In early December, two political appointees at the Centers for Disease Control and Prevention began an unusual quest: to find a division within the sprawling agency that could process a grant proposal from a Danish research duo long admired by the Secretary of Health and Human Services, Robert F. Kennedy Jr.
As previously reported by Rolling Stone, the grant request, marked as unsolicited, proposed a randomized controlled trial in the impoverished West African nation of Guinea-Bissau. The research would examine whether a birth dose of the hepatitis B vaccine — proven safe over decades — had potentially negative effects, such as skin ailments or neurodevelopmental disorders.
Inside the CDC, according to seven current and former employees, almost everything about the proposal and its pathway through the agency set off alarm bells and sparked fears of inadequate human research protections.
The proposal had come without standard scientific review or typical competitive bidding. It planned to provide only half of the more than 14,000 enrolled infants with a highly protective birth dose of the hepatitis B vaccine, in a nation where hepatitis B plagues one in five adults, leading to high transmission rates from mothers to infants. And, CDC sources say, it came with intense pressure for approval from the director’s office. “None of our scientists would touch this with a 10-foot pole,” a CDC employee tells Rolling Stone.
The grant request was so radioactive, one scientist even refused to have it sent to their inbox.
New documents obtained by Rolling Stone reveal that the proposal was not vetted by, or homed within, a scientific center at the CDC. Instead, these documents show, it was routed straight from the director’s office to grant management officials who approved it, a process that took only 10 days. An ordinary grant review process can take upward of a year.
Almost immediately after the $1.6 million grant was posted in the federal register on Dec. 18, scientists around the world denounced the study as unethical. Though U.S. health officials contended publicly that the study was proceeding, the Guinea-Bissau health secretary announced on Jan. 22 that it would be halted while officials assessed the ethics of continuing.
On Thursday, in response to questions about irregularities with the Guinea-Bissau ethics approval identified by Rolling Stone, Ole Skøtt, dean of the health sciences faculty at the University of Southern Denmark, the study’s listed grantee and home to its lead scientists, responded, “Your enquiry contains new information in relation to the validity of the ethical approval. I have therefore decided that this should be investigated. The Hepatitis B project has therefore been put on hold in order to assess the new information you have submitted.”
The study had been the subject of intensifying controversy for weeks. On Feb. 6, three ranking members on the House Energy and Commerce Committee demanded answers about the study from then-acting CDC director Jim O’Neill (who was recently removed in a staff shuffle). On Feb. 13, the World Health Organization released a statement expressing “significant concerns” with the study’s scientific justification, ethical safeguards, and adherence to established research principles. Amid this uproar, the study’s lead scientist, Christine Stabell Benn, has vehemently rebutted critics and defended the study’s ethical underpinnings.
In response to queries from Rolling Stone, Stabell Benn states that she and the study leaders “respectfully disagree” with the characterization that the study is unethical. “The trial complies with current national policy in Guinea-Bissau and has been reviewed and approved by the competent national ethics committee. It is designed to address an important and unresolved public health question regarding the introduction of hepatitis B vaccination at birth in settings where it is not yet part of routine practice — which remains the case in the majority of African countries.”
However, Rolling Stone found that the Guinea-Bissau ethics committee was not in compliance with U.S. rules that govern grant funding, as required. The committee had a lapsed registration with the HHS Office for Human Research Protections and an insufficient number of active committee members. And while the approval letter from November 2025 bears the name of an ethics committee president, Cunhate Na Bangna, he tells Rolling Stone that he had resigned from the committee three years earlier and that his name was used on the letter without his knowledge or permission: “Thank you for this revelation,” Na Bangna said in an email. “I will activate the internal mechanism here in the country to rectify the situation.”
With an average clinical trial costing 20 times as much, how did a relatively low-dollar CDC research grant become an international ethics fiasco?
A Rolling Stone investigation, based on a review of over two dozen previously undisclosed CDC and grant documents, and interviews with 20 current and former CDC employees, medical ethicists, and experts, found that CDC appointees allied with Kennedy circumvented critical scientific and ethical safeguards in an apparent rush to fund research that might loan support for sweeping changes to the U.S. vaccination schedule.
