Controversial US-backed vaccine trial in African newborns halted

Uma mulher está em um quarto compartilhado em uma instalação residencial de cuidados para mães grávidas em Gabu, Guiné-Bissau, em 22 de maio de 2012. Fotografia: Rebecca Blackwell/APView imagem em tela cheia Uma mulher está em um quarto compartilhado em uma instalação residencial de cuidados para mães grávidas em Gabu, Guiné-Bissau, em 22 de maio de 2012.

Prefer the Guardian on GoogleThe US-backed hepatitis B vaccine trial in African newborns that drew global backlash was halted, the lead researcher said on Wednesday.

É “agora claro” que o estudo “não avançará em Guiné-Bissau”, escreveu Frederik Schaltz-Buchholzer, pesquisador dinamarquês, no LinkedIn, acrescentando: “não nos foi concedida a aprovação governamental necessária.”.

The minister of health in Guinea-Bissau, Quinhin Nantote, previously denied that the project would move forward. “This is not even remotely true,” Nantote told the Guardian in Portuguese last week.

The government of Guinea-Bissau now has control over the researchers’ vaccines, which they apprehended when they searched the offices of the Bandim Health Project on Monday.

É vital apoiar a Guiné‑Bissau na implementação das imunizações para todos os recém‑nascidos o mais rápido possível, disse Offit. A Guiné‑Bissau atualmente planeja oferecer a dose universal de nascimento em 2028.

The Danish researchers, led by Schaltz-Buchholzer, Christine Stabell Benn and Peter Aaby, hypothesized giving live vaccines, like the Bacillus Calmette-Guérin (BCG), may have an overall mortality benefit beyond simply preventing illnesses like tuberculosis – but giving another vaccine like hepatitis B alongside it could dampen that effect.

View image in fullscreenMinister of health, Quinhin Nantote, at the presidential palace in Guinea-Bissau on 29 November 2025. Photograph: Patrick Meinhardt/AFP/Getty ImagesSuch a hypothesis is “fanciful” because the hepatitis B vaccine is a single protein among billions encountered by the immune system each day, Offit said.

Os pesquisadores dinamarqueses não responderam, até o prazo de imprensa, a perguntas sobre o estudo ou a essa crítica. O CDC não respondeu, até o prazo de imprensa, a perguntas sobre se o financiamento, que foi apropriado por meio de seu trabalho em saúde global, seria agora usado para implantar a vacina em todos os recém‑nascidos da Guiné‑Bissau, conforme recomendado pela World Health Organization (WHO).

Those who declined participation in the study would not have received the vaccines – making true informed consent impossible, experts say.

The proposed trial led to distrust among Bissau-Guineans, who wondered if the vaccine – which has a decades-long record of being safe and effective – was being tested on Africans because it was dangerous, Schaltz-Buchholzer said in his post.

Ele escreveu que “deve ficar claro” que ambos os esquemas de vacinação ao nascer – com ou sem hepatite B – não são “perigosos para ninguém”. Há um benefício claro em administrar vacinas contra hepatite B ao nascer, e não fazê‑lo pode levar a um perigo permanente, dizem especialistas.

Conducting a study like this “makes the case that there’s something that’s worthy of study, for which they have no evidence,” Offit said.

Schaltz-Buchholzer also cast doubt on the effectiveness and safety of the hepatitis B vaccine at birth, noting that he believes the study was canceled because it challenges “prevailing medical assumptions, such as that HBV0 does not have non-specific effects”.

The study, in addition to looking at mortality, would have also examined side effects like skin conditions and neurodevelopmental conditions. Dozens of studies have shown no link between vaccination and autism.