Controversial study approved

A controversial research study involving newborns in Guinea-Bissau was given approval to move forward this month. Conducted by Danish researchers and funded by the US Department of Health, the study will put to the test a new hepatitis B vaccine, according to a report by The Guardian. The study is a key component of the vision held by Robert F. Kennedy Jr., the head of the US Department of Health and a long-time vaccine sceptic. It is supported by 1.6 million USD in funding from the US Centers for Disease Control and Prevention (CDC). A representative from the University of Southern Denmark confirmed to “CIDRAP News“ that he had granted approval for the study in early October—despite widespread ethical concerns. Rolling Stone had previously reported that the US CDC was pushing for the study to be conducted. Professor Jakob Grauslund, Dean of the Faculty of Health Sciences, stated - according to “CIDRAP News" - that he approved the study based on an "independent ethical assessment" conducted by the university's research ethics committee. “The revised protocol also received ethical approval from the relevant ethics committee in Guinea-Bissau this summer,” Grausland told “CIDRAP News“. “Final governmental authorisation in Guinea-Bissau has, however, not yet been granted, and the study cannot begin until the necessary national authorisation has been obtained.” But according to “The Guardian“, authorities in Guinea-Bissau also already gave the green light for the project, which Health Minister Quinhin Nantote had initially suspended earlier this year following international criticism. According to reports, the Danish researchers plan to enrol 14 000 infants in Guinea-Bissau in the study. Half of the babies are to be vaccinated against hepatitis B immediately after birth, while the other half will receive the vaccine during their first six weeks of life. Risks for newborns are determined "by lottery". Stig Børsen Hansen, a founding member and one of the two reviewers who presented the study to the Danish committee, resigned from the group on Friday in protest, according to the British newspaper. He cited serious ethical concerns as his reason. "You are now enrolling newborns in a lottery to test a hypothesis," Hansen said, as quoted by “The Guardian“. Children who are randomly selected not to receive the initial vaccination are exposed to the risk of contracting hepatitis B during their first days of life - an infection that could lead to lifelong, irreversible damage. “They contracted hepatitis B in the context of being part of a research project,” Hansen said, which made their infection happen, in effect, “by design”. Three other committee members also resigned. The Danish researchers leading the study in Guinea-Bissau, Dr Peter Aaby and Dr Christine Stabell Benn, could not be reached for comment, according to several media outlets. In response to earlier criticism, her research group, the “Bandim Health Project", had defended the decision to withhold the hepatitis B vaccine from half of the 14,000 newborns immediately after birth. In a statement published on the Bandim website, the researchers wrote, "No child enrolled in the study will receive fewer vaccines than under current national policy in Guinea-Bissau.” Guinea-Bissau does not currently vaccinate newborns against hepatitis B, as recommended by the World Health Organization, but plans to begin doing so in 2028, according to "CIDRAP News". "Stand Up for Science", a non-profit advocacy group, has announced it wants to stop the Danish study. Almost one in five people in Guinea-Bissau is infected with hepatitis B. In cases of chronic infection, the disease leads to death - via cancer or liver failure - in 15% to 25% of those affected. Vaccinating infants immediately after birth is safe and can prevent lifelong infections.

Controversial study approved

Comments

Namibian Sun 2026-10-15

Please login to leave a comment

Controversial study approved

Comments

Namibian Sun 2026-10-15

Please login to leave a comment

Subscription Required to Access Content ×

Login

Subscription Required to Access Content