
A controversial vaccine study in Guinea-Bissau has ended, according to an announcement by the lead researcher on Wednesday. The trial, which was designed to examine hepatitis B vaccination protocols in newborns, faced significant opposition from medical experts and government officials. The Danish researcher coordinating the project stated that governmental approval was not secured, leading to the decision to discontinue the research in the West African nation.
The study had been allocated $1.6 million in funding from the US Centers for Disease Control and Prevention, with an additional $1.6 million pledged by private organizations including the Pershing Square Foundation and the Bluebell Foundation. The research team hypothesized that combining live vaccines with hepatitis B vaccination might reduce certain health benefits, though this theory was criticized by prominent vaccine researchers as lacking biological basis. The government of Guinea-Bissau confiscated vaccine supplies from the research team’s offices during an inspection.
Medical experts raised substantial objections to the trial’s design and methodology. Critics argued that informed consent could not genuinely be obtained when study participants choosing not to enroll would have zero access to the vaccine, whereas those participating would have a fifty percent chance of receiving it. Additionally, concerns emerged that the trial could undermine public confidence in vaccine safety, particularly given the hepatitis B vaccine’s decades-long safety record and effectiveness globally.
The World Health Organization recommends that all infants receive a hepatitis B vaccine dose within 24 hours of birth, followed by additional doses. Guinea-Bissau currently plans to implement universal birth-dose vaccination in 2028. Vaccine experts have emphasized the particular importance of this vaccination program for Guinea-Bissau, given high prevalence rates of hepatitis B in the country and associated risks of chronic infection and mortality. The CDC did not respond regarding whether the allocated funding would now support broader vaccination rollout efforts aligned with WHO recommendations.
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