Croatia and Macedonia have temporarily suspended a BCG tuberculosis vaccine made by Bulgarian manufacturer Bul Bio NCIPD. The decision follows four suspected cases of a rare bone complication in young children in Croatia.
Croatia’s medicines regulator, HALMED, stopped the distribution and use of all batches as a precaution. Authorities are now investigating a possible quality issue.
Macedonia also temporarily postponed BCG immunization after receiving information about the Croatian cases. The country uses a BCG vaccine from the same Bulgarian manufacturer.
BCG Vaccination Suspended as Croatia Investigates Cases
Croatian health authorities reported four suspected cases of osteitis or osteomyelitis in young children during 2026. The children received the BCG vaccine in 2024 and early 2025.
The reports involved batches 807-1 and 683-1. However, HALMED extended the precautionary suspension to all batches from the manufacturer that entered the Croatian market.
Osteitis and osteomyelitis are known but rare potential reactions following BCG vaccination. Croatian authorities are investigating why they recorded more suspected cases than expected.
HALMED stressed that parents do not need to take special measures if their children have no symptoms. Healthy children also do not need preventive X-rays, ultrasound scans, MRI scans or other diagnostic tests.
However, parents should watch for persistent or gradually developing swelling around a bone or joint. Other possible symptoms include pain, tenderness, restricted movement and limping.
The condition usually does not cause a high fever or pronounced general symptoms. Parents should contact a pediatrician if any of these symptoms appear. They should also tell the doctor that the child received a BCG vaccine.
HALMED said the vaccine suspension will remain in place while authorities investigate the suspected quality issue.
Macedonia Temporarily Postpones BCG Vaccination
Macedonia also temporarily postponed BCG vaccination as a precaution following the developments in Croatia.
Health authorities contacted the Medicines and Medical Devices Agency, MALMED, for information about the vaccine batches used in the country. Officials are reviewing available information about their quality and the suspected reactions reported in Croatia.
BCG vaccination forms part of Macedonia’s mandatory immunization program. The vaccine primarily protects children against severe forms of tuberculosis, including tuberculous meningitis.
For now, authorities have not established that the vaccine caused the reported cases or that it has a quality defect. Croatia continues to investigate the suspected reactions, while Macedonia is reviewing information about the vaccine batches it uses.
Parents whose children previously received the vaccine do not need to seek testing solely because of the suspension. Croatian authorities recommend routine monitoring for children who remain healthy and show no symptoms.
