US — Ars Technica
US-backed vaccine trial on babies canceled after international outcry
Policy1 min read
Officials in Guinea-Bissau have rejected a planned study on newborn babies. The study was to be run by Danish researchers and funded by the US, and it would have tested the hepatitis B vaccine.
What happened
The government of Guinea-Bissau formally said no to a clinical trial. A clinical trial is a test where people are given a treatment to see if it is safe or works. The trial would have checked for possible side effects of the newborn dose of the hepatitis B vaccine. Days later, police raided the offices of Bandim Health Project, the group behind the study, and took vaccines. The lead researcher said the rejection came before the police search.
Key facts
- The government reaffirmed its rejection on 16 October.
- The trial would have withheld the newborn hepatitis B dose from half of the participants.
- The hepatitis B vaccine is recommended for all newborns around the world.
Why people are worried
Hepatitis B is a liver virus. It can cause a lifelong infection. Over time, it can lead to liver scarring, cancer, and early death. Guinea-Bissau has many chronic hepatitis B infections. The vaccine has been used safely for decades, and experts say there is no strong scientific reason to test it this way.
Why it matters
The World Health Organization (WHO) and many experts called the study unethical. They said it would put thousands of babies at risk of a serious infection just to test a safety idea with little proof. The story shows how hard it is to balance research goals with the health of children, and how much power national governments have to approve or stop studies in their countries.
What to watch
- Whether the police search leads to more legal action.
- Whether the researchers or the US funder change the plan or try again elsewhere.
- How health groups respond to the rules for testing vaccines on babies.
Glossary
- Bandim Health Project
- A health research group that works in Guinea-Bissau and was behind the planned trial.
- hepatitis B vaccine
- A shot that protects people from hepatitis B, a virus that harms the liver.
- clinical trial
- A careful test of a medicine or vaccine in people, to see if it is safe and works.
- World Health Organization
- The United Nations agency that works on global health and sets health guidance for countries.