Safety of the Polish BCG-10 Vaccine During a Period of BCG Vaccine Shortage: An Australian Experience.
Journal
The Pediatric infectious disease journal
ISSN: 1532-0987
Titre abrégé: Pediatr Infect Dis J
Pays: United States
ID NLM: 8701858
Informations de publication
Date de publication:
06 2020
06 2020
Historique:
pubmed:
10
3
2020
medline:
7
4
2021
entrez:
10
3
2020
Statut:
ppublish
Résumé
Bacille Calmete-Guerin vaccine is widely administered to reduce the risk of severe tuberculosis disease in children. Recent global vaccine supply issues have led to the use of alternative products, which may vary in side effect profile. We report on the safety of the Polish (Moreau strain) "Bacille Calmete-Guerin-10" vaccine in an Australian cohort. Using active surveillance, we identified an adverse event rate of 54.6 per 10,000 doses (95% confidence interval: 38.5-75.2), which was comparable to that reported with the Danish Sanofi-Pasteur and Connaught strains.
Identifiants
pubmed: 32150004
doi: 10.1097/INF.0000000000002630
pii: 00006454-202006000-00020
doi:
Substances chimiques
BCG Vaccine
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
e66-e68Références
Australian Technical Advisory Group on Immunisation. The Australian Immunisation Handbook. 2017.10th ed. Canberra: Australian Government Department of Health.
Lotte A, Wasz-Höckert O, Poisson N, et al. BCG complications. Estimates of the risks among vaccinated subjects and statistical analysis of their main characteristics. Adv Tuberc Res. 1984;21:107–193.
Hendry AJ, Dey A, Beard FH, et al. Adverse events following immunisation with bacille Calmette-Guérin vaccination: baseline data to inform monitoring in Australia following introduction of new unregistered BCG vaccine. Commun Dis Intell Q Rep. 2016;40:E470–E474.
Liu J, Tran V, Leung AS, et al. BCG vaccines: their mechanisms of attenuation and impact on safety and protective efficacy. Hum Vaccin. 2009;5:70–78.
Milstien JB, Gibson JJ. Quality control of BCG vaccine by WHO: a review of factors that may influence vaccine effectiveness and safety. Bull World Health Organ. 1990;68:93–108.
Krysztopa-Grzybowska K, Paradowska-Stankiewicz I, Lutyńska A. The rate of adverse events following BCG vaccination in Poland. Przegl Epidemiol. 2012;66:465–469.
Bellet JS, Prose NS. Skin complications of Bacillus Calmette-Guérin immunization. Curr Opin Infect Dis. 2005;18:97–100.
Clothier HJ, Hosking L, Crawford NW, et al. Bacillus Calmette-Guérin (BCG) vaccine adverse events in Victoria, Australia: analysis of reports to an enhanced passive surveillance system. Drug Saf. 2015;38:79–86.
Global Vaccine Safety, Immunization Vaccines and Biologicals, World Health Organization. Observed rate of vaccine reactions: Bacille Calmette-Guerin (BCG) vaccine.2012.