The health ministry, state-owned Bul Bio – National Centre of Infectious and Parasitic Diseases, and the Bulgarian Drug Agency have no official information from Croatia or North Macedonia about the Bulgarian BCG vaccine, health minister Katya Ivkova said at a briefing at the Council of Ministers. See our original report: Two of four Croatian BCG vaccine reports involve a dose 10 times higher.
Ivkova said the only information on the case comes from posts on the websites of Croatian institutions. "We checked with Bul Bio – it concerns suspicions about four cases, which have not been confirmed," she said.
On October 6, the Croatian Agency for Medicinal Products and Medical Devices temporarily halted distribution and use of the vaccine over suspected quality problems. Later the same day, North Macedonia temporarily suspended BCG vaccinations until it receives full data on the batches used, their quality and a possible link to adverse reactions.
Earlier today, the ministry said the data on the four reports do not show a quality problem with the vaccine. Bul Bio checked the cases, and the maker has also opened an investigation. The reports were registered in 2026. The company says three of the vaccinations were given in 2024 and one in 2023.
In two of the reports, the dose was 0.5 ml, ten times the amount set out in the product information. The link to the vaccine in the third case was later ruled out. In the fourth case, which the ministry says involved a vaccination in 2024, Mycobacterium bovis BCG was found in a bone tissue test.
Bul Bio said the vaccine is also used in other EU countries. A check of the European database of adverse drug reactions found no other reports of such reactions after use of the product.