North Macedonia pauses BCG newborn vaccinations after Croatia suspension
The Ministry of Health has asked MALMED for batch and quality information after Croatia halted use of the same Bulgarian-produced vaccine.
North Macedonia has temporarily paused newborn vaccination with the BCG vaccine after Croatia suspended its immunization program amid concerns about adverse reactions. The vaccine in question is produced by the Bulgarian company Bul Bio NCIPD from Sofia.
The Ministry of Health said the producer is the same, so officials immediately contacted the Agency for Medicines and Medical Devices (MALMED) and requested detailed information on the batches currently used in the country.
"The Immunization Commission has concluded to temporarily postpone immunization with this vaccine until complete information is obtained regarding the batches, their quality and association with the occurrence of adverse reactions. We emphasize that immunization with this vaccine in our country is mandatory given that the country is at high risk of tuberculosis," the Ministry of Health said.
Health authorities examine batches and patient data
The Ministry added that the Institute for Tuberculosis (TBC) currently records 95 patients with tuberculosis, of whom 83 are from this year. Officials said Kozle Children's Hospital registered 15 infected children in 2025 and 12 new sick children in 2026.
Authorities said the pause is temporary and will remain in effect until regulators provide complete results on the quality and possible association of the vaccine batches with reported adverse events. Health institutions will inform the public and pediatric services when the review is complete.
Photo: SDK.MK)
