The University of Southern Denmark has approved a $1.6 million study in Guinea-Bissau that will withhold birth-dose hepatitis B vaccines from half of the 14,000 enrolled newborns. Despite international outcry and a temporary suspension earlier this year, the research project is proceeding pending final authorization from the government of Guinea-Bissau.
University Committee Grants Ethical Approval for Trial
He stated that the approval was granted following an independent ethical assessment conducted by the university’s research ethics committee. According to Grauslund, the protocol also received ethical approval from the relevant committee in Guinea-Bissau during the summer.
The clinical trial, which is funded by the US Centers for Disease Control and Prevention (CDC), aims to enroll 14,000 newborns. Researchers associated with the Bandim Health Project have defended the trial, noting that Guinea-Bissau is a developing country with fewer resources than the United States and Europe.
“No child enrolled in the study will receive fewer vaccines than under current national policy in Guinea-Bissau.”
Bandim Health Project statement
Global Health Advocates Criticize Newborn Study Design
The study’s design has drawn sharp criticism from global health advocates who compare the randomization process to a lottery.
“You are now enrolling newborns in a lottery to test a hypothesis.”
Stig Børsen Hansen
The experiment has faced comparisons to the Tuskegee syphilis experiment, a historical study starting in the 1930s where hundreds of Black men were denied treatment for medical experimentation. Paul Offit, an infectious disease physician at the Children’s Hospital of Philadelphia, also criticized the trial, suggesting that the goal of the effort is to avoid using a birth dose of the vaccine in the United States. Offit stated that such an experiment would likely not be permitted in the US due to significant ethical concerns, questioning whether children in Africa are being treated as more expendable.
The project is backed by Health Secretary Robert F. Kennedy Jr., whose agency has faced internal accusations regarding eugenics. Demetre Daskalakis, a former CDC official, noted in a resignation letter that rhetoric regarding eugenics has played a prominent role at the agency. The trial has also been criticized for the Trump administration's broader strategy toward Africa, which has been accused of seeking to exploit the continent's resources, including health data.
Advocacy Groups Vow Continued Opposition to Research
While the university has cleared the protocol, the study remains in a state of partial limbo.
Advocacy groups, including the nonprofit Stand Up for Science, have signaled their intent to continue opposing the trial. Colette Delawalla, the group’s founder and CEO, described the project as a gross violation of human rights and the use of bad science against some of the most vulnerable people in the world.
She stated that the organization is exploring all available actions to halt the research. The Danish researchers leading the study, Peter Aaby, PhD, and Christine Stabell Benn, MD, PhD, could not be reached for comment, and the Department of Health and Human Services did not respond to questions before press time.
Readers should be aware that questions regarding the safety of the hepatitis B vaccine for newborns have been addressed by scientists. Anyone with concerns regarding clinical trials or vaccine schedules should consult with a qualified medical professional.
