First trimester influenza vaccination and risks for major structural birth defects in offspring.
Open accessAbstract
Objective To examine risks for major structural birth defects in infants after first trimester inactivated influenza vaccine (IIV) exposures.Study design In this observational study, we used electronic health data from 7 Vaccine Safety Datalink sites to examine risks for selected major structural defects in infants after maternal IIV exposure. Vaccine exposures for women with continuous insurance enrollment through pregnancy who delivered singleton live births between 2004 and 2013 were identified from standardized files. Infants with continuous insurance enrollment were followed to 1 year of age. We excluded mother-infant pairs with other exposures that potentially increased their background risk for birth defects. Selected cardiac, orofacial or respiratory, neurologic, ophthalmologic or otologic, gastrointestinal, genitourinary and muscular or limb defects were identified from diagnostic codes in infant medical records using validated algorithms. Propensity score adjusted generalized estimating equations were used to estimate prevalence ratios (PRs).Results We identified 52 856 infants with maternal first trimester IIV exposure and 373 088 infants whose mothers were unexposed to IIV during first trimester. Prevalence (per 100 live births) for selected major structural birth defects was 1.6 among first trimester IIV exposed versus 1.5 among unexposed mothers. The adjusted PR was 1.02 (95% CI 0.94-1.10). Organ system-specific PRs were similar to the overall PR.Conclusion First trimester maternal IIV exposure was not associated with an increased risk for selected major structural birth defects in this large cohort of singleton live births.
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Timing of influenza vaccination, including administration in the first trimester, has been repeatedly shown to be safe.
“Impact of timing of vaccination including risk of administration in the first trimester has also been studied and repeatedly shown to be safe (Kharbanda et al., 2017).”
From Vaccine Safety: Myths and Misinformation (2020) · cites this paper as Kharbanda et al., 2017
The Discussion reports no increased risk of selected major structural birth defects after first-trimester influenza vaccination and describes several other studies with reassuring findings. That supports the claim of repeated study, but the evidence cited here concerns birth defects, not safety across all possible outcomes or vaccination times. (LLM, conf=0.84)
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Vaccine Safety: Myths and Misinformation
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“The attributable risks of admissions for GBS within 6 weeks were 1·03 per million vaccinations, compared with 17·2 GBS admissions per million influenza-coded health-care encounters (Kwong et al., 2013).”
BackgroundDonahue, J. G., Kieke, B. A., King, J. P., Mascola, M. A., Shimabukuro, T. T., DeStefano, F., Hanson, K. E., McClure, D. L., Olaiya, O., Glanz, J. M., et al. (2019) · Vaccine · doi:10.1016/j.vaccine.2019.09.035 · Cited by 59 · see citing works
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- Authors
- Kharbanda, E. O., Vazquez-Benitez, G., Romitti, P. A., Naleway, A. L., Cheetham, T. C., Lipkind, H. S., Klein, N. P., Lee, G., Jackson, M. L., Hambidge, S. J., McCarthy, N., DeStefano, F., & Nordin, J. D.
- Affiliations
- HealthPartners (US)
- University of Iowa (US)
- Kaiser Permanente (US)
- Yale University (US)
- Kaiser Permanente Northern California (US)
- Harvard University (US)
- Kaiser Permanente Washington Health Research Institute (US)
- Centers for Disease Control and Prevention (US)
- Corresponding author
- Kharbanda, Elyse Olshen
- ORCID
- Venue
- The Journal of Pediatrics
- Publisher
- Elsevier BV
- Published
- 2017-08
- Volume
- 187
- Pages
- 234-239.e4
- ISSN
- 0022-3476 (ISSN-L)
- PMC
- PMC6506840
- OpenAlex
- W2620006863
- Cited by
- 53
- References
- 32
- Citations by year
- 2026: 1 · 2025: 3 · 2024: 7 · 2023: 3 · 2022: 7 · 2021: 3 · 2020: 8 · 2019: 10 · 2018: 5 · 2017: 6
- FWCI
- 6.21
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- The Journal of Pediatrics (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Institutes of Health (CC999999)
- Topics
- Health Sciences › Medicine › Epidemiology › Influenza Virus Research Studies
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Pregnancy and Medication Impact
- Social Sciences › Health › Vaccine Coverage and Hesitancy
- Keywords
- influenza vaccination, inactivated influenza vaccine, maternal immunization, structural birth defects, congenital malformations, vaccine safety
- MeSH terms
- Congenital Abnormalities, Adult, Female, Humans, Infant, Influenza, Human, Influenza Vaccines, Pregnancy, Pregnancy Complications, Pregnancy Trimester, First, Prenatal Exposure Delayed Effects, Risk, Propensity Score
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