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BCG vaccine suspension in Southeast Europe

Updated 2 times since CLSTR started tracking revisions of this situation.

What changed

2026-10-07 21:02 UTC → 2026-10-08 12:33 UTC · added removed

Health authorities in Croatia, North Macedonia, and Republika Srpska Bosnia and Herzegovina have suspended the distribution and use of the BCG tuberculosis vaccine produced by Bulgarian manufacturer Bul Bio NCIPD Ltd. The suspension follows reports from the Croatian Medicines Agency (HALMED) regarding four suspected cases of osteomyelitis—a rare bone infection—in children vaccinated during 2024 and early 2025. This represents a significant increase compared to a single report recorded between 2005 and 2025. In Croatia, the distributor Medical Intertrade halted all series of the vaccine pending an investigation into potential quality defects. While North Macedonia and Republika Srpska implemented precautionary suspensions, the Federation of Bosnia and Herzegovina has also implemented preventive measures. The Institute of Public Health of Bosnia and Herzegovina noted that no serious adverse reactions had been reported within their territory since the vaccine's introduction in 2019. The Bulgarian manufacturer has claimed rejected claims of quality issues, asserting that an internal investigations suggest investigation found that in two of the suspected cases involved doses four Croatian cases, a dose ten times higher than prescribed. the prescribed amount was administered. However, Croatian authorities stated they health officials, including Krunoslav Capak, have no suggested this may be a data confirming incorrect dosing entry error in the European database, where ‘0.5 ml might have been recorded instead of the correct 0.05 ml’. In Bosnia and are conducting further verification. Herzegovina, the Agency for Medicines and Medical Devices (ALMBiH) reported that all vaccine batches imported in 2026 passed quality controls, noting that no adverse reactions have been reported in the country since 2020. Montenegro has also clarified that the specific batches under investigation in Croatia were not distributed in its country. Montenegro’s immunization program currently utilizes a vaccine from Danish manufacturer AJ Vaccines A/S, country and officials noted that no adverse reactions were have been reported during the period when the Bulgarian manufacturer’s vaccine was previously used in Montenegro between August 2022 and August 2025. locally.

Versions

  1. 2026-10-08 12:33 UTC BCG vaccine suspension in Southeast Europe
  2. 2026-10-07 21:02 UTC BCG vaccine suspension in Southeast Europe
  3. 2026-10-07 14:29 UTC BCG vaccine suspension in Southeast Europe

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