CDC Is Moving Forward With a Previously Shelved Controversial Hepatitis B Vaccine Study

“It’s a wholly unethical trial, and it shouldn’t be allowed,” says Dr. Paul Offit Two months after the Senate confirmed Dr. Erica Schwartz as the new director of the Centers for Disease Control and Prevention, her office has moved to allocate new funds for a controversial clinical trial of the hepatitis B vaccine in Guinea-Bissau, which was previously suspended. Researchers revised the study protocol in January, amid an international uproar over medical ethics. While it is not clear how much Schwartz was involved in, or knew about, the budget requests from her office, her appointment to the directorship came amid questions about how independent she would be from Health Secretary Robert F. Kennedy Jr. In late September, a staff member within the CDC director’s office instructed the agency’s budget office to set aside $1.6 million to help fund the trial, Rolling Stone has learned. The new funding is being pulled from money directed by Congress for CDC global health security programs, two sources with knowledge of the study plans say. Amid an Ebola outbreak in the Democratic Republic of Congo and swirling questions around a possible lab accident in Eastern Siberia that may have resulted in the release of plague bacteria, there are any number of vital uses for such funding. “Everyone agrees, the point of global health security is to fight [the diseases] overseas, so they don’t come here,” says a CDC employee. Instead, the $1.6 million will be slated for a clinical trial in Guinea-Bissau seeking to examine whether the birth dose of the hepatitis B vaccine, used safely for decades, has potential negative health effects such as skin ailments or neurodevelopmental disorders. The study would be led by Christine Stabell Benn and Peter Aaby, married researchers at the University of Southern Denmark long lionized by Secretary Kennedy for their controversial vaccine research. Presently, they are facing accusations of scientific misconduct, unrelated to the hepatitis B trial, that are under review by the Danish Committee on Research Misconduct. Editor’s picks The study, should it proceed, would be a randomized controlled trial in Guinea-Bissau that would give a birth dose of the hepatitis B vaccine to half of the 14,000 newborn participants, but not to the other half, a step the researchers justified as aligning with the standard of care in Guinea-Bissau, where the birth dose of the vaccine is not routinely provided to newborns but will be officially recommended there by 2028. However, in a nation where one in five adults have hepatitis B, the study design could result in some of the newborn participants being infected but receiving no birth dose of the vaccine, clinical trial and infectious disease experts contend. The revised protocol from January includes limited measures for screening mothers for hepatitis B, by asking them if they are infected, and blood tests for 250 mothers and children to screen for infection. It was not immediately clear by press time whether the researchers had made further revisions to the protocol. “It’s a wholly unethical trial, and it shouldn’t be allowed,” says Dr. Paul Offit, a pediatrician and director of the Vaccine Education Center at the Children’s Hospital of Philadelphia. “It saddens me to think that our country would in any way participate in a trial where half of the children would be receiving substandard care and thousands will be doomed to develop cirrhosis or liver cancer.” Stabell Benn has vehemently defended the ethics of the clinical trial, asserting that no child would receive less than the standard of care in Guinea-Bissau, and no participant would be denied treatment they would otherwise receive. “The trial complies with current national policy in Guinea-Bissau and has been reviewed and approved by the competent national ethics committee,” she previously told Rolling Stone. The research project she and Aaby run in Guinea-Bissau, the Bandim Health Project, has responded to these concerns on its website. Related Content Professors Stabell Benn and Aaby, and officials from the Health and Human Services Agency and CDC, did not respond to requests for comment for this story. Rolling Stone sent questions for this story to the University of Southern Denmark on October 6. In response, the dean of the faculty of health sciences, Jakob Grauslund, said in a lengthy statement that “as of today, October 7, 2026, I have given the researchers approval to proceed with the revised Hepatitis B study.” He says that he had communicated that decision to Stabell Benn today. The approval was based on an “independent ethical assessment” carried out by the university’s research ethics committee, Grauslund says. He adds that because a foreign ethics review panel — in this case, one in Guinea-Bissau — had already approved the study, Danish law precluded its regional or national ethics committees from conducting a separate review. Consequently, he says the university approached both the World Health Organization’s Research Ethics Review Committee and the European Network of Research Ethics Committees to conduct an independent review, but both said they were unable to. He notes that authorities in Guinea-Bissau had yet to give their final approval, and “the study cannot begin until the necessary national authorization has been obtained.” Inside CDC, proponents of the clinical trial had been waiting on the outcome of the University of Southern Denmark’s ethics review in order to resurrect the study, Rolling Stone has learned from agency sources. When news of the CDC grant for the trial first broke last December, infectious disease experts around the world denounced it as unethical and a potential violation of the Helsinki declaration, which requires studies to provide participants with the most effective known medical intervention, not just what is standard. In January, confusion swirled after the Africa CDC announced the study was suspended, but Danish researchers and HHS officials insisted it would launch. In February, the World Health Organization stated it had “significant concerns regarding the study’s scientific justification, ethical safeguards, and overall alignment with established principles for research involving human participants.” Later that month, after questions from Rolling Stone about irregularities in the ethics approval process in Guinea-Bissau, Ole Skøtt, then the dean of the health sciences faculty at the University of Southern Denmark, said that the study would be placed on hold. In the fall of 2025, Stabell Benn had been in confidential discussions with U.S. health officials to obtain funding for the study through a no-bid grant. Stuart Burns, a political appointee and senior advisor in the CDC director’s office, and an ally of Kennedy’s with a long history of anti-vaccine activities, had championed the grant, calling it a “funding priority for CDC/HHS” in a November 2025 email to Stabell Benn obtained by Rolling Stone. Notice of the award was published in the federal register last December, kicking off the firestorm over ethics. Last month, it was Burns again who was involved in directing the budget office to find a source of funding for the clinical trial, according to two sources with knowledge of the study plans. “The fact that CDC leadership is now advocating for RFK Jr.’s unethical and deeply disturbing vaccine trial is a new low for an agency that has been fundamentally compromised by the Secretary’s work to advance” his “anti-vaccine agenda,” Senator Angela Alsobrooks (D-MD) tells Rolling Stone in a statement. The CDC’s renewed plans to fund the grant have come even after an academic committee at the University of Southern Denmark elevated concerns in February about the scientists’ research practices to the Danish Committee on Research Misconduct. That committee is now weighing whether the researchers essentially falsified data by not publishing findings from a clinical trial that would have undercut their claims that the DTP vaccine, which protects against diphtheria, tetanus and pertussis, was unsafe. Trending Stories A months-long series of probing articles in the Danish newspaper Weekendavisen was the first to raise questions about Stabell Benn and Aaby’s research practices. The couple has stated in response to the reporting, “We categorically deny that we have deliberately withheld data or attempted to misrepresent our research.” Now it appears that, despite a global effort to stop the Guinea-Bissau trial, Kennedy’s allies within the CDC have made plans to restart it. “Some of these things don’t die,” says a government health official with knowledge of the plans. “They go into hibernation.”