CDC hepatitis – The CDC is moving to fund a previously suspended hepatitis B vaccine trial in Guinea-Bissau, despite global warnings that the study design is unethical and endangers newborn participants.
Two months after Dr. Erica Schwartz took the helm at the Centers for Disease Control and Prevention. the agency has moved to resurrect a dormant and deeply divisive clinical trial. Behind the scenes. the director’s office has acted to allocate $1.6 million in funding toward a study in Guinea-Bissau that seeks to test the birth dose of the hepatitis B vaccine—a vaccine used safely for decades—for potential negative effects like neurodevelopmental disorders or skin ailments.
This capital is being pulled from funds Congress specifically earmarked for global health security programs. The diversion comes at a time when those same resources are facing heavy pressure from an active Ebola outbreak in the Democratic Republic of Congo and an unexplained release of plague bacteria in Eastern Siberia. To critics inside the agency, the decision represents a profound misuse of vital public health funds. As one CDC employee put it. the core mission of global health security is to stop diseases overseas so they do not arrive here.
The trial itself, slated to involve 14,000 newborns, would withhold the birth dose of the vaccine from half the participants. Because the study is based in a nation where one in five adults carries hepatitis B. experts warn that children denied the vaccine face a significant risk of infection. potentially dooming them to lifelong complications like liver cancer or cirrhosis. While researchers Christine Stabell Benn and Peter Aaby argue the trial aligns with current Guinea-Bissau standards—where the vaccine is not yet routinely provided—critics view the methodology as a violation of the Helsinki declaration. which requires participants receive the most effective known medical intervention.
The path to this point has been marked by a series of internal maneuvers. In late September, a staff member in the director’s office ordered the budget office to set aside the $1.6 million. This follows a pattern established in the fall of 2025. when Stuart Burns. a senior advisor and political appointee in the director’s office with a history of anti-vaccine activism. championed the grant as a “funding priority.” Burns. an ally of Health Secretary Robert F. Kennedy Jr., has remained central to the effort to restart the project.
Senator Angela Alsobrooks (D-MD) described the agency’s support for the trial as a “new low” for a body she believes has been compromised by the Secretary’s agenda. The project’s leaders. Stabell Benn and Aaby. are also facing separate scrutiny; they are currently under review by the Danish Committee on Research Misconduct for allegations unrelated to this specific trial. which they have categorically denied. Despite this. the dean of the University of Southern Denmark’s faculty of health sciences. Jakob Grauslund. recently approved the researchers to proceed. citing an “independent ethical assessment” while acknowledging that the University was unable to secure a review from the World Health Organization or the European Network of Research Ethics Committees.
The international scientific community has spent the better part of a year attempting to stop the study. The World Health Organization previously expressed “significant concerns” regarding the trial’s justification and ethical safeguards. and in February. the university placed the project on hold following questions regarding local approval irregularities. Now, the momentum has shifted back in favor of the researchers.
As the study remains pending final authorization from authorities in Guinea-Bissau. the decision to revive it highlights a widening divide between the agency’s historical commitment to established standards and the current leadership’s priorities. For those tracking the process, the reality is stark. As one government official noted, the proposal didn’t disappear after the international outcry; it simply went into hibernation.
CDC Erica Schwartz Robert F. Kennedy Jr. Hepatitis B Guinea-Bissau vaccine study public health