Bulgarian-made BCG vaccine suspended in the Federation and Croatia
The Public Health Institute of the Federation of BiH temporarily suspended distribution of a Bulgarian-made BCG vaccine from 6 October and recommended halting its use. The Institute says the measure is preventive, following reports of adverse reactions in Croatia, and that no serious reactions have been reported in the Federation, where the vaccine has been used since 2019. In Croatia, the medicines agency HALMED said distribution and use of all batches of the tuberculosis vaccine were being suspended over suspected quality defects. The trigger was four reports of suspected osteomyelitis in infants vaccinated in 2024 and early 2025. HALMED said the reports concern two batches but the concern covers all 11 batches sold since 2017, and vaccination in maternity wards will not resume until the investigation ends.