{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,2]],"date-time":"2026-09-02T02:23:21Z","timestamp":1788315801659,"version":"build-2803163510"},"reference-count":23,"publisher":"MDPI AG","issue":"9","license":[{"start":{"date-parts":[[2024,9,14]],"date-time":"2024-09-14T00:00:00Z","timestamp":1726272000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Public Health Agency of Canada","award":["492071"],"award-info":[{"award-number":["492071"]}]},{"name":"Canadian Institutes for Health Research","award":["492071"],"award-info":[{"award-number":["492071"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Vaccines"],"abstract":"<jats:p>In Canada, vaccine safety studies are often conducted at the provincial\/territorial level where the primary data on vaccination reside. Combining health services data from multiple jurisdictions using a pooled data analytic approach would reduce the amount of time needed to detect vaccine safety signals. To determine the difference in the time it would take to identify safety signals using different proportions of the Canadian population, we conducted power and sample size calculations for a hypothetical self-controlled case series-based surveillance analysis. We used scenarios modeled after the real-world examples of myocarditis and vaccine-induced immune thrombotic thrombocytopenia (VITT) following COVID-19 vaccination as our base cases. Our calculations demonstrated that in the case of a myocarditis-type event, a pooled analysis would reduce the time needed to detect a safety signal by over 60% compared to using Ontario data alone. In the case of a VITT-type event, a pooled analysis could detect a safety signal 49 days sooner than using Ontario data alone, potentially averting as many as 30 events. Our analysis demonstrates that there is substantial value in using pan-Canadian health services data to evaluate the safety of vaccines. Efforts should be made to develop a pan-Canadian vaccine data source to allow for an earlier evaluation of suspected adverse events following immunization.<\/jats:p>","DOI":"10.3390\/vaccines12091052","type":"journal-article","created":{"date-parts":[[2024,9,16]],"date-time":"2024-09-16T04:14:07Z","timestamp":1726460047000},"page":"1052","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Using Vaccine Safety Data to Demonstrate the Potential of Pooled Data Analysis"],"prefix":"10.3390","volume":"12","author":[{"given":"Steven","family":"Hawken","sequence":"first","affiliation":[{"name":"Clinical Epidemiology Program, Ottawa Hospital Research Institute, 1053 Carling Avenue, Ottawa, ON K1Y 4E9, Canada"},{"name":"School of Epidemiology and Public Health, University of Ottawa, 600 Peter Morand Cres., Ottawa, ON K1G 5Z3, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lindsay A.","family":"Wilson","sequence":"additional","affiliation":[{"name":"School of Population and Public Health, University of British Columbia, Vancouver, BC V6T 1Z3, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1741-7705","authenticated-orcid":false,"given":"Kumanan","family":"Wilson","sequence":"additional","affiliation":[{"name":"Clinical Epidemiology Program, Ottawa Hospital Research Institute, 1053 Carling Avenue, Ottawa, ON K1Y 4E9, Canada"},{"name":"Bruyere Research Institute, Ottawa, ON K1R 6M1, Canada"},{"name":"Department of Medicine, University of Ottawa, Ottawa, ON K1H 8M5, Canada"},{"name":"CANImmunize Inc., Ottawa, ON K2A 2E5, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2024,9,14]]},"reference":[{"key":"ref_1","unstructured":"Government of Canada (2024, January 22). Canadian Immunization Registry Functional Standards 2020 to 2024: Recommendations from the Canadian Immunization Registry and Coverage Network, Available online: https:\/\/www.canada.ca\/en\/public-health\/services\/publications\/vaccines-immunization\/canadian-immunization-registry-functional-standards-2020-2024.html."