Statement on Ethical Questions Raised About the planned Hepatitis B Birth Dose Trial in Guinea-Bissau
In recent weeks, questions have been raised publicly about the ethics of our planned randomized trial, which aims to evaluate the overall health effects of hepatitis B vaccination at birth in Guinea-Bissau.
We take ethical scrutiny seriously. The study has been reviewed and approved by the Guinean National Ethics Committee and developed within a long-standing Danish–Guinean research collaboration with deep local engagement.
We welcome informed discussion. At the same time, we believe it is important to clarify key points.
No Child Receives Less Than Standard Care
No child enrolled in the study will receive fewer vaccines than under current national policy in Guinea-Bissau.
All children receive vaccines according to the routine vaccination schedule. Half receive an additional hepatitis B vaccine at birth that is not yet part of the national program.
The study evaluates the introduction of a new policy; it does not remove an existing one.
Importantly, the trial will increase access to routine birth vaccines (BCG and oral polio vaccine), as the study team will ensure vaccine availability on weekends and public holidays, when access would otherwise be limited. In that sense, participation is associated with strengthened vaccine delivery.
Contradictory Accusations Highlight an Evidence Gap
The vaccine’s protective effect against hepatitis B infection is well established and is not in question.
The trial addresses a different question:
What are the overall health effects – positive, neutral, or negative – of introducing the birth dose together with BCG and oral polio vaccine in this specific context?
Public discussion has included two opposing claims:
- That children are being deprived of a critically important vaccine.
- That children are being exposed to a potentially harmful intervention.
Both claims cannot simultaneously be correct.
Their coexistence highlights a deeper issue: there is limited high-quality randomized evidence on the broader health effects of administering hepatitis B vaccine at birth together with BCG and oral polio vaccine in high-mortality settings.
It is precisely this evidence gap that the study seeks to close.
Clinical Equipoise and Ethical Research
The ethical foundation of randomized trials rests on the principle of clinical equipoise – the presence of honest, professional disagreement within the expert community about the comparative merits of interventions.
Clinical equipoise does not require uncertainty about whether a vaccine prevents its target infection. It requires uncertainty about the overall balance of benefits and risks relevant to the population in question.
In this case:
- The vaccine’s efficacy against hepatitis B infection is established.
- There is genuine scientific uncertainty regarding its broader health effects when administered at birth in this context.
Where scientific disagreement exists about overall effects, randomized evaluation is not unethical – it is the appropriate method for resolving uncertainty.
The Declaration of Helsinki and Local Context
Questions have also been raised regarding the Declaration of Helsinki and its requirement that new interventions be tested against the “best proven intervention(s).”
The interpretation of this clause in global health settings has been debated for decades, including during the HIV prevention and treatment discussions of the 1990s.
Global health ethics has evolved to recognize that:
- Research must not deprive participants of interventions they would otherwise receive.
- At the same time, it must be possible to evaluate locally relevant policy questions.
- Ethical analysis must consider feasibility, sustainability, justice, and local health system realities.
In this trial:
- The hepatitis B birth dose is not yet national standard of care in Guinea-Bissau.
- No participant is denied an intervention they would otherwise receive.
- The study evaluates policy introduction prior to nationwide implementation.
The results will be directly relevant for the Ministry of Health in Guinea-Bissau and for other African countries, of which the majority has not implemented hepatitis B vaccination at birth.
Ethical evaluation must consider local health system realities, sustainability, feasibility, and justice – alongside international recommendations. Ensuring that locally embedded researchers and national ethics authorities can determine appropriate study designs within their context is an important element of ethical global health research.
On Maternal Screening
We carefully considered incorporating maternal hepatitis B screening.
Screening immediately after delivery in a setting without established long-term follow-up or treatment programs raises complex ethical questions:
- What obligations arise toward mothers who test positive?
- What about their previously born children?
- What sustained care can realistically be guaranteed?
Ethical responsibility includes ensuring that diagnostic practices do not create obligations that cannot be met. These issues are complex and require thoughtful consideration. We remain open to continued dialogue with national authorities and partners about the best way forward.
Ethics Requires Both Protection and Evidence
Ethics in public health involves avoiding harm to individual participants and generating reliable evidence to inform policy decisions that affect entire populations.
When opposing claims arise – that a vaccine is both urgently needed and potentially harmful – this signals uncertainty about overall effects.
Responsible, ethically reviewed research is the appropriate way to resolve such uncertainty.
The central question is therefore:
What best serves children in Guinea-Bissau – and globally – in the long term?
- Implementing national policy without randomized evidence on overall health effects?
- Or conducting a monitored study to generate that evidence?
We believe that rigorous, transparent research strengthens both public health decision-making and long-term vaccine confidence.
We remain committed to respectful dialogue and to protecting the interests of participating children and their families.