Outrage grows as CDC reportedly poised to fund "unethical" vaccine trial

Federal health officials have quietly set aside $1.6 million to support a controversial vaccine trial that would enroll 14,000 newborns in Guinea-Bissau, randomizing half to receive the standard birth dose of hepatitis B vaccine and half to receive no newborn dose. The study, led by Danish researchers Christine Stabell Benn and Peter Aaby and funded via an unsolicited grant to the University of Southern Denmark, was suspended earlier this year after international outcry about its design. Critics say U.S. funding would divert money from global health security efforts and that the investigators are already under Danish investigations for alleged research misconduct. The trial remains paused pending Guinea-Bissau authorization, though university and CDC budget actions indicate an intent to resume if cleared.

Ethicists, the World Health Organization, and other public‑health experts condemn the trial as fundamentally unethical because it withholds a proven, life‑saving intervention from infants in a country with high hepatitis B prevalence. Withholding the birth dose would expose newborns to a high risk of chronic, potentially fatal infections that can cause cirrhosis and liver cancer; WHO emphasizes that established standards of care cannot be ignored for research. A revised protocol would screen some mothers for infection, but opponents say that change does not address the core violation of the Declaration of Helsinki. Advocacy groups vow to block the study if it proceeds.