Demonstration of background rates of three conditions of interest for vaccine safety surveillance

• Published in: PloS one Vol. 14; no. 1; p. e0210833
• Main Authors: Wormsbecker, Anne E, Johnson, Caitlin, Bourns, Laura, Harris, Tara, Crowcroft, Natasha S, Deeks, Shelley L
• Format: Journal Article
• Language: English
• Published: United States Public Library of Science 15.01.2019; Public Library of Science (PLoS)
• Subjects: Access to information; Adolescent; Adverse Drug Reaction Reporting Systems; Age; Analysis; Annual reports; Biology and Life Sciences; Child; Child, Preschool; Children; Databases, Factual; Drug dosages; Emergency management; Emergency medical services; Epidemiology; Female; Guillain-Barre syndrome; Health surveillance; Hepatitis; Human papillomavirus; Humans; Idiopathic thrombocytopenic purpura; Immunization; Incidence; Infant; Kawasaki disease; Kawasaki syndrome; Male; Measles; Medicine and Health Sciences; Mucocutaneous lymph node syndrome; Mucocutaneous Lymph Node Syndrome - epidemiology; Mucocutaneous Lymph Node Syndrome - etiology; Multiple sclerosis; Multiple Sclerosis - epidemiology; Multiple Sclerosis - etiology; Mumps; Ontario - epidemiology; Pediatrics; People and places; Personal health; Population statistics; Prevalence studies (Epidemiology); Prevention; Public concern; Public health; Public Health Surveillance; Purpura, Thrombocytopenic, Idiopathic - epidemiology; Purpura, Thrombocytopenic, Idiopathic - etiology; Rubella; Safety; Safety and security measures; Surveillance; Teenagers; Thrombocytopenia; Thrombocytopenic purpura; Vaccination - adverse effects; Vaccines; Ontario; Canada; Ontario Canada; Toronto Ontario Canada; United States > US
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0210833

Adverse events following immunization (AEFIs) are unwanted or unexpected health outcomes following vaccination, which may or may not be causally-linked to vaccines. AEFI reporting is important to post-marketing vaccine safety surveillance and has the potential to identify new or rare AEFIs, show increases in known AEFIs, and help to maintain public confidence in vaccine programs. Knowledge of the expected incidence (i.e. background rate) of a possible AEFI is essential to the investigation of vaccine safety signals. We selected three rarely reported AEFIs representing the spectrum of causal association with vaccines, from proven (immune thrombocytopenia [ITP]) to questioned (Kawasaki disease [KD]) to unsubstantiated (multiple sclerosis [MS]) and determined their background rates. We extracted data on hospitalizations (CIHI Discharge Abstract Database) for ITP, KD, and MS among Ontario children for the period 2005 to 2014 from IntelliHEALTH. As ITP can be managed without hospitalization, we also extracted emergency department (ED) visits from the CIHI National Ambulatory Care Reporting System. For all conditions, we only counted the first visit and if the same child had both an ED visit and a hospitalization for ITP, only the hospitalization was included. We calculated rates by year, age group and sex using population estimates from 2005-2014, focusing on age groups within the Ontario immunization schedule around vaccine(s) of interest. Per 100,000 population, annual age-specific incidence of ITP in children age 1 to 7 years ranged from 8.9 to 12.2 and annual incidence of KD in children less than 5 years ranged from 19.1 to 32.1. Average annualized incidence of adolescent (11-17 years) MS across the study period was 0.8 per 100,000. Despite limitations, including lack of clinical validation, this study provides an example of how health administrative data can be used to determine background rates which may assist with interpretation of passive vaccine safety surveillance.