Guinea-Bissau Suspends Hepatitis B Vaccine Study

DAKAR, Senegal — Guinea-Bissau has put a hold on a hepatitis B vaccine study involving newborns, which was backed by the Trump administration, while an ethical review takes place, according to the health minister’s announcement on Thursday.

The health minister, Quinhi Nantot, indicated that a six-person ethics committee had not convened to assess the study during its initial confirmation phase, as stated during a press conference hosted by the Africa Centers for Disease Control and Prevention.

The research aims to conduct a randomized controlled trial, where some newborns receive the hepatitis B vaccine at birth while others do not. The health outcomes of the children will be monitored, focusing on mortality, health issues, and long-term development. Concerns have been raised by some experts regarding the ethics of the study, criticizing the decision to withhold a life-saving vaccine from infants deemed at high risk of infection.

Jean Kaseya, the Director-General of Africa CDC, expressed full support for the ethical review and emphasized the importance of prioritizing the health interests of the African population over any individual agendas.

“Our focus is on the well-being of our people in Africa,” Kaseya remarked. “We are not driven by the minor interests of individuals.”

Despite the suspension, U.S. health officials stated on Wednesday that the study is meant to continue as planned.

Andrew Nixon, a spokesperson for the U.S. Department of Health and Human Services, mentioned, “The study is proceeding as intended, and we are collaborating with partners to finalize its protocols.”

The Trump administration had previously awarded a $1.6 million no-bid contract to a university in Denmark for the purposes of this hepatitis B vaccination research in Guinea-Bissau.

Some of the scientists involved have faced criticism from anti-vaccine activists and have had their work questioned by prominent public health authorities. The general consensus in research indicates that the hepatitis B vaccine is protective for newborns, raising ethical concerns about withholding it from certain infants.

The U.S. Centers for Disease Control and Prevention (CDC) provided funding to a research team at the University of Southern Denmark, which has received praise from U.S. Health Secretary Robert F. Kennedy Jr. One prominent member of the team, Christine Stabell Benn, serves as a consultant for a Kennedy-appointed committee that recently made the controversial decision to cease recommending hepatitis B vaccinations for all newborns in the U.S.

The study was initially slated to kick off early this year in Guinea-Bissau, which is known for high rates of hepatitis B infection. Researchers have secured funding for a five-year period to observe 14,000 newborns.

Most children in the study will be observed for less than two years to monitor any side effects, but the first 500 participants will be observed for five years to scrutinize behavioral and developmental issues. Notably, there was no placebo group included in the initial study design.

Nixon did not provide additional information regarding modifications to the current study design.