Fetal death and preterm birth associated with maternal influenza vaccination: Systematic review

BJOG: An International Journal of Obstetrics and Gynaecology

Volumn 122, Issue 1, 2015, Pages 17-26

  Fell, D B ^a,b   Platt, R W ^a   Lanes, A ^c   Wilson, K ^b,d,e   Kaufman, J S ^a   Basso, O ^a   Buckeridge, D ^a  

^a MCGILL UNIVERSITY   (Canada)

^b OTTAWA HOSPITAL RESEARCH INSTITUTE   (Canada)

^c UNIVERSITY OF OTTAWA   (Canada)

^d UNIVERSITY OF OTTAWA   (Canada)

^e INSTITUTE FOR CLINICAL EVALUATIVE SCIENCES   (Canada)

Author keywords

Fetal death; influenza vaccination; monovalent pandemic H1N1 vaccine; preterm birth; systematic review; trivalent inactivated influenza vaccine

Indexed keywords

INFLUENZA VACCINE;

FETUS DEATH; GESTATIONAL AGE; HUMAN; INFLUENZA; INFLUENZA A (H1N1); INFLUENZA VACCINATION; INFLUENZA VIRUS A H1N1; PREMATURE LABOR; PRENATAL EXPOSURE; REVIEW; FEMALE; FETUS MORTALITY; INFLUENZA, HUMAN; PERINATAL MORTALITY; PREGNANCY; PREGNANCY COMPLICATIONS, INFECTIOUS; PREGNANCY OUTCOME; PREMATURE BIRTH; RISK FACTOR;

FEMALE; FETAL DEATH; FETAL MORTALITY; GESTATIONAL AGE; HUMANS; INFLUENZA VACCINES; INFLUENZA, HUMAN; PERINATAL MORTALITY; PREGNANCY; PREGNANCY COMPLICATIONS, INFECTIOUS; PREGNANCY OUTCOME; PREMATURE BIRTH; RISK FACTORS;

EID: 84920173386     PISSN: 14700328     EISSN: 14710528     Source Type: Journal    
DOI: 10.1111/1471-0528.12977     Document Type: Review

References (75)

