Controversial vaccine trial touted by RFK Jr gets green light in Guinea-Bissau | Vaccines and immunization

A controversial research trial that would refuse to vaccinate some African newborns against hepatitis B received approval to move forward this week.

It is a central part of the vaccine vision of Robert F. Kennedy Jr., secretary of the U.S. Department of Health and Human Services (HHS) and a longtime vaccine opponent.

At an anti-vaccine conference last month, Kennedy praised the Danish researchers behind the trial and touted U.S.-backed research into hepatitis B in newborns as an example of the Trump administration’s vaccine agenda, which has included scaling back vaccine recommendations and casting doubt on the safety and effectiveness of the shots.

Kennedy “wants to make sure that we don’t use a birth dose here in this country,” said Paul Offit, an infectious disease doctor at Children’s Hospital of Philadelphia. “That’s the point.”

Kennedy would never be able to conduct the trial in the United States due to significant ethical concerns, Offit added. “He is taking advantage of a developing country… Is it because children in Africa are more valuable 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 rest for the first six weeks of life.

An ethics committee at the researchers’ home institution of the University of Southern Denmark voted this week to continue the trial, and officials in Guinea-Bissau also gave the green light to the project, which Health Minister Quinhin Nantote initially said was on hold after international outcry earlier this year.

Stig Børsen Hansen, a founding member and one of the 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’re now entering newborns into a lottery to test a hypothesis,” Hansen said. Children randomly selected not to receive the vaccine dose at birth, those who “lost the lottery”, run the risk of contracting hepatitis B from an early age, which can cause irreversible lifelong damage. “They contract hepatitis B as part of their participation in a research project,” Hansen said, which actually caused their infection “on purpose.”

Three other committee members also resigned in protest.

The US Centers for Disease Control and Prevention (CDC) has reportedly set aside $1.6 million in this year’s budget for the project, and that money will be supplemented by private funding from the Pershing Square Foundation, co-founded by billionaire activist Bill Ackman, and the Bluebell Foundation.

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

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

The protocol for the Guinea-Bissau study has changed since it was published in January, according to details shared with the Guardian. Researchers will now test mothers for hepatitis B before delivery. Babies whose mothers test positive will receive the vaccine and will not be included in the trial. But babies of mothers who test negative can be enrolled. The new protocol has not been shared publicly.

In previous research, half of children who contracted hepatitis B did so after birth, following community exposures. “This virus can be transmitted incidentally,” Offit said. It can live on surfaces for up to seven days and can be acquired by sharing washcloths, toothbrushes and nail clippers. Additionally, the hepatitis B test has a 5% false negative rate, which could provide false assurance that a biological parent does not carry the virus.

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

According to the Declaration of Helsinki, international medical research must be approved by the ethics committees of the host and sponsoring 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. While committee members with expertise opposed its approval, the majority decided to move forward.

“It’s very unusual to bring this issue to a committee like this,” Støvring said. Denmark’s national ethics committee oversees medical research, but this study did not fall under its jurisdiction because it would not take place in Denmark.

Still, “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 generally not given to newborns in Denmark unless the mother tests positive for the virus, for which all pregnant people are tested in Denmark.

Guinea-Bissau has one of the highest rates of hepatitis B in the world, with around 18% of adults carrying the virus. Although it can be passed from mother to child during birth, it can also be passed on from another parent, family members, siblings, or caregivers. Children infected with hepatitis B in the first year of life are much more likely to develop serious outcomes, including chronic infection and liver cancer.

The Bandim Health project, led by Danish researchers Peter Aaby and Christine Stabell Benn, has been operating in Guinea-Bissau for decades and is closely linked to the country’s health system. At least one senior official, the current public health director, held dual positions with Bandim as recently as December.

Kennedy praised Danish researchers at a recent anti-vaccine conference, calling them “deities of vaccine research.” Kennedy claimed that a previous study they conducted indicated that after vaccination, “you can have massive injuries and catastrophic injuries, and they’re hiding in plain sight.” He didn’t mention that another follow-up study by the same researchers found no effect.

This study will focus on vaccination and mortality, as well as outcomes such as skin conditions and neurodevelopmental conditions. “The main problem with this trial is that you have very well-known bad diseases that you can protect with this vaccine,” Støvring said. “And what they want to study next is something highly speculative – in a situation where the WHO and others are saying give this vaccine at birth, period. »

Asked about the study at a press briefing Thursday, an Africa CDC official, who opposed the lawsuit, said “discussions were ongoing” between the United States and Guinea-Bissau and that further details would be shared shortly. Guinea-Bissau planned to start vaccinating all newborns against hepatitis B in 2027, but pushed back the campaign to 2028.

Kennedy and the Danish researchers were “taking advantage of this delay in implementing standard care to unnecessarily put these children at risk,” Offit said. “What a terrible thing to do. What a horribly unethical and cruel thing to do.”