North Macedonia temporarily pauses BCG vaccination while batches are checked
Vaccination is on hold while MALMED and the immunisation commission verify the vaccine batches after reports from Croatia.
The Government health authorities in North Macedonia have temporarily suspended BCG vaccination while the vaccine batches used in the country are being reviewed after reports of suspected adverse events in neighbouring Croatia.
The Ministry of Health said the national Commission for Immunization examined the matter and requested detailed information from the Agency for Medicines and Medical Devices (MALMED) about the specific batches currently in use.
Why the pause
The suspension is described as a preventive measure and will remain in force until complete data on the batches, their quality and any possible link to the reported reactions are obtained.
The move was prompted by events in Croatia, where the competent authority halted distribution and administration of a BCG vaccine produced by the Bulgarian manufacturer "Bul Bio NCIPD". During 2026, Croatian health authorities received reports of four suspected cases of osteitis or osteomyelitis in young children.
Croatian officials said the affected children had been vaccinated in 2024 and in early 2025; because vaccinations occurred across different health facilities, an additional investigation of the product and its quality has been launched there.
In North Macedonia the BCG vaccine is part of the mandatory childhood immunisation schedule and is intended to protect against severe forms of tuberculosis. The Ministry emphasised that tuberculosis remains a public health risk in the country, which is why the temporary postponement will be kept in place while institutions establish all relevant information about the vaccines in use.
Photo: press material from the event