1. Pazos M, Sperling RS, Moran TM, Kraus TA,. The influence of pregnancy on systemic immunity. Immunol Res 2012; 54: 254-61.
2. Jamieson DJ, Theiler RN, Rasmussen SA,. Emerging infections and pregnancy. Emerg Infect Dis 2006; 12: 1638-43.
3. Steinhoff MC, MacDonald NE,. Influenza pandemics-pregnancy, pathogenesis, and perinatal outcomes. J Am Med Assoc 2012; 308: 184-5.
4. Steinhoff MC, Omer SB,. A review of fetal and infant protection associated with antenatal influenza immunization. Am J Obstet Gynecol 2012; 207: S21-7.
5. Harris J,. Influenza occurring in pregnant women. J Am Med Assoc 1919; 72: 978-80.
6. Freeman DW, Barno A,. Deaths from Asian influenza associated with pregnancy. Am J Obstet Gynecol 1959; 78: 1172-5.
7. Pierce M, Kurinczuk JJ, Spark P, Brocklehurst P, Knight M,. Perinatal outcomes after maternal 2009/H1N1 infection: national cohort study. BMJ 2011; 342: d3214.
8. Håberg SE, Trogstad L, Gunnes N, Wilcox AJ, Gjessing HK, Samuelsen SO, et al. Risk of fetal death after pandemic influenza virus infection or vaccination. N Engl J Med 2013; 368: 333-40.
9. Hartert TV, Neuzil KM, Shintani AK, Mitchel EF, Snowden MS, Wood LB, et al. Maternal morbidity and perinatal outcomes among pregnant women with respiratory hospitalizations during influenza season. Am J Obstet Gynecol 2003; 189: 1705-12.
10. McNeil SA, Dodds LA, Fell DB, Allen VM, Halperin BA, Steinhoff MC, et al. Effect of respiratory hospitalization during pregnancy on infant outcomes. Am J Obstet Gynecol 2011; 204: S54-7.
11. Irving WL, James DK, Stephenson T, Laing P, Jameson C, Oxford JS, et al. Influenza virus infection in the second and third trimesters of pregnancy: a clinical and seroepidemiological study. BJOG 2007; 107: 1282-9.
12. Bánhidy F, Acs N, Puhõ EH, Czeizel AE,. Maternal acute respiratory infectious diseases during pregnancy and birth outcomes. Eur J Epidemiol 2008; 23: 29-35.
13. National Advisory Committee on Immunization (NACI). Statement on seasonal influenza vaccine for 2011-2012. Can Commun Dis Rep 2011; 37: 1-55.
14. Gruslin A, Steben M, Halperin S, Money DM, Yudin MH,. Immunization in pregnancy. J Obstet Gynaecol Can 2009; 31: 1085-101.
15. ACOG Committee Opinion Number 305, November 2004. Influenza vaccination and treatment during pregnancy. Obstet Gynecol 2004; 104: 1125-6.
16. Mak T, Mangtani P, Leese J,. Influenza vaccination in pregnancy: current evidence and selected national policies. Lancet Infect Dis 2008; 8: 44-52.
17. Luteijn JM, Dolk H, Marnoch GJ,. Differences in pandemic influenza vaccination policies for pregnant women in Europe. BMC Public Health 2011; 11: 819.
18. Artenstein AW,. Influenza. In:, Artenstein AW, editor. Vaccines: A Biography. New York, NY: Springer; 2010. pp 191-205.
19. Fiore AE, Uyeki TM, Broder K, Finelli L, Euler GL, Singleton JA, et al. Prevention and control of influenza with vaccines: recommendations of the Advisory Committee on Immunization Practices (ACIP), 2010. Morb Mortal Wkly Rep 2010; 59: 1-62.
20. Schatz M, Chambers CD, Jones KL, Louik C, Mitchell AA,. Safety of influenza immunizations and treatment during pregnancy: the Vaccines and Medications in Pregnancy Surveillance System. Am J Obstet Gynecol 2011; 204: S64-8.
21. MacDonald NE, Riley LE, Steinhoff MC,. Influenza immunization in pregnancy. Obstet Gynecol 2009; 114: 365-8.
22. Centers for Disease Control. Use of influenza A (H1N1) 2009 monovalent vaccine: recommendations of the Advisory Committee on Immunization Practices (ACIP), 2009. Morb Mortal Wkly Rep 2009; 58: 1-8.
