Guinea-Bissau denies it has approved controversial vaccine trial in newborns

O experimento impediria a vacinação contra hepatite B de milhares de recém‑nascidos em um país onde a doença é generalizada. Fotografia: Phanie/Sipa Press/AlamyView imagem em tela cheia.

Fotografia: Phanie/Sipa Press/Alamy Guiné-Bissau nega ter aprovado ensaio controverso de vacina em recém‑nascidos Ministro da Saúde afirma que o governo 'não autorizou' ensaio de hepatite B liderado pela Dinamarca em bebês apoiado por RFK Jr.

Prefer the Guardian on GoogleGuinea-Bissau has not approved the controversial hepatitis B study in newborns that would be funded by the US government and private partners, the African country’s minister of health said on Tuesday.

The study, which would not investigate the safety or effectiveness of vaccines but would instead track “nonspecific” health outcomes like overall mortality or neurodevelopmental conditions, has been championed by Robert F Kennedy Jr, secretary of the US Department of Health and Human Services (HHS) and a longtime anti-vaccine activist.

Membros de um comitê de ética em pesquisa dinamarquês foram informados de que autoridades em Guiné-Bissau haviam aprovado um desenho atualizado do estudo, o que influenciou alguns votos dos membros do comitê para prosseguir com o ensaio na semana passada.

But the health ministry never agreed to or authorized the trial, said Quinhin Nantote in Portuguese at a press briefing, where he referred to the study as “tests”.

Read more“The ministry did not authorize the tests under the terms presented in the publications currently in circulation,” the health minister said. He said officials in Guinea-Bissau were “surprised” to see media reports that the country had given approval to the study.

Ele falou depois de convocar uma reunião de emergência na Guiné-Bissau com o Projeto de Saúde de Bandim, o comitê local de ética, o Instituto Nacional de Saúde Pública (Inasa) e o Programa de Vacinação Expandido (PAV).

The Bandim Health Project is run by the Danish researchers Peter Aaby and Christine Stabell Benn, whose decades of research have been called into question in the past year.

The claims made in nearly all of their papers are “highly misleading”, said Charlotte Strøm, a Danish researcher who has co-authored research showing that Aaby, Stabell Benn, and their co-authors had no significant findings in 24 out of 25 studies and that they’ve chosen not to publish research that may not support their viewpoints.

She added: “I believe there is serious cause for concern.”.

Kennedy tem elogiado repetidamente o trabalho deles, que ele diz demonstrar que, após a vacinação, “você pode ter lesões em massa, lesões catastróficas, e elas estão escondidas à vista de todos”.

Aaby, Stabell Benn and Frederik Schaltz-Buchholzer did not respond by press time to the Guardian’s questions about why the Danish ethics committee members were told the trial had been approved by local authorities and why it could not be held in Denmark.

In Denmark, infants born to hepatitis B-negative parents do not receive the shot, there is widespread testing for and low incidence of the virus, and the robust healthcare system can track health outcomes and provide timely and comprehensive medical care – making it an ideal location for such a study.

É “reassuring” ver a Guiné-Bissau se posicionar contra o ensaio, disse Titanji, acrescentando: “Um estudo como este precisa do mais alto nível de escrutínio ético.

Você vai conduzir um estudo na população mais vulnerável, que são os recém‑nascidos, em um país com recursos limitados.”.

When Titanji recently applied for approval of a collaborative study in Cameroon, she had to include extensive documentation in her application – and it was a survey, not medical research on human subjects, she said.

Os pesquisadores deveriam divulgar esses documentos e um protocolo atualizado mostrando como o estudo seria conduzido, disse ela.

Experts have decried the African experiment as “horribly unethical and cruel”, “neocolonialist” and “damaging”.

Todos os envolvidos devem trabalhar juntos para garantir que todos os bebês na Guiné-Bissau recebam a dose de nascimento da vacinação contra hepatite B, ela acrescentou.

6m for funding for the trial this year, to be matched by private funding from the Pershing Square Foundation and the Bluebell Foundation.

At least four members of the Danish committee resigned after approval for the trial was fast-tracked. The rules of the committee had to be changed because randomized controlled trials were outside of its purview.

When committee members requested more information about the Guinea-Bissau approval, no further details were provided.

O estudo incluiria 14. 000 recém‑nascidos na Guiné‑Bissau, metade dos quais seria vacinada ao nascer e a outra metade seria privada da imunização nas primeiras seis semanas de vida.

Hepatitis B is widespread in the country, and infection in children can have serious lifelong effects.

Guinea-Bissau, which currently has a transitional military government following a coup in November, requested in January a team of experts from the Africa Centres for Disease Control and Prevention (Africa CDC) to help evaluate the study.

Entretanto, Nantote disse na época que estava “canceled or suspended”.

Other officials in Guinea-Bissau also pushed back on the research. “It’s not going to happen, period,” the foreign minister, João Bernardo Vieira, said in February.

A Organização Mundial da Saúde (OMS) ofereceu apoio na implementação da vacina contra hepatite B no nascimento para todos os recém‑nascidos em Guiné‑Bissau. “WHO stands ready to support Guinea‑Bissau as it considers its way forward and in accelerating the introduction of the birth dose and strengthening implementation,” a organização disse em uma declaração de fevereiro, contestando o ensaio.