James G Donahue1, Burney A Kieke2, Jennifer P King3, Maria A Mascola4, Tom T Shimabukuro5, Frank DeStefano6, Kayla E Hanson7, David L McClure8, Oluwatosin Olaiya9, Jason M Glanz10, Rulin C Hechter11, Stephanie A Irving12, Lisa A Jackson13, Nicola P Klein14, Allison L Naleway15, Eric S Weintraub16, Edward A Belongia17. 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@marshfieldresearch.org. 3. Marshfield Clinic Research Institute, 1000 N Oak Ave, Marshfield, WI 54449, United States. Electronic address: king.jennifer@marshfieldresearch.org. 4. Marshfield Clinic, Department of Obstetrics and Gynecology, 1000 N Oak Ave, Marshfield, WI 54449, United States. Electronic address: mascola.maria@marshfieldclinic.org. 5. Centers for Disease Control and Prevention, Immunization Safety Office, 1600 Clifton Road NE, MS V18-4 Atlanta, GA 30329, United States. Electronic address: ayv6@cdc.gov. 6. Centers for Disease Control and Prevention, Immunization Safety Office, 1600 Clifton Road NE, MS V18-4 Atlanta, GA 30329, United States. Electronic address: fxd1@cdc.gov. 7. Marshfield Clinic Research Institute, 1000 N Oak Ave, Marshfield, WI 54449, United States. Electronic address: hanson.kayla@marshfieldresearch.org. 8. Marshfield Clinic Research Institute, 1000 N Oak Ave, Marshfield, WI 54449, United States. Electronic address: mcclure.david@marshfieldresearch.org. 9. Marshfield Clinic Research Institute, 1000 N Oak Ave, Marshfield, WI 54449, United States. Electronic address: olaiya.oluwatosin@marshfieldresearch.org. 10. Kaiser Permanente Colorado, 10065 E Harvard Ave, Suite 300, Denver, CO 80231, United States. Electronic address: jason.m.glanz@kp.org. 11. Kaiser Permanente Southern California, 100 S Los Robles Ave., 2nd Floor, Pasadena, CA 91101, United States. Electronic address: rulin.c.hechter@kp.org. 12. Kaiser Permanente Northwest, 3800 N Interstate Ave, Portland, OR 97227, United States. Electronic address: stephanie.a.irving@kpchr.org. 13. Kaiser Permanente Washington, 1730 Minor Ave, Suite 1600, Seattle, WA 98101, United States. Electronic address: lisa.a.jackson@kp.org. 14. Kaiser Permanente Northern California, 1 Kaiser Plaza, 16th Floor, Oakland, CA 94612, United States. Electronic address: Nicola.Klein@kp.org. 15. Kaiser Permanente Northwest, 3800 N Interstate Ave, Portland, OR 97227, United States. Electronic address: Allison.Naleway@kpchr.org. 16. Centers for Disease Control and Prevention, Immunization Safety Office, 1600 Clifton Road NE, MS V18-4 Atlanta, GA 30329, United States. Electronic address: eiw8@cdc.gov. 17. Marshfield Clinic Research Institute, 1000 N Oak Ave, Marshfield, WI 54449, United States. Electronic address: belongia.edward@marshfieldclinic.org.
Abstract
INTRODUCTION: A recent study reported an association between inactivated influenza vaccine (IIV) and spontaneous abortion (SAB), but only among women who had also been vaccinated in the previous influenza season. We sought to estimate the association between IIV administered in three recent influenza seasons and SAB among women who were and were not vaccinated in the previous influenza season. METHODS: We conducted a case-control study over three influenza seasons (2012-13, 2013-14, 2014-15) in the Vaccine Safety Datalink (VSD). Cases (women with SAB) and controls (women with live births) were matched on VSD site, date of last menstrual period, age group, and influenza vaccination status in the previous influenza season. Of 1908 presumptive cases identified from the electronic record, 1236 were included in the main analysis. Administration of IIV was documented in several risk windows, including 1-28, 29-56, and >56 days before the SAB date. RESULTS: Among 627 matched pairs vaccinated in the previous season, no association was found between vaccination in the 1-28 day risk window and SAB (adjusted odds ratio (aOR) 0.9; 95% confidence interval (CI) 0.6-1.5). The season-specific aOR ranged from 0.5 to 1.7 with all CIs including the null value of 1.0. Similarly, no association was found among women who were not vaccinated in the previous season; the season-specific aOR in the 1-28 day risk window ranged from 0.6 to 0.7 and the 95% CI included 1.0 in each season. There was no association found between SAB and influenza vaccination in the other risk windows, or when vaccine receipt was analyzed relative to date of conception. CONCLUSION: During these seasons we found no association between IIV and SAB, including among women vaccinated in the previous season. These findings lend support to current recommendations for influenza vaccination at any time during pregnancy, including the first trimester.
