In Croatia, the distribution and administration of all batches of Bul Bio BCG vaccine have been suspended following four reports of suspected osteomyelitis in newborns vaccinated against tuberculosis. The measure was requested by the Croatian Agency for Medicinal Products and Medical Devices (HALMED) on Monday, as a precaution while the investigation is ongoing.
Minister of Health Irena Hrstić stated that claims by the Bulgarian side regarding a tenfold dose should be treated with caution, and that a professional and official verification is needed to establish all facts. She explained that at this stage, the ministry is not intervening directly, as clinicians are required to report adverse events to HALMED, which then assesses whether the number of complications exceeds the norm and, if so, initiates a procedure. Hrstić added that, according to her information, there is no evidence of an incorrectly administered dose, and confirmed that the clinical condition of the four children in whom the adverse reaction was recorded is good.
HALMED stated on Wednesday that it currently has no data indicating the application of an incorrect dose of the BCG vaccine, and that it is conducting additional checks. The agency is verifying information that a dose of 0.5 millilitres was recorded in the documentation for two children in Croatia, which is ten times the prescribed amount for infants, but emphasises that there is currently no evidence that such a quantity of vaccine was actually administered to the children. They also warn that the manufacturer itself does not consider this data from the European database EudraVigilance as definitive proof of incorrect dosing, and one possibility is an error in entering data into the documentation. There is also no confirmation that any potential incorrect dosing would be the cause of the reported cases of osteomyelitis.
The Bulgarian state manufacturer Bul Bio NCIPD rejected claims about problems with the quality of its vaccine, stating that in two cases in Croatia a dose ten times greater than prescribed was injected. According to data published by the manufacturer, the Croatian distributor informed it on 5 October of four reports of osteomyelitis following BCG vaccination. For two cases, relating to vaccinations carried out during 2024, data in EudraVigilance showed a dose of 0.5 millilitres; these reports were entered into the European database on 29 June this year. In the third case, the link between the health event and the vaccine was subsequently dismissed, and the fourth case is being investigated in particular, which concerns a child vaccinated on 23 November 2024, in whom osteomyelitis was diagnosed approximately a year and a half later, with confirmation of the bacterium Mycobacterium bovis BCG in a sample of bone tissue.
HALMED requested the temporary suspension of the distribution and administration of Bul Bio BCG vaccine on 5 October, as a precaution while the investigation is ongoing. The reported cases are linked to batches 807-1 and 683-1, which were used in Croatia from approximately the third quarter of 2023 to the beginning of 2026, during which period approximately 60,000 doses were administered. The precautionary measure has been extended to all 11 batches of the vaccine from this manufacturer that have been available on the Croatian market since 2017. As there is no other BCG vaccine for newborns, vaccination in Croatian maternity hospitals will not take place until the investigation is concluded.
The Croatian Institute of Public Health (HZJZ) previously noted that the children in whom complications were recorded were vaccinated in different health institutions, which reduces the likelihood of a common error during vaccine administration. During 2026, four suspicions of BCG osteitis or osteomyelitis were recorded in young children, while according to the Institute, not a single such case has been recorded in Croatia over the previous ten years. Epidemiological studies generally estimate the frequency of BCG osteitis and osteomyelitis at approximately one to three cases per million doses administered, and osteomyelitis is listed in the summary of product characteristics for the BCG vaccine as a rare side effect.
Bul Bio states that factors relevant to such reactions include the patient's immune status, the dose administered, the technique of administration, the simultaneous administration of other vaccines, and the experience of the healthcare staff, and that an investigation has already been launched. The manufacturer notes that it has delivered five batches to Croatia since 2021, a total of 21,000 ampoules, equivalent to a quantity corresponding to 420,000 doses, and claims that the batches passed the prescribed marketing authorisation procedure and received the European EU-OCABR certificate. HZJZ has assured parents of already vaccinated children that they do not need to take them for preventive scans or additional examinations if they have no symptoms, but that attention should be paid to prolonged or gradually developing swelling in the area of bone or joint, pain, reduced mobility, limping, or avoiding leaning on an arm or leg, in which case it is recommended to consult a paediatrician. The BCG vaccine is used to protect children from the most severe forms of tuberculosis.
