Croatia halts use of Bulgarian BCG vaccine for infants
The Croatian Agency for Medicinal Products and Medical Devices has decided to suspend the distribution and use of all batches of the tuberculosis (BCG) vaccine produced in Bulgaria. The measure was taken as a precautionary step following reports of health issues in newborns.
The reason for this decision is four cases of rare bone inflammation in children who were immunized with the product. Croatian health authorities are investigating the link between the vaccine and the reported side effects to ensure patient safety.
At present, additional checks on the batches are being carried out to determine whether these are isolated cases or a problem with the quality of the product itself. The Bulgarian manufacturer and regulatory authorities in the country have not yet issued an official statement on the matter.
The BCG vaccine is a mandatory part of the immunization schedule in many countries, including Bulgaria and Croatia. It is administered to babies shortly after birth to protect them from developing severe forms of tuberculosis.
More details regarding the investigation are expected to be announced in the coming days. Parents in Croatia are urged to follow the guidance of their pediatricians while the vaccine safety review process is underway.