The Ministry of Health of North Macedonia has decided to temporarily suspend immunization with the BCG vaccine following reports in the Croatian media about the occurrence of adverse reactions. The Immunization Commission has asked the Agency for Medicines and Medical Devices (MALMED) for data on the vaccine batches used in the country, as it comes from the same manufacturer.
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Although BCG vaccination is mandatory in the country, the measure will remain in force until the batches, the quality of the product and any possible link to the reported reactions have been fully verified. According to the ministry, North Macedonia is classified as a high-risk area for tuberculosis, which is why immunization with this vaccine is part of the country’s health requirements.
The official statement says that 95 tuberculosis patients are currently being treated at the Institute for Tuberculosis. Of these, 83 cases were registered during this year. Meanwhile, 15 cases were recorded at the Kozle Children’s Hospital in 2025, along with 12 new cases in 2026.
The decision was made after the Immunization Commission met immediately following the publication of the information from Croatia. Since the vaccine is produced by the same company, MALMED was asked to clarify which batches are used in North Macedonia and whether they are linked in any way to the cases reported abroad.
The ministry also announced that over the past ten years, MALMED had received only one report of a suspected reaction following BCG vaccination. The case was recorded in August 2022 and involved the appearance of an abscess at the site where the vaccine had been administered. According to the authorities, this effect is included in the instructions for using the vaccine.
In Croatia, the use of the BCG vaccine in newborns was temporarily suspended after four rare cases of bone inflammation were reported, suspected to be adverse reactions following immunization.
All four affected children had been vaccinated during 2024 and at the beginning of 2025 with a product from the same Bulgarian manufacturer. As a result, the Croatian authorities have halted the distribution and use of all batches of the vaccine produced by this company.
