1887
  1. Home
  2. Eurosurveillance
  3. Volume 22, Issue 20, 18/May/2017
  4. Article
Surveillance and outbreak report Open Access
Like 0
Download

Abstract

Australia was alerted to a possible increase in allergy-related adverse events following immunisation (AEFI) with 2015 seasonal trivalent influenza vaccines (TIV) by the Victorian state vaccine safety service, SAEFVIC. We describe SAEFVIC’s initial investigation and upon conclusion of the 2015 influenza vaccination programme, to define the signal event and implications for vaccine programmes. Allergy-related AEFI were defined as anaphylaxis, angioedema, urticaria or generalised allergic reaction. Investigations compared 2015 TIV AEFI reports to previous years as proportions and reporting risk (RR) per 100,000, stratified by influenza vaccine brand. The initial investigation showed an increased proportion of allergy-related AEFI compared with 2014 (25% vs 12%), predominantly in adults, with insufficient clinical severity to alter the programme risk-benefit. While overall TIV AEFI RR in 2015 was similar to previous years (RR: 1.07, 95% confidence interval (CI): 0.88–1.29), we identified a near-doubling RR for allergy-related AEFI in 2015 (RR: 1.78, 95% CI: 1.14­– 2.80) from 2011 to 2014 with no difference by vaccine brand or severity increase identified. This increase in generalised allergy-related AEFI, across all used vaccine brands, supports evidence of variable reactogenicity arising from influenza vaccine strain variations. This investigation underlines the importance of effective seasonal influenza vaccine pharmacovigilance.

© Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 International License.
Loading

Article metrics loading...

/content/10.2807/1560-7917.ES.2017.22.20.30535
2017-05-18
2018-06-19
http://instance.metastore.ingenta.com/content/10.2807/1560-7917.ES.2017.22.20.30535
Loading
Loading full text...

Full text loading...

/deliver/fulltext/eurosurveillance/22/20/eurosurv-22-20-2.html?itemId=/content/10.2807/1560-7917.ES.2017.22.20.30535&mimeType=html&fmt=ahah