The status of the study remains unclear. On Feb. 18, Reuters reported that the Guinea-Bissau foreign minister said the study had been closed for good, due to scientific concerns. But Stabell Benn tells Rolling Stone, “We are currently working with officials in Guinea-Bissau to ensure that the study moves forward.” A CDC official says that the Guinea-Bissau health ministry plans to resubmit a revised study protocol to the ethics committee for review.
An HHS spokesman, Andrew Nixon, says, “The proposal underwent review through appropriate channels in accordance with CDC procedures.” He disputed that the scientific centers were not involved in the review, saying that a “group of subject matter experts” within the director’s office of science reviewed the proposal and “relevant leadership within CDC’s global health enterprise was aware of the proposal.”
Calling the study “unjustifiable,” the CDC’s former chief medical officer, Dr. Debra Houry, says it is “unfathomable that the CDC’s name is even implicated in this.”
OVER THE LAST YEAR, Stabell Benn, 57, and her husband and research partner Peter Aaby, 81, have faced allegations from Danish colleagues and the press that they engaged in dubious research practices, and failed to publish data that would have contradicted their theories that certain vaccines can have harmful secondary effects.
Strenuously denying these allegations, and claiming their science has been ethical and transparent, the duo have pursued their critics, demanded retractions of critical scientific papers, and lodged a complaint with the Danish Press Council in response to negative articles from a Danish weekly newspaper, Weekendavisen. (Stabell Benn tells Rolling Stone the complaint is related to “specific factual inaccuracies and methodological claims” unrelated to the proposed hepatitis B trial. Weekendavisen has not issued any corrections and continues its reporting.)
On Oct. 3, 2025, amid these claims, Stabell Benn wrote to Lyn Redwood, a political appointee and Kennedy advisor at HHS. She described how a Guinea-Bissau research outpost that she and Aaby had run for years was planning a clinical trial to examine potential secondary harms from the hepatitis B vaccine birth dose but needed to secure additional funding. She had already received a pledge of $1.8 million from Pershing Square Foundation — established by billionaire hedge-fund manager Bill Ackman — provided they could raise the same amount within the month.
Redwood, who had previously served as president of Children’s Health Defense, the anti-vaccine organization founded by Kennedy, wrote back admiringly: “Thank you for sharing this opportunity. The Secretary has followed your work with Dr. Aaby in Guinea-Bissau over the years. I will be sure to let him know about your upcoming research initiatives.”
The proposed research by the outpost, the Bandim Health Project, sprang from Aaby’s decades-long inquiry into whether vaccines have potentially unknown and nonspecific effects on the immune system. He and Stabell Benn have studied whether some vaccines that use weakened live viruses can reduce mortality, while others using inactivated viruses can increase it.
The birth dose of the hepatitis B vaccine, in use for over 30 years, has been highly effective in blocking transmission of the disease from mother to infant. Under its current vaccination schedule, Guinea-Bissau infants receive their first hepatitis B vaccination at six weeks, which cannot protect against transmission at birth if the mother is infected. In line with World Health Organization recommendations, the nation was set to introduce the birth dose in 2027 (last month, it pushed the target date back to 2028).
As Stabell Benn explained to Redwood in an email last October, that lag time presented “the world’s first and perhaps only opportunity to test the overall health effects” of the vaccine. Under the study, no child would get less vaccine than they ordinarily would under Guinean government policy, Benn has stated repeatedly.
But under the Helsinki Declaration, international guidelines first adopted in 1964 that govern human subject research, studies must provide participants with the most effective known medical intervention, not just what is standard. Additionally, the proposed study protocol failed to universally screen every enrolled mother for hepatitis B, to ensure that all infants born to infected mothers would receive the birth dose. Instead, it planned to sample-test only 250 enrolled mothers, and otherwise rely on whether the women know they are infected.
In response to these concerns, Stabell Benn tells Rolling Stone, “The interpretation of the relevant clause of the Helsinki Declaration in global health settings has been debated for decades,” further emphasizing that “in this trial, no participant is denied any vaccine they would otherwise receive under national policy.” She goes on to note: “Reasonable experts may disagree about” the best way to design a clinical trial. “But that disagreement does not make the study unethical.”
