A planned hepatitis B vaccine trial in Guinea-Bissau has prompted ethical objections after it was decided that it would involve about 14,000 children, only half of whom would receive the vaccine at birth, while the other half would not receive it during the first six weeks of their lives. The project is being led by Danish researchers in a country with high rates of infection with the virus.
The trial’s links to Robert F Kennedy Jr’s policy agenda
The project aligns with the agenda of US Health Secretary Robert F Kennedy Jr, who is known for opposing vaccines and praised the researchers running the trial at an anti-vaccination conference held last month, according to the British newspaper The Guardian.
Paul Offit, an infectious diseases specialist at Children’s Hospital of Philadelphia, said Kennedy was seeking to stop the administration of the vaccine dose at birth in the United States, but would test his plan in Guinea-Bissau. Offit said the trial exploited the circumstances of a developing country, stressing that the ethical concerns surrounding it prevented it from being conducted in the United States.
Danish resignations in protest at denying infants the vaccine
In Denmark, four members of the research ethics committee at the University of Southern Denmark resigned in protest at the project. Stig Børsen Hansen was among those who resigned, describing the inclusion of newborns in a study in which some would be denied the vaccine as akin to subjecting children to a lottery that could expose those who lost to the risk of infection with the virus.
The objections relate to the possibility that hepatitis B could cause permanent health damage, including chronic infection and liver cancer, particularly among children infected with the virus during their first year of life. Transmission is not limited to an infected mother passing the virus to her child during childbirth; the virus can also spread in other ways and can survive on surfaces for up to seven days.
Under the trial protocol, all participating mothers will be tested for the virus before giving birth. Babies of mothers who test positive will receive the vaccine and will not be included in the trials, while babies of mothers whose test results are negative may be selected to participate.
Henrik Støvring, a professor of statistics and pharmacoepidemiology at Denmark’s Aarhus University, said decades of research had demonstrated the benefits of the vaccine. He added that dividing children into a vaccinated group and an unvaccinated group raised ethical concerns, particularly because the risks of the disease were already known.
The US Centres for Disease Control and Prevention has allocated $1.6 million from its budget for this year to support the project, according to reports, with the remaining funding to come from private sources. The trial is being conducted in Guinea-Bissau, which is among the countries with the highest rates of hepatitis B worldwide; estimates indicate that about 18 per cent of adults there carry the virus.
