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Adverse events associated with 2010 CSL and other inactivated influenza vaccines

Heath A Kelly, Danuta M Skowronski, Gaston De Serres and Paul V Effler
Med J Aust 2011; 195 (6): 318-320. || doi: 10.5694/mja11.10941
  • Heath A Kelly1
  • Danuta M Skowronski2
  • Gaston De Serres3
  • Paul V Effler4

  • 1 Epidemiology Unit, Victorian Infectious Diseases Reference Laboratory, Melbourne, VIC.
  • 2 BC Centre for Disease Control, Vancouver, British Columbia, Canada.
  • 3 Institut national de santé publique du Québec, Québec, Canada.
  • 4 Communicable Disease Control Directorate, WA Health, Perth, WA.

Correspondence: heath.kelly@mh.org.au

Competing interests:

Heath Kelly has received funding from CSL Biotherapies to attend a study design meeting. Danuta Skowronski was the principal investigator on a clinical trial for which influenza vaccine was provided free by Sanofi Pasteur. Gaston De Serres has previously received research grants for unrelated studies from GlaxoSmithKline and Sanofi Pasteur. The views expressed are ours and may not represent the views of our respective institutions.

  • 1. Armstrong PK, Dowse GK, Effler PV, 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 May. doi: 10.1136/bmjopen-2010-000016.
  • 2. Australian Technical Advisory Group on Immunisation. Clinical advice for immunisation providers on resumption of the use of 2010 trivalent seasonal vaccines in children less than 5 years of age, 30 July 2010. http://www.health.gov.au/internet/immunise/Publishing.nsf/content/immunise-atagi-statement-tiv (accessed Aug 2011).
  • 3. Therapeutic Goods Administration. The TGA and the USA FDA agree about problems at CSL Biotherapies. Canberra: TGA, 2011. http://www.tga.gov.au/newsroom/btn-csl-tga-statement-110708.htm (accessed Aug 2011).
  • 4. Furminger IGS. Vaccine production. In: Nicholson KG, Webster RG, Hay AJ, editors. Textbook of influenza. Oxford: Blackwell Science, 1998: 324-332.
  • 5. Institute for Vaccine Safety. Excipients in vaccines. Baltimore: IVS, 2010. http://hopkinsvaccine.org/components-Excipients.htm (accessed Aug 2011).
  • 6. Gross PA, Ennis FA, Gaerlan PF, et al. A controlled double-blind comparison of reactogenicity, immunogenicity and protective efficacy of whole-virus and split-influenza product vaccines in children. J Infect Dis 1977; 136: 623-632.
  • 7. al-Mazrou A, Scheifele DW, Soong T, Bjornson G. Comparison of adverse reactions to whole-virion and split-virion influenza vaccines in hospital personnel. CMAJ 1991; 145: 213-218.
  • 8. Skowronski DM, Strauss B, De Serres G, et al. Oculo-respiratory syndrome: a new influenza vaccine-associated adverse event? Clin Infect Dis 2003; 36: 705-713.
  • 9. National Advisory Committee on Immunization. Supplementary statement for the 2001–2002 season: influenza vaccination of persons who experienced oculo-respiratory syndrome following previous influenza vaccination. Can Commun Dis Rep 2001; 27: 1-7.
  • 10. Global Advisory Committee on Vaccine Safety. Oculorespiratory syndrome. Week Epi Rec 2003; 78: 17–24. http://www.who.int/wer/2003/en/wer7804.pdf (accessed Jul 2011).
  • 11. Skowronski DM, De Serres G, Scheifele D, et al. Randomized, double-blind, placebo-controlled trial to assess the rate of recurrence of oculorespiratory syndrome following influenza vaccination among persons previously affected. Clin Infect Dis 2003; 37: 1059-1066.
  • 12. Splia-Alegani S, Salmaso S, Rota MC, et al. Reactogenicity in the elderly of nine commercial influenza vaccines: results from the Italian SVEVA study. Vaccine 1999; 17: 1898-1904.
  • 13. Tumova B, Schramlova J, Vitkova E, et al. Is the release control of influenza vaccine sufficient? In: Programs and abstracts of Options for the Control of Influenza III; Cairns, Queensland; 1996.
  • 14. Tannock GA, Bryce DA, Hensley MJ, et al. Responses to one or two doses of a deoxycholate subunit influenza vaccine in a primed population. Vaccine 1984; 2: 100-106.
  • 15. Therapeutic Goods Administration. Overview of vaccine regulation and safety monitoring and investigation into adverse events following 2010 seasonal influenza vaccination in young children. Attachment E: TGA influenza seasonal trivalent influenza vaccine laboratory investigation program. http://www.tga.gov.au/safety/alerts-medicine-seasonal-flu-101008.htm#attachments (accessed Aug 2011).
  • 16. Centers for Disease Control and Prevention (US). ACIP recommendation for use of CSL influenza vaccine [media statement]. 6 Aug 2010. http://www.cdc.gov/media/pressrel/2010/s100806.htm (accessed Sep 2011).
  • 17. Food and Drug Administration (US). Inspections, compliance, enforcement, and criminal investigations. Warning letter to Commonwealth Serum Laboratories (CSL) Ltd. June 15, 2011. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm259888.htm (accessed Jul 2011).
  • 18. Nolan T, Richmond PC, McVernon J, et al. Safety and immunogenicity of an inactivated thimerosal-free influenza vaccine in infants and children. Influenza Other Resp Viruses 2009; 3: 315-325.
  • 19. Commonwealth Serum Laboratories. Influenza virus vaccine, 2010–2011 formula (STN BL 125254/181). Highlights of prescribing information. http://www.fda.gov/downloads/biologicsbloodvaccines/vaccines/approvedproducts/ucm220730.pdf (accessed Aug 2011).
  • 20. ClinicalTrials.gov. A study to determine the immunogenicity and safety profile of CSL Limited’s influenza virus vaccine compared to a US licensed comparator influenza virus vaccine in a pediatric population. http://clinicaltrials.gov/ct2/show/results/NCT00959049 (accessed Aug 2011).

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