--- title: "Vaccine Trial Involving Newborns Given Green Light to Proceed" url: https://noti.group/vaccine-trial-involving-newborns-given-green-light-to-proceed/ language: en publisher: "Noti Group" section: "World News" published: 2026-10-09T21:36:18.000Z updated: 2026-10-10T01:26:26.256Z id: 4ad4a167-666d-43bb-bea2-84d803ff7504 source: "The Guardian World https://www.theguardian.com/society/2026/oct/09/vaccine-trial-guinea-bissau-rfk-jr" attribution: "Link to https://noti.group/vaccine-trial-involving-newborns-given-green-light-to-proceed/ and name Noti Group when you quote or summarize this story." --- # Vaccine Trial Involving Newborns Given Green Light to Proceed A research study involving withholding hepatitis B vaccines from thousands of newborns in Guinea-Bissau has been approved to proceed. A highly contentious research study that involves withholding hepatitis B vaccines from thousands of newborns in Guinea-Bissau has been given the green light to proceed this week. The trial is a key component of a broader vaccine strategy championed by Robert F Kennedy Jr, who has long been an outspoken critic of vaccination policies. Kennedy's views on vaccines have been shaped by his role as secretary of the US Department of Health and Human Services (HHS) under the Trump administration. This administration has been notable for its efforts to reduce vaccine recommendations and cast doubt on their safety and effectiveness. Kennedy has publicly praised researchers involved in a similar trial, which was presented at an anti-vaccine conference last month. According to Paul Offit, an infectious disease physician at Children's Hospital of Philadelphia, Kennedy's ultimate goal is to eliminate the birth dose of hepatitis B vaccine in the US. He wants to make it so we don't use a birth dose here in this country, Offit said. This would require taking advantage of countries with more lenient regulations and ethics standards. The trial itself will involve enrolling 14,000 infants in Guinea-Bissau, with half receiving the hepatitis B vaccine at birth and the other half going without it for the first six weeks of life. Critics have raised concerns about the ethics of conducting such a trial in a developing country, where children may be more vulnerable to the risks associated with delayed vaccination. The Danish researchers behind the study are set to begin enrolling participants in Guinea-Bissau, despite ongoing controversy surrounding their research. The implications of this trial and its potential impact on global vaccine policies remain unclear, but it is likely to continue sparking intense debate in the coming weeks. The ethics committee at the University of Southern Denmark has given its approval for a controversial vaccine trial to proceed, following a similar decision from officials in Guinea-Bissau. This development comes after international outcry earlier this year led health minister Quinhin Nantote to initially suspend the project. Stig Børsen Hansen, a founding member and reviewer of the study, has resigned from the group in protest over major ethical concerns. He cited the trial's design, which involves enrolling newborns in a lottery to test a hypothesis, effectively putting them at risk of contracting hepatitis B. This could cause irreversible lifelong damage. Hansen expressed his objections, stating that children who "lost the lottery would be exposed to the risk of hepatitis B as part of a research project. He argued that their infection would occur by design, highlighting the potential ethical implications of the trial's setup. Three other members of the committee have also resigned in protest against the trial. The controversy surrounding this vaccine trial is likely to continue, with various stakeholders weighing in on its merits and drawbacks. The US Centers for Disease Control and Prevention has allocated $1.6m from its budget for the project, which will be matched by private funding from organizations including the Pershing Square Foundation and the Bluebell Foundation. The trial's updated protocol has been disclosed, revealing significant changes to the study design. In response to concerns raised about the potential for hepatitis B transmission through casual contact, researchers will now test mothers for the virus before administering the vaccine to their newborns. This new approach ensures that babies born to mothers who test positive for hepatitis B are not included in the trial, but those born to mothers with negative results may still be enrolled. The updated protocol has not been made publicly available, leaving many questions unanswered about the trial's methodology and ethics. Experts have long emphasized the risks associated with hepatitis B transmission, which can occur through community exposures or even everyday activities such as sharing personal care items. The controversial vaccine trial has received approval from a Danish research ethics committee, despite concerns raised by some members about its safety and efficacy. The University of Southern Denmark's committee had previously not considered medical studies, but made an exception to review this particular case. Committee members with expertise in the field argued against approving the trial, but the majority voted in favor of moving forward. Støvring, a member of the committee, expressed surprise at the decision, stating that it was unusual for such a case to be brought before them. The national ethics committee in Denmark typically oversees medical research, but this study fell outside their jurisdiction since it would take place abroad. The conditions in Guinea-Bissau make it an attractive location for the trial. The country has one of the highest rates of hepatitis B infection worldwide, with approximately 18% of adults carrying the virus. This high prevalence rate presents a unique opportunity to test the vaccine's effectiveness in a real-world setting. The Bandim Health Project, a research initiative led by Danish scientists Peter Aaby and Christine Stabell Benn, has been operating in Guinea-Bissau for several decades. This long-standing presence within the country's health system has raised concerns about potential conflicts of interest. Kennedy Jr., a vocal critic of vaccination policies, has expressed admiration for the work of the Bandim researchers, describing them as the deities of vaccine research." He cited one of their studies to support his claim that vaccines can cause mass injuries and catastrophic effects, which are allegedly being concealed. However, another study conducted by the same team found no adverse outcomes. The upcoming trial will focus on the impact of vaccination on mortality rates, as well as its potential effects on skin conditions and neurodevelopmental disorders. Critics argue that this research is misguided, given the established benefits of immunization against serious diseases such as hepatitis B. They point out that the World Health Organization recommends vaccinating newborns against hepatitis B at birth. The trial has sparked controversy, with some questioning the ethics of conducting such a study in Guinea-Bissau. The Africa CDC has expressed opposition to the trial, citing concerns about its methodology and potential impact on public health policies. An official from the organization stated that there are ongoing discussions between the US and Guinea-Bissau regarding the trial. The planned vaccination campaign against hepatitis B was initially set to begin in 2027 but has been pushed back to 2028. This delay is likely due to the controversy surrounding the Bandim Health Project's research initiative, which has raised concerns about the country's commitment to immunization programs. The Bandim Health Project's research initiative has been met with criticism from experts who argue that it poses unnecessary risks to children participating in the trial. The controversy surrounding this project suggests a lack of urgency in implementing standard care practices in Guinea-Bissau, allowing researchers to proceed with their vaccine trial without addressing underlying concerns. --- Source: [The Guardian World](https://www.theguardian.com/society/2026/oct/09/vaccine-trial-guinea-bissau-rfk-jr) Published by Noti Group: https://noti.group/vaccine-trial-involving-newborns-given-green-light-to-proceed/