US-backed hepatitis B vaccine trial in newborns in Guinea-Bissau halted
The lead researcher said the controversial hepatitis B vaccine study in newborns will not go ahead in Guinea-Bissau because government approval was not granted. It was to be funded by the US CDC and private partners.
Danish researcher Frederik Schaltz-Buchholzer, who led a US-backed study of hepatitis B vaccination in newborns in the West African country of Guinea-Bissau, said on Wednesday that the trial will not proceed there. In a LinkedIn post, he said the team had not received the necessary governmental approval. The project had drawn sharp international criticism because some newborns would not have received the vaccine.
Guinea-Bissau's health minister, Quinhin Nantote, had earlier told the Guardian that the project would not move forward. The government now controls the researchers' vaccines, which were seized when the offices of the Bandim Health Project were searched on Monday.
Funding and hypothesis
The study was to receive $1.6m from the US Centers for Disease Control and Prevention (CDC) and another $1.6m from private partners, including the Pershing Square Foundation and the Bluebell Foundation. The Danish team — Schaltz-Buchholzer, Christine Stabell Benn and Peter Aaby — hypothesized that live vaccines such as BCG may reduce overall mortality, and that giving a hepatitis B vaccine alongside could dampen that effect.
Paul Offit, a vaccines expert at the Children's Hospital of Philadelphia, called the hypothesis fanciful and said there is no evidence for it. He stressed that the benefit is clear, given high hepatitis B rates in the country and the risk of lifelong illness and death. He said Guinea-Bissau should vaccinate all newborns as soon as possible; the country currently plans to offer a universal birth dose in 2028.
Ethical concerns
Experts say those who declined to take part would not have received the vaccine, making true informed consent impossible. Danish researcher Henrik Støvring noted that participants' children would have had a 50% chance of getting the vaccine, while those who stayed out would have had none.
The World Health Organization (WHO) recommends that all infants receive a first dose as soon as possible after birth, preferably within 24 hours. Schaltz-Buchholzer acknowledged the trial caused distrust among Bissau-Guineans. The CDC and the researchers did not respond to questions by press time.
