Elyse Olshen Kharbanda1, Gabriela Vazquez-Benitez2, Paul A Romitti3, Allison L Naleway4, T Craig Cheetham5, Heather S Lipkind6, Nicola P Klein7, Grace Lee8, Michael L Jackson9, Simon J Hambidge10, Natalie McCarthy11, Frank DeStefano11, James D Nordin2. 1. HealthPartners Institute, Minneapolis, MN. Electronic address: elyse.o.kharbanda@healthpartners.com. 2. HealthPartners Institute, Minneapolis, MN. 3. University of Iowa, Iowa City, IA. 4. Center for Health Research, Kaiser Permanente Northwest, Portland, OR. 5. Kaiser Permanente Southern California, Pasadena, CA. 6. Yale University School of Medicine, New Haven, CT. 7. Kaiser Permanente Northern California, Oakland, CA. 8. Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA. 9. Kaiser Permanente Washington Health Research Institute, Seattle, WA. 10. Institute for Health Research, Kaiser Permanente Colorado and Ambulatory Care Services, Denver Health, Colorado Springs, CO. 11. Centers for Disease Control and Prevention, Atlanta, GA.
Abstract
OBJECTIVE: To examine risks for major structural birth defects in infants after first trimester inactivated influenza vaccine (IIV) exposures. STUDY DESIGN: In this observational study, we used electronic health data from 7 Vaccine Safety Datalink sites to examine risks for selected major structural defects in infants after maternal IIV exposure. Vaccine exposures for women with continuous insurance enrollment through pregnancy who delivered singleton live births between 2004 and 2013 were identified from standardized files. Infants with continuous insurance enrollment were followed to 1 year of age. We excluded mother-infant pairs with other exposures that potentially increased their background risk for birth defects. Selected cardiac, orofacial or respiratory, neurologic, ophthalmologic or otologic, gastrointestinal, genitourinary and muscular or limb defects were identified from diagnostic codes in infant medical records using validated algorithms. Propensity score adjusted generalized estimating equations were used to estimate prevalence ratios (PRs). RESULTS: We identified 52 856 infants with maternal first trimester IIV exposure and 373 088 infants whose mothers were unexposed to IIV during first trimester. Prevalence (per 100 live births) for selected major structural birth defects was 1.6 among first trimester IIV exposed versus 1.5 among unexposed mothers. The adjusted PR was 1.02 (95% CI 0.94-1.10). Organ system-specific PRs were similar to the overall PR. CONCLUSION: First trimester maternal IIV exposure was not associated with an increased risk for selected major structural birth defects in this large cohort of singleton live births.
OBJECTIVE: To examine risks for major structural birth defects in infants after first trimester inactivated influenza vaccine (IIV) exposures. STUDY DESIGN: In this observational study, we used electronic health data from 7 Vaccine Safety Datalink sites to examine risks for selected major structural defects in infants after maternal IIV exposure. Vaccine exposures for women with continuous insurance enrollment through pregnancy who delivered singleton live births between 2004 and 2013 were identified from standardized files. Infants with continuous insurance enrollment were followed to 1 year of age. We excluded mother-infant pairs with other exposures that potentially increased their background risk for birth defects. Selected cardiac, orofacial or respiratory, neurologic, ophthalmologic or otologic, gastrointestinal, genitourinary and muscular or limb defects were identified from diagnostic codes in infant medical records using validated algorithms. Propensity score adjusted generalized estimating equations were used to estimate prevalence ratios (PRs). RESULTS: We identified 52 856 infants with maternal first trimester IIV exposure and 373 088 infants whose mothers were unexposed to IIV during first trimester. Prevalence (per 100 live births) for selected major structural birth defects was 1.6 among first trimester IIV exposed versus 1.5 among unexposed mothers. The adjusted PR was 1.02 (95% CI 0.94-1.10). Organ system-specific PRs were similar to the overall PR. CONCLUSION: First trimester maternal IIV exposure was not associated with an increased risk for selected major structural birth defects in this large cohort of singleton live births.
Authors: Benjamin J S Al-Haddad; Elizabeth Oler; Blair Armistead; Nada A Elsayed; Daniel R Weinberger; Raphael Bernier; Irina Burd; Raj Kapur; Bo Jacobsson; Caihong Wang; Indira Mysorekar; Lakshmi Rajagopal; Kristina M Adams Waldorf Journal: Am J Obstet Gynecol Date: 2019-06-15 Impact factor: 8.661
Authors: Ajoke Sobanjo-Ter Meulen; Flor M Munoz; David C Kaslow; Keith P Klugman; Saad B Omer; Prachi Vora; Andy Stergachis Journal: Vaccine Date: 2019-04-04 Impact factor: 3.641
Authors: Elyse O Kharbanda; Gabriela Vazquez-Benitez; Malini B DeSilva; Alicen B Spaulding; Matthew F Daley; Allison L Naleway; Stephanie A Irving; Nicola P Klein; Hung Fu Tseng; Lisa A Jackson; Simon J Hambidge; Oluwatosin Olaiya; Catherine A Panozzo; Tanya R Myers; Paul A Romitti Journal: Pharmacoepidemiol Drug Saf Date: 2020-12-03 Impact factor: 2.732