The Immunization Commission within the Macedonian Ministry of Health (MoH) convened following reports in Croatian media regarding adverse reactions to the BCG vaccine; consequently, vaccination with this vaccine has been temporarily suspended in the country, the Health Ministry said Tuesday.
“Given that the same manufacturer is involved, the Medicines and Medical Devices Agency (MALMED) was immediately contacted to request information regarding the vaccine batches used in our country. We emphasize that immunization with this vaccine is mandatory in our country, as the nation is at high risk for tuberculosis. Currently, the Institute for Tuberculosis is treating 95 tuberculosis patients, 83 of whom were diagnosed this year, while the Kozle Children’s Hospital recorded 15 cases in 2025 and 12 new cases in 2026,” the Ministry said in a press release.
Based on the situation, the Immunization Commission decided to temporarily postpone immunization with this vaccine until complete information is obtained regarding the batches, their quality, and any link to the reported adverse reactions.
“Furthermore, we emphasize that over the past ten years, MALMED has received only one report of a suspected adverse reaction to the BCG vaccine (in August 2022), involving an abscess at the injection site, a reaction that is described in the vaccine’s instructions for use,” reads the Ministry of Health’s press release.