Health · Public Health & Disease · 5 hrs ago
Guinea-Bissau approves hepatitis B vaccine trial involving 14,000 newborns
A hepatitis B vaccine trial involving 14,000 newborns has been approved to move forward in Guinea-Bissau.
Danish researchers plan to give the vaccine to half the babies and withhold it from the other half for their first six weeks.
The US Department of Health is funding the $1.6 million study.
The trial was paused in January after scientists raised concerns that some babies would be denied a vaccine known to protect against hepatitis B. More than 12% of adults in Guinea-Bissau are estimated to have chronic hepatitis B, and infection among children under five is about 2%.
Africa CDC has opposed the trial, while officials in Denmark and Guinea-Bissau have approved it.
Guinea-Bissau plans to vaccinate all newborns against hepatitis B starting in 2028.
Guinea-Bissau officials and a Danish ethics committee approved a hepatitis B vaccine trial involving 14,000 newborns.
Danish researchers plan to withhold the vaccine from half the babies for their first six weeks.
The trial had been paused in January after drawing criticism from scientists and the Africa Centres for Disease Control and Prevention.
The project is funded by the United States Department of Health and costs $1.6 million.
Guinea-Bissau plans to vaccinate all newborns against hepatitis B from 2028.
- Who
- Danish researchers plan to conduct the trial, which was approved by officials in Guinea-Bissau and a Danish ethics committee.
- What
- A hepatitis B vaccine trial involving 14,000 newborns will withhold the vaccine from half of them for six weeks.
- When
- It was approved last week, according to the article published on October 12, 2026.
- Where
- Guinea-Bissau.
- Why
- Not stated.
Critics of the trial
Danish researchers
Vaccine access
Critics of the trial
Critics say the study would deliberately and randomly deprive infants of a vaccine proven to protect them.
Danish researchers
Researchers plan to withhold the vaccine from half of the newborns for six weeks; their rationale is not stated.
The trial was paused for review after it caused outrage among scientists.
A Danish ethics committee and officials in Guinea-Bissau approved the project, according to the article.
Guinea-Bissau plans to begin vaccinating all newborns against hepatitis B.
- Trial participants
- 14,000 newborns
- Vaccine withholding period
- First six weeks of life
- Project cost
- $1.6 million
- Funding source
- United States Department of Health
- Planned national vaccination start
- 2028
What people are saying
ongoing discussions
Sources
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