BCG VACCINE DISTRIBUTION AND USE SUSPENDED

ZAGREB, OCTOBER 5 /SRNA/ - Croatia is suspending the distribution and use of all batches of the BCG vaccine against severe forms of tuberculosis after suspected serious adverse reactions were reported in children, the Agency for Medicinal Products and Medical Devices said today.

The decision to suspend use of the vaccine was taken after the Agency received four reports this year involving suspected osteomyelitis following administration of the vaccine. The vaccine, manufactured by Bul Bio of Sofia, protects against severe forms of tuberculosis and is administered to children immediately after birth or during the first months of life. Osteomyelitis is a serious and painful infection of the bone and bone marrow, most commonly caused by bacteria. The vaccines were administered at different healthcare institutions, making it less likely that the cases were caused by errors during vaccination, Croatian media reported. Vaccination will not be carried out in maternity hospitals until the investigation is completed. The Croatian Institute of Public Health said children in Croatia have for some time faced a very low risk of contracting tuberculosis and that their health would not be endangered by the temporary suspension. From 2005 to 2025, only one report was recorded involving suspicion of the same adverse reaction linked to BCG vaccines.