Two of four suspected adverse reaction reports from Croatia record a BCG vaccine dose ten times the prescribed amount, Bulgaria’s Health Ministry said on Wednesday.
A link to the vaccine was ruled out in another case. The Ministry’s press office cited information from BulBio – National Centre of Infectious and Parasitic Diseases concerning suspected adverse reactions following BCG vaccination in Croatia.
The manufacturer said the data in the four reports do not establish a vaccine quality problem. Two list a dose ten times the prescribed amount. In another case, a link to the vaccine was ruled out. These circumstances are crucial to assessing the cases.
On October 5, 2026, the distributor notified BulBio of four reports of osteomyelitis, inflammation of the bone, following administration of the BCG vaccine. The company’s prompt search of EudraVigilance, the European database of suspected adverse drug reactions, found that two reports recorded an administered dose of 0.5 ml, ten times the amount specified in the product information.
Both concern vaccinations in 2024 and were registered on June 29, 2026. The information on the administered doses remains subject to verification during the investigation. In a third report, a link to the vaccine was subsequently ruled out. That report was registered on April 17, 2026, and concerns an event in 2023 which the manufacturer said was unrelated to the typical adverse reactions following BCG vaccination.
The fourth report concerns a vaccination on November 23, 2024. Osteomyelitis was diagnosed approximately a year and a half later. On April 27, 2026, the presence of Mycobacterium bovis BCG was confirmed in a bone tissue sample. This is the only case reported directly to BulBio in 2026. The manufacturer received the report on May 14 and submitted it to EudraVigilance the following day. Croatia’s medicines agency HALMED registered it on May 20.
The review also clarifies the chronology of the four reports: all were registered in 2026, but three concern vaccinations in 2024, while the remaining report relates to 2023.
Five different batches of BCG vaccine have been supplied to Croatia since 2021, with the latest two delivered this year. The total quantity is 21,000 ampoules, equivalent to 420,000 doses. All five batches were released by the Bulgarian Drug Agency with EU-OCABR certificates. Vaccines from the same batches have also been supplied to many other EU countries.
BulBio said a further search of EudraVigilance covering those countries found no other registered reports of adverse reactions following administration of the product. The search covers data from 2019 to the present, the press office added.
The manufacturer said osteomyelitis is listed as a rare adverse reaction in the BCG vaccine’s approved Summary of Product Characteristics, with a frequency of more than one in 10,000 and fewer than one in 1,000. Its occurrence alone does not establish a product defect. BulBio said factors relevant to such reactions include the patient’s immune status, the dose administered, the administration technique, co-administration with other vaccines and the experience of healthcare staff. Clarifying the information about doses ten times the prescribed amount in two of the reports is therefore an essential part of the investigation.
Despite these findings, BulBio has already launched an investigation and will provide timely updates on its progress. The company takes every report of a possible adverse reaction seriously. Conclusions about the vaccine’s quality must, however, be drawn objectively, taking all available facts into account, the press office added.
Croatia’s Agency for Medicinal Products and Medical Devices suspended distribution and use of a Bulgarian BCG vaccine over a suspected quality problem, the Croatian news agency HINA said on Tuesday. Later that day, media in North Macedonia said the Republic of North Macedonia’s Health Ministry had temporarily suspended vaccination with the BCG tuberculosis vaccine. The measure followed a similar suspension by Croatia’s medicines agency involving a BCG vaccine made by a Bulgarian manufacturer, pending an investigation into whether it had caused osteomyelitis in four infants in Croatia.
Two Croatian BCG Reports List Doses Ten Times Prescribed Amount, Health Ministry Says 2026 THE NEWS FROM BULGARIA – NEWS AGENCY 2009-2025 2026-10-07 09:18:42
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BULGARIA NEWS – NEWS AGENCY 2009–2026 2026-10-07 09:18:42
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