Using Vaccine Safety Data to Demonstrate the Potential of Pooled Data Analysis
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 sig...
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| Format: | Article |
| Language: | English |
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MDPI AG
2024-09-01
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| Series: | Vaccines |
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| Online Access: | https://www.mdpi.com/2076-393X/12/9/1052 |
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| author | Steven Hawken Lindsay A. Wilson Kumanan Wilson |
| author_facet | Steven Hawken Lindsay A. Wilson Kumanan Wilson |
| author_sort | Steven Hawken |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-96b25bac49f942e1b174abe639b8aa07 |
| institution | OA Journals |
| issn | 2076-393X |
| language | English |
| publishDate | 2024-09-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Vaccines |
| spelling | doaj-art-96b25bac49f942e1b174abe639b8aa072025-08-20T01:55:57ZengMDPI AGVaccines2076-393X2024-09-01129105210.3390/vaccines12091052Using Vaccine Safety Data to Demonstrate the Potential of Pooled Data AnalysisSteven Hawken0Lindsay A. Wilson1Kumanan Wilson2Clinical Epidemiology Program, Ottawa Hospital Research Institute, 1053 Carling Avenue, Ottawa, ON K1Y 4E9, CanadaSchool of Population and Public Health, University of British Columbia, Vancouver, BC V6T 1Z3, CanadaClinical Epidemiology Program, Ottawa Hospital Research Institute, 1053 Carling Avenue, Ottawa, ON K1Y 4E9, CanadaIn 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.https://www.mdpi.com/2076-393X/12/9/1052adverse events following immunizationCOVID-19pooled dataself-controlled case seriesvaccine safety |
| spellingShingle | Steven Hawken Lindsay A. Wilson Kumanan Wilson Using Vaccine Safety Data to Demonstrate the Potential of Pooled Data Analysis Vaccines adverse events following immunization COVID-19 pooled data self-controlled case series vaccine safety |
| title | Using Vaccine Safety Data to Demonstrate the Potential of Pooled Data Analysis |
| title_full | Using Vaccine Safety Data to Demonstrate the Potential of Pooled Data Analysis |
| title_fullStr | Using Vaccine Safety Data to Demonstrate the Potential of Pooled Data Analysis |
| title_full_unstemmed | Using Vaccine Safety Data to Demonstrate the Potential of Pooled Data Analysis |
| title_short | Using Vaccine Safety Data to Demonstrate the Potential of Pooled Data Analysis |
| title_sort | using vaccine safety data to demonstrate the potential of pooled data analysis |
| topic | adverse events following immunization COVID-19 pooled data self-controlled case series vaccine safety |
| url | https://www.mdpi.com/2076-393X/12/9/1052 |
| work_keys_str_mv | AT stevenhawken usingvaccinesafetydatatodemonstratethepotentialofpooleddataanalysis AT lindsayawilson usingvaccinesafetydatatodemonstratethepotentialofpooleddataanalysis AT kumananwilson usingvaccinesafetydatatodemonstratethepotentialofpooleddataanalysis |