Controversial Vaccine Trial Backed by RFK Jr Approved in Guinea-Bissau

A controversial research trial that will withhold the hepatitis B vaccine from some African newborns was approved to proceed this week. It is a centerpiece of the vaccine vision of Robert F Kennedy Jr, the head of the US 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 promoted the US-backed research on hepatitis B in newborns as an example of the Trump administration's vaccine agenda, which includes cutting back vaccine recommendations and sowing doubt about vaccine safety and efficacy.

Kennedy "wants to get us to not use the birth dose in this country," said Paul Offit, an infectious disease physician at Children's Hospital of Philadelphia. "That's the goal."

Offit added that Kennedy could never conduct the trial in the US because of serious ethical concerns. "He's taking advantage of a developing country… Is it because children in Africa are more expendable than children here?"

The Danish researchers plan to enroll 14,000 newborns in Guinea-Bissau in the trial, giving half the vaccine at birth and withholding it from the others during their first six weeks of life.

An ethics committee at the researchers' home university, the University of Southern Denmark, voted this week to proceed with the trial, and Guinea-Bissau officials have also greenlit the project. Health Minister Quinhin Nantote initially said the project had been suspended after an international backlash earlier this year.

Stig Børsen Hansen, a founding member and one of two reviewers who presented the research to the Danish committee, resigned from the panel on Friday in protest, citing grave ethical problems with the study.

"Now you are putting newborns into a lottery to test a hypothesis," Hansen said. Babies randomly selected not to receive the birth dose, the "losers of the lottery", face the risk of hepatitis B infection in the first days of life, a disease that can cause irreversible, lifelong damage. "They get hepatitis B as part of a research project," Hansen said, which makes their infection effectively happen "by design".

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, to be matched by private funding from the Pershing Square Foundation, co-founded by activist billionaire Bill Ackman, and the Bluebell Foundation.

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

News of the trial's approval by the Danish ethics committee was first reported by CIDRAP News on Thursday. It is the first time details of the updated protocol have been made public.

According to information shared with the Guardian, the research protocol in Guinea-Bissau has changed since it was posted in January. Researchers will now test mothers for hepatitis B before birth. Babies of mothers who test positive will be vaccinated and excluded from the trial. But babies of mothers who test negative may be enrolled. The new protocol has not been published publicly.

In previous studies, half of babies who contracted hepatitis B were infected after birth, through community exposure. "This virus can be transmitted casually," Offit said. It can survive on surfaces for up to seven days and can spread through sharing washcloths, toothbrushes and nail clippers. In addition, hepatitis B tests have a 5% false-negative rate, which can create false reassurance that a birthing parent does not carry the virus.

Decades of research clearly show the vaccine would be beneficial, meaning it would not be fair to place some babies in the vaccinated group and some in the unvaccinated group, according to Henrik Støvring, a professor of statistics and pharmacometrics at Aarhus University in Denmark.

Under the Declaration of Helsinki, international medical research must be approved by ethics committees in both the host and sponsoring countries.

The Danish research ethics committee at the University of Southern Denmark had not previously reviewed medical studies, but changed its rules to vote on this research. While members with expertise argued against approval, the majority decided to proceed.

"It's very unusual to put something like this before such a committee," Støvring said. Denmark's national ethics committee oversees medical research, but this study falls outside its remit because it will not take place in Denmark.

However, "I don't see why it couldn't be done in Denmark," Støvring said of the trial. In fact, some conditions make it a better location. The hepatitis B vaccine is not routinely given to newborns in Denmark unless the mother tests positive for the virus, and all pregnant women in Denmark are tested.

Guinea-Bissau has the highest hepatitis B rate in the world, with about 18% of adults carrying the virus. Although it can be transmitted from mother to child during birth, the virus can also spread from other parents, relatives, siblings or caregivers. Babies infected with hepatitis B in their first year of life are at significantly higher risk of serious outcomes, including chronic infection and liver cancer.

The Bandim Health Project, run by Danish researchers Peter Aaby and Christine Stabell Benn, has operated in Guinea-Bissau for decades and is closely tied to the country's health system. At least one senior official, the current public health director, has held a concurrent position at Bandim as recently as December.

Kennedy praised the Danish researchers at a recent anti-vaccine conference, calling them "the gods of vaccine research". Kennedy claimed an earlier study of theirs showed that after vaccination, "you can have mass injury, and catastrophic injury, and they're hiding it right in front of you". He did not mention that a follow-up study by the same researchers found no such effects at all.

The research 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 some very well-known bad diseases that are vaccine-preventable," Støvring said. "And what they want to study afterwards is something very speculative – in a situation where the WHO and others are saying this vaccine should be given at birth, full stop."

Asked about the research at a press conference on Thursday, an official with the Africa CDC, which opposes the trial, said there were "ongoing discussions" between the US and Guinea-Bissau and that more details would be shared soon. Guinea-Bissau plans to begin vaccinating all newborns against hepatitis B in 2027, but has pushed the campaign back to 2028.

Kennedy and the Danish researchers are "taking advantage of that delay in standard-of-care practice to put these children at unnecessary risk", Offit said. "What a terrible thing. What a terribly unethical and cruel thing."