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Safety of trivalent inactivated influenza vaccines in adults: Background for pandemic influenza vaccine safety monitoring
Abstract
In preparation for pandemic vaccine safety monitoring, we assessed adverse events reported to the Vaccine Adverse Event Reporting System following receipt of trivalent inactivated influenza vaccines among adults from 1990 through 2005. We calculated reporting rates for nonserious, serious, and neurological adverse events. We reviewed reports of recurrent events and deaths, as well as reports identified through advanced signal detection. The most frequently reported events were local reactions and systemic symptoms. Guillain-Barré syndrome was the most frequently reported serious event (0.70 reports per million vaccinations). Adverse event reporting rates have been reasonably constant over time. No new safety concerns emerged after our review of 15 years of post-licensure surveillance data. These findings provide useful information if pandemic vaccine is rapidly distributed and pre-licensure data are limited.
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“Purified inactivated viruses have been traditionally used for vaccine development and such vaccines have been found to be safe and effective for the prevention of diseases caused by viruses like influenza virus and poliovirus (7, 8).”
From Development of an inactivated vaccine candidate for SARS-CoV-2 (2020) · cites this paper as [8]
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Metadata
- Authors
- Vellozzi, C., Burwen, D. R., Dobardzic, A., Ball, R., Walton, K., & Haber, P.
- Affiliations
- Centers for Disease Control and Prevention (US)
- Center for Biologics Evaluation and Research (US)
- Corresponding author
- Vellozzi, Claudia
- ORCID
- Ball, Robert
- Venue
- Vaccine
- Publisher
- Elsevier BV
- Published
- 2009-03
- Volume
- 27
- Issue
- 15
- Pages
- 2114-2120
- ISSN
- 0264-410X (ISSN-L)
- OpenAlex
- W2008361529
- Cited by
- 188
- References
- 64
- Citations by year
- 2025: 1 · 2024: 5 · 2023: 7 · 2022: 16 · 2021: 24 · 2020: 12 · 2019: 5 · 2018: 11 · 2017: 11 · 2016: 9 · 2015: 14 · 2014: 7 · 2013: 11 · 2012: 17
- FWCI
- 26.57
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Vaccine (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
- Health Sciences › Medicine › Epidemiology › Influenza Virus Research Studies
- Health Sciences › Medicine › Epidemiology › Data-Driven Disease Surveillance
- Keywords
- trivalent inactivated influenza vaccine, vaccine safety, adverse events, VAERS, post-licensure surveillance, pandemic influenza vaccine, Guillain-Barré syndrome, neurological adverse events, local reactions, signal detection, adults
- MeSH terms
- Adult, Female, Humans, Influenza, Human, Influenza Vaccines, Male, Middle Aged, United States, Adverse Drug Reaction Reporting Systems, Guillain-Barre Syndrome
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