Guinea-Bissau suspends Trump-backed hepatitis B vaccine study for ethical review

Guinea-Bissau has suspended a controversial hepatitis B vaccine study on newborns that was backed by the Trump administration, pending a thorough ethical review, the country’s Health Minister Quinhi Nantot announced Thursday.

During a news conference organized by the Africa Centers for Disease Control and Prevention (Africa CDC), Nantot revealed that a six-person ethics committee failed to properly review the study during its initial approval process, raising serious concerns about its implementation.

The research, designed as a randomized controlled trial, planned to give some infants the hepatitis B vaccine at birth while withholding it from others. Researchers would then track children for death, illness, and long-term developmental outcomes. This approach has drawn criticism from numerous public health experts who argue it is unethical to deny proven vaccines to vulnerable newborns at high risk of infection.

Jean Kaseya, Director-General of the Africa CDC, expressed full support for the ethical review while emphasizing the organization’s commitment to African interests. “We are led by the interests of our people in Africa,” Kaseya stated. “We are not led by the small interests of individual people.”

The suspension highlights growing tensions between African health authorities asserting sovereignty over research conducted on their soil and foreign-funded health initiatives with questionable ethical foundations.

Despite Guinea-Bissau’s announcement, U.S. health officials maintained on Wednesday that the study would proceed as planned. “The study is proceeding as planned, and we continue to work with our partners to finalize the study’s protocols,” said Andrew Nixon, spokesman for the U.S. Department of Health and Human Services, in a statement that now appears at odds with the West African nation’s decision.

The controversial study stems from a $1.6 million no-bid contract awarded by the Trump administration to researchers at the University of Southern Denmark. This team has been cited favorably by anti-vaccine activists and has faced scrutiny from mainstream public health experts. The grant was awarded by the U.S. Centers for Disease Control and Prevention.

One of the research team’s leaders is Christine Stabell Benn, who serves as a consultant for a committee appointed by U.S. Health Secretary Robert F. Kennedy Jr. This committee recently voted to discontinue recommendations for administering the hepatitis B vaccine to all American newborns, despite strong scientific consensus supporting the practice.

Guinea-Bissau, one of the poorest countries in West Africa, has a high prevalence of hepatitis B infection, making the population particularly vulnerable to the disease’s long-term complications, including liver cirrhosis and cancer. The original study design called for enrolling 14,000 newborns over five years, with most children followed for less than two years to monitor for side effects.

The first 500 enrolled children would have been followed for five years to assess potential behavioral and developmental impacts. According to the initial design, no placebo would be involved, though U.S. officials have not released details about the current version of the study protocol.

The suspension reflects growing concerns about the ethics of conducting medical research in low-income countries that might not receive approval in wealthier nations with more robust regulatory frameworks. Health sovereignty has become an increasingly important issue across Africa, with many countries asserting greater control over how international health research is conducted on their territories.

The situation also highlights tensions between scientific consensus on vaccine safety and efficacy and the growing influence of vaccine skepticism in policy circles, particularly in relation to the current U.S. health administration’s approach to immunization programs.

As the ethical review proceeds, the future of the study remains uncertain, potentially impacting both research participants in Guinea-Bissau and wider global health policy regarding hepatitis B vaccination protocols for newborns.