A controversial trial that will withhold the recommended dose of hepatitis B vaccine from thousands of newborns in Guinea-Bissau has been approved to move forward, in a study linked to US Health Secretary Robert F Kennedy Jr.
Key facts
- The trial will withhold hepatitis B vaccines from some African newborns.
- It was given approval to move forward this week.
- The study is being run by Danish researchers.
- It is described as a central part of the vaccine vision for US Health Secretary Robert F Kennedy Jr.
A controversial research trial that will withhold hepatitis B vaccines from some newborns in Guinea-Bissau has been given approval to move forward this week, according to the Guardian.
The trial involves withholding the recommended dose of hepatitis B vaccine from thousands of newborns, with the research being carried out by Danish researchers.
The Guardian reports that the study is a central part of the vaccine vision for Robert F Kennedy Jr, the secretary of the US Department of Health and Human Services (HHS), who has long been an opponent of vaccines.
The approval allows the trial to proceed in Guinea-Bissau, a country in West Africa. The Guardian characterises the research as controversial given that it involves withholding a vaccine that is normally recommended for newborns.
Hepatitis B vaccination at birth is a standard component of immunisation programmes in many countries, which is why a trial withholding the recommended dose has drawn scrutiny.
Why it matters
The trial raises ethical questions about withholding a routinely recommended vaccine from newborns in a lower-income country. Because it is tied to the vaccine agenda of a senior US health official who has opposed vaccines, the decision is likely to intensify debate over research ethics and vaccine policy.
Frequently asked questions
What does the vaccine trial involve?
According to the Guardian, the trial will withhold the recommended dose of hepatitis B vaccine from thousands of newborns in Guinea-Bissau, with the research conducted by Danish researchers.
Who is connected to the trial?
The Guardian reports the study is a central part of the vaccine vision for Robert F Kennedy Jr, the secretary of the US Department of Health and Human Services and a longtime vaccine opponent.
Where is the trial taking place?
The trial is set to take place in Guinea-Bissau, a country in West Africa, after being given approval to move forward this week.

