Controversial vaccine trial touted by RFK Jr gets go-ahead in Guinea-Bissau

A child receives a hepatitis B vaccine in Lomé, Togo, on 7 August 2015. Photograph: BSIP/Universal Images Group/Getty ImagesView image in fullscreenA child receives a hepatitis B vaccine in Lomé, Togo, on 7 August 2015.

Prefer the Guardian on GoogleA controversial research trial that will withhold hepatitis B vaccines from some African newborns was given approval to move forward this week.

É uma parte central da visão de vacinas de Robert F Kennedy Jr, o secretário do Departamento de Saúde e Serviços Humanos dos EUA (HHS) e um opositor de longa data das vacinas.

Em uma conferência anti‑vacina no mês passado, Kennedy elogiou os pesquisadores dinamarqueses por trás do ensaio e destacou pesquisas apoiadas pelos EUA sobre hepatite B em recém‑nascidos como exemplo da agenda da administração Trump para vacinas, que incluiu cortes nas recomendações de vacinação e a geração de dúvidas sobre a segurança e eficácia das injeções.

Kennedy “quer fazer com que não usemos uma dose de nascimento aqui neste país”, disse Paul Offit, médico de doenças infecciosas do Children’s Hospital of Philadelphia.

Kennedy would never be able to do the trial in the US because of its significant ethical concerns, Offit added. “He’s taking advantage of a developing country.

Is it because children in Africa are more expendable than children here?”.

Danish researchers plan to enroll 14,000 infants in Guinea-Bissau in the trial, giving the hepatitis B vaccine to half of the babies at birth and withholding it from the others for the first six weeks of life.

Um comitê de ética da instituição de origem dos pesquisadores, a University of Southern Denmark, votou esta semana para prosseguir com o ensaio, e autoridades em Guiné-Bissau também aprovaram o projeto, que o ministro da saúde, Quinhin Nantote, inicialmente afirmou ter sido suspenso após o tumulto internacional no início deste ano.

Stig Børsen Hansen, a founding member who was one of two reviewers who presented the study to the Danish committee, resigned from the group in protest on Friday, citing major ethical issues with the study.

Three other members of the committee have also resigned in protest.

The CDC, the Danish researchers, Pershing Square and Nantote have not responded to the Guardian’s questions about this trial.

The news that the trial was approved by the Denmark ethics committee was first reported on Thursday by CIDRAP News. This is the first time details of the updated protocol have been disclosed.

O protocolo do estudo da Guiné-Bissau mudou desde que foi publicado em January, de acordo com detalhes compartilhados com o Guardian. Os pesquisadores agora testarão as mães para hepatite B antes de elas parturirem.

The babies of mothers who test positive will be given the vaccine and will not be included in the trial. But the babies of mothers whose tests are negative may be enrolled.

The new protocol has not been shared publicly.

Em pesquisas anteriores, metade das crianças que contraiam hepatite B fizeram isso após o nascimento, por exposições comunitárias. “Este vírus pode ser transmitido casualmente,” disse Offit.

It can live on surfaces for up to seven days, and it can be acquired by sharing washcloths, toothbrushes and fingernail clippers. In addition, the hepatitis B test has a 5% false negative rate, which could provide false assurance that a birthing parent does not have the virus.

Decades of research make it clear that the vaccine would be beneficial, which means it would be unfair to place some children in the vaccinated group and some children in the unvaccinated group, said Henrik Støvring, a professor of statistics and pharmacometrics at Aarhus University in Denmark.

According to the Helsinki declaration, international medical research must be approved by ethics committees in both the host and sponsor countries.

The Danish research ethics committee at the University of Southern Denmark had never considered medical studies before, but it changed the rules in order to vote on this one.

Enquanto membros do comitê com expertise argumentaram contra a aprovação, a maioria decidiu avançar.

Yet “I don’t see why you couldn’t do it in Denmark,” Støvring said of the trial. In fact, several conditions make it a better location. The hepatitis B vaccine is not usually given to newborns in Denmark unless the mother is positive for the virus, for which all pregnant people are tested in Denmark.

Guinea-Bissau has some of the highest rates of hepatitis B in the world, with about 18% of adults carrying the virus. While it may be transmitted from mother to child during birth, it could also be transmitted from another parent, relatives, siblings or caregivers.

Crianças que são infectadas com hepatite B no primeiro ano de vida têm significativamente mais chances de desenvolver desfechos graves, incluindo infecção crônica e câncer de fígado.

The Bandim Health Project, run by Danish researchers Peter Aaby and Christine Stabell Benn, has operated in Guinea-Bissau for decades and is closely enmeshed in the country’s health system.

Pelo menos um alto funcionário, o atual diretor de saúde pública, teve uma dupla designação com Bandim ainda em dezembro.

Kennedy praised the Danish researchers at a recent anti-vaccine conference, calling them “the deities of vaccine research”. Kennedy claimed that a prior study they conducted indicated that after vaccination, “you can have mass injuries, and catastrophic injuries, and they’re hiding in plain sight.” He did not mention that another follow-up study from the same researchers found no effects at all.

Este estudo se concentrará na vacinação e mortalidade, bem como em resultados como condições de pele e condições neurodesenvolvimentais. “O principal problema deste ensaio é que você tem algumas doenças muito conhecidas e ruins que você pode proteger com esta vacina,” disse Støvring.

Quando questionado sobre o estudo em um briefing de quinta-feira, um funcionário da Africa CDC, que se opôs ao ensaio, disse que havia “discussões em andamento” entre os EUA e Guiné-Bissau e que mais detalhes seriam compartilhados em breve.

Guinea-Bissau planned to begin vaccinating all newborns against hepatitis B in 2027, but they pushed the campaign back to 2028.

Kennedy e os pesquisadores dinamarqueses estavam “se aproveitando desse atraso na prática do cuidado padrão para colocar essas crianças em risco desnecessariamente”, disse Offit.

What a horribly unethical and cruel thing to do.”.