Batches of the BCG vaccine from Bulgarian maker BulBio were never in circulation in Serbia, says Pavle Zelic of Serbia's Medicines and Medical Devices Agency. Croatia and Bosnia and Herzegovina have halted those batches. Both countries stopped the vaccine as a precaution after four children developed osteitis, an inflammation of the bone.
This report follows our earlier story on Croatia's decision to suspend the vaccine over four suspected cases of osteitis in babies.
The affected children in Croatia and Bosnia and Herzegovina were vaccinated in 2024 and early 2025. The Serbian agency says Bulgaria had two cases in 2024, when children there were mistakenly given a dose 10 times higher than prescribed.
Zelic says the quality of the vaccine should be kept separate from human error in giving it. He says a wrong dose strongly affects side effects, and that this shifts responsibility to the medical staff who vaccinated the children.
Serbia uses a vaccine from a Danish maker, and every imported batch is tested in a national laboratory. Zelic added that Serbia's register of cases gives no cause for alarm.
Osteitis is a known and expected side effect of BCG. Zelic says it occurs in about 67 of every 1 million people vaccinated. Experts in Serbia say unusually frequent cases need attention.
The same experts say parents have no reason to worry. Redness and a slight fever after the shot are common and normal, because they show the immune system is responding. Tuberculosis has not been eradicated, and without the vaccine the effects on newborns can be severe, so the experts recommend regular vaccination.
The BCG vaccine protects young children from severe forms of tuberculosis. It has been used since 1921, when it was first given in France, so for 105 years.
Zelic also commented on the case of plague at an institute in the Russian city of Irkutsk, reported in early October. It is a laboratory infection. Zelic says there is no room for sensation or panic, and the incident is isolated, contained and confined to the institute. The World Health Organization is monitoring the situation, and so far there are no signs the disease is spreading. No special measures are needed for the public. Plague is now treated successfully with antibiotics and is rare, with endemic cases in a few countries.
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