23. World Health Organization. Pregnancy and pandemic influenza A (H1N1) 2009: Information for programme managers and clinicians. 2009 [ www.who.int/csr/resources/publications/swineflu/h1n1-guidance-pregnancy.pdf ]. Accessed 11 January 2014.
24. Centers for Disease Control. Seasonal influenza and 2009 H1N1 influenza vaccination coverage among pregnant women -10 states, 2009-10 influenza season. Morb Mortal Wkly Rep 2010; 59: 1541-5.
25. Liu N, Sprague AE, Yasseen AS III, Fell DB, Wen SW, Smith GN, et al. Vaccination patterns in pregnant women during the 2009 H1N1 influenza pandemic: a population-based study in Ontario, Canada. Can J Public Health 2012; 103: 353-8.
26. Gilmour H, Hofmann N,. H1N1 vaccination. Health Rep 2010; 21: 63-9.
27. Stewart L, Moher D, Shekelle P,. Why prospective registration of systematic reviews makes sense. Syst Rev 2012; 1: 7.
28. Moher D, Liberati A, Tetzlaff J, Altman DG,; PRISMA Group. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. BMJ 2009; 339: b2535.
29. McGowan J, Sampson M, Lefebvre C,. Evidence based checklist for the peer review of electronic search strategies (PRESS EBC). Evid Based Libr Inf Pract 2010; 5: 149-54. [ http://ejournals.library.ualberta.ca/index.php/EBLIP/article/view/7402/6436 ]. Accessed 11 January 2014.
30. Ahrens K,. Consequences of controlling viral diseases during pregnancy: antiherpetic medication and influenza vaccination. PhD Dissertation, Boston University, 2012: 36-67.
31. Wells GA, Shea B, O'Connell D, Peterson J, Welch V, Losos MTP,. The Newcastle-Ottawa Scale (NOS) for Assessing the Quality of Nonrandomized Studies in Meta-Analyses. Ottawa, ON: Ottawa Hospital Research Institute. [ www.ohri.ca/programs/clinical-epidemiology/oxford.htm ]. Accessed 11 January 2014.
32. Downs SH, Black N,. The feasibility of creating a checklist for the assessment of the methodological quality both of randomised and non-randomised studies of health care interventions. J Epidemiol Community Health 1998; 52: 377-84.
33. Deeks JJ, Higgins JPT, Altman DG, on behalf of the Cochrane Statistical Methods Group. Analysing data and undertaking meta-analyses. In:, Higgins JPT, Green S, editors. Cochrane Handbook for Systematic Reviews of Interventions, Version 5.1.0 (updated March 2011). The Cochrane Collaboration; 2011. pp. 9.1-9.43. [ www.cochrane.org/training/cochrane-handbook ]. Accessed 11 January 2014.
34. Higgins JPT, Thompson SG, Deeks JJ, Altman DG,. Measuring inconsistency in meta-analyses. BMJ 2003; 327: 557-60.
35. Ioannidis JPA, Patsopoulos NA, Evangelou E,. Uncertainty in heterogeneity estimates in meta-analyses. BMJ 2007; 335: 914-16.
36. Thompson SG, Higgins JPT,. How should meta-regression analyses be undertaken and interpreted? Stat Med 2002; 21: 1559-73.
37. Ioannidis JP, Patsopoulos NA, Rothstein HR,. Reasons or excuses for avoiding meta-analysis in forest plots. BMJ 2008; 336: 1413-15.
38. Nelson JC, Jackson ML, Weiss NS, Jackson L,. New strategies are needed to improve the accuracy of influenza vaccine effectiveness estimates among seniors. J Clin Epidemiol 2009; 62: 687-94.
39. Conlin AMS, Bukowinski AT, Sevick CJ, DeScisciolo C, Crum-Cianflone NF,. Safety of the pandemic H1N1 influenza vaccine among pregnant U.S. military women and their newborns. Obstet Gynecol 2013; 121: 511-18.
40. Doumbia M, Teguete I, Orenstein EW, Orenstein LA, Dembele S, Traore A, et al. Abstract 236: Rates and causes of serious adverse events in the first 25 weeks of a clinical trial of maternal influenza vaccine during the third trimester in Bamako, Mali. 61st Annual Meeting of the American Society of Tropical Medicine and Hygiene, Atlanta, GA, 2012. [ www.astmh.org/AM/Template.cfm?Section=Meeting-Archives&Template=/CM/ContentDisplay.cfm&ContentID=4683 ]. Accessed 14 April 2014.