INTRODUCTION: A recent study reported an association between inactivated influenza vaccine (IIV) and spontaneous abortion (SAB), but only among women who had also been vaccinated in the previous influenza season. We sought to estimate the association between IIV administered in three recent influenza seasons and SAB among women who were and were not vaccinated in the previous influenza season. METHODS: We conducted a case-control study over three influenza seasons (2012-13, 2013-14, 2014-15) in the Vaccine Safety Datalink (VSD). Cases (women with SAB) and controls (women with live births) were matched on VSD site, date of last menstrual period, age group, and influenza vaccination status in the previous influenza season. Of 1908 presumptive cases identified from the electronic record, 1236 were included in the main analysis. Administration of IIV was documented in several risk windows, including 1-28, 29-56, and >56 days before the SAB date. RESULTS: Among 627 matched pairs vaccinated in the previous season, no association was found between vaccination in the 1-28 day risk window and SAB (adjusted odds ratio (aOR) 0.9; 95% confidence interval (CI) 0.6-1.5). The season-specific aOR ranged from 0.5 to 1.7 with all CIs including the null value of 1.0. Similarly, no association was found among women who were not vaccinated in the previous season; the season-specific aOR in the 1-28 day risk window ranged from 0.6 to 0.7 and the 95% CI included 1.0 in each season. There was no association found between SAB and influenza vaccination in the other risk windows, or when vaccine receipt was analyzed relative to date of conception. CONCLUSION: During these seasons we found no association between IIV and SAB, including among women vaccinated in the previous season. These findings lend support to current recommendations for influenza vaccination at any time during pregnancy, including the first trimester.
Authors: Flor M Munoz; Anthony J Greisinger; Oscar A Wehmanen; Melanie E Mouzoon; James C Hoyle; Frances A Smith; W Paul Glezen Journal: Am J Obstet Gynecol Date: 2005-04 Impact factor: 8.661
Authors: James Baggs; Julianne Gee; Edwin Lewis; Gabrielle Fowler; Patti Benson; Tracy Lieu; Allison Naleway; Nicola P Klein; Roger Baxter; Edward Belongia; Jason Glanz; Simon J Hambidge; Steven J Jacobsen; Lisa Jackson; Jim Nordin; Eric Weintraub Journal: Pediatrics Date: 2011-04-18 Impact factor: 7.124
Authors: Stephanie A Irving; Burney A Kieke; James G Donahue; Maria A Mascola; James Baggs; Frank DeStefano; T Craig Cheetham; Lisa A Jackson; Allison L Naleway; Jason M Glanz; James D Nordin; Edward A Belongia Journal: Obstet Gynecol Date: 2013-01 Impact factor: 7.661
Authors: Björn Pasternak; Henrik Svanström; Ditte Mølgaard-Nielsen; Tyra G Krause; Hanne-Dorthe Emborg; Mads Melbye; Anders Hviid Journal: BMJ Date: 2012-05-02
Authors: Deshayne B Fell; Eduardo Azziz-Baumgartner; Michael G Baker; Maneesh Batra; Julien Beauté; Philippe Beutels; Niranjan Bhat; Zulfiqar A Bhutta; Cheryl Cohen; Bremen De Mucio; Bradford D Gessner; Michael G Gravett; Mark A Katz; Marian Knight; Vernon J Lee; Mark Loeb; Johannes M Luteijn; Helen Marshall; Harish Nair; Kevin Pottie; Rehana A Salam; David A Savitz; Suzanne J Serruya; Becky Skidmore; Justin R Ortiz Journal: Vaccine Date: 2017-09-01 Impact factor: 3.641
Authors: Lisa A Grohskopf; Lenee H Blanton; Jill M Ferdinands; Jessie R Chung; Karen R Broder; H Keipp Talbot; Rebecca L Morgan; Alicia M Fry Journal: MMWR Recomm Rep Date: 2022-08-26
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: Allison L Naleway; Bradley Crane; Stephanie A Irving; Don Bachman; Kimberly K Vesco; Matthew F Daley; Darios Getahun; Sungching C Glenn; Simon J Hambidge; Lisa A Jackson; Nicola P Klein; Natalie L McCarthy; David L McClure; Lakshmi Panagiotakopoulos; Catherine A Panozzo; Gabriela Vazquez-Benitez; Eric S Weintraub; Ousseny Zerbo; Elyse O Kharbanda Journal: Ther Adv Drug Saf Date: 2021-06-14