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Cited by 188Pharmacovigilance and Adverse Drug ReactionsInfluenza Virus Research StudiesData-Driven Disease Surveillance

Safety of trivalent inactivated influenza vaccines in adults: Background for pandemic influenza vaccine safety monitoring

Vellozzi, Claudia, Burwen, Dale R., Dobardzic, Azra, Ball, Robert, Walton, Kimp, Haber, Penina·2009·Vaccine
DOI 10.1016/j.vaccine.2009.01.125
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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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Crossref · 10.1016/j.vaccine.2009.01.125

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  • Purified inactivated viruses have been traditionally used for vaccine development and have been found safe and effective for preventing diseases caused by influenza virus and poliovirus.

    “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]

    The Background describes influenza vaccines as the primary method for controlling influenza and reports reassuring trial safety findings for trivalent inactivated influenza vaccine. The Discussion says the vaccines reviewed included purified subunit formulations. The paper does not address poliovirus vaccines, and its safety surveillance does not establish effectiveness for every purified inactivated vaccine. (LLM, conf=0.87)

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4 of the 64 references couldn’t be matched to a known paper.

Research works printed but not linked: 5

  1. [14][14] LuP,BridgesC,EulerG,SingletonJ.Influenzavaccinationofrecommendedadult populations, U.S., 1989-2005. Vaccine 2008;26:1786-93. -
  2. [30][30] KaplanJE,KatonaP,HurwitzES,SchonbergerLB.Guillain-Barresyndromeinthe United States, 1979-1980 and 1980-1981. Lack of an association with influenza vaccination. JAMA 1982;248(6):698-700. -
  3. [32][32] HughesRA,CharltonJ,LatinovicR,GullifordMC.Noassociationbetweenimmunization and Guillain-Barré Syndrome in the United Kingdom, 1992 to 2000. Arch Int Med 2006;166:1301-4. -
  4. [33][33] Juurlink DN, Stukel TA, Kwong J, Kopp A, McGeer A, Upshur RE, et al. GuillainBarréSyndromeafterinfluenzavaccinationinadults:apopulation-basedstudy. Arch Int Med 2006;166:2217-21. -
  5. [56][56] May S, Netto G, Domiati-Saad R, Kasper C. Cutaneous lymphoid hyperplasia andmarginalzoneB-celllymphomafollowingvaccination.JAmAcadDermatol 2005;53:512-6. -

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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)
DOI
10.1016/j.vaccine.2009.01.125
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
Licence
www.elsevier.com/tdm/userlicense/1.0/ (tdm)
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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