A controversial hepatitis B vaccine trial involving 14,000 newborns in Guinea-Bissau is set to proceed following approval by ethics officials in Denmark and authorities in the West African country, according to a report by The Guardian.
The study, backed by the United States government, will involve Danish researchers withholding the hepatitis B vaccine from half of the participating newborns for the first six weeks of life.
The $1.6 million project is funded by the US Department of Health and Human Services, headed by Robert F. Kennedy Jr., who has repeatedly expressed scepticism about vaccines. Late last year, his advisers removed the universal recommendation for hepatitis B vaccination among American infants.
The trial was suspended for review in January following widespread criticism from scientists and public health experts.
However, The Guardian reported that a Danish ethics committee approved the project last week, alongside officials in Guinea-Bissau.
Opponents of the study have raised concerns that the research would deliberately and randomly deny some newborns access to a vaccine proven to protect against hepatitis B, particularly in a country where the infection remains prevalent.
The Africa Centres for Disease Control and Prevention has also opposed the trial. According to The Guardian, the agency said last week that discussions between the United States and Guinea-Bissau were ongoing, adding that further details would be provided shortly.
The World Health Organisation estimates that more than 12 per cent of adults in Guinea-Bissau are living with chronic hepatitis B, while infection among children under five stands at about two per cent.
The prevalence among young children is significantly higher than the global target of below 0.1 per cent, underscoring concerns about the potential public health implications of delaying vaccination for some newborns.
Guinea-Bissau plans to introduce hepatitis B vaccination for all newborns from 2028.