},{"key":"ref_2","unstructured":"Government of Canada SC (2024, January 22). Profile Table, Census Profile, 2021 Census of Population\u2014Canada, Available online: https:\/\/www12.statcan.gc.ca\/census-recensement\/2021\/dp-pd\/prof\/index.cfm?Lang=E."},{"key":"ref_3","unstructured":"Government of Canada (2024, January 22). Highlights from the 2021 Childhood National Immunization Coverage Survey (cNICS), Available online: https:\/\/www.canada.ca\/en\/public-health\/services\/immunization-vaccines\/vaccination-coverage\/2021-highlights-childhood-national-immunization-coverage-survey.html."},{"key":"ref_4","unstructured":"Government of Canada (2024, January 22). Vaccine Uptake in Canadian Adults 2021, Available online: https:\/\/www.canada.ca\/en\/public-health\/services\/immunization-vaccines\/vaccination-coverage\/highlights-2020-2021-seasonal-influenza-survey\/full-report.html."},{"key":"ref_5","unstructured":"Government of Canada (2024, January 22). Seasonal Influenza Vaccination Coverage in Canada, 2021\u20132022: Full Report, Available online: https:\/\/www.canada.ca\/en\/public-health\/services\/immunization-vaccines\/vaccination-coverage\/seasonal-influenza-survey-results-2021-2022\/full-report.html."},{"key":"ref_6","doi-asserted-by":"crossref","unstructured":"Ontario Agency for Health Protection and Promotion (Public Health Ontario) (2024, January 22). Myocarditis and Pericarditis after COVID-19 mRNA Vaccines. Queen\u2019s Printer for Ontario, Available online: https:\/\/www.publichealthontario.ca\/-\/media\/documents\/ncov\/vaccines\/2021\/11\/myocarditis-pericarditis-mrna-vaccines.pdf?sc_lang=en.","DOI":"10.1007\/s40278-022-17308-z"},{"key":"ref_7","doi-asserted-by":"crossref","first-page":"e000373","DOI":"10.1136\/bmjmed-2022-000373","article-title":"Clinical outcomes of myocarditis after SARS-CoV-2 mRNA vaccination in four Nordic countries: Population based cohort study","volume":"2","author":"Husby","year":"2023","journal-title":"BMJ Med."},{"key":"ref_8","doi-asserted-by":"crossref","unstructured":"Farrington, P., Whitaker, H., and Weldeselassie, Y.G. (2018). Self-Controlled Case Series Studies: A Modelling Guide with R, Chapman and Hall\/CRC. [2nd ed.].","DOI":"10.1201\/9780429491313"},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"1768","DOI":"10.1002\/sim.2302","article-title":"Tutorial in biostatistics: The self-controlled case series method","volume":"25","author":"Whitaker","year":"2006","journal-title":"Stat. Med."},{"key":"ref_10","first-page":"1","article-title":"Vaccine-Induced Immune Thrombotic Thrombocytopenia (VITT) Following Adenovirus Vector COVID-19 Vaccination. Ontario COVID-19 Science Advisory Table.","volume":"2","author":"Pai","year":"2021","journal-title":"Sci. Briefs Ont. COVID-19 Sci. Advis. Table"},{"key":"ref_11","doi-asserted-by":"crossref","first-page":"e12698","DOI":"10.1002\/rth2.12698","article-title":"Risk of thrombosis with thrombocytopenia syndrome after COVID-19 vaccination prior to the recognition of vaccine-induced thrombocytopenia and thrombosis: A self-controlled case series study in England","volume":"6","author":"Higgins","year":"2022","journal-title":"Res. Pract. Thromb. Haemost."},{"key":"ref_12","unstructured":"Weldeselassie, Y., Whitaker, H., and Farrington, P. (2024, January 22). SCCS: The Self-Controlled Case-Series Method. Available online: https:\/\/CRAN.R-project.org\/package=SCCS."