Croatia and North Macedonia have paused use of the BCG vaccine made by Bulgarian company Bul Bio, citing concerns about side effects and a possible defect.

This report follows our earlier story on Croatia's decision to stop using the baby vaccine over a suspected rare bone reaction.

Croatia's medicines agency has received four reports of a probable bone infection after vaccination, and it suspects a defect in the vaccine.

Bul Bio says the reports were filed this year and the children were vaccinated in 2023 and 2024. The company says two of them got a dose 10 times higher than prescribed. In the third case, it says a link to the vaccine has been ruled out. The fourth case is osteomyelitis, an infection of the bone, found a year and a half after vaccination.

The maker says no defect has been proven. It says bone infection is a rare but known side effect, and its appearance does not prove that the vaccine is defective.