BCG Vaccine in Serbia: Bulgarian Batches Never Arrived
Pavle Zelic of Serbia's medicines agency says the disputed batches never reached the country, while Croatia is still checking whether any dose was wrong.
In brief
- The BCG vaccine batches behind the halt of vaccination in the region were never on the market in Serbia, said Pavle Zelic of the Medicines and Medical Devices Agency of Serbia.
- Serbia currently uses a vaccine from a Danish manufacturer, and every imported batch is tested in the national laboratory.
- Croatia’s agency HALMED is still checking whether a wrong dose was involved in the four reported cases.
Did babies in Serbia receive the BCG vaccine that has stopped vaccination in Croatia and Bosnia and Herzegovina? According to the Medicines and Medical Devices Agency of Serbia, they did not: batches from the Bulgarian manufacturer never reached the Serbian market. Pavle Zelic said so on October 9, 2026, and his statement is the first from Serbia since the two neighboring countries acted.
What exactly was halted in Croatia and Bosnia?
The vaccine in question protects against tuberculosis and is known as BCG. On October 5, 2026, the Croatian Agency for Medicinal Products and Medical Devices, HALMED, suspended distribution and use of all batches of BCG Vaccine, freeze dried, in packs of 20 ampoules with 20 doses each. The manufacturer is Bulgarian, based in Sofia, and the distributor is Medical Intertrade. The halt also applies in Bosnia and Herzegovina.
The trigger was four reports of suspected osteomyelitis, an inflammation of the bone, in children. HALMED says those reports arrived in 2026, and that between 2005 and 2025 there was a total of one report of the same adverse reaction. Serbian media have reported that the children received the vaccine during 2024 and early 2025. The two sources differ on timing, so that point remains open.
What did the Serbian medicines agency say?
Zelic says Serbia currently uses a vaccine from a Danish manufacturer and that every imported batch is tested in the national laboratory. We previously wrote about which BCG vaccine babies in Serbia receive, and the answer was the same: the Danish one. About the disputed batches, he said:
“At the moment the vaccine manufacturer is Danish, and the records of cases in Serbia have not shown any reason for concern.”
Zelic added that bone inflammation, osteitis, is a known adverse reaction to the BCG vaccine, with a usual frequency of about 67 cases per million vaccinated people.
What about the wrong dose?
The sources disagree here, so both are worth reading. Zelic says Bulgaria recorded that in two cases from 2024 children were mistakenly given a dose ten times larger than prescribed.
On October 7, HALMED stated that it currently has no data pointing to a wrong dose in any of the four Croatian cases. It is checking this as a priority, and the manufacturer also says the claim about a wrong dose needs further verification and confirmation. For now, the Croatian agency does not claim that the four reports resulted from a dosing error, nor that they did not.
The difference over timing and the difference over dose are the two points where the sources do not match. The first concerns when the children were vaccinated and when the reports arrived, the second whether the dose was wrong at all. Until HALMED finishes its check, neither side has a final answer.
What does it look like in Croatia?
Until the investigation ends, Croatia will not vaccinate in maternity wards, because no other BCG vaccine for newborns is available. The vaccine was obtained there as an emergency import, without a marketing authorization. The Croatian Institute of Public Health assesses the risk of tuberculosis among children in Croatia as very low.
The BCG vaccine has been in use since 1921, when it was first given in France. Parents with questions about vaccinating their child can ask a pediatrician or their local health center.
