Two of four reports in Croatia of bone infection after the BCG vaccine list a dose ten times higher than prescribed. In a third, a link to the vaccine has been ruled out. The Ministry of Health said this, citing data from Bul Bio - National Centre of Infectious and Parasitic Diseases.

The maker says the four reports do not prove a quality problem with the vaccine. The company has already begun an investigation.

On 5 October 2026, the distributor told Bul Bio about four cases of osteomyelitis, or bone inflammation, after a BCG shot. The first two involve vaccinations in 2024. They were registered on 29 June 2026 and record a dose of 0.5 ml, ten times the amount given in the product information. The investigation will check what dose was actually given. The third report was registered on 17 April 2026 and concerns an event in 2023. Its link to the vaccine was later ruled out.

The fourth case is a child vaccinated on 23 November 2024. Osteomyelitis was found about a year and a half later, and on 27 April 2026 a bone tissue sample confirmed the presence of Mycobacterium bovis BCG. Bul Bio received the report on 14 May. It was filed the next day in EudraVigilance, the European database of suspected drug side effects, and on 20 May the Croatian agency HALMED registered it. This is the only case reported directly to the company in 2026.

The Croatian Agency for Medicinal Products and Medical Devices has halted the distribution and use of the Bulgarian BCG vaccine over concerns about its quality. It is checking whether the vaccine caused osteomyelitis in four babies. Later the same day, after the Croatian decision, North Macedonia's Ministry of Health temporarily stopped BCG vaccination.

Since 2021, Croatia has received five different batches, 21,000 vials in all, or 420,000 doses. The last two arrived this year. The Bulgarian Drug Agency released all five with the European EU-OCABR certificate.

Vaccines from the same batches have also gone to many other EU countries. Bul Bio says a check of EudraVigilance for those batches, with data since 2019, shows no other reports of side effects after use of the product. The summary of product characteristics lists osteomyelitis as a rare side effect, occurring in more than 1 in 10,000 and fewer than 1 in 1,000 people.

Bul Bio said the occurrence of osteomyelitis alone does not prove a product defect. The patient's immune system, the dose given, the way it was injected, other vaccines given at the same time and the experience of the medical staff all matter. The company says the third report has nothing to do with the typical side effects after BCG. It says conclusions on quality must be objective and take account of all available facts.

Bul Bio - NCIPD will release information from its investigation in good time.