Guinea-Bissau will implement a universal birth-dose policy for the Hepatitis B vaccine in 2027.Credit: Enrique Lopez-Tapia/Nature Picture Library/Alamy
Public-health authorities in Guinea-Bissau say that they have suspended a controversial US-funded hepatitis B vaccine study that has raised questions about who has authority over clinical research conducted in Africa conducted by research teams from other countries. At a press conference held on 22 January, officials from Guinea-Bissau’s ministry of health said that the study was being suspended pending a technical and ethical review by the nation’s public-health institute. The announcement followed multiple conflicting statements over whether or not the trial would proceed.
“There has been no sufficient coordination in order to take a final decision regarding the study,” said Quinhin Nantote, the minister of public health for Guinea-Bissau. “Faced with this situation, we decided to suspend it.”
Mixed messages
The meeting, convened by the Africa Centres for Disease Control and Prevention (Africa CDC), comes after an official at the organization signalled last week that the trial would not proceed. In an e-mail to Nature the day of the press conference, an official at the US Department of Health and Human Services (HHS), a prominent funder of the research, said that the study was still on track, leaving the trial’s status uncertain.
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“The study is proceeding as planned and we continue to work with our partners to finalize the study’s protocols,” wrote Emily Hilliard, a spokesperson for the HHS.
The continuing row highlights long-standing tensions over clinical research trials in Africa that are proposed and run by researchers in other countries. African scientists say that the Guinea-Bissau study shows how political pressure, funding interests and fragmented oversight can push local health priorities aside.
The hepatitis B vaccine trial was designed by researchers at the Bandim Health Project, which is based at the University of Southern Denmark in Copenhagen, and funded, in part, by a US$1.6-million research grant from the US Centers for Disease Control and Prevention, part of the HHS. The study aims to randomize 14,000 newborns in Guinea-Bissau, starting in early 2026, to receive their first dose of the hepatitis B vaccine either at birth or at the age of six weeks, when it is currently given, before the country’s planned universal birth-dose vaccine policy begins in 2027.
The Bandim researchers have said that the study offers a chance to investigate whether the vaccine has broader effects on infant health outcomes.
But vaccine scientists, public health researchers and bioethicists around the world have argued that by randomizing some newborns to not receive the vaccine at birth, the trial would deny a safe and life-saving intervention to infants in Guinea-Bissau, where the prevalence of hepatitis B is about 19%. The immune systems of newborns are immature, and about 90% of those infected at birth go on to develop chronic, lifelong infections that can lead to liver disease and early death.
Researchers who oppose the study also argue that it is structured in a way that increases the likelihood of detecting harm from the birth dose, even if that harm is not real or clinically meaningful. “They’re trying to use African children to prove a case for reducing vaccines in the US,” says Seye Abimbola, a health-systems specialist at the University of Sydney in Australia who researches decolonizing global health. “That’s problematic.” The United States cut its own recommendations for a birth dose of the hepatitis B vaccine in December.
Bandim Health did not respond to Nature’s request for comments on the study design. Hilliard said that the research “is based on the highest scientific and ethical standards”.
