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Adverse events associated with 2010 CSL and other inactivated influenza vaccines

Heath A Kelly1, Danuta M Skowronski, Gaston De Serres

  • 1Epidemiology Unit, Victorian Infectious Diseases Reference Laboratory, Melbourne, VIC, Australia. heath.kellyATmh.org.au

The Medical Journal of Australia
|September 21, 2011
PubMed

Insights

The 2010 CSL trivalent influenza vaccine (TIV) was linked to increased febrile reactions in children. Further investigation into the deoxycholate splitting agent is recommended to ensure vaccine safety and public confidence.

Area of Science:

  • Immunology
  • Vaccinology
  • Public Health

Background:

  • The 2010 trivalent influenza vaccine (TIV) from CSL Biotherapies (CSL) in Australia was associated with a rise in febrile reactions, including febrile convulsions, in children.
  • CSL utilizes deoxycholate as a virus-splitting agent, a method previously linked to adverse events following immunization (AEFI) clusters with other deoxycholate-split TIVs in Europe and Canada.

Purpose of the Study:

  • To investigate the potential role of the deoxycholate virus-splitting agent in the adverse events associated with the 2010 CSL TIV.
  • To explore whether suboptimal virus splitting or other deoxycholate-related mechanisms contributed to the observed adverse events.

Main Methods:

  • Review of adverse event data following TIV administration.
  • Analysis of manufacturing processes, specifically the use of deoxycholate as a virus-splitting agent.
  • Consideration of regulatory warnings regarding CSL's manufacturing practices.

Main Results:

  • The 2010 CSL TIV was associated with increased febrile reactions and febrile convulsions in Australian children.
  • Previous clusters of AEFI were linked to deoxycholate-split TIVs in other regions.
  • A US FDA warning letter indicated CSL's failure to validate virus splitting assays and determine optimal splitting conditions.

Conclusions:

  • The use of deoxycholate as a virus-splitting agent in TIV manufacturing warrants further investigation as a potential cause for the observed adverse events.
  • Comprehensive and timely investigations of AEFI are crucial for preventing recurrence and maintaining public trust in vaccination programs.

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