BCG vaccines suspected of causing side effects following their administration in Croatia are from 2022 and 2023 and have expired for use in North Macedonia, meaning they are not being administered there, North Macedonia’s Health Minister Sasho Klekovski said, according to local media.
He said the suspension of immunization in North Macedonia was a precautionary measure. At the same time, checks have been ordered and steps are being taken to ensure the continuity of vaccination. An agreement has been reached with UNICEF to secure BCG vaccines from a Japanese manufacturer for one year, Klekovski said.
According to Prof. Aleksandra Grozdanova, Chair of the Immunization Committee, the Croatian Agency for Medicinal Products and Medical Devices continues to confirm that there is no direct link between vaccination and the development of osteomyelitis in four children. Around 15,000 children a year have been vaccinated with this vaccine over the past two years, she said.
The Croatian Agency for Medicinal Products and Medical Devices suspended the distribution and use of a Bulgarian-made BCG vaccine over concerns about a possible quality issue. North Macedonia’s Ministry of Health took the same step on Wednesday.
Bulgaria’s Health Minister Katya Ivkova said that the Bulgarian Ministry of Health, Bul Bio – National Centre of Infectious and Parasitic Diseases EAD and the Bulgarian Drug Agency had received no official information from the Croatian or North Macedonian authorities concerning the Bulgarian BCG vaccine. According to Ivkova, an investigation was conducted at Bul Bio following four reports from Croatia, but none of them was confirmed.
Earlier on Wednesday, Bulgaria’s Health Ministry said that the data from the four reports in Croatia did not demonstrate a problem with the quality of the vaccine. Two of the reports stated that a dose 10 times higher than the one prescribed in the product information had been administered. A link to the vaccine was subsequently ruled out in the third case, while the fourth concerned a vaccination administered in 2024. An examination of bone tissue in that case found the presence of Mycobacterium bovis BCG.
/KI/