Outrage of the Month: CDC Funding of a Troubling Guinea-Bissau Hepatitis B Vaccine Study
Health Letter, February 2026
By Robert Steinbrook, M.D.
Director, Public Citizen's Health Research Group
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In December 2025 the Centers for Disease Control and Prevention (CDC) awarded a single-source, unsolicited $1.6-million grant to the University of Southern Denmark to conduct a five-year “comparable study of the optimal timing and delivery of monovalent Hepatitis B vaccinations on newborns in Guinea-Bissau.”
The Danish researchers have ties to Tracy Beth Høeg, a top Food and Drug Administration official, who is also the agency’s representative to the CDC’s Advisory Committee on Immunization Practices (ACIP). One of the researchers was recently appointed to an ACIP work group.
Additional funding for the research comes from the Pershing Square Foundation, which is led by billionaire hedge fund manager Bill Ackman. Ackman shares Health Secretary Robert F. Kennedy Jr.’s vaccine skepticism and supported his 2024 presidential campaign.
Everything is wrong with the study and the CDC funding, including the approval process, concerns about conflict of interest, and the dubious ethics of the research. The CDC should not fund a study that would be unethical to conduct in the United States.
After reports in January that the study had been cancelled, federal health officials doubled down, dismissed concerns about ethical violations, and said the research would proceed as planned. Days later, however, public health officials in Guinea-Bissau blocked the study, stating that it had received inadequate ethical review and perhaps had not been reviewed at all. It is also uncertain whether the study has been evaluated by an institutional review board at the University of Southern Denmark or in the United States. No credible institutional review board in Europe or the United States would approve the study.
Guinea-Bissau is a country in West Africa with a population of about 2 million and a high prevalence (about 20%) of chronic hepatitis B infection. Guinea-Bissau is also one of the world’s least developed nations and one of the world’s 10 poorest countries.
In 2027 Guinea-Bissau plans to implement a universal hepatitis B vaccine policy for newborns, as recommended by the World Health Organization and, until recently, by the ACIP and the CDC. Without such a policy, many babies exposed to the hepatitis B virus at birth will continue to become chronically infected and eventually die of hepatitis B-related liver failure or liver cancer.
During 2026 the researchers planned to randomize newborns to receive the hepatitis B vaccine at birth (the 2027 policy) or no hepatitis B vaccine at birth (the current policy). All children were to receive the hepatitis B vaccine at 6, 10 and 14 weeks after birth, under Guinea-Bissau’s current vaccination program. Thus, half of the children were to receive an additional dose of hepatitis B vaccine at birth.
Even if Guinea-Bissau has yet to transition to a universal birth dose of the hepatitis B vaccine, it is ethically and medically wrong to randomize children to an inferior vaccination schedule. The benefits of the birth dose of the hepatitis B vaccine are fully established and extend throughout life; they are not limited to five years after birth.
As discussed in Public Citizen’s Health Letter in January, the ACIP and the CDC senselessly undermined the success of hepatitis B vaccination in the United States by recommending replacing the universal birth dose of the vaccine with individual-based decision-making, a change that the American Academy of Pediatrics promptly condemned.
The CDC should come to its senses. The Guinea-Bissau hepatitis B vaccine study should be permanently cancelled and the funds used to help the country make a birth dose of the hepatitis B vaccine available to all newborns.