41. Guo Y, Allen V, Bujold E, Coleman B, Drews S, Gouin K, et al. Abstract P087: efficacy and safety of pandemic influenza vaccine in pregnancy. 9th Canadian Immunization Conference, Québec City, QC, 2010. Can J Infect Dis Med Microbiol 2010; 21: 173-234.
42. Dodds L, Macdonald N, Scott J, Spencer A, Allen VM, McNeil S,. The association between influenza vaccine in pregnancy and adverse neonatal outcomes. J Obstet Gynaecol Can 2012; 34: 714-20.
43. Steinhoff MC, Omer SB, Roy E, El Arifeen S, Raqib R, Dodd C, et al. Neonatal outcomes after influenza immunization during pregnancy: a randomized controlled trial. Can Med Assoc J 2012; 184: 645-53.
44. Sammon CJ, Snowball J, McGrogan A, de Vries CS,. Evaluating the hazard of foetal death following H1N1 influenza vaccination; a population based cohort study in the UK GPRD. PLoS One 2012; 7: e51734-42.
45. Pasternak B, Svanström H, Mølgaard-Nielsen D, Krause TG, Emborg H-D, Melbye M, et al. Vaccination against pandemic A/H1N1 2009 influenza in pregnancy and risk of fetal death: cohort study in Denmark. BMJ 2012; 344: e2794.
46. Black SB, Shinefield HR, France EK, Fireman BH, Platt ST, Shay D,. Effectiveness of influenza vaccine during pregnancy in preventing hospitalizations and outpatient visits for respiratory illness in pregnant women and their infants. Am J Perinatol 2004; 21: 333-9.
47. Deinard AS, Ogburn P,. A/NJ/8/76 influenza vaccination program: effects on maternal health and pregnancy outcome. Am J Obstet Gynecol 1981; 140: 240-5.
48. Munoz FM, Greisinger AJ, Wehmanen OA, Mouzoon ME, Hoyle JC, Smith FA, et al. Safety of influenza vaccination during pregnancy. Am J Obstet Gynecol 2005; 192: 1098-106.
49. Omer SB, Goodman D, Steinhoff MC, Rochat R, Klugman KP, Stoll BJ, et al. Maternal influenza immunization and reduced likelihood of prematurity and small for gestational age births: a retrospective cohort study. PLoS Med 2011; 8: e1000441.
50. Irving SA, Kieke BA, Donahue JG, Mascola MA, Baggs J, Destefano F, et al. Trivalent inactivated influenza vaccine and spontaneous abortion. Obstet Gynecol 2013; 121: 159-65.
51. Louik C, Ahrens K, Kerr S, Pyo J, Chambers C, Jones KL, et al. Risks and safety of pandemic H1N1 influenza vaccine in pregnancy: exposure prevalence, preterm delivery, and specific birth defects. Vaccine 2013; 31: 5033-40.
52. Fell DB, Sprague AE, Liu N, Yasseen AS, Wen SW, Smith G, et al. H1N1 influenza vaccination during pregnancy and fetal and neonatal outcomes. Am J Public Health 2012; 102: e33-40.
53. Heikkinen T, Young J, van Beek E, Franke H, Verstraeten T, Weil JG, et al. Safety of MF59-adjuvanted A/H1N1 influenza vaccine in pregnancy: a comparative cohort study. Am J Obstet Gynecol 2012; 207: 177.e1-8.
54. Källén B, Olausson P,. Vaccination against H1N1 influenza with Pandemrix(®) during pregnancy and delivery outcome: a Swedish register study. BJOG 2012; 1190: 1583-90.
55. Launay O, Krivine A, Charlier C, Truster V, Tsatsaris V, Lepercq J, et al. Low rate of pandemic A/H1N1 2009 influenza infection and lack of severe complication of vaccination in pregnant women: a prospective cohort study. PLoS One 2012; 7: e52303.
56. Lin T-H, Lin S-Y, Lin C-H, Lin R-I, Lin H-C, Chiu T-H, et al. AdimFlu-S(®) influenza A (H1N1) vaccine during pregnancy: the Taiwanese Pharmacovigilance Survey. Vaccine 2012; 30: 2671-5.
57. Ludvigsson JF, Zugna D, Cnattingius S, Richiardi L, Ekbom A, Ortqvist A, et al. Influenza H1N1 vaccination and adverse pregnancy outcome. Eur J Epidemiol 2013; 28: 579-88.
