Influenza vaccination during pregnancy: a systematic review of fetal death, spontaneous abortion, and congenital malformation safety outcomes
- PMID: 25758932
- DOI: 10.1016/j.vaccine.2015.02.068
Influenza vaccination during pregnancy: a systematic review of fetal death, spontaneous abortion, and congenital malformation safety outcomes
Abstract
Background: Pregnant women are considered the most important risk group for influenza vaccination. Despite this, the potential risk of harm from the vaccine on the fetus is a key factor in low uptake of the vaccine. This systematic review aimed to synthesize the best available evidence on the safety of influenza vaccination during pregnancy on fetal development.
Methods and findings: A search of the literature was undertaken from the inception of each database up to March 2014. Both observational and clinical trials were considered. Fetal outcomes were present in 19 observational studies, and 14 of those were primarily investigating the monovalent influenza A (H1N1) 2009 vaccine. There was significant methodological and clinical heterogeneity of the included studies and a narrative summary and tabling of results was performed. Fetal death outcomes for women in later pregnancy ranged from OR 0.34 to 2.95 with 95% confidence intervals crossing or below the null value. Spontaneous abortion less than 24 weeks ranged from HR 0.45 to OR 1.23, with 95% confidence intervals crossing or below the null value. Congenital malformations for women vaccinated during their first trimester ranged from OR 0.67 to 2.18 and imprecise confidence intervals crossed the null value. Included in this review were some high quality studies, although overall the studies have a high risk of selection and confounding bias.
Conclusions: Results do not indicate that maternal influenza vaccination is associated with an increased risk of fetal death, spontaneous abortion, or congenital malformations. Statistical imprecision and clinical and methodological heterogeneity of the observational studies mean it is not possible to totally exclude adverse effects. Further studies investigating women vaccinated during their first trimester should be the highest priority to allow for more precise estimates, especially for spontaneous abortion, and congenital abnormality outcomes.
Copyright © 2015 Elsevier Ltd. All rights reserved.
Similar articles
-
Safety of influenza A (H1N1) 2009 live attenuated monovalent vaccine in pregnant women.Obstet Gynecol. 2013 Dec;122(6):1271-8. doi: 10.1097/AOG.0000000000000010. Obstet Gynecol. 2013. PMID: 24201689
-
Risks and safety of pandemic H1N1 influenza vaccine in pregnancy: birth defects, spontaneous abortion, preterm delivery, and small for gestational age infants.Vaccine. 2013 Oct 17;31(44):5026-32. doi: 10.1016/j.vaccine.2013.08.097. Epub 2013 Sep 7. Vaccine. 2013. PMID: 24016809
-
A systematic review and meta-analysis of fetal outcomes following the administration of influenza A/H1N1 vaccination during pregnancy.Int J Gynaecol Obstet. 2018 May;141(2):141-150. doi: 10.1002/ijgo.12394. Epub 2017 Dec 18. Int J Gynaecol Obstet. 2018. PMID: 29149524 Review.
-
The PREGVAXGRIP study: a cohort study to assess foetal and neonatal consequences of in utero exposure to vaccination against A(H1N1)v2009 influenza.Drug Saf. 2013 Jun;36(6):455-65. doi: 10.1007/s40264-013-0030-1. Drug Saf. 2013. PMID: 23516007
-
Fetal death and preterm birth associated with maternal influenza vaccination: systematic review.BJOG. 2015 Jan;122(1):17-26. doi: 10.1111/1471-0528.12977. Epub 2014 Jul 10. BJOG. 2015. PMID: 25040307 Review.
Cited by
-
Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices - United States, 2024-25 Influenza Season.MMWR Recomm Rep. 2024 Aug 29;73(5):1-25. doi: 10.15585/mmwr.rr7305a1. MMWR Recomm Rep. 2024. PMID: 39197095 Free PMC article.
-
Are maternal vaccines effective and safe for mothers and infants? A systematic review and meta-analysis of randomised controlled trials.BMJ Glob Health. 2023 Oct;8(10):e012376. doi: 10.1136/bmjgh-2023-012376. BMJ Glob Health. 2023. PMID: 37899087 Free PMC article.
-
Safety of influenza vaccination during pregnancy: a systematic review.BMJ Open. 2023 Sep 6;13(9):e066182. doi: 10.1136/bmjopen-2022-066182. BMJ Open. 2023. PMID: 37673449 Free PMC article.
-
Safety and Protective Effects of Influenza Vaccination in Pregnant Women on Pregnancy and Birth Outcomes in Pune, India: A Cross-Sectional Study.Vaccines (Basel). 2023 May 28;11(6):1034. doi: 10.3390/vaccines11061034. Vaccines (Basel). 2023. PMID: 37376423 Free PMC article.
-
Immunization during pregnancy: do healthcare workers recommend vaccination against influenza?Front Public Health. 2023 Jun 2;11:1171142. doi: 10.3389/fpubh.2023.1171142. eCollection 2023. Front Public Health. 2023. PMID: 37333535 Free PMC article.
Publication types
MeSH terms
Substances
LinkOut - more resources
Full Text Sources
Other Literature Sources
Medical