The Centers for Disease Control and Prevention (CDC) has awarded a $1.6 million grant to researchers at the University of Southern Denmark for a study on hepatitis B vaccines. This decision has sparked controversy due to the researchers’ connections with Tracy Beth Høeg, a senior official at the Food and Drug Administration (FDA). Critics argue that the study may be unethical and question its relevance to vaccine use in the United States.
Leading the research efforts are Christine Stabell Benn and her husband, Peter Aaby, who direct the Bandim Health Project in Guinea-Bissau, West Africa. The CDC’s grant will fund a placebo-controlled trial of the hepatitis B vaccine administered to newborns. Currently, infants in Guinea-Bissau receive their first dose of the vaccine at 6 weeks of age, but the country plans to implement a universal birth dose protocol by 2027, as recommended by the World Health Organization.
The CDC’s decision followed an “unsolicited proposal,” as noted in documents from the Federal Register. The University of Southern Denmark confirmed to STAT that Stabell Benn and Aaby are the recipients of this funding. However, details about the trial’s design remain limited. According to a statement from the Bandim Health Project, some newborns will receive the hepatitis B vaccine at birth while others will follow the existing standard of care, allowing researchers to assess “overall health outcomes.”
The CDC stated that the trial aims to evaluate the impact of the hepatitis B birth dose on “early-life mortality, morbidity, and long-term developmental outcomes.” A vaccine expert, William Moss, executive director of the International Vaccine Access Center, expressed concerns regarding the study’s design and duration. He noted that while the funding spans five years, it may not adequately capture the benefits of the vaccine, as the positive effects of hepatitis B vaccination may take decades to manifest.
Earlier this month, a panel advising the CDC on vaccine policy recommended eliminating the universal hepatitis B vaccine birth dose policy in the U.S. This long-standing guideline has contributed to a 99% reduction in hepatitis B infections among American infants. Babies infected with hepatitis B at birth face a 90% risk of developing chronic infections, which can lead to premature death from liver disease.
Critics have pointed out that the advisory committee’s recommendations were not based on new evidence about the vaccine’s dangers or effectiveness but rather arose from public objections. Stabell Benn and Aaby have long suggested that vaccines can have effects beyond their intended purpose, known as non-specific effects. While they have claimed some non-specific effects can be beneficial, they have also reported adverse outcomes, such as increased susceptibility to other infections, particularly among girls.
Recent analyses of their studies have raised doubts about the validity of their claims regarding non-specific effects. Concerns have also emerged around the ethical implications of conducting a study in Guinea-Bissau that would not be permissible in the United States. Vaccine experts worry that assigning some newborns to receive no vaccination at birth could expose them to unnecessary risks, especially given the high prevalence of chronic hepatitis B infection in Guinea-Bissau, estimated at 13% to 18% of the population.
Moss underscored the ethical dilemma, stating that withholding the birth dose could significantly endanger many children. He emphasized that any study design must undergo rigorous ethical review, which he suspects has not yet occurred. Other experts, including pediatrician and allergist-immunologist Zachary Rubin, echoed these concerns, highlighting the ethical gap between research conducted in high-income countries and that in low-resource settings like Guinea-Bissau.
The Department of Health and Human Services, in response to inquiries about the ethical implications of the study, stated that the CDC would uphold the highest scientific and ethical standards. Spokeswoman Emily Hilliard asserted that the study aims to address existing evidence gaps to inform global hepatitis B vaccine policy. Nonetheless, many scientists have cautioned that the differences between Guinea-Bissau and the U.S. regarding infant mortality rates, healthcare access, and disease burden render the study’s findings unlikely to be applicable in an American context.
Stabell Benn has maintained a close association with Høeg, who serves as an adviser to FDA Commissioner Marty Makary and recently assumed the role of acting director of the FDA’s drug center. Høeg has also participated in the CDC’s Advisory Committee on Immunization Practices, advocating for a reduction in the number of vaccines administered to newborns in the U.S.
In prior interviews, Stabell Benn has expressed a desire for stricter standards in vaccine approval, emphasizing the need for evidence not only of antibody production but also of improvements in overall health. She stated, “There is a misunderstood fear that if we start digging down and scrutinizing vaccine effects on overall health, then we might reveal something that could shatter confidence.”
Stabell Benn and Aaby founded the Bandim Health Project in 1978, initially focusing on malnutrition and vaccination impacts. Their research has garnered attention and criticism alike, particularly regarding a previous observational study that suggested increased mortality among children vaccinated against diphtheria, tetanus, and whooping cough. The couple faced scrutiny in the Danish press for not publishing results from a randomized controlled trial they conducted on the DTP vaccine in 2011. They attributed the delay to personal circumstances affecting their research team.
As the CDC moves forward with this funding decision, the implications for both public health policy and ethical research practices remain significant, raising questions about the future of vaccine research in diverse global contexts.
