Health authorities in Croatia and North Macedonia have temporarily halted the use of a Bulgarian-made BCG tuberculosis vaccine following reports of rare osteomyelitis in children, prompting a safety review and raising concerns over vaccine quality amidst ongoing tuberculosis prevention efforts.
Health authorities in Croatia and North Macedonia have temporarily paused use of a Bulgarian-made BCG tuberculosis vaccine after reports of possible serious side effects in young children prompted a wider safety review. The move has put fresh attention on a preventive jab given to newborns and infants to protect against severe forms of tuberculosis, even as officials in both countries say the precaution is meant to remain in place only until the facts are clearer.
According to Croatian medicines regulator HALMED, distribution and administration of the vaccine were stopped after four reports this year of suspected osteomyelitis, a rare bone infection, in children who had received the shot. The children were vaccinated at different medical facilities, which the agency said made a vaccination error less likely and raised the possibility of a manufacturing or quality problem. Croatian health officials also noted that only one similar report had been recorded between 2005 and 2025, underlining why the cluster of cases has drawn concern.
North Macedonia’s health ministry has now followed with a temporary suspension of BCG vaccination while it waits for fuller information on the batch involved, its quality and any possible link to adverse reactions. Macedonian media, cited by the national news agency, said the country uses the same Bulgarian manufacturer as Croatia. The ministry said that in the past decade it had received only one suspected adverse reaction report connected to this vaccine, dating to 2022 and involving an abscess at the injection site.
Officials in Skopje have stressed that the pause is a precaution rather than a conclusion that the vaccine is unsafe. They also pointed to the country’s continuing tuberculosis burden, saying immunisation remains compulsory and that the issue must be balanced against the disease risk. In Croatia, public health officials have said the risk of tuberculosis among children is very low, so the temporary suspension should not put child health in danger. Health experts cited by HINA say osteomyelitis after BCG vaccination is uncommon, may emerge months or even years later, and is usually treatable if caught early, while ordinary local reactions to the vaccine are expected within a few weeks and are typically much milder.
Disclaimer: This content is for informational purposes only and is not intended to be a substitute for professional medical judgment, advice, diagnosis, or treatment.
