CIDRAP News broke the news of the study in December, shortly after the single-blinded clinical trial was announced in the Federal Register. Since then, the trial has been widely criticized for proposing to provide a life-saving birth dose of the hepatitis B vaccine—as endorsed by the WHO— to only half of the 14,000 babies to be studied, while allowing the other half to be vaccinated at six weeks of age, the current policy in Guinea-Bissau.
The study also does not call for hepatitis B screenings in pregnant women, who can transmit the virus to infants during delivery. Nearly one in five people in Guinea-Bissau has chronic hepatitis B.
Providing the first dose of hepatitis B vaccine within 24 hours of delivery protects newborns from infection. Without vaccination, 90% percent of babies exposed to hepatitis B at birth will contract chronic hepatitis B. About 25% of infected children will die prematurely of liver cancer or liver failure.
Guinea-Bissau health officials announced last month that they have suspended the study pending further technical reviews.
In a statement, the WHO said it “has significant concerns regarding the study’s scientific justification, ethical safeguards, and overall alignment with established principles for research involving human participants.”
Withholding the hepatitis B vaccine for six weeks “exposes newborns to serious and potentially irreversible harm,” the WHO said. “Placebo or no‑treatment vaccine trials are only acceptable when no proven intervention exists or when such a design is indispensable to answer a critical question of efficacy or safety.”
CDC gave controversial Danish researchers $1.6 million to lead study
Three US lawmakers have asked why the CDC is funding the study. In a letter to CDC leadership, Democratic members of the House Energy & Commerce Committee wrote, “Using taxpayer dollars in such a study, rather than using those dollars to provide proven, life-saving vaccinations to babies, is abhorrent.”
Hepatitis B vaccines are extremely safe and are credited with reducing rates of the infection in the United States by 90%, according to a report from the Vaccine Integrity Project published by CIDRAP, which publishes CIDRAP News.
The CDC awarded researchers from the University of Southern Denmark a $1.6 million, unsolicited, non-competitive grant for a clinical trial of hepatitis B vaccines in infants. The researchers, who lead the Bandim Health Project in Guinea-Bissau, have been criticized for overstating their research findings and failing to publish their results.
The new study “posits hypothetical safety outcomes without sufficient credible evidence of a safety signal that would warrant exposing participants to risk,” the WHO said in its statement. In addition, the “the single‑blind, no‑treatment‑controlled design raises a significant likelihood of substantial risk of bias, limiting interpretability of the study results and their policy relevance.”
Because of limited public health resources, Guinea-Bissau does not yet provide the hepatitis B vaccine at birth. The western African nation, which has a poverty rate of 60%, currently vaccinates children against hepatitis B at age 6 weeks, but plans to begin vaccinating newborns at birth next year.
That gives researchers a “window of opportunity” to compare outcomes in vaccinated versus unvaccinated babies, Bandim researchers wrote on their website.
But the WHO’s statement argues that “exploiting scarcity is not ethical.”
Its statement says, “Resource constraints cannot be used to justify withholding proven care in a research study involving people. Ethical obligations require minimizing risk and ensuring a prospect of benefit for participants. From what is publicly described, the protocol does not appear to ensure even a minimum level of harm reduction and benefit to the study participants.”
In response to the WHO, Bandim researchers responded to the WHO in a post on their website Saturday. “The hepatitis B birth dose is not currently part of routine national practice in Guinea-Bissau,” they wrote. “No child enrolled in the study would receive fewer vaccines than under current national policy. The study examines its introduction prior to planned nationwide rollout.”
In their response, Bandim researchers said they are open to future discussions about the study’s design: “We respect Guinea-Bissau’s decision to pause implementation pending further technical review and welcome continued discussion.”
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