James G Donahue1, Burney A Kieke2, Jennifer P King3, Frank DeStefano4, Maria A Mascola5, Stephanie A Irving6, T Craig Cheetham7, Jason M Glanz8, Lisa A Jackson9, Nicola P Klein10, Allison L Naleway11, Eric Weintraub12, Edward A Belongia13. 1. Marshfield Clinic Research Institute, 1000 N. Oak Ave, Marshfield, WI 54449, United States. Electronic address: donahue.james@mcrf.mfldclin.edu. 2. Marshfield Clinic Research Institute, 1000 N. Oak Ave, Marshfield, WI 54449, United States. Electronic address: kieke.burney@mcrf.mfldclin.edu. 3. Marshfield Clinic Research Institute, 1000 N. Oak Ave, Marshfield, WI 54449, United States. Electronic address: king.jennifer@mcrf.mfldclin.edu. 4. Centers for Disease Control and Prevention, Immunization Safety Office, 1600 Clifton Road NE, MS-D26 Atlanta, GA 30333, United States. Electronic address: fxd1@cdc.gov. 5. Marshfield Clinic, Department of Obstetrics and Gynecology, 1000 N. Oak Ave, Marshfield, WI 54449, United States. Electronic address: mascola.maria@marshfieldclinic.org. 6. Kaiser Permanente Northwest, 3800 N. Interstate Ave, Portland, OR 97227, United States. Electronic address: stephanie.a.irving@kpchr.org. 7. Kaiser Permanente Southern California, 100 S. Los Robles Ave., 2nd Floor, Pasadena, CA 91101, United States. Electronic address: craig.t.cheetham@kp.org. 8. Kaiser Permanente Colorado, 10065 E. Harvard, Suite 300, Denver, CO 80231, United States. Electronic address: jason.m.glanz@kp.org. 9. Group Health Research Institute, 1730 Minor Avenue, Suite 1600, Seattle, WA 98101, United States. Electronic address: jackson.l@ghc.org. 10. Kaiser Permanente Northern California, 1 Kaiser Plaza, 16th Floor, Oakland, CA 94612, United States. Electronic address: Nicola.Klein@kp.org. 11. Kaiser Permanente Northwest, 3800 N. Interstate Ave, Portland, OR 97227, United States. Electronic address: Allison.Naleway@kpchr.org. 12. Centers for Disease Control and Prevention, Immunization Safety Office, 1600 Clifton Road NE, MS-D26 Atlanta, GA 30333, United States. Electronic address: eiw8@cdc.gov. 13. Marshfield Clinic Research Institute, 1000 N. Oak Ave, Marshfield, WI 54449, United States. Electronic address: belongia.edward@marshfieldclinic.org.
Abstract
INTRODUCTION: Inactivated influenza vaccine is recommended in any stage of pregnancy, but evidence of safety in early pregnancy is limited, including for vaccines containing A/H1N1pdm2009 (pH1N1) antigen. We sought to determine if receipt of vaccine containing pH1N1 was associated with spontaneous abortion (SAB). METHODS: We conducted a case-control study over two influenza seasons (2010-11, 2011-12) in the Vaccine Safety Datalink. Cases had SAB and controls had live births or stillbirths and were matched on site, date of last menstrual period, and age. Of 919 potential cases identified using diagnosis codes, 485 were eligible and confirmed by medical record review. Exposure was defined as vaccination with inactivated influenza vaccine before the SAB date; the primary exposure window was the 1-28days before the SAB. RESULTS: The overall adjusted odds ratio (aOR) was 2.0 (95% CI, 1.1-3.6) for vaccine receipt in the 28-day exposure window; there was no association in other exposure windows. In season-specific analyses, the aOR in the 1-28days was 3.7 (95% CI 1.4-9.4) in 2010-11 and 1.4 (95% CI 0.6-3.3) in 2011-12. The association was modified by influenza vaccination in the prior season (post hoc analysis). Among women who received pH1N1-containing vaccine in the previous influenza season, the aOR in the 1-28days was 7.7 (95% CI 2.2-27.3); the aOR was 1.3 (95% CI 0.7-2.7) among women not vaccinated in the previous season. This effect modification was observed in each season. CONCLUSION: SAB was associated with influenza vaccination in the preceding 28days. The association was significant only among women vaccinated in the previous influenza season with pH1N1-containing vaccine. This study does not and cannot establish a causal relationship between repeated influenza vaccination and SAB, but further research is warranted.
