The recent award of a $1.6 million unsolicited, single-source grant to the Bandim Health Project for a clinical trial in the impoverished West African country of Guinea-Bissau marks a significant shift in federal research priorities, directing US public funds to investigators, who are deliberately withholding life-saving treatment from children.
The study is a randomized controlled trial that intentionally delays a proven, life-saving hepatitis B vaccine for newborns in a region with high endemic prevalence—estimated in some populations to affect up to one in five people—thereby exposing infants to a known and preventable risk. From the standpoint of medical ethics, it is more than dubious. It is potentially criminal.
The CDC’s unsolicited grant supports a five-year randomized controlled trial involving approximately 14,000 newborns in Guinea-Bissau, comparing vaccination at birth with a delayed first dose at six weeks to assess purported “non-specific effects” on mortality and development. Critics, including virologist Angela Rasmussen, have described the award process as “blatant cronyism,” citing its circumvention of standard review mechanisms.
The trial violates the principle of clinical equipoise by knowingly assigning infants to a delayed-vaccination arm despite the existence of a proven, life-saving intervention. This violation is magnified in a region with high endemic hepatitis B prevalence, where delay increases the risk of lifelong, irreversible infection. Compounding the ethical travesty, the study’s five-year follow-up window cannot capture the true disease trajectory, as the most severe consequences of hepatitis B—cirrhosis and liver cancer—often emerge decades later.
Any claim of scientific validity is further undermined by Guinea-Bissau’s own policy commitments. The government has formally pledged to implement a universal birth-dose program beginning in 2027. Internal CDC communications have compared the study to the Tuskegee syphilis experiment, noting the shared structure of government-funded researchers observing preventable disease in a vulnerable population while withholding an established intervention.
Dr. Robert Steinbrook, Health Research Group Director at Public Citizen, issued the following statement:
Everything is wrong with awarding this unsolicited single source grant, including the approval process, concerns about conflict of interest and the dubious ethics of the research. Newly born children, regardless of where they live, should be protected against hepatitis B by receiving the first dose of the vaccine within 24 hours after birth, as recommended by the WHO, leading medical professional organizations worldwide, and, until earlier this week, by the CDC. The benefits of the birth dose of the hepatitis B vaccine extend throughout life; they are not limited to five years after birth.
The CDC should not fund a study involving children in another country that would be unethical to conduct in the US. The award should be paused; the full study protocol should immediately be made public and receive independent scientific and ethics review in both Guinea-Bissau and the US. Bioethicists and medical professional organizations must demand that the CDC reconsider this outrageous grant award.
These events cannot be understood without reference to the ethical frameworks created explicitly to prevent such abuses. The Nuremberg Code (1947) established that human experimentation must be voluntary, scientifically justified and designed to avoid unnecessary suffering. The Declaration of Helsinki (1964) affirmed that the well-being of the research subject must always take precedence over scientific aims, forbidding inferior interventions when effective ones exist. The Belmont Report (1979) embedded these principles into US governance, warning explicitly against the exploitation of vulnerable populations for administrative convenience.
Under Health and Human Services (HHS) Secretary Robert F. Kennedy Jr., the CDC is systematically dismantling these guardrails. The dismissal of the entire 17-member Advisory Committee on Immunization Practices (ACIP) panel and its replacement with figures hostile to a genuinely scientific framework institutionalized this shift.
By replacing rigorous evaluation with a process engineered to deliver preordained outcomes, the administration is trashing science. The Guinea-Bissau trial is the worst manifestation of this anti-science, anti-human perspective. It sacrifices participant welfare to ideological propaganda value, in direct defiance of long-settled ethical norms.
In sum, the Guinea-Bissau study functions not as a good faith search for knowledge but as a mechanism for deliberately manufacturing “doubt,” providing cover for dismantling public health protections at home. Children in Guinea-Bissau are being used as instruments to rationalize US policy reversals, most notably the abandonment of the hepatitis B birth dose.
By subordinating scientific infrastructure to a preexisting anti-vaccine ideology, Robert F. Kennedy Jr. has transformed the HHS into an instrument of foreseeable harm. His policies invite the return of diseases once controlled and will predictably result in preventable illness and death. In this context, it is no exaggeration to describe Kennedy as a “secretary of sickness and death.”
