From Rolling Stone · Katherine Eban · · 2m
CDC Moves Forward With Controversial Hepatitis B Vaccine Trial
CDC allocates $1.6m for hepatitis B vaccine trial in Guinea-Bissau after protocol revisions.
In brief
CDC allocates $1.6m for hepatitis B vaccine trial in Guinea-Bissau after protocol revisions. CDC director's office funds controversial hepatitis B vaccine trial in Guinea-Bissau that may expose children to hepatitis B without vaccination, despite ethical concerns. Originally reported by Rolling Stone.
CDC director's office funds hepatitis B trial
Two months after Senate confirmed Dr. Erica Schwartz as CDC director, her office allocated $1.6 million for a hepatitis B vaccine trial in Guinea-Bissau that was previously suspended.
Protocol revisions amid ethics concerns
Researchers revised the study protocol in January after international uproar over medical ethics, with the trial seeking to examine potential negative health effects of the hepatitis B birth dose.
CDC director's independence questioned
Schwartz's appointment came amid questions about her independence from Health Secretary Robert F. Kennedy Jr., who has a history of anti-vaccine activities.
Funding pulled from global health security
The $1.6 million is being pulled from money directed by Congress for CDC global health security programs, two sources say.
Trial design raises ethical concerns
The trial would give a birth dose of hepatitis B vaccine to half of 14,000 newborns but not the other half, potentially exposing some to hepatitis B without vaccination.
Experts condemn trial design
Clinical trial experts say the design could result in newborns being infected but receiving no vaccine, risking cirrhosis or liver cancer.
Dr. Paul Offit criticizes trial
Dr. Paul Offit, a pediatrician, calls the trial 'wholly unethical' and warns thousands could develop liver cancer without vaccination.
“It's a wholly unethical trial, and it shouldn't be allowed”
Stabell Benn defends trial ethics
Stabell Benn claims the trial complies with Guinea-Bissau national policy and has been approved by local ethics committees.
“The trial complies with current national policy in guinea-bissau and has been reviewed and approved by the competent national ethics committee”
University approves trial
The University of Southern Denmark's research ethics committee approved the trial on October 7, 2026, but Guinea-Bissau authorities must still grant final approval.
Guinea-Bissau approval pending
The study cannot begin until Guinea-Bissau authorities provide final national authorization, according to the university.
The bottom line
CDC director's office funds controversial hepatitis B vaccine trial in Guinea-Bissau that may expose children to hepatitis B without vaccination, despite ethical concerns.
