Danish University Approves Controversial Hepatitis B Trial Despite CDC Funding and Ethical Outcry

Key points

• The University of Southern Denmark granted approval for the trial on October 7, 2026, following an independent ethical review.
• The CDC allocated $1.6 million from global health security funds to support the study, which aims to test for alleged harms of the birth dose.
• The trial design splits 14,000 newborns into two groups, with one group receiving no vaccine, a practice condemned by the WHO and experts as unethical.
• Researchers Peter Aaby and Christine Stabell Benn are currently under investigation in Denmark for alleged scientific misconduct in previous vaccine studies.
• The trial cannot begin until the government of Guinea-Bissau grants final national authorization, which has not yet been issued.

Background

The controversy began in late 2025 when the CDC awarded a no-bid grant to the Bandim Health Project. The trial was suspended in January 2026 after international outcry and a review by the Africa CDC. The WHO issued a formal rebuke in February 2026, stating that resource constraints cannot justify withholding proven care. The current approval follows a revised protocol that includes limited maternal screening, but critics argue the core design remains fundamentally flawed.

How outlets are covering it

CIDRAP and Ars Technica report that the trial remains on hold pending final government approval in Guinea-Bissau, despite the Danish university's recent green light. Rolling Stone highlights that CDC officials, including Stuart Burns, are actively pushing to restart the study, drawing funding from global health security budgets. Stand Up for Science frames the trial as a 'gross violation of human rights' linked to the anti-vaccine agenda of Health Secretary Robert F. Kennedy Jr. Conversely, the researchers defend the trial by arguing it aligns with current national policy in Guinea-Bissau, where the birth dose is not yet routinely administered.

Why it matters

The trial raises critical questions about the ethical standards of international health research and the influence of political agendas on public health funding. If the trial proceeds, it could expose thousands of infants to a high risk of chronic hepatitis B infection, potentially leading to liver cancer and premature death, while diverting resources from other global health priorities like the Ebola outbreak in the DRC.

What to watch

The trial cannot commence until the government of Guinea-Bissau grants final national authorization. Advocacy groups like Stand Up for Science are exploring all possible actions to prevent the study from moving forward, while the CDC and HHS have not yet responded to requests for comment regarding the funding decision.