A controversial research trial that will withhold hepatitis B vaccines from some African newborns was given approval to move forward this week.
asserted
that → withhold → approval
At an anti-vaccine conference last month, Kennedy praised the Danish researchers behind the trial and touted US-supported research on hepatitis B in newborns as exemplifying the Trump administration’s agenda for vaccines, which has included slashing vaccine recommendations and casting doubt on the safety and effectiveness of shots.
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which → praise → shots
Kennedy “wants to make it so we don’t use a birth dose here in this country,” said Paul Offit, an infectious disease physician at Children’s Hospital of Philadelphia.
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Offit → want → Philadelphia
“That’s the goal.”
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That → ’ → ?
Kennedy would never be able to do the trial in the US because of its significant ethical concerns, Offit added.
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Offit → do → concerns
“He’s taking advantage of a developing country …
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He → take → country
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.
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researchers → plan → life
An ethics committee at the researchers’ home institution of the University of Southern Denmark voted this week to proceed with the trial, and officials in Guinea-Bissau have also greenlit the project, which the health minister, Quinhin Nantote, initially said was suspended after international uproar earlier this year.
asserted
minister → vote → uproar
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.
“You are now enrolling newborns in a lottery to test a hypothesis,” Hansen said.
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Hansen → present → hypothesis
The children who are randomly selected not to receive the birth dose of the vaccine, those who “lost the lottery”, face in their earliest days the risk of contracting hepatitis B, which can cause irreversible lifelong damage.
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which → select → damage
“They contract hepatitis B in the context of being part of a research project,” Hansen said, which made their infection happen, in effect, “by design”.
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infection → contract → design
Three other members of the committee have also resigned in protest.
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members → resign → protest
The US Centers for Disease Control and Prevention (CDC) has reportedly set aside $1.6m in this year’s budget for the project, and it will be matched with private funding from the Pershing Square Foundation, which was co-founded by the billionaire activist Bill Ackman, and the Bluebell Foundation.
uncertain
which → set → activist
The CDC, the Danish researchers, Pershing Square and Nantote have not responded to the Guardian’s questions about this trial.
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CDC → respond → trial
The news that the trial was approved by the Denmark ethics committee was first reported on Thursday by CIDRAP News.
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trial → approve → News
This is the first time details of the updated protocol have been disclosed.
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details → update → protocol
The Guinea-Bissau study protocol has changed since it was posted in January, according to details shared with the Guardian.
uncertain
it → change → Guardian
The researchers will now test mothers for hepatitis B before they give birth.
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they → test → birth
The babies of mothers who test positive will be given the vaccine and will not be included in the trial.
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who → test → trial
But the babies of mothers whose tests are negative may be enrolled.
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tests → enrol → mothers
The new protocol has not been shared publicly.
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protocol → share → ?
In previous research, half of children who contracted hepatitis B did so after birth, through community exposures.
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who → contract → exposures
“This virus can be transmitted casually,” Offit said.
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Offit → transmit → ?
It can live on surfaces for up to seven days, and it can be acquired by sharing washcloths, toothbrushes and fingernail clippers.
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it → live → washcloths
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.
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parent → have → 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.
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Støvring → make → Denmark
According to the Helsinki declaration, international medical research must be approved by ethics committees in both the host and sponsor countries.
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research → accord → 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.
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it → consider → one
While committee members with expertise argued against approving it, the majority ruled to move forward.
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majority → argue → it
“It’s very unusual to bring this into a committee like that,” Støvring said.
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Støvring → ’ → that
The national ethics committee in Denmark oversees medical research, but this study was outside of their purview because it won’t take place in Denmark.
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it → oversee → Denmark
Yet “I don’t see why you couldn’t do it in Denmark,” Støvring said of the trial.
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Støvring → see → trial
In fact, several conditions make it a better location.
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it → make → fact
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.
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people → give → Denmark
Guinea-Bissau has some of the highest rates of hepatitis B in the world, with about 18% of adults carrying the virus.
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% → have → virus
While it may be transmitted from mother to child during birth, it could also be transmitted from another parent, relatives, siblings or caregivers.
uncertain
it → transmit → parent
Children who are infected with hepatitis B in the first year of life are significantly more likely to develop severe outcomes, including chronic infection and liver cancer.
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who → infect → infection
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.
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Project → run → system
At least one top official, the current director of public health, held a dual appointment with Bandim as recently as December.
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official → hold → December
Kennedy praised the Danish researchers at a recent anti-vaccine conference, calling them “the deities of vaccine research”.
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Kennedy → praise → research
…and 8 more, not listed.
The Aporia
