Inactivated influenza vaccine during pregnancy and risks for adverse obstetric events.

Kharbanda, Elyse Olshen; Vazquez-Benitez, Gabriela; Lipkind, Heather; Naleway, Allison; Lee, Grace; Nordin, James D.

doi:10.1097/aog.0b013e3182a1118a

Cited by 85Influenza Virus Research StudiesPregnancy and Medication ImpactPharmacovigilance and Adverse Drug Reactions

Inactivated influenza vaccine during pregnancy and risks for adverse obstetric events.

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Kharbanda, Elyse Olshen, Vazquez-Benitez, Gabriela, Lipkind, Heather, Naleway, Allison, Lee, Grace, Nordin, James D.·2013·Obstetrics & Gynecology

DOI 10.1097/aog.0b013e3182a1118aPMC PMC13445607

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Abstract

OBJECTIVE: To compare risks for adverse obstetric events between females who did and did not receive trivalent inactivated influenza vaccine during pregnancy. METHOD: This retrospective, observational cohort study was conducted at seven Vaccine Safety Datalink sites. Pregnancies were identified from administrative and claims data using a validated algorithm. Females vaccinated while pregnant from 2002 to 2009 were matched one-to-two with replacement to unvaccinated pregnant females. Using a generalized estimating equation method with a Poisson distribution and log link, we evaluated the association of trivalent inactivated influenza vaccine with 13 outcomes. Given our large sample size and multiple comparisons (19 contrasts), a cutoff for significance of P<.005 was selected a priori. RESULTS: Our cohort included 74,292 vaccinated females matched on age, site, and pregnancy start date with 144,597 unvaccinated females. We did not observe increased risks within 42 days of vaccination for hyperemesis, chronic hypertension, gestational hypertension, gestational diabetes, proteinuria, or urinary tract infection. Using a risk window from vaccination through pregnancy end, we did not observe increased risks after vaccination for proteinuria, urinary tract infection, gestational hypertension, preeclampsia or eclampsia, chorioamnionitis, puerperal infection, venous complications, pulmonary embolism, or peripartum cardiomyopathy. A reduced risk for gestational diabetes after vaccination was detected (adjusted hazard rate ratio 0.88, 95% confidence interval 0.83-0.93), likely as a result of healthy vaccine bias or earlier detection among vaccinees. CONCLUSION: In this large cohort, influenza vaccination during pregnancy was not associated with increased risks for medically attended adverse obstetric events. LEVEL OF EVIDENCE: II.

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Authors: Kharbanda, E. O., Vazquez-Benitez, G., Lipkind, H., Naleway, A., Lee, G., & Nordin, J. D.
Affiliations: HealthPartners (US)
Kaiser Permanente (US)
ORCID: Kharbanda, Elyse Olshen
Lipkind, Heather
Naleway, Allison
Lee, Grace
Nordin, James D.
Venue: Obstetrics & Gynecology
Publisher: Ovid Technologies (Wolters Kluwer Health)
Published: 2013-09
Volume: 122
Issue: 3
Pages: 659-667
ISSN: 0029-7844 (ISSN-L)
DOI: 10.1097/aog.0b013e3182a1118a
PMC: PMC13445607
OpenAlex: W2003539475
Cited by: 85
References: 26
Citations by year: 2026: 1 · 2025: 4 · 2024: 4 · 2023: 3 · 2022: 3 · 2021: 4 · 2020: 5 · 2019: 10 · 2018: 7 · 2017: 5 · 2016: 11 · 2015: 14 · 2014: 11 · 2013: 3
FWCI: 9.47
Type: journal article
Language: en
Open access: green
pmc.ncbi.nlm.nih.gov
Locations: Obstetrics and Gynecology (publishedVersion)
PubMed Central (publishedVersion)
PubMed (publishedVersion)
Funders: GlaxoSmithKline
Centers for Disease Control and Prevention (200-2002-00732)
U.S. Public Health Service (200-2002-00732)
Topics: Health Sciences › Medicine › Epidemiology › Influenza Virus Research Studies
Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Pregnancy and Medication Impact
Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
Keywords: inactivated influenza vaccine, pregnancy, vaccine safety, gestational diabetes mellitus, preeclampsia, eclampsia, chorioamnionitis, postpartum infection, hyperemesis gravidarum, gestational hypertension, proteinuria, urinary tract infection, peripartum cardiomyopathy, pulmonary embolism, venous complications
MeSH terms: Adolescent, Adult, Female, Humans, Influenza Vaccines, Obstetric Labor Complications, Middle Aged, Pregnancy, Retrospective Studies, Vaccines, Inactivated, Young Adult

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Inactivated influenza vaccine during pregnancy and risks for adverse obstetric events.

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