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Guinea-Bissau Halts US-Funded Hepatitis B Vaccine Study for Ethics Review

lite News Desk 2 min read

At a glance

  • Guinea-Bissau suspended a US-backed hepatitis B vaccine trial on newborns
  • The study assigned some infants to delayed vaccination
  • An emergency ethical review is underway by national authorities

Guinea-Bissau’s Ministry of Health suspended a hepatitis B vaccine study funded by the United States, pending an emergency review by an ethics committee. The development centers on how the trial was approved and the procedures for protecting newborn participants.

The halted study involved randomly selecting some newborns to receive the hepatitis B vaccine at birth, while others were scheduled to get the vaccine at six weeks of age. The suspension was announced as officials called for a review of the study’s ethical approval process.

According to Guinea-Bissau’s health minister, a six-member ethics committee had not reviewed the vaccine trial before it received approval. The Africa Centres for Disease Control and Prevention stated its support for the ongoing ethical review and highlighted the importance of prioritizing public health interests in Africa.

The United States Department of Health and Human Services said the study is proceeding as planned, subject to final protocol approval. The trial is being conducted under a $1.6 million contract awarded to the University of Southern Denmark.

What the numbers show

  • The study planned to enroll about 14,000 newborns in Guinea-Bissau
  • The first 500 infants were to be followed for five years to monitor outcomes
  • The US contract funding the study was valued at $1.6 million

The research protocol included long-term tracking of behavioral and developmental outcomes in the initial group of newborns. The trial’s design, which delayed vaccination for some infants, has drawn attention from health authorities and international observers.

Researchers and media outlets have described the study as unethical, citing concerns about withholding a proven vaccine from infants. These reactions have contributed to the scrutiny surrounding the trial’s approval and conduct.

Industry reaction

The Africa Centres for Disease Control and Prevention supported the decision to conduct an emergency ethical review and stated that African public health interests should be prioritized in such studies.

The US Department of Health and Human Services stated that the study is continuing as planned, pending approval of the final protocol.

* This article is based on publicly available information at the time of writing.

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