Is it ethical to do placebo testing in Guinea-Bissau?

A new Rolling Stone article has ethicists and scientists concerned because it says that CDC will conduct a vaccine study in Guinea-Bissau where 7,000 newborn babies will receive a Hepatitis B vaccine at birth and 7,000 will not.

• Guinea-Bissau’s government says it has not approved the study.
• Hepatitis B at birth can lead to lifelong infection and liver cancer.
• Vaccination at birth helps prevent infection, raising ethical concerns about delaying it.

Hepatitis B is a virus that can cause lasting liver damage. A mother with the infection can pass it to her baby during birth. Vaccination at birth helps prevent this.

Hepatitis B is common in Guinea-Bissau. One study in Bissau, the country’s capital, found signs of a current infection in about 19% of adults—nearly 1 in 5. This finding came from adults in the study, so it does not tell us the exact rate across the whole country.

Some mothers have a very high chance of passing the virus to their babies. Without steps to prevent infection, that risk can be 70% to 90% when the mother has a blood marker showing that the virus can spread easily. This high risk does not apply to every mother with hepatitis B.

Infection at birth often lasts for life. About 9 in 10 babies who get hepatitis B during birth develop a chronic infection. “Chronic” means the infection lasts a long time and may never go away.

The damage may appear years later. Chronic hepatitis B can cause cirrhosis, which is serious scarring of the liver, or liver cancer. People infected at birth who receive no medical care or treatment may have up to a 1 in 4 chance of developing liver cancer during their lifetime.

Vaccination starting at birth can prevent infection. For babies born to mothers with hepatitis B, vaccination prevents about 75% of infections passed during birth. Protection rises to about 94% when babies also get hepatitis B immune globulin, or HBIG. This extra shot contains antibodies—proteins that fight the virus right away. Babies still need the rest of their vaccine doses.

The ethical concern is that delaying a proven vaccine could leave babies exposed to a serious infection. The World Health Organization says withholding the birth dose in this study could cause lasting, preventable harm.