INTRODUCTION: Inactivated influenza vaccine is recommended in any stage of pregnancy, but evidence of safety in early pregnancy is limited, including for vaccines containing A/H1N1pdm2009 (pH1N1) antigen. We sought to determine if receipt of vaccine containing pH1N1 was associated with spontaneous abortion (SAB). METHODS: We conducted a case-control study over two influenza seasons (2010-11, 2011-12) in the Vaccine Safety Datalink. Cases had SAB and controls had live births or stillbirths and were matched on site, date of last menstrual period, and age. Of 919 potential cases identified using diagnosis codes, 485 were eligible and confirmed by medical record review. Exposure was defined as vaccination with inactivated influenza vaccine before the SAB date; the primary exposure window was the 1-28days before the SAB. RESULTS: The overall adjusted odds ratio (aOR) was 2.0 (95% CI, 1.1-3.6) for vaccine receipt in the 28-day exposure window; there was no association in other exposure windows. In season-specific analyses, the aOR in the 1-28days was 3.7 (95% CI 1.4-9.4) in 2010-11 and 1.4 (95% CI 0.6-3.3) in 2011-12. The association was modified by influenza vaccination in the prior season (post hoc analysis). Among women who received pH1N1-containing vaccine in the previous influenza season, the aOR in the 1-28days was 7.7 (95% CI 2.2-27.3); the aOR was 1.3 (95% CI 0.7-2.7) among women not vaccinated in the previous season. This effect modification was observed in each season. CONCLUSION: SAB was associated with influenza vaccination in the preceding 28days. The association was significant only among women vaccinated in the previous influenza season with pH1N1-containing vaccine. This study does not and cannot establish a causal relationship between repeated influenza vaccination and SAB, but further research is warranted.
Authors: Elyse O Kharbanda; Gabriela Vazquez-Benitez; Heather S Lipkind; Sangini S Sheth; Jingyi Zhu; Allison L Naleway; Nicola P Klein; Rulin Hechter; Matthew F Daley; James G Donahue; Michael L Jackson; Alison Tse Kawai; Lakshmi Sukumaran; James D Nordin Journal: Obstet Gynecol Date: 2018-07 Impact factor: 7.661
Authors: Elizabeth P Schlaudecker; Lilliam Ambroggio; Monica M McNeal; Fred D Finkelman; Sing Sing Way Journal: Vaccine Date: 2018-06-22 Impact factor: 3.641
Authors: Bahaa Abu-Raya; Kirsten Maertens; Kathryn M Edwards; Saad B Omer; Janet A Englund; Katie L Flanagan; Matthew D Snape; Gayatri Amirthalingam; Elke Leuridan; Pierre Van Damme; Vana Papaevangelou; Odile Launay; Ron Dagan; Magda Campins; Anna Franca Cavaliere; Tiziana Frusca; Sofia Guidi; Miguel O'Ryan; Ulrich Heininger; Tina Tan; Ahmed R Alsuwaidi; Marco A Safadi; Luz M Vilca; Nasamon Wanlapakorn; Shabir A Madhi; Michelle L Giles; Roman Prymula; Shamez Ladhani; Federico Martinón-Torres; Litjen Tan; Lessandra Michelin; Giovanni Scambia; Nicola Principi; Susanna Esposito Journal: Front Immunol Date: 2020-06-24 Impact factor: 7.561
Authors: Lisa A Grohskopf; Leslie Z Sokolow; Karen R Broder; Emmanuel B Walter; Alicia M Fry; Daniel B Jernigan Journal: MMWR Recomm Rep Date: 2018-08-24