Incidence of adverse events following BCG vaccination with Russia and Moreau strains: a surveillance study in Brazil
1
Institute of Collective Health, Federal University of Bahia, Salvador, Brazil
Popul. Med. 2026;8(Supplement Supplement 1):
ABSTRACT
INTRODUCTION:
Bacille-Calmette-Guérin is the only vaccine available for the prevention of severe tuberculosis. There is scientific evidence of its high safety, effectiveness and is recognized for its low level of adverse events1-5. Given the replacement of the BCG-Moreau vaccine strain by BCG-Russia in the routine of health services in Brazil, since January 2018, monitoring the occurrence of adverse events became a priority. To estimate the incidence of adverse events following BCGRussia vaccination compared to BCG-Moreau.
METHODS:
This is a retrospective observational study that used national surveillance data obtained from the Adverse Events Information System (SIE) associated with BCG in children under 1 year of age who were vaccinated. The incidence and characteristics of adverse events were estimated for each vaccine strain.
RESULTS:
In the period analyzed, 3901 records of Adverse Events PostVaccination were observed in children under 1 year of age. In the group of children vaccinated by BCG-Moreau, the incidence of adverse events following vaccination was 41,4 cases/100,000 doses applied in the last year. While for children vaccinated by BCG-Russia, the incidence of adverse events was 4,1 to 6,7 cases/100000 doses applied, in 2018 and 2019, respectively. Both strains presented local or regional and systemic clinical manifestations, the prevalence of these manifestations was lower in the Russia strain when compared to Moreau.
CONCLUSIONS:
The Moreau strain presented a higher occurrence of adverse events when compared to Russia. Replacing BCG-Russia with BCGMoreau does not appear to influence vaccine safety in the Brazilian population. In the event of a supply crisis of the local reference strain, BCG-Russia is a possible alternative to ensure vaccination of Brazilian children. The adoption of ongoing education strategies for vaccinators regarding the correct handling and good practices of immunobiologicals is considered, in addition to the acquisition of practical devices for the application of immunobiologicals.
Bacille-Calmette-Guérin is the only vaccine available for the prevention of severe tuberculosis. There is scientific evidence of its high safety, effectiveness and is recognized for its low level of adverse events1-5. Given the replacement of the BCG-Moreau vaccine strain by BCG-Russia in the routine of health services in Brazil, since January 2018, monitoring the occurrence of adverse events became a priority. To estimate the incidence of adverse events following BCGRussia vaccination compared to BCG-Moreau.
METHODS:
This is a retrospective observational study that used national surveillance data obtained from the Adverse Events Information System (SIE) associated with BCG in children under 1 year of age who were vaccinated. The incidence and characteristics of adverse events were estimated for each vaccine strain.
RESULTS:
In the period analyzed, 3901 records of Adverse Events PostVaccination were observed in children under 1 year of age. In the group of children vaccinated by BCG-Moreau, the incidence of adverse events following vaccination was 41,4 cases/100,000 doses applied in the last year. While for children vaccinated by BCG-Russia, the incidence of adverse events was 4,1 to 6,7 cases/100000 doses applied, in 2018 and 2019, respectively. Both strains presented local or regional and systemic clinical manifestations, the prevalence of these manifestations was lower in the Russia strain when compared to Moreau.
CONCLUSIONS:
The Moreau strain presented a higher occurrence of adverse events when compared to Russia. Replacing BCG-Russia with BCGMoreau does not appear to influence vaccine safety in the Brazilian population. In the event of a supply crisis of the local reference strain, BCG-Russia is a possible alternative to ensure vaccination of Brazilian children. The adoption of ongoing education strategies for vaccinators regarding the correct handling and good practices of immunobiologicals is considered, in addition to the acquisition of practical devices for the application of immunobiologicals.
| eISSN: | 2654-1459 |
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