The BCG vaccines that are believed to have caused side effects during their application in Croatia are from 2022 and 2023 and their expiration dates in North Macedonia have expired, which is why they are not being applied, announced the Minister of Health Sasho Klekovski, the media in the country reported, BTA reported.
According to him, the announced suspension of immunization in North Macedonia is a preventive measure, and in parallel with the scheduled inspections, measures are being taken to ensure the continuity of vaccination, as an agreement has been reached with UNICEF to provide BCG vaccines from a Japanese manufacturer for one year.
„This one year will be "enough to have results from both Croatia and (North) Macedonia whether these adverse events can be linked to the vaccine from Bulgaria or not, so that we can see next year how we will organize things," the media quoted Klekovski as saying.
According to the Chairperson of the Immunization Commission, Prof. Aleksandra Grozdanova, the Croatian Agency for Medicines and Medical Products continues to confirm that there is no direct link between vaccination and the occurrence of osteomyelitis in four children, and for the last two years, around 15,000 children per year have been vaccinated with this vaccine.
„Osteomyelitis can also arise from other conditions, far from only vaccination, but can also appear a few weeks to several years after the vaccine is administered. "Each of the adverse reactions that are reported will be closely monitored," Grozdanova said.
According to Klekovski, the inspections of the Ministry of Health include searching for unregistered cases of osteomyelitis in the country in order to assess whether there is one that is due to an adverse reaction to the vaccine.
The Croatian Agency for Medicines and Medical Devices has stopped the distribution and use of the Bulgarian BCG vaccine due to suspicions of a quality problem, and yesterday the Ministry of Health in North Macedonia did the same.
The Bulgarian Ministry of Health, “Bul Bio – National Center for Infectious and Parasitic Diseases“ EAD and the Executive Agency for Medicines have not received any official information from the authorities in Croatia and North Macedonia regarding the Bulgarian BCG vaccine, said Minister of Health Katya Ivkova. According to her, “Bull Bio“ has conducted an inspection of four reports from Croatia, but they have not been confirmed.
Earlier today, the Ministry of Health in Sofia announced that the data on the four reports in Croatia do not prove a problem with the quality of the vaccine. In two of them, it was recorded that a dose ten times higher than prescribed in the product information was administered. A connection with the vaccine was subsequently rejected in the third report, and the fourth case refers to vaccination in 2024, and the presence of Mycobacterium bovis BCG was found in bone tissue.