References

  1. National Health and Medical Research Council (NHMRC). Australian Immunisation Handbook 10th edn. Canberra: NHMRC. National Capital Press, 2013.
  2. Clothier HJ, Crawford NW, Kempe A, Buttery JP. Surveillance of adverse events following immunisation: the model of SAEFVIC, Victoria. Commun Dis Intell Q Rep. 2011;35(4):294-8. PMID: 22624490 
  3. Clothier HJ, Selvaraj G, Easton ML, Lewis G, Crawford NW, Buttery JP. Consumer reporting of adverse events following immunization. Hum Vaccin Immunother. 2014;10(12):3726-30.  https://doi.org/10.4161/hv.34369  PMID: 25483686 
  4. Therapeutic Goods Administration. Investigation into febrile reactions in young children following 2010 seasonal trivalent influenza vaccination. Canberra: Australian Government. Department of Health and Ageing. 24 Sep 2010. Available from: https://www.tga.gov.au/sites/default/files/alerts-medicine-seasonal-flu-100702.pdf
  5. Armstrong PK, Dowse GK, Effler PV, Carcione D, Blyth CC, Richmond PC, et al. Epidemiological study of severe febrile reactions in young children in Western Australia caused by a 2010 trivalent inactivated influenza vaccine. BMJ open. 2011;30;1(1). PMID: 22021725.
  6. Therapeutic Goods Administration. Reporting adverse events. Canberra: Australian Government. Department of Health. [Accessed 22 Feb 2016]. Available from: https://www.tga.gov.au/reporting-adverse-events
  7. Rüggeberg JU, Gold MS, Bayas JM, Blum MD, Bonhoeffer J, Friedlander S, et al. Anaphylaxis: case definition and guidelines for data collection, analysis, and presentation of immunization safety data. Vaccine. 2007;25(31):5675-84.  https://doi.org/10.1016/j.vaccine.2007.02.064  PMID: 17448577 
  8. Therapeutic Goods Administration. Database of Adverse Event Notifications (DAEN). Canberra: Australian Government. Department of Health. [Accessed May 2015]. Available from: http://www.tga.gov.au/database-adverse-event-notifications-daen
  9. Victoria State Government. Department of Health & Human Services. Immunisation. Victoria: Victoria State Government. [Accessed Jan 2016]. Available from: https://www2.health.vic.gov.au/public-health/immunisation
  10. Therapeutic Goods Administration. Advisory Committee on the Safety of Vaccines (ACSOV) meeting statement. Meeting 8 on 11 Jun 2015. Canberra: Australian Government. Department of Health. 16 Sep 2015. Available from: https://www.tga.gov.au/committee-meeting-info/acsov-meeting-statement-meeting-8-11-june-2015
  11. Horvath J. Review of the management of adverse effects associated with Panvax and Fluvax. Canberra: Australian Government. Department of Health and Ageing. 25 May 2011. Available from: https://www.tga.gov.au/media-release/review-management-adverse-events-associated-panvax-and-fluvax
  12. Chin LK, Crawford NW, Rowles G, Buttery JP. Australian immunisation registers: established foundations and opportunities for improvement. Euro Surveill. 2012;17(16):20148. Available from: http://www.eurosurveillance.org/ViewArticle.aspx?ArticleId=20148 PMID: 22551464 
  13. Immunise Australia Program. Update: Expansion of Australia’s Immunisation Registers. Canberra: Australian Government. Department of Health. [Accessed 12 Jan 2016]. Available from: http://www.immunise.health.gov.au/internet/immunise/publishing.nsf/Content/news-20152310
  14. Crawford NW, Clothier H, Hodgson K, Selvaraj G, Easton ML, Buttery JP. Active surveillance for adverse events following immunization. Expert Rev Vaccines. 2014;13(2):265-76.  https://doi.org/10.1586/14760584.2014.866895  PMID: 24350637 
  15. Cheng DR, Perrett KP, Choo S, Danchin M, Buttery JP, Crawford NW. Pediatric anaphylactic adverse events following immunization in Victoria, Australia from 2007 to 2013. Vaccine. 2015;33(13):1602-7.  https://doi.org/10.1016/j.vaccine.2015.02.008  PMID: 25698493 
  16. Therapeutic Goods Administration. 2015 seasonal influenza vaccines. Canberra: Australian Government. Department of Health. 3 Mar 2015. Available from: http://www.tga.gov.au/media-release/2015-seasonal-influenza-vaccines
  17. Effler P, Kelly HA. In response to: scientific investigations into febrile reactions observed in the paediatric population following vaccination with a 2010 Southern Hemisphere Trivalent Influenza Vaccine. Vaccine. 2013;31(35):3467-8.  https://doi.org/10.1016/j.vaccine.2013.03.061  PMID: 23632308 
  18. Effler PV, Kelly H. Statement that clinical studies had demonstrated bioCSL’s seasonal influenza vaccines had acceptable safety profile in all age groups is not supported by the data. Vaccine. 2013;32(1):1.  https://doi.org/10.1016/j.vaccine.2013.08.095  PMID: 24055086 
  19. Effler PV, Kelly HA. bioCSL Limited’s 2009 clinical trial to assess the immunogenicity and safety of trivalent influenza vaccine in US children raises concern. Vaccine. 2015;33(42):5492.  https://doi.org/10.1016/j.vaccine.2015.05.020  PMID: 26119986 
  20. Waldman EA, Luhm KR, Monteiro SA, Freitas FR. Surveillance of adverse effects following vaccination and safety of immunization programs. Rev Saude Publica. 2011;45(1):173-84.  https://doi.org/10.1590/S0034-89102011000100020  PMID: 21181055 
  21. Huang YL, Moon J, Segal JB. A comparison of active adverse event surveillance systems worldwide. Drug Saf. 2014;37(8):581-96.  https://doi.org/10.1007/s40264-014-0194-3  PMID: 25022829 
  22. Trifirò G, Coloma PM, Rijnbeek PR, Romio S, Mosseveld B, Weibel D, et al. Combining multiple healthcare databases for postmarketing drug and vaccine safety surveillance: why and how? J Intern Med. 2014;275(6):551-61.  https://doi.org/10.1111/joim.12159  PMID: 24635221 
  23. Chen RT, Glasser JW, Rhodes PH, Davis RL, Barlow WE, Thompson RS, et al. Vaccine Safety Datalink project: a new tool for improving vaccine safety monitoring in the United States. Pediatrics. 1997;99(6):765-73.  https://doi.org/10.1542/peds.99.6.765  PMID: 9164767 
  24. Pillsbury A, Cashman P, Leeb A, Regan A, Westphal D, Snelling T, et al. Real-time safety surveillance of seasonal influenza vaccines in children, Australia, 2015. Euro Surveill. 2015;20(43):30050.  https://doi.org/10.2807/1560-7917.ES.2015.20.43.30050  PMID: 26536867 
  25. Broder KR, Martin DB, Vellozzi C. In the heat of a signal: responding to a vaccine safety signal for febrile seizures after 2010-11 influenza vaccine in young children, United States. Vaccine. 2012;30(11):2032-4.  https://doi.org/10.1016/j.vaccine.2011.12.040  PMID: 22361305 
Allergic adverse events following 2015 seasonal influenza vaccine, Victoria, Australia
<p class="citation"> <span>Citation style for this article:</span> <span class="meta-value authors"> <a href="/search?value1=Hazel+J+Clothier&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Clothier Hazel J</a>, <a href="/search?value1=Nigel+Crawford&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Crawford Nigel</a>, <a href="/search?value1=Melissa+A+Russell&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Russell Melissa A</a>, <a href="/search?value1=Jim+P+Buttery&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Buttery Jim P</a></span>. Allergic adverse events following 2015 seasonal influenza vaccine, Victoria, Australia. <a href="/content/ecdc">Euro Surveill.</a> 2017;22(20):pii=30535. <a href="https://doi.org/10.2807/1560-7917.ES.2017.22.20.30535" title="doi link" target="_blank">https://doi.org/10.2807/1560-7917.ES.2017.22.20.30535</a> <span class="ES_Article_citation"> <span class="generated">Received</span>: 26 May 2016;&nbsp;&nbsp; <span class="generated">Accepted</span>: 22 Dec 2016 </span> </p>
/content/10.2807/1560-7917.ES.2017.22.20.30535
/content/10.2807/1560-7917.ES.2017.22.20.30535
Loading

Data & Media loading...

Comment has been disabled for this content
Submit comment
Close
Comment moderation successfully completed
This is a required field
Please enter a valid email address
Approval was a Success
Invalid data
An Error Occurred
Approval was partially successful, following selected items could not be processed due to error