Abstract
Objectives: To estimate the risk of recurrence of adverse events following immunization (AEFIs) upon revaccination and to determine among patients with suspected vaccine allergy whether allergy skin test positivity was associated with AEFI recurrence. Study design: This prospective observational study included patients assessed in the Canadian Special Immunization Clinic Network from 2013 to 2019 with AEFIs who required revaccination with the vaccine temporally associated with their AEFI. Participants underwent standardized assessment and data collection. Special Immunization Clinic physicians used guidelines to inform their recommendations. Participants were followed up after revaccination to capture AEFI recurrences. Data were transferred to a central database for descriptive analysis. Results: Overall, 588 participants were assessed for 627 AEFIs; 570 (91%) AEFIs occurred in children <18 years of age. AEFIs included immediate hypersensitivity (130/627; 21%), large local reactions (110/627; 18%), nonurticarial rash (51/627; 8%), seizures (26/627; 4%), and thrombocytopenia (11/627; 2%). Revaccination was recommended to 513 of 588 (87%) participants. Among participants recommended and due for revaccination during the study period, 63% (299/477) were revaccinated. AEFI recurrence was 10% (31/299) overall, 31% (15/49) for large local reactions, and 7% (5/66) for immediate hypersensitivity. No recurrence was serious. Among 92 participants with suspected vaccine allergy who underwent skin testing and were revaccinated, the negative predictive value of skin testing for AEFI recurrence was 96% (95% CI 92.5%-99.5%). Conclusions: Most individuals with AEFIs were safely revaccinated. Among those with suspected vaccine allergy, skin testing may help determine the safety of revaccination.
| Original language | English |
|---|---|
| Journal | Journal of Pediatrics |
| DOIs | |
| Publication status | Accepted/In press - 2022 |
Bibliographical note
Funding Information:This study was funded by the Public Health Agency of Canada and Canadian Institutes of Health Research as part of the Canadian Immunization Research Network (to S.H., A.P.-H., W.V., J.P., F.B., C.C., B.T., M.S., F.N., S.M., A.M., G.D.S., K.T.). C.M. was supported by the Dalhousie Faculty of Medicine-Dalhousie Medical Research Foundation 2019 Infection, Immunity, Inflammation, and Vaccinology (I3V) Graduate Studentship. B.M. was supported by the Dalhousie University Faculty of Medicine Professor Murray MacNeill Summer Medical Research Studentship. M.S. is supported via salary awards from the BC Children's Hospital Foundation and Michael Smith Health Research BC. The other authors received no additional funding. The funders had no role in the study design, data collection or analysis, manuscript preparation or the decision to submit for publication. Z.A. reports honoraria for speaker fees for Pfizer, Sanofi-Genzyme, and Merck, as well as the advisory board for Sanofi-Genzyme, all outside of the submitted work. C.C. reports honoraria for speaker fees for GlaxoSmithKline (GSK) and Merck, all outside of the submitted work, and grants as co-investigator from GSK and Merck. J.C. reports consultancy fees from Takeda, OctaPharma, GSK, Sanofi, Alexion, EMD serono, and grants from Octapharma outside of the submitted work. G.D.S. reports grants outside the submitted work from Pfizer. S.H. has served on ad hoc advisory committees and received contracts for undertaking clinical trials from multiple vaccine manufacturers outside the submitted work. A.M. has served on an advisory board for Pfizer and Viiv outside of the submitted work. S.M. is co-PI on an investigator led grant from Pfizer, has served on an advisory board for Pfizer, and has received speaker's fees from GSK, all outside of the submitted work. J.P. reports grants from MedImmune outside the submitted work. M.S. has been an investigator on projects funded by GSK, Merck, Moderna, Pfizer, Sanofi Pasteur, Seqirus, Symvivo, and VBI Vaccines; all funds have been paid to his institute, and he has not received any personal payments. B.T. reports research grants from GSK, Merck, and Pfizer, all outside of the submitted work. K.T. reports grants from GSK outside the submitted work. J.U. reports investigator-lead clinical trial support from Novartis, speaker fees from Astra Zeneca, and has served on an advisory board for Pfizer, all outside the submitted work. M.M. has been on advisory board for Sanofi Genzyme outside of the submitted work. K.H. is a voting member of the National Advisory Committee on Immunization and a member of the board of directors for the Canadian Society of Allergy and Clinical Immunology. W.V. has served on an advisory board for Sanofi outside the submitted work. All other authors declare no conflicts of interest.
Funding Information:
This study was funded by the Public Health Agency of Canada and Canadian Institutes of Health Research as part of the Canadian Immunization Research Network (to S.H., A.P.-H., W.V., J.P., F.B., C.C., B.T., M.S., F.N., S.M., A.M., G.D.S., K.T.). C.M. was supported by the Dalhousie Faculty of Medicine-Dalhousie Medical Research Foundation 2019 Infection, Immunity, Inflammation, and Vaccinology (I3V) Graduate Studentship. B.M. was supported by the Dalhousie University Faculty of Medicine Professor Murray MacNeill Summer Medical Research Studentship . M.S. is supported via salary awards from the BC Children's Hospital Foundation and Michael Smith Health Research BC . The other authors received no additional funding. The funders had no role in the study design, data collection or analysis, manuscript preparation or the decision to submit for publication. Z.A. reports honoraria for speaker fees for Pfizer, Sanofi-Genzyme, and Merck, as well as the advisory board for Sanofi-Genzyme, all outside of the submitted work. C.C. reports honoraria for speaker fees for GlaxoSmithKline (GSK) and Merck, all outside of the submitted work, and grants as co-investigator from GSK and Merck . J.C. reports consultancy fees from Takeda, OctaPharma, GSK, Sanofi, Alexion, EMD serono, and grants from Octapharma outside of the submitted work. G.D.S. reports grants outside the submitted work from Pfizer . S.H. has served on ad hoc advisory committees and received contracts for undertaking clinical trials from multiple vaccine manufacturers outside the submitted work. A.M. has served on an advisory board for Pfizer and Viiv outside of the submitted work. S.M. is co-PI on an investigator led grant from Pfizer , has served on an advisory board for Pfizer, and has received speaker's fees from GSK, all outside of the submitted work. J.P. reports grants from MedImmune outside the submitted work. M.S. has been an investigator on projects funded by GSK , Merck , Moderna , Pfizer , Sanofi Pasteur , Seqirus , Symvivo , and VBI Vaccines ; all funds have been paid to his institute, and he has not received any personal payments. B.T. reports research grants from GSK , Merck , and Pfizer , all outside of the submitted work. K.T. reports grants from GSK outside the submitted work. J.U. reports investigator-lead clinical trial support from Novartis , speaker fees from Astra Zeneca, and has served on an advisory board for Pfizer, all outside the submitted work. M.M. has been on advisory board for Sanofi Genzyme outside of the submitted work. K.H. is a voting member of the National Advisory Committee on Immunization and a member of the board of directors for the Canadian Society of Allergy and Clinical Immunology. W.V. has served on an advisory board for Sanofi outside the submitted work. All other authors declare no conflicts of interest.
Publisher Copyright:
© 2022 The Author(s)
ASJC Scopus Subject Areas
- Pediatrics, Perinatology, and Child Health
PubMed: MeSH publication types
- Journal Article
- Observational Study
