At the request of the Agency for Medicinal Products and Medical Devices (HALMED), the distributor Medical Intertrade is suspending the distribution and administration of all batches of the Bul Bio NCIPD Ltd BCG vaccine. This is a vaccine against the most severe forms of tuberculosis, administered to newborns immediately after birth or in the first months of life.
The temporary suspension was introduced as a precautionary measure due to concerns regarding the quality of the vaccine, and will remain in place until the investigation is concluded. As there is currently no other BCG vaccine available in Croatia, the vaccination will not be administered in maternity hospitals until the investigation is completed.
The Croatian Institute of Public Health states that children in Croatia have long had a very low risk of contracting tuberculosis, and that the temporary suspension will not endanger their health.
The trigger for the investigation and suspension was a sudden increase in reports of a rare side effect. During 2026, HALMED received four reports of suspected osteomyelitis following vaccination, whereas in the period from 2005 to 2025, only one such report was recorded for the BCG vaccine. As the vaccines were administered in different healthcare facilities, the possibility of a single administration error is reduced, leading to the suspicion of a defect in the vaccine itself.
Osteomyelitis is a rare infection of the bones caused by the attenuated strain of Mycobacterium bovis present in the vaccine. The infection most commonly affects the bones of the limbs, sternum, or ribs. Symptoms include pain, swelling, and reduced mobility in the affected limb, and can occur from a few months to several years after vaccination, most commonly one year after. With timely diagnosis and treatment, a full recovery is achieved, and medical attention should be sought if symptoms appear.
HALMED stresses that osteomyelitis must be distinguished from the normal local reaction at the injection site. The normal reaction occurs within two to three weeks in the form of redness and a small swelling that may turn into a small sore, with healing taking several months and leaving a small scar, which is a sign of successful vaccination.
The vaccine in question is part of the mandatory vaccination programme in Croatia, but is procured via import as it does not have marketing authorisation in the Republic of Croatia. BCG vaccine is a live attenuated vaccine against the most severe forms of tuberculosis, produced by Bul Bio NCIPD Ltd. in Sofia, Bulgaria. It is procured based on consent for import.
The agency reminds healthcare professionals of their obligation to report any suspected adverse reactions and quality defects, while the public can report concerns directly to HALMED or their doctor. In the event that the vaccine is to be administered again, the public will be informed in good time. HALMED published the decision on its official website.