Benjamin Cowie, an Australian infectious disease specialist and director of the WHO Collaborating Centre for Viral Hepatitis, tells Rolling Stone that, given the prevalence of hepatitis B in Guinea-Bissau, the study would likely doom a number of the enrolled infants to “be living with chronic hepatitis B for the rest of their life.” Chances are high that a percentage of those would go on to develop liver cancer and liver failure, he says, all of which could be prevented with a birth dose of the vaccine.
Nonetheless, on Nov. 5, Guinea-Bissau’s National Committee on Ethics in Health Research issued a letter approving the study. It said that the committee had met five days earlier, on Oct. 31, and after a “succinct and thorough analysis” determined that the protocol “fully complies with all the parameters” required.
On Nov. 10, Redwood wrote back to Stabell Benn, asking, “Are you still in need of funding for this project? If so, are you available for a call to discuss today or tomorrow?”
Two days later, the CDC’s director of grants services notified Stabell Benn that her funding request had been forwarded to the agency. On Nov. 14, Stuart Burns, a senior advisor in the CDC director’s office and ally of Kennedy’s with a long history of anti-vaccine activities, emailed Stabell Benn, saying the grant was a “funding priority for CDC/HHS” (emphasis Burns’).
IN THE U.S., THE RULES governing human research grew out of the Tuskegee scandal, the infamous U.S. medical study launched in 1932 that withheld antibiotics from Black sharecroppers infected with syphilis. Since then, a body of international agreements and U.S. laws, including federal regulations called the Common Rule, govern the treatment of human research subjects.
Among the requirements, researchers must secure informed consent, protect participants from harm, and have their plans cleared by an ethics committee prior to starting research. Any proposed medical research funded with U.S. dollars must comply with these standards, and so is typically reviewed by a U.S. institutional review board (IRB). “The regulations travel with the money,” says Seema Shah, a bioethicist at Lurie Children’s Hospital in Chicago.
Studies are also typically vetted by the institution that is home to a study. In this case, the University of Southern Denmark, where Stabell Benn and Aaby are professors, is the listed grantee. Like most of the world’s research institutes, the University of Southern Denmark has a written agreement with the U.S. Department of Health and Human Services, called a Federalwide Assurance, pledging to comply with U.S. research standards.
But no ethics review of the study was undertaken by either the University of Southern Denmark or the CDC, Rolling Stone has learned. The entire study, its compliance with U.S. regulations, and the University of Southern Denmark’s guarantee of that compliance, rested on the review by the Guinea-Bissau ethics committee.
HHS spokesman Andrew Nixon says that because CDC was “not conducting or collaborating in this study,” the agency’s IRB did not review the study. He adds, “Questions regarding the internal governance, composition, or documentation of the Guinea-Bissau ethics committee are best directed to the appropriate authorities or the applicant institution.”
Though the Guinea-Bissau committee was required to have an active registration with the HHS Office of Human Research Protections, a review of records reveals that its registration had expired in 2018 and is listed as deactivated in the OHRP database. The committee’s secretary, Mohammed Djico, tells Rolling Stone, through a translator, that the committee only had four active members when it voted to approve the study. The U.S. rules require that ethics committees have at least five voting members.
The Nov. 5 approval letter bears the name of the ethics committee’s president, Dr. Cunhate Na Bangna. Reached by Rolling Stone, Dr. Na Bangna said that he resigned from the committee in 2022 and that his name was used on the document without his knowledge or permission. “It shows that someone has been using my [name],” he wrote in an email. Djico, who signed his name over Na Bangna’s printed name, tells Rolling Stone that because Dr. Na Bangna never formally resigned, ethics approvals from the committee still bear his name, a situation that three medical ethicists say is irregular at best. Djico defended the committee’s work, saying that its members are well qualified and have received training through a European Union program.
As Rolling Stone was going to press, Stabell Benn provided a new letter from the Guinea-Bissau ethics committee, dated Feb. 20 and signed by Djico, saying that the initial approval letter was valid and he had been authorized to sign it.
But Holly Fernandez Lynch, associate professor of medical ethics and health policy at the University of Pennsylvania, says the committee’s procedural breaches raise red flags about the quality of its review. “Do they have their act together or not? It should not take a reporter and an expert in [institutional review boards] to figure out who approved a study.”
