Controversial $1.6 Million Vaccine Study in Guinea-Bissau Sparks Ethical Concerns and Potential Cancellation
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A $1.6 million vaccine study conducted in Guinea-Bissau, announced last month by teh Centers for Disease Control and Prevention (CDC), has ignited a firestorm of controversy, drawing condemnation from scientists worldwide. The research, first reported by CIDRAP News, proposes a clinical trial that would randomly assign only half of 14,000 newborns to receive a birth dose of the hepatitis B vaccine, despite guidance from the world Health Association (WHO) recommending universal birth vaccination to prevent infection during delivery.
The study’s future is now uncertain, with reports emerging that it may be canceled altogether. At a briefing of the Africa Centres for Disease Control and Prevention (Africa CDC) on Thursday, an official announced the study would not proceed as planned. “We are glad that at this point, the study has been canceled,” stated Yap Boum, PhD, MPH, deputy incident manager for continental mpox response for Africa CDC.
However, this assertion was met with surprise from officials at the Department of Health and Human services (HHS). “it is indeed not our view that the study has been canceled,” said an HHS official, speaking on background. researchers are reportedly still refining the study protocol and “proceeding as planned.”
Guinea-Bissau: A Nation Vulnerable to Hepatitis B
Guinea-Bissau faces a particularly acute hepatitis B burden, with an estimated 8-10% of the population infected. The country’s healthcare system is fragile, and resources are limited, making it particularly vulnerable to outbreaks of infectious diseases. Critics argue that deliberately withholding a potentially life-saving vaccine from half of the newborns is unethical, especially given the country’s circumstances.
“This study would likely never be approved in the United States – reflects a troubling history of exploiting africa for research purposes. Titanji argued the study “reeks of practices that are from a different time,” and represents a continuation of colonialist attitudes.
The controversy is further compounded by recent shifts in US vaccine policy. While the hepatitis B vaccine has been credited with a 99% reduction in infections sence it’s introduction in 1991, a federal advisory panel handpicked by HHS Secretary Robert F. Kennedy Jr. recently voted to stop recommending universal newborn vaccination. The CDC now only recommends a birth dose for infants born to mothers who test positive for the virus or whose status is unknown.
Vaccine developer Paul Offit has sharply criticized the Guinea-Bissau study, comparing it to the infamous Tuskegee syphilis experiment. “RFK Jr’s Tuskegee Experiment,” Offit called it, referencing the ancient injustice where US researchers deliberately withheld treatment from Black men infected with syphilis to study the disease’s progression. Offit argued that the $1.6 million would be better spent directly vaccinating newborns. “That would be a far better thing to do.”
A Flawed Study Protocol
The Danish researchers maintain they aim to study the “non-specific effects” of vaccines, with previous research from the Bandim Project suggesting vaccines may, in some cases, worsen overall health and even increase mortality rates. A 2017 observational study, later unable to be replicated, indicated poorer health outcomes for girls after receiving a combined vaccine against diphtheria, pertussis, and tetanus.
according to a study protocol posted online by Jeremy Faust, MD, the trial will assess whether mortality rates within the first six weeks of life differ between infants vaccinated against hepatitis B at birth or in the first week, compared to those not vaccinated.Researchers also plan to monitor rates of atopic dermatitis (itchy, inflamed skin) by age two and neurodevelopmental disorders, such as autism, by age five.
Faust, writing in his Substack column, described the study as “heavily biased.” He explained that short-term vaccine effects, like rashes, appear quickly, while the long-term benefits – preventing cancer and liver scarring – take decades to manifest. “Trying to detect a decrease in all-cause mortality at 42 days (or 6 months, or 6 years), is doomed to fail,” Faust wrote. “It’s like doing a trial of chemotherapy and asking if the patient is alive a week later.”
Furthermore, Faust pointed out the study utilizes vaccines not approved for use in the United States, raising questions about the relevance of the findings. “It is remarkable that the US CDC is funding a study of vaccines that are not on the US market.” .
