Why a US-funded vaccine trial on babies was cancelled in Guinea-Bissau

What the report says

A proposed US-funded hepatitis B vaccine trial involving newborn babies in Guinea-Bissau has been cancelled after drawing criticism from health officials, ethicists and international observers, according to Nile Post’s cited BBC report. The study was planned at the Bandim Health Project in Bissau and was expected to involve about 14,000 newborns, with half receiving a vaccine shortly after birth and the other half not receiving it. Critics argued that withholding a vaccine recommended by the World Health Organization from babies in a country where hepatitis B is widespread raised serious ethical concerns.

The report says the project was intended to examine whether the birth-dose vaccine may have health effects beyond preventing hepatitis B infection. Researchers involved said Guinea-Bissau offered a rare setting because routine birth vaccination has not yet been introduced there, although officials had been considering adding it to the immunisation schedule earlier than 2028. The funding came through the US government, with the CDC awarding the University of Southern Denmark $1.6 million, according to the article.

Guinea-Bissau’s government had already prohibited hepatitis B vaccine trials involving children in January, and the health minister said the suspension had not been lifted. The World Health Organization’s representative in the country also objected, saying the planned design would withhold a proven intervention from newborns. Police later searched the Bandim Health Project in Bissau and seized a batch of hepatitis B vaccines, though they did not say whether the action was linked directly to the proposed trial. The dispute has highlighted wider concerns about research ethics and whether vulnerable populations in poorer countries are being asked to accept risks that would not be considered acceptable elsewhere.