Inactivated influenza vaccine and spontaneous abortion in the Vaccine Safety Datalink in 2012-13, 2013-14, and 2014-15.
Open accessAbstract
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.
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A follow-up study of 2762 women showed no significant association between spontaneous abortion and influenza vaccine regardless of prior season vaccination status.
“A follow up study by the same group looking at a larger sample size of 2762 women (three times the amount of the original paper) showed no significant association between spontaneous abortion and influenza vaccine regardless of prior season vaccination status (Donahue et al., 2019).”
From Vaccine Safety: Myths and Misinformation (2020) · cites this paper as Donahue et al., 2019
The Results report no significant association between influenza vaccination and spontaneous abortion in either prior-season vaccination group. But the Results describe 1,236 matched pairs in the main analysis—2,472 women—not 2,762. The stated sample size is therefore unsupported. (LLM, conf=0.90)
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- Authors
- Donahue, 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., Hechter, R. C., Irving, S. A., Jackson, L. A., Klein, N. P., Naleway, A. L., Weintraub, E. S., & Belongia, E. A.
- Affiliations
- Marshfield Clinic Research Foundation (US)
- Marshfield Clinic (US)
- Centers for Disease Control and Prevention (US)
- Kaiser Permanente (US)
- Corresponding author
- Donahue, James G.
- ORCID
- Venue
- Vaccine
- Publisher
- Elsevier BV
- Published
- 2019-10
- Volume
- 37
- Issue
- 44
- Pages
- 6673-6681
- ISSN
- 0264-410X (ISSN-L)
- PMC
- PMC6906603
- OpenAlex
- W2973829310
- Cited by
- 59
- References
- 55
- Citations by year
- 2026: 4 · 2025: 5 · 2024: 11 · 2023: 9 · 2022: 7 · 2021: 10 · 2020: 11 · 2019: 2
- FWCI
- 5.71
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Vaccine (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion, cc-by-nc-nd)
- Funders
- Centers for Disease Control and Prevention
- Topics
- Health Sciences › Medicine › Epidemiology › Influenza Virus Research Studies
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Pregnancy and Medication Impact
- Keywords
- inactivated influenza vaccine, miscarriage, pregnancy, vaccine safety, influenza vaccination during pregnancy, Vaccine Safety Datalink
- MeSH terms
- Abortion, Spontaneous, Adolescent, Adult, Female, Humans, Influenza Vaccines, Seasons, Vaccination, Vaccines, Inactivated, Odds Ratio, Case-Control Studies, History, 21st Century, Young Adult, Public Health Surveillance
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