North Macedonia pauses newborn BCG vaccinations after adverse events reported in Croatia

The Ministry of Health's Immunisation Commission has recommended a temporary halt to newborn BCG vaccinations in North Macedonia after reports of adverse events involving the same vaccine manufacturer surfaced in Croatia.

The suspension will remain in place until the Agency for Medicines (MALMED) provides full information on the vaccine batches, their quality and any possible link to the reported reactions.

What authorities in Croatia reported

Yesterday the Croatian Agency for Medicines stopped using the BCG vaccine supplied by the Bulgarian National Centre for Infectious and Parasitic Diseases (Bul Bio) while an extraordinary inspection of the vaccines is carried out to determine possible causes of the side effects. Croatian health authorities received four reports alleging the vaccine caused bone inflammation (ostitis and osteomyelitis) in young children.

"Given that we want to act preventively, the Commission recommended a temporary postponement of vaccination with the BCG vaccine until we receive complete information, namely whether the batches currently used in Croatia correspond to the batches in our country and whether MALMED, together with the Institute of Public Health and the Ministry, will investigate whether any additional adverse reactions will be reported. At the moment we do not have such information," said Dr. Aleksandra Grozdanova, president of the Immunisation Commission.

Pediatricians note that bone inflammation is a serious condition that would not go unnoticed. "So far we really have not registered osteomyelitis as a complication of the BCG vaccine. There is no need to cause panic among parents," says Dr. Stavrić.

The Ministry of Health adds that over the past ten years it has received only one report to MALMED about a suspected adverse reaction to the BCG vaccine — in 2022, a case of an abscess at the injection site, which is listed as a possible reaction in the product information.

Separately, free seasonal influenza vaccination for pensioners, people with chronic illnesses and pregnant women faces delays because no offers were submitted to the procurement tender. The Ministry says global vaccine production has been delayed due to the emergence of new influenza strains. Procurement records show that in previous years purchase contracts for seasonal influenza vaccines had been completed by mid-September.

Photo: press material from the event