BiH Medicines Agency: No special measures needed for asymptomatic children

The Agency's statement followed information published by the Croatian Agency for Medicinal Products and Medical Devices (HALMED) on October 5 on the suspension of the distribution and use of BCG vaccines manufactured by Bul Bio NCIPD Ltd. of Sofia due to suspected quality defects. In response, ALMBIH took steps to gather relevant information, the Agency said.

According to ALMBIH, the Agency carried out an emergency import of the vaccine in question in 2026. The ALMBIH Control Laboratory conducted special quality control on all imported batches and found the imported vaccines' quality satisfactory.

Furthermore, no suspected adverse reactions to this BCG vaccine have been reported in Bosnia and Herzegovina from 2020 to date.

The Agency recommended that parents and pediatricians take no special measures if a child has no symptoms. If symptoms occur that could indicate osteitis/osteomyelitis, the child should be examined by a pediatrician, who will assess whether further tests are needed.

ALMBIH will continue to monitor developments, and the professional and general public will be informed promptly of any new developments.