A US-backed study in Guinea-Bissau on the effects of the hepatitis B vaccine birth dose has been suspended pending a technical review, the director general of Public Health of Guinea-Bissau said on Thursday.
“We don’t have technical evidence from the ethical committee to make a decision,” Director General Armando Sifna said through a translator during a press conference hosted by the Africa Centers for Disease Control and Prevention. “We canceled the trial because our national ethical committee did not have the required technical resources.”
The hepatitis B vaccine study, which was set to be carried out by a Danish research group and funded in part by a $1.6 million grant from the Centers for Disease Control and Prevention, was criticized by public health experts for withholding the hepatitis B vaccine birth dose from some infants in order to determine whether the timing of the vaccine affected their health.
“The only thing that would alleviate my concern is if they took that $1.6 million and vaccinated as many kids at birth as the WHO recommends,” Paul Offit, co-inventor of the rotavirus vaccine, told NOTUS last week, referring to the funding the study received from the CDC.
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A spokesperson from the Department of Health and Human Services confirmed via email to NOTUS that the study was paused, saying that it “should proceed following further evaluation.”
“The CDC is funding a gold-standard, independent study designed to answer questions about the broader health effects of the hepatitis B vaccine. This research aims to fill existing evidence gaps to help inform global hepatitis B vaccine policy and is based on the highest scientific and ethical standards,” the spokesperson wrote after publication.
The study would give some infants the birth dose of the vaccine and others their first dose at 6 weeks, which is when the country currently recommends infants receive their first dose. The study’s leaders said previously that the study had been approved by the ethics committee in Guinea-Bissau.
The group leading the study has ties to health officials in the U.S., including Tracy Beth Høeg, who is currently serving within the Food and Drug Administration.
The study’s leaders, the Bandim Health Group at the University of Southern Denmark, said their study was designed to take advantage of a “window of opportunity” afforded by Guinea-Bissau’s decision to implement a hepatitis B birth dose in 2028, which the director general of Public Health confirmed was still planned.
The study’s future has been in question for weeks. While the initial announcement by the Bandim Health Project said the study would begin in January, researchers from the group told NOTUS last week that they did not have a start date scheduled and that they had met with representatives from the World Health Organization and UNICEF who were concerned about the study.
A representative from Africa CDC said last week that the trial had been canceled, but that was later contradicted by a spokesperson from the U.S. Department of Health and Human Services.
During Thursday’s press conference, the director general of Africa CDC, Jean Kaseya, said the organization was “respecting and supporting the sovereignty” of Guinea-Bissau.
“Africa CDC doesn’t make the decision,” Kaseya said.
When asked by a reporter about comments made by an HHS spokesperson calling Africa CDC a “powerless, fake organization,” Kaseya said he met with high-level HHS officials Wednesday, and their relationship was continuing.
“We have a diplomatic relationship with the U.S. Yesterday, senior people from HHS were talking with senior people from Africa CDC,” Kaseya said. “I trust them, I’ve closed the chapter, and I will not continue to talk about that one.”
Africa CDC is the official health agency of the African Union, which represents 55 countries.
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