Why was the newborn vaccine trial in Guinea-Bissau suspended?

The trial was suspended on January 22 pending a review due to public outrage and ethical concerns raised by international health experts and local officials.

What was the main objective of the Danish researchers' trial?

The Danish researchers aimed to assess the health outcomes of 14,000 newborn babies in Guinea-Bissau by comparing those who received the hepatitis B vaccine at birth versus those who received it six weeks later.

What ethical issues were raised regarding the Guinea-Bissau vaccine study?

Critics argued that withholding a known effective hepatitis B vaccine from infants at a critical time for research purposes was unethical, despite the current practice of delayed vaccination.

Home / Health / Guinea-Bissau Halts US-Funded Infant Vaccine Study

Guinea-Bissau Halts US-Funded Infant Vaccine Study

7 Feb

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Summary

Newborn hepatitis B vaccine trial suspended amid ethical outrage.
Danish researchers planned to study 14,000 babies in Guinea-Bissau.
Concerns raised over withholding vaccines from infants for research.

Guinea-Bissau Halts US-Funded Infant Vaccine Study

A planned US-funded vaccine trial involving 14,000 newborns in Guinea-Bissau was suspended last month due to significant public and expert outrage over its ethical implications. Danish researchers intended to compare the health outcomes of babies receiving the hepatitis B vaccine at birth versus six weeks later over five years.

Concerns were voiced by international health experts and former Guinea-Bissau health minister Magda Robalo, who stated the study was unethical for withholding a known effective intervention from infants. The national public health institute was reportedly not fully informed, raising questions about regulatory oversight.

The trial, led by scientists from the University of Southern Denmark's Bandim Health Project, has also drawn scrutiny due to past accusations against lead researchers Peter Aaby and Christine Stabell Benn regarding claims about vaccine side effects and selective reporting of study results.