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2 clusters · 68 sources · 3 days · First seen · Last updated

BCG vaccine suspension in Southeast Europe

Overview

Health authorities in Croatia, North Macedonia, and 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.

The Bulgarian manufacturer has rejected claims of quality issues, asserting that an internal investigation found that in two of the four Croatian cases, a dose ten times higher than the prescribed amount was administered. However, Croatian health officials, including Krunoslav Capak, have suggested this may be a data entry error in the European database, where ‘0.5 ml might have been recorded instead of the correct 0.05 ml’.

In Bosnia and 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 and that no adverse reactions have been reported locally.

Entities

Bul Bio NCIPD Ltd. · Bosnia and Herzegovina · HALMED · Bulgaria · Croatia

Claims

What the coverage asserts, and how many sources carry each claim.

Coverage disagrees

Sources make claims that cannot both be true. CLSTR reports the disagreement; it does not decide who is right.

  • "Krunoslav Capak suggested the reported ten-fold overdose might be a data entry error in the European database, where 0.5 ml was entered instead of 0.05 ml." www.tportal.hr · www.index.hr

    vs

    "The Bulgarian manufacturer Bul Bio claims its internal investigation found that in two cases, a dose ten times higher than prescribed was administered." prigorski.hr · www.novilist.hr

    One claim asserts that an internal investigation found a ten-fold overdose actually occurred, while the other suggests the overdose might be a data entry error.

Timeline

  1. [HEALTH] 24 sources
    Bulgarian BCG vaccine suspended in several Balkan countries

    Croatia, Bosnia and Herzegovina, and North Macedonia have suspended the Bulgarian-made BCG vaccine following suspected adverse reactions in Croatia, amid investigations into potential dosing errors.

  2. [HEALTH] 54 sources
    BCG vaccine suspension in Croatia and neighboring regions

    Croatia, North Macedonia, and Republika Srpska have suspended the Bulgarian-made BCG vaccine following four suspected cases of osteomyelitis in children, pending quality investigations.

Sources

072info.com · 24sata.hr · 6yka.com · actualno.com · aktuelno.me · atvbl.rs · banjaluka.com · bigportal.ba · bijeljina.com · bizniscg.me · bl-portal.com · burgasmedia.com · centar.mk · centralna.ba · dalmacijadanas.hr · dalmatinskiportal.hr · dennews.bg · emedjimurje.net.hr · etv.me · eventbrite.co.uk · glas-slavonije.hr · index.hr · kozarski.com · lavoce.hr · lexmedicanews.com · lider.mk · lokalno.mk · makpress.mk · megafon.si · metropolitan.si · moreto.net · n1info.ba · n1info.hr · n24.ba · nezavisen.mk · novilist.hr · novosti.hr · nsuzivo.rs · ohridsky.com · opserver.mk · oslobodjenje.ba · pogled.ba · portalb.mk · poslovni.hr · prigorski.hr · prv.mk · radiobrcko.ba · radiokameleon.ba

This summary has been updated 2 times: see revision history