The Health Ministry has received no official information from Croatian or North Macedonian authorities about the Bulgarian BCG vaccine, Health Minister Katya Ivkova said on Wednesday.
She told a Council of Ministers briefing that vaccine manufacturer BulBio and the Bulgarian Drug Agency had received no official information either.
Ivkova said information on the matter was available only on Croatian institutions’ websites. “We have carried out a check at BulBio. These are four suspected cases that have not been confirmed,” she said.
Earlier on Wednesday, the Ministry said the data in the four reports did not establish a vaccine quality problem. Two listed a 0.5 ml dose, ten times the amount specified in the product information. A link to the vaccine was subsequently ruled out in a third case. The fourth concerned a vaccination in 2024, with Mycobacterium bovis BCG detected in bone tissue.
BulBio said all four reports were registered in 2026. Three concerned vaccinations in 2024 and the remaining one a vaccination in 2023. The manufacturer has launched an investigation.
Croatia’s Agency for Medicinal Products and Medical Devices temporarily suspended distribution and use of the vaccine on October 6 over a suspected quality problem. North Macedonia also temporarily halted BCG immunization later that day pending full information on the batches used, their quality and any possible link to adverse reactions.
BulBio said the vaccine is also used in other EU countries. A search of the European adverse drug reaction database found no other registered adverse reaction reports following administration of the product.
Health Minister Ivkova: No Official BCG Vaccine Information from Croatia, North Macedonia 2026 THE NEWS FROM BULGARIA – NEWS AGENCY 2009-2025 2026-10-07 11:39:14
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BULGARIA NEWS – NEWS AGENCY 2009–2026 2026-10-07 11:39:14
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