Pediatrics 2022

Marina F. Gubkina

Central TB Research Institute/N.I. Pirogov Russian National Research Medical University, Russian Federation

Title: BCG immunization: complications and causes of their development


Introduction: The BCG vaccine remains the only licensed vaccine against tuberculosis (TB) in the world. The optimal immunization method is still considered intradermal injection of the BCG vaccine, which requires professional skills for correct administration and precise dosage to induce adequate cellular immune responses and minimize post vaccinal complications. 
Aim: To demonstrate frequency of BCG-induced complications and causes of their development. 
Materials and methods: The official statistical data of the Russian Federation, a clinical observation. 
Results: There is a monitoring and reporting system to register post vaccinal complications after BCG immunization in the Russian Federation. The frequency of BCG-induced complications has not been more than 0.02% (21.1 per 100,000 vaccinated individuals) for many years in Russia. The complications include suppurative lymphadenitis – 0.01% (11.5 per 100,000), cold abscesses – 0.006% (5.9 per 100,000), ulcers – 0.002% (1.7 per 100,000), keloid scars – 0.004% (0.4 per 100,000), and osteitis – 0.00006% (0.06 per 100,000 vaccinated individuals). However, it is difficult to diagnose disseminated BCG infection as its symptoms are similar to those of TB infection. It is illustrated by a clinical observation of delayed diagnosis of disseminated BCG infection and innate primary immunodeficiency in a ten-year-old child. Conclusion: Complications following BCG immunization can be local or generalized; their development is associated with several factors: an excessive number of viable microorganisms in the vaccine, inadequate intradermal administration. The severest complication is disseminated BCG infection, which is a rare complication only observed in children with innate immune defects.


Marina F. Gubkina is a Doctor of Medical Sciences, Principal Researcher, Central TB Research Institute, Moscow. Professor of Phthisiology Department, N.I. Pirogov Russian National Research Medical University, Moscow. Research interests – diagnosis and chemotherapy of childhood TB. More than 150 scientific publications, 6 patents for invention, Hirsch index – 10.