Nijmegen researcher quits ‘unethical’ vaccine trial

Hepatitis B Vaccine Trial in Guinea-Bissau Halted Amid Ethical Backlash and Political Turmoil

A planned hepatitis B vaccine study in newborns in guinea-Bissau has been paused amid intense ethical scrutiny and a destabilizing political climate. The project would have enrolled 14,000 infants—7,000 recieve the hepatitis B shot shortly after birth while 7,000 would not—too assess potential side effects and broader health impacts.

Experts warn that hepatitis B poses a important risk in the country, where about 18% of adults carry the virus. Early infection can lead to serious liver disease later in life, a reality underscored by the World Health Organization’s guidance that children in high-prevalence areas should be vaccinated as soon as possible.Critics argue that a trial exposing newborns to additional risk in a setting with fragile governance contravenes best practices for public health research.

The study was funded by the U.S. Centers for Disease Control and Prevention and led by researchers from the University of Southern Denmark. Critics demanded a more ethically rigorous approach, with one prominent health scholar describing the plan as inconsistent with established vaccination priorities in high-risk regions.

Controversy Sparks a Halt, Than Uncertainty

Following a wave of criticism, officials signaled that the trial had been stopped. A senior Africa CDC figure affiliated with the African Union suggested the pause, but it remained unclear whether the project had been permanently scrapped. The guardian noted broader dialog challenges in Guinea-Bissau after a military coup in November 2025, complicating oversight and transparency around health initiatives.

In the weeks that followed, a protocol outline leaked to a medical blog raised new questions. The leak indicated that a Nijmegen-based researcher was listed as a leader of the effort, a claim the scientist denied, stating they contributed only to laboratory work and not to study design. The researcher indicated that any actual participation would hinge on addressing ethical concerns before moving forward.

Advocates for greater caution argued that any expansion of vaccination research in the region should include pre-screening mothers for hepatitis B infection and vaccinating at-risk infants promptly. Supporters of the plan contended that the data could illuminate potential ancillary benefits of the vaccine against other infections, a point disputed by critics who fear the study could fuel anti-vaccine narratives in the united States and beyond.

Despite the turmoil, discussions continue among international partners about the path forward. The inquiry into governance, consent, and risk mitigation remains central to any future proposals in Guinea-Bissau and similar contexts.

Key Facts at a Glance

Key Fact	Details
location	Guinea-Bissau, West Africa
Study design	Newborn vaccination trial with 14,000 participants (7,000 vaccinated, 7,000 control)
Intervention	Hepatitis B vaccination given at birth; control group would not receive the shot
Purpose	Assess potential side effects and whether the vaccine affects other infections
funding	U.S. Centers for Disease Control and prevention (CDC) and researchers from the University of Southern Denmark
Ethical concerns	Critics call the plan unethical and possibly neocolonial, given local risk and governance questions
Political context	Guinea-Bissau experienced a military coup in November 2025; governance and communication have been disrupted
Current status	Pausing discussions; protocol and participation details are under review
notable figures	Critics including international health experts; some researchers deny full involvement beyond laboratory work

Evergreen Takeaways for Health Research

Ethical safeguards are non-negotiable in trials involving newborns and vulnerable populations. Independent review, transparent risk assessment, and clear alignment with local health priorities should guide any future work in similar settings.The debate underscores the need for culturally and politically aware implementation plans, especially in regions facing governance challenges.

Beyond this case,researchers and funders should foreground community engagement,explicit consent processes,and rigorous oversight to ensure that potential benefits truly outweigh risks for participants. When global partners consider studies in lower-resource countries, they must weigh local health needs against the imperative to avoid exploitation or perceived neocolonial motives.

For readers seeking authoritative context on hepatitis B and vaccination policies, the World Health Organization and the U.S.Centers for Disease Control and Prevention offer extensive guidance on prioritizing vaccination in high-risk regions.

External resources:
WHO: Hepatitis B overview and vaccination guidance •
CDC: Hepatitis B information

Reader Questions

– Do you think such trials can be ethically conducted in settings with political instability or recent governance changes? How should oversight adapt?

– What safeguards are essential to protect child participants in vaccine research, and who should oversee them?

Share your thoughts in the comments and join the discussion about ethics, governance, and global health research.

Disclaimer: This article provides context on health research ethics and does not constitute medical advice. For health decisions,consult qualified health professionals.