Health · Medical Research · 3 hrs ago
Guinea-Bissau cancels proposed hepatitis B vaccine trial on newborns
Guinea-Bissau cancelled a proposed trial of a hepatitis B vaccine on newborns after it drew criticism over its ethics.
The study was planned at the Bandim Health Project and would have involved 14,000 babies, with half not receiving the vaccine.
The US-funded study aimed to examine whether a birth dose has health effects beyond preventing hepatitis B, but critics said withholding it could expose babies to a preventable infection.
The WHO recommends vaccination at birth, while Guinea-Bissau currently gives the shot at six weeks, when it is less effective.
Hepatitis B is widespread in the country, and infection during infancy can lead to chronic illness and death.
Police seized a batch of vaccines from the research centre, and the government is considering bringing forward routine birth-dose vaccination, which had been planned for 2028.
Guinea-Bissau cancelled a proposed trial of a hepatitis B vaccine on newborn babies.
The study was planned to include 14,000 newborns, with half receiving the vaccine shortly after birth and half not receiving it.
Critics said withholding a vaccine recommended by the World Health Organization (WHO) from some babies was unethical.
Researchers said the study would investigate whether the birth-dose vaccine has broader health effects beyond preventing infection.
Police seized a batch of vaccines from the research centre at the centre of the controversy.
- Who
- Guinea-Bissau cancelled the proposed trial, which was planned by the Bandim Health Project.
- What
- The planned study would compare newborns given a hepatitis B vaccine shortly after birth with newborns not given it.
- When
- The cancellation was reported on 5 November 2026. The sources do not state when the cancellation occurred.
- Where
- Guinea-Bissau, at the Bandim Health Project research centre.
- Why
- The study faced criticism for withholding a WHO-recommended vaccine from some newborns. The sources do not state the government’s specific reason for cancelling it.
Researchers behind the study
WHO and other critics
Ethics
Researchers behind the study
Researchers said the absence of routine birth-dose vaccination in Guinea-Bissau offered an opportunity to study the vaccine’s effects.
WHO and other critics
Critics said withholding a vaccine proven to protect newborns was unethical.
Purpose
Researchers behind the study
The Bandim Health Project said the trial would investigate possible broader health effects beyond preventing hepatitis B infection.
WHO and other critics
Critics questioned the risks to vulnerable babies and the decision to withhold the vaccine.
The Bandim Health Project began operating in Guinea-Bissau.
The CDC awarded the University of Southern Denmark $1.6m for the proposed study.
Guinea-Bissau’s government prohibited hepatitis B vaccine trials involving children and requested an Africa CDC expert team to help evaluate the study.
Health Minister Quinhin Nantote spoke about the study.
The BBC reported that the proposed trial had been cancelled.
- Planned participants
- 14,000 newborns
- Study site
- Bandim Health Project, Guinea-Bissau
- Funding
- $1.6m awarded to the University of Southern Denmark by the CDC
- Routine vaccination timing
- Guinea-Bissau currently vaccinates children against hepatitis B at six weeks
- Expected birth-dose rollout
- Officials had expected to add the vaccine to the routine schedule in 2028
- Population infection rate
- Nearly a fifth of Guinea-Bissau’s population is infected with hepatitis B
What people are saying
A study that will withhold that intervention from other newborns is unethical.
The vaccine has been used for more than 30 years in more than 115 countries.