FBiH temporarily suspends distribution of Bulgarian-made BCG vaccine following Croatia reports

Following reports of adverse reactions after immunization in the Republic of Croatia, the Public Health Institute of the Federation of Bosnia and Herzegovina (PHI FBiH) is temporarily suspending distribution and recommending a temporary suspension of the use of the BCG vaccine produced by Bulgarian manufacturer BB-NCIPD Ltd. in the Federation of Bosnia and Herzegovina as of October 6.
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The PHI FBiH said the recommendation was issued as a preventive precaution and to allow for further investigation, as part of responsible management of the immunization program.
“The safety of vaccinated individuals and careful assessment of all available information are the fundamental principles guiding us in implementing the program,” it said.
The BCG vaccine produced by the manufacturer in question has been used in the Federation of Bosnia and Herzegovina since 2019.
No serious adverse reactions following its administration have been reported to the Institute so far.
The professional community, public and media will be promptly informed about the outcome of the investigation, further recommendations and the continuation of tuberculosis immunization.
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