Guinea-Bissau Approves Hepatitis B Vaccine Trial Review

A controversial hepatitis B vaccine study involving 14,000 newborns in Guinea-Bissau has received approval from an ethics committee at the University of Southern Denmark and authorization from Guinea-Bissau officials after earlier criticism over its design.

The trial will give the vaccine at birth to half of participating infants while delaying vaccination for the others until six weeks of age, according to reports from The Guardian and UA.News. The updated protocol excludes babies whose mothers test positive for hepatitis B.

The study is supported by US funding, with the Centers for Disease Control and Prevention reportedly allocating $1.6 million, according to Ars Technica. Private funding from the Pershing Square Foundation and the Bluebell Foundation is also expected to support the project.

Robert F. Kennedy Jr., US secretary of Health and Human Services, previously praised the Danish researchers behind the project and promoted the research as part of the administration's vaccine approach.

Paul Offit, an infectious disease physician at Children's Hospital of Philadelphia, criticized the proposal and raised concerns about conducting the study in a country with limited resources. Offit said, "He is taking advantage of a developing country … Is it because children in Africa are more expendable than children here?"

Offit also said the trial would not be possible in the United States because of ethical concerns. The researchers plan to compare infants receiving the birth dose with those whose vaccination is delayed.

Stig Borsen Hansen, a reviewer who resigned from the University of Southern Denmark committee, objected to the trial design. Hansen said, "You are now enrolling newborns in a lottery to test a hypothesis".

Hansen described infants who do not receive the birth dose as those who "lost the lottery" and face potential hepatitis B exposure during their earliest weeks of life.

Hansen said, "They contract hepatitis B in the context of being part of a research project," and added that infection occurs "by design".

Henrik Stovring, a professor of statistics and pharmacometrics at Aarhus University, argued that existing evidence shows the vaccine's benefits and questioned the need for the comparison. Stovring said, "It's very unusual to bring this into a committee like that".

Stovring also questioned why the trial could not be conducted elsewhere, saying, "I don't see why you couldn't do it in Denmark".

The World Health Organization criticized the trial's design in February, saying the research premise did not justify withholding proven care. The organization stated, "Resource constraints cannot be used to justify withholding proven care in a research study involving people. Ethical obligations require minimizing risk and ensuring a prospect of benefit for participants."

Guinea-Bissau has one of the world's highest hepatitis B burdens, with about 18% of adults carrying the virus, according to reports. Infection during the first year of life can increase the risk of chronic disease and liver cancer.

Guinea-Bissau Public Health Minister Quinhin Nantote previously announced a suspension while reviews continued. Nantote said, "There has been no sufficient coordination in order to take a final decision regarding the study".

Nantote later explained the suspension decision, saying, "Faced with this situation, we decided to suspend it".

University officials said the study cannot begin until national authorization is complete. Jakob Grauslund, dean of the University of Southern Denmark's faculty of health sciences, said, "The relevant ethics committee in Guinea-Bissau" and added, "The study cannot begin until the necessary national authorization has been obtained".

Advocacy group Stand Up for Science opposed the project after the revised approval. CEO Colette Delawalla said, "We stopped this unethical study the first time and we'll do it again".

Delawalla also said, "This is a gross violation of human rights and the use of bad science against some of the most vulnerable people in the world."