A planned study of a hepatitis B vaccine in newborns in Guinea-Bissau, funded by the US government, has been threatened with cancellation after heated debates about its ethics.
The project, partially funded by $1.6 million from the US Centers for Disease Control and Prevention (CDC), aimed to study the overall effects of administering the hepatitis B vaccine at birth compared to later vaccination at six weeks of age. The researchers planned to enroll about 14,500 infants in a randomized controlled trial, monitoring mortality, morbidity, and child development over several years. But the project drew criticism from international medical and ethics experts, who called it “unethical” and compared it to historically notorious experiments in which vulnerable groups were denied proven protection for the sake of scientific observation.
Critics point out that the hepatitis B vaccine has long been recognized as safe and effective in preventing mother-to-child transmission of the virus, and that refusing to administer it to some newborns in a country with a high infection rate could put them at serious risk. The government of Guinea-Bissau has announced that it is suspending or canceling the study pending additional ethical review, as the local ethics committee did not have sufficient resources and coordination to evaluate the project, and the situation was complicated by the recent change of power in the country.
African CDC leaders have affirmed their support for the ethical review and emphasized that the final decision must be made by the country itself, while US officials argue that the trial should continue after the protocols are agreed upon. The controversy surrounding this study raises important questions about ethical standards in global medical trials and how scientific research should be conducted in the most vulnerable communities, where basic health safeguards are not yet fully in place.