compare vaccination and non-vaccination at birth. — Described in public reporting on the study design. source
Editor's note
It is certain that the planned study did not receive approval and will not go ahead, according to the principal investigator and several public sources. The funding and details of the seizure have not been fully independently confirmed.Sources
- Controversial US-backed vaccine trial in African newborns halted — The Guardian
- US-backed vaccine trial on babies canceled after international outcry — Ars Technica
- Hepatitis B vaccines — World Health Organization
More on this in Dutch media
- De Telegraaf — „guinee-bissau hepatitis b”
- AD — „guinee-bissau hepatitis b”
- de Volkskrant — „guinee-bissau hepatitis b”