The University of Southern Denmark has given the green light to the controversial $1.6m CDC-funded study in Guinea-Bissau that plans to offer life-saving hepatitis B vaccines to only half of enrolled babies.
An international storm erupted when news of the project was first reported in December by CIDRAP News, with health groups and political leaders condemning its design as unethical.
Those concerns led Guinea-Bissau officials and administrators at the Danish university to place the study on hold for several months.
Nearly one in five people in Guinea-Bissau is infected with hepatitis B, which kills 15% to 25% of people with chronic infections by causing cancer or liver failure. Vaccinating babies at birth is safe and can prevent lifelong infections.
Last week, citing unnamed sources, Rolling Stone reported that the Danish university had approved the clinical trial and that CDC leaders were pushing for the study to resume.
The Department of Health and Human Services, which oversees the CDC, did not respond to questions before press time.
The Danish researchers leading the study in Guinea-Bissau, Peter Aaby, PhD, and Christine Stabell Benn, MD, PhD, could not be reached for comment. In response to earlier criticism, their research group, the Bandim Health Project, defended their choice to withhold the birth dose of hepatitis B vaccine from half of the 14 000 newborns to be enrolled in the clinical trial.
In a statement on Bandim’s website, researchers wrote: “No child enrolled in the study will receive fewer vaccines than under current national policy in Guinea-Bissau,” a developing country with far fewer resources than the United States and Europe.
Guinea-Bissau does not currently vaccinate newborns against hepatitis B, as recommended by the World Health Organisation, but plans to begin in 2028.
Revised study protocol
An official at the University of Southern Denmark confirmed to CIDRAP News that he had granted approval to proceed with the study, despite widespread ethical concerns.
Professor Jakob Grauslund, PhD, MD, dean of the university’s faculty of health sciences, said his approval was study based on “an independent ethical assessment” carried out by the school’s research ethics committee.
“The revised protocol also received ethical approval from the relevant ethics committee in Guinea-Bissau,” Grausland said. “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.”
An official from the Africa Centres for Disease Control and Prevention (Africa CDC) had little to say when asked about the study at a press conference last week.
“There were ongoing discussions between the US Government, which is supporting this research, and also the Government of Guinea-Bissau,” said Wessam Mankoula, MD, a medical epidemiologist and acting director of Africa CDC’s Centre of Public Health Emergency. “We can give you later updates about the most recent development and the implementation of the study.”
Stand Up for Science, a non-profit advocacy group, vowed to stop the Danish study. “This is a gross violation of human rights and the use of bad science against some of the most vulnerable people in the world,” said Colette Delawalla, PhD, the group’s founder and CEO.
“We are exploring all possible actions at our disposal to prevent this study from happening.”
See more from MedicalBrief archives:
Controversial study will delay life-saving vaccine for Guinea-Bissau babies
US plan to test vaccine in West African babies halted
US to end recommendations for newborns’ hepatitis B jabs