},{"key":"ref_13","unstructured":"Hawken, S. (2024, January 22). Time to Detect a Safety Signal in an SCCS Surveillance Analysis. Available online: https:\/\/stevenhawken.shinyapps.io\/sccs_time_to_detect\/."},{"key":"ref_14","unstructured":"Xavier-Carter, B. (2024, January 22). Ontario Tops 50,000 Vaccine Doses Administered on One Day for First Time. Toronto Star. Available online: https:\/\/www.thestar.com\/news\/gta\/ontario-tops-50-000-vaccine-doses-administered-on-one-day-for-first-time\/article_ac657ec9-a366-5bc4-b213-4ffe2daa9b48.html."},{"key":"ref_15","doi-asserted-by":"crossref","first-page":"1680","DOI":"10.1056\/NEJMoa2109908","article-title":"Clinical Features of Vaccine-Induced Immune Thrombocytopenia and Thrombosis","volume":"385","author":"Pavord","year":"2021","journal-title":"N. Engl. J. Med."},{"key":"ref_16","doi-asserted-by":"crossref","first-page":"S47","DOI":"10.1016\/S0264-410X(01)00291-2","article-title":"Detection of Adverse Events: What are the Current Sensitivity Limits during Clinical Development?","volume":"20","author":"Fritzell","year":"2001","journal-title":"Vaccine"},{"key":"ref_17","doi-asserted-by":"crossref","first-page":"E1529","DOI":"10.1503\/cmaj.220676","article-title":"Observed versus expected rates of myocarditis after SARS-CoV-2 vaccination: A population-based cohort study","volume":"194","author":"Naveed","year":"2022","journal-title":"CMAJ"},{"key":"ref_18","unstructured":"News CBC (2024, January 22). \u201cMild Risk\u201d Prompts Ontario to Recommend Pfizer over Moderna for Those Aged 18\u201324 | CBC News. CBC. Available online: https:\/\/www.cbc.ca\/news\/canada\/toronto\/covid-19-ontario-september-29-moore-briefing-update-1.6193455."},{"key":"ref_19","doi-asserted-by":"crossref","unstructured":"Barker CIS, Snape MD (2014). Pandemic influenza A H1N1 vaccines and narcolepsy: Vaccine safety surveillance in action. Lancet Infect. Diseases, 14, 227\u2013238.","DOI":"10.1016\/S1473-3099(13)70238-X"},{"key":"ref_20","doi-asserted-by":"crossref","first-page":"321","DOI":"10.1086\/603560","article-title":"\u201cPrepandemic\u201d Immunization for Novel Influenza Viruses, \u201cSwine Flu\u201d Vaccine, Guillain-Barr\u00e9 Syndrome, and the Detection of Rare Severe Adverse Events","volume":"200","author":"Evans","year":"2009","journal-title":"J. Infect. Dis."},{"key":"ref_21","doi-asserted-by":"crossref","first-page":"769","DOI":"10.1016\/S1473-3099(13)70104-X","article-title":"Risk of Guillain-Barr\u00e9 syndrome after seasonal influenza vaccination and influenza health-care encounters: A self-controlled study","volume":"13","author":"Kwong","year":"2013","journal-title":"Lancet Infect. Dis."},{"key":"ref_22","unstructured":"(2024, January 22). CNODES | About CNODES. Available online: https:\/\/www.cnodes.ca\/about\/."},{"key":"ref_23","unstructured":"(2024, January 22). Home | Global Vaccine Data Network. Available online: https:\/\/www.globalvaccinedatanetwork.org\/."}],"container-title":["Vaccines"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2076-393X\/12\/9\/1052\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,10]],"date-time":"2025-10-10T15:56:21Z","timestamp":1760111781000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2076-393X\/12\/9\/1052"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,9,14]]},"references-count":23,"journal-issue":{"issue":"9","published-online":{"date-parts":[[2024,9]]}},"alternative-id":["vaccines12091052"],"URL":"https:\/\/doi.org\/10.3390\/vaccines12091052","relation":{},"ISSN":["2076-393X"],"issn-type":[{"value":"2076-393X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,9,14]]}}}