Alison Tse Kawai1, David Martin2, Martin Kulldorff3, Lingling Li3, David V Cole3, Cheryl N McMahill-Walraven4, Nandini Selvam5, Mano S Selvan6, Grace M Lee7. 1. Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts; Alison_Kawai@harvardpilgrim.org. 2. US Food and Drug Administration Center for Biologics Evaluation and Research, Silver Spring, Maryland; 3. Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts; 4. Aetna, Blue Bell, Pennsylvania; 5. HealthCore, Wilmington, Delaware; 6. Comprehensive Health Insights, Humana Inc, Louisville, Kentucky; and. 7. Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts; Division of Infectious Diseases, Boston Children's Hospital, Boston, Massachusetts.
Abstract
OBJECTIVES: In the Post-Licensure Rapid Immunization Safety Monitoring Program, we examined risk of febrile seizures (FS) after trivalent inactivated influenza vaccine (TIV) and 13-valent pneumococcal conjugate vaccine (PCV13) during the 2010-2011 influenza season, adjusted for concomitant diphtheria tetanus acellular pertussis-containing vaccines (DTaP). Assuming children would receive both vaccines, we examined whether same-day TIV and PCV13 vaccination was associated with greater FS risk when compared with separate-day vaccination. METHODS: We used a self-controlled risk interval design, comparing the FS rate in a risk interval (0-1 days) versus control interval (14-20 days). Vaccinations were identified in claims and immunization registry data. FS were confirmed with medical records. RESULTS: No statistically significant TIV-FS associations were found in unadjusted or adjusted models (incidence rate ratio [IRR] adjusted for age, seasonality, and concomitant PCV13 and DTaP: 1.36, 95% confidence interval [CI] 0.78 to 2.39). Adjusted for age and seasonality, PCV13 was significantly associated with FS (IRR 1.74, 95% CI 1.06 to 2.86), but not when further adjusting for concomitant TIV and DTaP (IRR 1.61, 95% CI 0.91 to 2.82). Same-day TIV and PCV13 vaccination was not associated with excess risk of FS when compared with separate-day vaccination (1.08 fewer FS per 100 000 with same day administration, 95% CI -5.68 to 6.09). CONCLUSIONS: No statistically significant increased risk of FS was found for 2010-2011 TIV or PCV13, when adjusting for concomitant vaccines. Same-day TIV and PCV13 vaccination was not associated with more FS compared with separate-day vaccination.
OBJECTIVES: In the Post-Licensure Rapid Immunization Safety Monitoring Program, we examined risk of febrile seizures (FS) after trivalent inactivated influenza vaccine (TIV) and 13-valent pneumococcal conjugate vaccine (PCV13) during the 2010-2011 influenza season, adjusted for concomitant diphtheria tetanus acellular pertussis-containing vaccines (DTaP). Assuming children would receive both vaccines, we examined whether same-day TIV and PCV13 vaccination was associated with greater FS risk when compared with separate-day vaccination. METHODS: We used a self-controlled risk interval design, comparing the FS rate in a risk interval (0-1 days) versus control interval (14-20 days). Vaccinations were identified in claims and immunization registry data. FS were confirmed with medical records. RESULTS: No statistically significant TIV-FS associations were found in unadjusted or adjusted models (incidence rate ratio [IRR] adjusted for age, seasonality, and concomitant PCV13 and DTaP: 1.36, 95% confidence interval [CI] 0.78 to 2.39). Adjusted for age and seasonality, PCV13 was significantly associated with FS (IRR 1.74, 95% CI 1.06 to 2.86), but not when further adjusting for concomitant TIV and DTaP (IRR 1.61, 95% CI 0.91 to 2.82). Same-day TIV and PCV13 vaccination was not associated with excess risk of FS when compared with separate-day vaccination (1.08 fewer FS per 100 000 with same day administration, 95% CI -5.68 to 6.09). CONCLUSIONS: No statistically significant increased risk of FS was found for 2010-2011 TIV or PCV13, when adjusting for concomitant vaccines. Same-day TIV and PCV13 vaccination was not associated with more FS compared with separate-day vaccination.
Authors: Shirley V Wang; Abdurrahman Abdurrob; Julia Spoendlin; Edwin Lewis; Sophia R Newcomer; Bruce Fireman; Matthew F Daley; Jason M Glanz; Jonathan Duffy; Eric S Weintraub; Martin Kulldorff Journal: Pharmacoepidemiol Drug Saf Date: 2018-02-13 Impact factor: 2.890
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Authors: Shirley V Wang; Kristina Stefanini; Edwin Lewis; Sophia R Newcomer; Bruce Fireman; Matthew F Daley; Jason M Glanz; Jonathan Duffy; Eric Weintraub; Martin Kulldorff Journal: Drug Saf Date: 2020-10 Impact factor: 5.606
Authors: Weiling Katherine Yih; Martin Kulldorff; Sukhminder K Sandhu; Lauren Zichittella; Judith C Maro; David V Cole; Robert Jin; Alison Tse Kawai; Meghan A Baker; Chunfu Liu; Cheryl N McMahill-Walraven; Mano S Selvan; Richard Platt; Michael D Nguyen; Grace M Lee Journal: Pharmacoepidemiol Drug Saf Date: 2015-11-17 Impact factor: 2.890