Controversial vaccine trial touted by RFK Jr gets go-ahead in Guinea-Bissau

A research trial that will withhold the hepatitis B birth‑dose vaccine from half of 14,000 newborns in Guinea‑Bissau has received ethical clearance to proceed. The study, led by Danish investigators from the University of Southern Denmark, will randomly assign infants of hepatitis‑negative mothers to either receive the vaccine at birth or have the dose delayed for six weeks, exposing the latter group to a heightened risk of infection. The protocol was approved this week by the university’s ethics committee and by Guinea‑Bissau’s health ministry, despite earlier statements that the project had been suspended after international criticism. Funding comes from a $1.6 million allocation in the U.S. Centers for Disease Control and Prevention’s budget, matched by private contributions from the Pershing Square Foundation and the Bluebell Foundation. The trial is a centerpiece of Robert F. Kennedy Jr.’s anti‑vaccine agenda, which he has promoted at recent anti‑vaccine conferences as an example of the Trump administration’s “vaccine‑skeptical” policies, and he has expressed a desire to eliminate the birth‑dose recommendation in the United States.

The ethical controversy centers on the deliberate exposure of healthy infants to a preventable disease for research purposes, a practice many experts deem unacceptable. Critics, including infectious‑disease specialist Paul Offit, argue that the study exploits a developing nation, noting that the same trial could not be conducted in the United States because of its profound ethical violations. Several members of the Danish ethics panel, including founding reviewer Stig Børsen Hansen, resigned in protest, calling the randomisation a “lottery” that intentionally places children at risk of hepatitis B, which can cause lifelong liver damage. The protocol also raises scientific concerns: hepatitis B can be transmitted through casual contact, the virus survives on surfaces for up to a week, and the maternal screening test used has a 5 percent false‑negative rate, potentially misclassifying infected mothers as safe. Decades of research have shown the birth‑dose vaccine to be highly beneficial, making the deliberate withholding of it appear both medically unnecessary and ethically indefensible.

The approval has sparked broader debate about the conduct of international medical research and the responsibilities of funding bodies. According to the Helsinki Declaration, such studies must obtain ethical clearance from both the sponsor’s and host country’s committees, yet the Danish national ethics board, which normally oversees domestic research, had to amend its rules to consider this overseas trial. Danish professor Henrik Støvring highlighted the irregularity of involving a committee without prior experience in medical studies, and noted that the trial could have been conducted in Denmark, where universal maternal hepatitis B testing already determines vaccine administration. The lack of response from the CDC, the Danish researchers, and Guinea‑Bissau officials to inquiries underscores the opacity surrounding the project. If carried out, the trial could set a precedent for future research that places vulnerable populations at risk, while also potentially influencing vaccine policy discussions in the United States, where Kennedy hopes to curtail the birth‑dose recommendation.

⚡ Effects Interpreter

🌍 Effects for your country