North Macedonia pauses BCG vaccination while batches are checked

The Immunisation Commission at the Ministry of Health (MoH) has temporarily paused BCG (besezhe) vaccinations as a precautionary measure while authorities check the vaccine batches used in North Macedonia.

Batch verification under way

The decision was taken after reports in Croatian media about adverse reactions to the same manufacturer’s BCG product. The MoH says it immediately contacted the Agency for Medicines and Medical Devices (MALMED) and requested information about the specific batches supplied and used domestically.

According to the Ministry, vaccination will resume only after complete information is received on the batches, their quality and any possible association with reported adverse events.

The BCG vaccine remains mandatory because North Macedonia is considered a high-risk area for tuberculosis. At the Institute for Tuberculosis there are currently 95 patients in treatment, of whom 83 were registered this year. The Children’s Hospital in Kozle recorded 15 cases in 2025 and 12 new cases in 2026.

The Ministry also noted that, over the past ten years, MALMED received a single report of a suspected adverse reaction in August 2022, which concerned an "abscess at the site of application" — a reaction listed in the vaccine’s product information.

Health authorities say they will monitor the situation and inform the public once laboratory and regulatory checks are complete; no new timetable for restarting the vaccination campaign was announced.

Photo: MIA