Despite widespread scrutiny, a halted clinical trial of the hepatitis B vaccine in Guinea-Bissau resumed last month due to expiring $1.6 million in CDC grant funds allocated to Danish researchers, according to Rolling Stone.
The study investigates potential adverse effects of the hepatitis B birth dose, traditionally considered safe, by administering it to only half of 14,000 enrolled newborns. This raises significant risks for the remaining 7,000 infants in a region where hepatitis B is endemic, potentially leading to infections that could cause cirrhosis, liver cancer, and lifelong health complications.
The birth dose, not routinely used in Guinea-Bissau, is set to become standard practice in 2028. The study proposes vaccinating all participants at six weeks of age, aligning with current local protocols. However, the World Health Organization (WHO) previously criticized the trial, prompting researchers to revise their protocol in August. The updated plan includes maternal screening for hepatitis B before randomization.
Experts argue the revisions fail to address deeper ethical and medical concerns. Dr. Robert Gish of the Hepatitis B Foundation notes that maternal screening alone cannot prevent transmission via household contacts or undetected infections. The revised protocol states, “Babies of mothers who are known to have hepatitis B, test positive, or whose status cannot be determined will not be randomized and will be offered the birth-dose vaccine promptly,” but critics remain unconvinced.
Rolling Stone first reported the trial’s resurrection and impending approval. Medical ethicist Dr. Arthur Caplan criticized the rushed review process, stating, “When subjects are in peril, in a dirt-poor nation, where charges of exploitation are flying, and knowing we have a treatment that can help subjects, that is the wrong place to hurry the review.”
The Danish University of Southern Denmark’s ethics committee faced time pressure to approve the study after Guinea-Bissau’s original ethics review raised irregularities. Four members resigned in protest, citing rushed deliberations and funding deadlines as key factors. The committee voted 5–4 to approve the study on Sept. 30, with final approval granted by the university’s dean on Oct. 7.
Committee member Stig Børsen Hansen stated the funding deadline “short-circuited the process,” leading to a flawed decision. Meanwhile, CDC officials sought alternative funding to avoid losing the grants by Sept. 30, ultimately redirecting funds from a global health security pool originally earmarked for pandemic preparedness and Ebola response efforts.
Denmark’s lead researcher, Christine Stabell Benn, defended the trial as compliant with local standards, though the Helsinki Declaration cautions against trials that match lower care standards when higher ones exist elsewhere. Guinea-Bissau’s health ministry initially denied approving the study but later acknowledged pending reviews. Both CDC and the ministry declined further comment.
Critics, including global health experts, highlighted the ethical implications. Dr. Gavin Yamey questioned, “If there is a worldwide outcry among ethicists, why wouldn’t you listen to your critics?” Medical ethicist Dr. Arthur Caplan added, “$1.6 million would go a long way in Guinea-Bissau if you just vaccinated everybody.”