The controversial hepatitis B vaccine safety trial in Africa will continue as planned, despite concerns raised by medical experts about its ethics and design. The U.S. Department of Health and Human Services confirmed that the trial, which aims to test the health effects of the hepatitis B vaccine on newborns in Guinea-Bissau, will proceed as scheduled. The trial, known as HBV0-NSE, will involve 14,000 newborns and is funded by a $1.6 million grant awarded to controversial Danish researchers.
The decision to move forward with the trial has sparked criticism from various quarters, with concerns raised about the study’s design and ethical implications. The trial will involve randomizing half of the newborns to receive the hepatitis B vaccine at birth, while the other half will not receive any vaccine. This approach aims to examine the short-term health effects of the vaccine on the newborns.
Despite reports in the media suggesting that the trial had been halted due to ethical concerns, an HHS official clarified that the trial will proceed as planned. The official emphasized that the study aims to fill existing evidence gaps and inform global hepatitis B vaccine policy. The decision to withhold vaccination from some babies was justified based on the current vaccination policy in Guinea-Bissau, which does not provide the vaccine to newborns until 2027.
Critics of the trial have raised concerns about the study protocol, which they argue fails to provide ethical justification for withholding a potentially life-saving vaccine from vulnerable infants. The leaked protocol drew comparisons to the infamous Tuskegee study of syphilis, as it did not include testing for hepatitis B among most mothers in the trial, potentially resulting in the transmission of the disease to unvaccinated babies.
In response to reports of a cancellation of the trial, Africa CDC forwarded a letter from Guinea-Bissau’s health ministry suggesting a delay in the country’s nationwide vaccination program to 2028. However, HHS spokesperson Andrew Nixon dismissed the letter as unrelated to the trial and part of a public relations campaign aimed at shaping public perception.
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