This funding decision coincides with a major domestic policy reversal, as acting CDC Director Jim O’Neill formally approved the abandonment of the 34-year-old universal hepatitis B birth-dose vaccination policy for infants born to mothers not known to be infected. Dismantling this birth-dose “safety net”—credited with reducing pediatric hepatitis B infections by approximately 99 percent—ignores persistent gaps in maternal screening, including the fact that nearly one in five pregnant women in the United States are not screened during pregnancy.
These developments unfold alongside a directive from President Trump to “fast-track” a reassessment of US immunization policy using international comparators, most prominently Denmark’s childhood vaccine schedule, which includes significantly fewer routine vaccinations than the US standard. Public health experts warn that reconfiguring the US schedule on ideological grounds—without Denmark’s universal healthcare system, national registries and near-universal maternal screening—would predictably lead to renewed outbreaks of preventable disease, including measles, whooping cough, and hepatitis B–related liver cancer.
Adopting the so-called “Danish schedule” would eliminate several routine US childhood immunizations, withdrawing established protections against serious infectious diseases, such as influenza, rotavirus, chickenpox and respiratory syncytial virus (RSV), the leading cause of infant hospitalizations in the United States. Experts emphasize that this comparison is medically indefensible, because Denmark’s reduced schedule is viable only within structural safeguards that the United States does not possess. Absent those conditions, rolling back routine immunization would foreseeably increase preventable illness, disability and death.
The Guinea-Bissau trial itself is led by Peter Aaby and Christine Stabell Benn, longtime affiliates of the University of Southern Denmark and central proponents of the “non-specific effects” hypothesis. For more than 25 years, they have argued that while live vaccines may confer broader benefits, non-live vaccines—most notably diphtheria-tetanus-pertussis (DTP)—may paradoxically increase all-cause mortality, particularly among girls. This claim collapsed under systematic review. A 2025 analysis published in Vaccine found that in 22 of 23 analyses, the purported harms disappeared once appropriate statistical corrections were applied, leading reviewers to conclude that the findings reflected systematic over-interpretation of fragile observational data.
Professor Henrik Støvring, who led the systematic review of their DTP study at Aarhus University, stated,
The group [had] systematically selected and highlighted results that supported their theories, while downplaying the fact that they did not confirm the primary hypothesis the trials were actually designed to test. ... When you look at the overall picture, there are almost no real findings left.
The policy influence of this research has been mediated through Tracy Beth Høeg, a dual US–Danish citizen and senior federal health official with advisory roles at HHS and the FDA (Food and Drug Administration), who previously served as an adjunct professor at the University of Southern Denmark. Høeg has collaborated closely with Benn, including co-hosting the podcast Vaccine Curious, which promotes skepticism toward established vaccine schedules, and authoring articles that challenge the evidentiary basis for universal immunization policies.
That influence became explicit when the reconstituted ACIP—whose members were selected by Kennedy—repeatedly cited the Bandim group’s Guinea-Bissau research during its September 2025 public meeting. These citations formed a key intellectual foundation for arguments suggesting that the United States should move toward a more restrictive, Denmark-style vaccine schedule.
The political utility of the Bandim research reached its apex when Kennedy publicly singled out a single 2017 observational DTP study to justify canceling more than $1 billion in previously committed US funding to Gavi, the Vaccine Alliance. This reliance persisted despite the fact that the DTP formulation studied has not been used in the United States for over 30 years, and despite the study’s rejection by mainstream scientists as a non-replicable outlier. Nevertheless, the administration claimed Gavi had “neglected vaccine safety”—an assertion unsupported by the scientific record.
The consequences of defunding Gavi are severe and foreseeable. According to Gavi’s own projections, the funding withdrawal will result in approximately 75 million children missing routine vaccinations over the next five years, leading to more than 1.2 million preventable deaths. The disruption has already undermined disease surveillance and emergency stockpiles in nearly 50 countries, increasing the risk that outbreaks of measles, yellow fever and Ebola will spread across borders.