started · updated
Bulgarian BCG vaccine suspended in several Balkan countries
Health authorities in Croatia, Bosnia and Herzegovina, and North Macedonia have implemented preventive measures to suspend the distribution and use of the BCG tuberculosis vaccine produced by the Bulgarian company Bul Bio NCIPD Ltd. This action follows four reported cases of suspected osteomyelitis (bone infection) in children following vaccination in Croatia.
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, and no adverse reactions have been reported in the country since 2020. Similarly, the Institute of Public Health in Montenegro stated that the specific batches suspended in Croatia were never distributed in Montenegro and that no adverse reactions have been reported locally.
Entities
AJ Vaccines A/S · BB-NCIPD Ltd. · Bosnia and Herzegovina · Bul Bio NCIPD Ltd. · Bulgaria · CInMED · Croatia · HALMED · Institute of Public Health of Montenegro · Irena Hrstić · Krunoslav Capak
Claims
What the coverage asserts, and how many sources carry each claim.
- [○ 1 SOURCE] The Agency for Medicines and Medical Devices of Bosnia and Herzegovina stated that all BCG vaccine batches imported in 2026 passed quality controls. n24.ba
- [DISPUTED] 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
- [○ 1 SOURCE] Croatia, North Macedonia, and Bosnia and Herzegovina have implemented preventive measures to suspend the use or distribution of the Bulgarian BCG vaccine. www.realitatea.net
- [● 2 SOURCES] The Bulgarian manufacturer Bul Bio has rejected claims regarding quality issues with its BCG vaccine. prigorski.hr · www.novilist.hr
- [DISPUTED] 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
- [● 3 SOURCES] The Croatian agency HALMED has not confirmed that incorrect doses were administered in the four suspected cases of osteomyelitis. prigorski.hr · www.24sata.hr · n1info.hr
- [● 2 SOURCES] Montenegro confirmed that the specific batches of the Bulgarian BCG vaccine suspended in Croatia were never distributed in Montenegro. bizniscg.me · www.aktuelno.me
- [● 2 SOURCES] Croatia has suspended the distribution and use of all batches of the Bul Bio BCG vaccine following four reports of suspected osteomyelitis. prigorski.hr · www.24sata.hr