Controversial Hepatitis B Vaccine Trial Approved in Africa

A research trial that will withhold hepatitis B vaccines from certain newborns in Africa has received approval to proceed this week, stirring some controversy.

This trial is pivotal to the vaccine agenda supported by Robert F Kennedy Jr, the secretary of the US Department of Health and Human Services (HHS), who has long opposed vaccines.

At a recent anti-vaccine conference, Kennedy commended the Danish researchers involved in the trial, promoting US-funded research on hepatitis B vaccination for newborns. He suggested this reflects the Trump administration’s goals regarding vaccines, which have involved reducing vaccine recommendations and questioning vaccine safety and efficacy.

According to Paul Offit, a physician at the Children’s Hospital of Philadelphia, “Kennedy’s aim is to eliminate the use of a birth dose in the U.S.” He added that such a trial could never take place in the US due to ethical issues, raising the question: “Is it because children in Africa are seen as less valuable than those in the U.S.?”

The researchers from Denmark plan to involve 14,000 infants in Guinea-Bissau, where half will receive the hepatitis B vaccine at birth and the other half will not be vaccinated for the first six weeks of life.

This week, an ethics committee at the researchers’ University of Southern Denmark approved the trial, with backing from Guinea-Bissau officials, despite earlier claims that it was suspended amid international backlash.

Stig Børsen Hansen, one of the founding members who reviewed the study, resigned in protest, highlighting significant ethical issues. He expressed concern that enrolling newborns to test a hypothesis feels like a lottery, with some children at risk of contracting hepatitis B due to being intentionally unvaccinated. “They contract hepatitis B as part of a research project,” Hansen pointed out.

Three more committee members have also stepped down in objection.

Reports indicate that the US Centers for Disease Control and Prevention (CDC) has allocated $1.6 million for the study this year, supplemented by private funding from the Pershing Square Foundation and the Bluebell Foundation.

Yet, the CDC, the researchers, and Guinea-Bissau officials have not responded to inquiries about the trial.

The Danish ethics committee’s decision to support the trial was first made known by CIDRAP News. They revealed that the study protocol had evolved since it was posted in January, including mandatory hepatitis B testing for mothers before childbirth. Babies born to mothers who test positive will receive the vaccine and won’t be part of the trial, whereas those born to negative-testing mothers might be enrolled. This updated protocol has not been publicly available.

Offit noted the virus can be transmitted casually and mentioned that previous research showed half of children who got hepatitis B did so through community contact after birth. Additionally, the hepatitis B test has a 5% false negative rate, which could mislead healthcare providers into thinking a parent is virus-free.

Henrik Støvring, a statistics professor at Aarhus University, emphasized that decades of research indicate a vaccine’s benefits. He argued that it isn’t ethical to allow some children to be vaccinated while withholding the vaccine from others. According to the Helsinki declaration, international medical research needs ethical approval from committees in both the host country and the sponsor country.

Interestingly, the Danish committee had altered its regulations to approve this trial. While some experts raised concerns against it, the majority favored proceeding with it.

Støvring remarked that it is unusual for a committee to handle studies like this one since it falls outside their usual purview, especially as it will take place in another country. He lamented, “I don’t see why you couldn’t conduct it in Denmark,” noting that it would actually be a preferable location for such research.

In Guinea-Bissau, hepatitis B rates are alarmingly high, affecting about 18% of adults. The virus can spread from various sources, not just from mother to child during birth, making young children particularly vulnerable to severe outcomes if infected.

The Bandim Health Project, which has collaborated with local health systems for years, is run by Danish researchers who have longstanding connections in Guinea-Bissau.

During the anti-vaccine conference, Kennedy lauded the Danish researchers as “the deities of vaccine research,” while making a claim about the risks of mass injuries from vaccination without addressing findings from a follow-up study that indicated no adverse effects.

This trial will explore vaccination impacts on mortality, skin conditions, and neurodevelopment. However, Støvring criticized that this inquiry feels unnecessary given that well-proven diseases can be mitigated with the vaccine. It raises questions, especially as international health organizations advocate for administering this vaccine immediately at birth.

An Africa CDC official, who previously voiced opposition to the trial, mentioned ongoing discussions between the US and Guinea-Bissau, promising more updates soon. The plan to vaccinate all newborns against hepatitis B in Guinea-Bissau has been postponed to 2028.

Offit expressed concern that the researchers are exploiting this delay to expose children to unnecessary risks, calling the situation “horribly unethical and cruel.”