Ultimately, the onus lies with U.S. health officials to make sure that “competent review” was given to such a high-risk proposal, says Dr. Arthur Caplan, founding head of the medical ethics division at NYU Grossman School of Medicine. The CDC could see the expired registration, “showing that the IRB was not even functioning so that in itself tells you [that the level of review] is not adequate, it’s irregular, it’s way outside the standard of practice” for approving such a sensitive study.
BY MID-NOVEMBER, when Stabell Benn and Aaby’s grant application was routed to CDC, the agency was in a state of siege. The agency’s director had been fired in late August, after refusing to rubber stamp the recommendations of a purged vaccine advisory committee that Kennedy had restaffed with allies. As she testified before a Senate committee, she was “fired for holding the line on scientific integrity.” Four top officials quit in protest. And that came on top of an early August shooting, when a gunman had strafed the CDC’s Atlanta headquarters and killed a responding police officer.
After losing roughly 3,000 employees to purges by the Department of Government Efficiency (DOGE) and subsequent layoffs, the remaining employees were attempting to keep the agency afloat. Then-acting director Jim O’Neill was working mostly from HHS headquarters in D.C. Day-to-day operations had fallen to a 24-year-old former DOGE operative, Sam Beyda, who graduated from Columbia University in 2023, had briefly worked at a company that manufactures cannabinoids, and was now deputy chief of staff.
As Beyda and Stuart Burns, neither of whom is a scientist, began their effort to get the anomalous grant funded — which required a scientific division to process it and a project officer who could vouch for its scientific merit — CDC employees grew alarmed by the proposal. “Clinical trials are a big deal,” especially ones that include babies, says a former CDC scientist who had refused to work on the grant. “Someone needs to make sure there’s no ethical violation.”
Normally, the CDC undertakes arduous and lengthy scientific reviews. Proposals are vetted by agency centers with relevant expertise. Those deemed worthy undergo a U.S.-based ethics review before being funded, as a regulatory requirement. “Typically, if you have a contract or grant, it would sit under the center, institute, or office [CIO] that has the subject matter expertise,” says the former CDC scientist.
On Dec. 1, the grant was routed directly from the director’s office to the grants management office, bypassing the agency’s scientific divisions. Where the grant would normally list the relevant scientists under CIO, Beyda and Burns were listed instead, along with their division: the director’s office.
“I worked at CDC for decades and I never saw anything like that,” says a former CDC operations official who reviewed the records at Rolling Stone’s request. “I don’t care if they were proposing to sell a pipette. The grants office just doesn’t make decisions like that.”
The grant bore a justification for approving the single-source contract, citing the “unique capabilities” of the Guinea-Bissau research outpost but also how the study’s findings would “provide critical data on the health effects of the hepatitis B birth dose (HBVO), informing national and international vaccine policy decisions.” It also emphasized the urgency of approving the grant, stating, “The study must be initiated promptly to take advantage of a narrow window before [the birth dose] becomes national policy in Guinea-Bissau.”
Documents obtained by Rolling Stone also show that just weeks after the grant was approved, the CDC revised and updated the policies and procedures for awarding more unsolicited, sole-source grants, suggesting that the irregular pathway of the Guinea-Bissau grant could become a new normal. However, even the recently updated standard operating procedure for reviewing unsolicited grants notes, “these types of grants should be infrequent due to HHS commitment to encourage fair competition.”
HHS spokesman Andrew Nixon says it is “misleading” to suggest that CDC had updated its policies on sole-source grants in response to the Guinea-Bissau award.
ON JAN. 5, ROUGHLY three weeks after the Guinea-Bissau grant became public, Kennedy announced that the CDC would no longer universally recommend six of 17 childhood vaccinations, including the hepatitis B vaccine, which for years was routinely given as a three- to four-dose series, starting at birth. While Kennedy claimed the shrunken vaccination schedule better aligned the U.S. with peer nations, particularly citing Denmark, major medical organizations denounced the move.
The decision will “kill Americans in the future. There is no question,” says Dr. Benjamin Cowie. “It will undoubtedly lead some American infants to acquire chronic hepatitis B and in the years to come, die of cirrhosis or liver cancer.”
Cowie, as well as other doctors, see a link between the policy shift and the rush to fund the Guinea-Bissau grant. Says Dr. Jake Scott, an infectious disease specialist at Stanford Medicine, “They are funding an unsolicited study to generate doubt about a vaccine that they have already decided to pull back.”
