Why US-funded vaccine study in West Africa is facing global scrutiny

This randomised controlled trial compares health outcomes between infants who receive the hepatitis B vaccine at birth and those who do not, tracking mortality, illness, and long-term development.

hepatitis b vaccine trial Representative Image

Guinea-Bissau has suspended a US-backed study on hepatitis B vaccines for newborns in the West African country, citing concerns over ethical review.

Health Minister Quinhin Nantote said that a six-person ethics committee did not meet to review the study during the initial confirmation process. 

This randomised controlled trial compares health outcomes between infants who receive the hepatitis B vaccine at birth and those who do not, tracking mortality, illness, and long-term development. 

Experts have opined that the research plan is unethical, because it will withhold vaccines that work from newborns at significant risk of infection. 

Africa Centres for Disease Control and Prevention Director-General Jean Kaseya said that he fully supports the ethical review and highlighted the agency's "excellent relationship" with the US government. 

"We are led by the interests of our people in Africa," Kaseya said. "We are not led by the small interests of individual people."

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US health officials said Wednesday that the study is still set to proceed.

"The study is proceeding as planned, and we continue to work with our partners to finalise the study's protocols," Andrew Nixon, spokesman for the US Department of Health and Human Services, said in a statement.

The Trump administration has faced ethical scrutiny after awarding a $1.6 million, no-bid contract to a Danish university to study hepatitis B vaccinations in Guinea-Bissau newborns. Because the vaccine is globally recognised as lifesaving, the decision to withhold it from a control group of infants has sparked significant alarm among medical experts.

The study was set to begin early this year in Guinea-Bissau, where hepatitis B is common. The researchers are funded for five years to study 14,000 newborns.