Croatia has temporarily suspended the distribution and use of the BCG vaccine for babies made by Bulgaria's Bul Bio NCIPD, the country's medicines agency, HALMED, says. The move is a precaution after four suspected cases of a rare bone side effect.
HALMED has told the vaccine's distributor in Croatia, Medical Intertrade, to pull all batches of the vaccine while it checks whether there is a quality problem.
The BCG vaccine protects babies against severe forms of tuberculosis. The suspected reaction is osteitis and osteomyelitis — inflammation and infection of the bone, a known but very rare side effect of the vaccine.
HALMED received the four reports in 2026, but the children were vaccinated in 2024 and in early 2025. By comparison, from 2005 to 2025 the agency received only one report of the same reaction after a BCG shot.
Two batches of the vaccine were used over that period, with around 60,000 doses given over roughly a year and a half.
Croatia's public health institute, HZJZ, says all four children got the vaccine from the same maker. The shots were given at different health centres, which the institute says makes it less likely the problem was a mistake during vaccination itself.
Health authorities are now checking whether there is a link between the vaccine and the reported cases, and whether the problem is tied to the quality of specific batches.