US-funded hepatitis B study in West Africa sparks ethical concerns

A vaccine study funded by the US Centers for Disease Control and Prevention (CDC) in Guinea-Bissau has drawn sharp criticism from health experts and internal officials, with one CDC official comparing it to the infamous Tuskegee syphilis experiment.

The study, which received $1.6 million in CDC funding, focuses on the effects of neonatal hepatitis B vaccination on infant mortality, morbidity, and long-term developmental outcomes, The New Republic, an American magazine, reported on Thursday.

It cited the Inside Medicine health newsletter as reporting that it had obtained the protocols for the study, described in a Federal Register notice as a “randomized controlled trial to assess the effects of neonatal Hepatitis B vaccination on early-life mortality, morbidity, and long-term developmental outcomes.”

According to the report, the trial involves infants in Guinea-Bissau and compares different vaccination approaches rather than using a placebo.

Concerns about the study were voiced by an unnamed CDC official, who spoke to Inside Medicine and likened the trial to the “Tuskegee experiment,” in which the US government allowed untreated syphilis to persist among African American men in Alabama from 1932 to 1972.

“This is another Tuskegee,” the official was quoted as saying, adding that the study allows infants to be exposed to hepatitis B, despite the availability of a preventive vaccine, while tracking outcomes for several years.

The study had already prompted ethical criticism when the funding grant was announced in December.

Professor Martin McKee of the London School of Hygiene and Tropical Medicine told The Guardian at the time that the trial had “set alarm bells ringing in the global health community.”

The World Health Organization has recommended hepatitis B vaccination at birth since 2009.

According to Inside Medicine, the trial does not include a placebo group and seeks to measure so-called “non-specific effects” of vaccination, a concept associated in the report with views held by Health Secretary Robert F. Kennedy Jr., who has previously questioned vaccine safety.

The report also highlighted several methodological concerns.

Hepatitis B is known to cause severe health problems later in life rather than immediately after birth, raising questions about the usefulness of measuring short-term mortality and morbidity outcomes.

In addition, Inside Medicine reported that none of the vaccines used in the study are approved by the US Food and Drug Administration, prompting questions about why the CDC is funding research involving vaccines not available to Americans.

Other cited issues include the lack of routine testing of mothers for hepatitis B, potentially leaving high-risk infants unprotected, and the absence of a predefined protocol to halt the trial if harmful outcomes emerge.

The US Department of Health and Human Services defended the study by stating that Guinea-Bissau was not mandating hepatitis B vaccination until 2027.

Critics cited in the report argued that the $1.6-million grant could instead be used to vaccinate children in Guinea-Bissau against hepatitis B for a decade, calling into question the necessity of the trial.

Following the publication of the report, a senior official at the Africa Centers for Disease Control and Prevention announced that the study had been cancelled.

The controversy has unfolded amid broader debate over vaccine policy and public health research ethics under the current US administration, with critics arguing that the study reflected a shift in CDC priorities.

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