58. Oppermann M, Fritzsche J, Weber-Schoendorfer C, Keller-Stanislawski B, Allignol A, Meister R, et al. A(H1N1)v2009: a controlled observational prospective cohort study on vaccine safety in pregnancy. Vaccine 2012; 30: 4445-52.
59. Pasternak B, Svanström H, Mølgaard-Nielsen D, Krause TG, Emborg H-D, Melbye M, et al. Risk of adverse fetal outcomes following administration of a pandemic influenza A(H1N1) vaccine during pregnancy. J Am Med Assoc 2012; 308: 165-74.
60. Richards JL, Hansen C, Bredfeldt C, Bednarczyk RA, Steinhoff MC, Adjaye-Gbewonyo D, et al. Neonatal outcomes after antenatal influenza immunization during the 2009 H1N1 influenza pandemic: impact on preterm birth, birth weight, and small for gestational age birth. Clin Infect Dis 2013; 56: 1216-22.
61. Rubinstein F, Micone P, Bonotti A, Wainer V, Schwarcz A, Augustovski F, et al. Influenza A/H1N1 MF59 adjuvanted vaccine in pregnant women and adverse perinatal outcomes: multicentre study. BMJ 2013; 346: f393.
62. Beau AB, Hurault-Delarue C, Vidal S, Guitard C, Vayssière C, Petiot D, et al. Pandemic A/H1N1 influenza vaccination during pregnancy: a comparative study using the EFEMERIS database. Vaccine 2014; 32: 1254-8.
63. Sheffield JS, Greer LG, Rogers VL, Roberts SW, Lytle H, McIntire DD, et al. Effect of influenza vaccination in the first trimester of pregnancy. Obstet Gynecol 2012; 120: 532-7.
64. Legge A, Dodds L, Macdonald NE, Scott J, McNeil S,. Rates and determinants of seasonal influenza vaccination in pregnancy and association with neonatal outcomes. Can Med Assoc J 2014; 186: E157-64.
65. Cantu J, Biggio J, Jauk V, Wetta L, Andrews W, Tita A,. Selective uptake of influenza vaccine and pregnancy outcomes. J Matern Fetal Neonatal Med 2013; 7058: 1-5.
66. Chambers CD, Johnson D, Xu R, Luo Y, Louik C, Mitchell AA, et al. Risks and safety of pandemic H1N1 influenza vaccine in pregnancy: birth defects, spontaneous abortion, preterm delivery, and small for gestational age infants. Vaccine 2013; 31: 5026-32.
67. Jacobson RM, Targonski PV, Poland GA,. Why is evidence-based medicine so harsh on vaccines? An exploration of the method and its natural biases. Vaccine 2007; 25: 3165-9.
68. Neuzil KM,. Influenza vaccination in 2013-2014: achieving 100% participation. J Am Med Assoc 2013; 310: 1681-2.
69. Moro PL, Broder K, Zheteyeva Y, Revzina N, Tepper N, Kissin D, et al. Adverse events following administration to pregnant women of influenza A (H1N1) 2009 monovalent vaccine reported to the Vaccine Adverse Event Reporting System. Am J Obstet Gynecol 2011; 205: 473-81.
70. Steinhoff MC,. Epidemiology and prevention of influenza. In:, Nelson K, Masters Williams C, editors. Infectious Disease Epidemiology. Theory and Practice, 2nd edn. Sudbury, MA: Jones and Bartlett Publishers; 2007. pp. 577-600.
71. Hardy JM, Azarowicz EN, Mannini A, Medearis DN, Cooke RE,. The effect of Asian influenza on the outcome of pregnancy, Baltimore, 1957-1958. Am J Public Health 1961; 51: 1182-8.
72. Widelock D, Csizmas L, Klein S,. Influenza, pregnancy, and fetal outcome. Public Health Rep 1963; 78: 1-11.
73. Mosby LG, Rasmussen SA, Jamieson DJ,. 2009 pandemic influenza A (H1N1) in pregnancy: a systematic review of the literature. Am J Obstet Gynecol 2011; 205: 10-18.
74. Osterholm MT, Kelley NS, Sommer A, Belongia E,. Efficacy and effectiveness of influenza vaccines: a systematic review and meta-analysis. Lancet Infect Dis 2012; 12: 36-44.
75. Simonsen L, Viboud C, Taylor RJ, Miller MA, Jackson L,. Influenza vaccination and mortality benefits: new insights, new opportunities. Vaccine 2009; 27: 6300-4.