Review of the management of adverse events associated with Panvax and Fluvax

Appendix I - Documents and other source materials reviewed

Page last updated: April 2015

Overview of Vaccine Regulation and Safety Monitoring and Investigation into Adverse Events Following 2010 Seasonal Influenza Vaccination in Young Children – TGA – 8 October 2010

Chronology of Events Associated with Influenza Vaccines – OHP – October 2010

Investigation into Febrile Reactions in Young Children Following 2010 Seasonal Trivalent Influenza Vaccination – TGA – 24 September 2010

Australian Technical Advisory Group on Immunisation (ATAGI) Review of Seasonal Trivalent Influenza Vaccine Adverse Events in Children – Interim Summary Report of Joint ATAGI/TGA Ad Hoc Working Group Meeting and ATAGI Advice to CMO – ATAGI – 13 May 2010

ATAGI and TGA Joint Working Group – Final – Review of Adverse Events Following Immunisation in Children Following Monovalent Pandemic H1N1 Vaccine (Panvax and Panvax Junior, CSL) – ATAGI – 27 September 2010

Government of Western Australia, Department of Health – Ministerial Review into the Public Health Response into the Adverse Events to the Seasonal Influenza Vaccine – Final Report to the Minister for Health – Professor Bryant Stokes – July 2010

Correspondence between Professor Bryant Stokes (WA Health) and Professor Jim Bishop, CMO regarding the Stokes Review – DoHA – 9 August 2010

Response to the West Australian (Stokes) Review into the Handling of AEFIs following 2010 Seasonal Flu Vaccination – TGA

Correspondence between Ms Jane Halton (Secretary, DoHA) and Kim Snowball (Director General – WA Health)

Bonhoeffer J. et al for the Brighton Collaboration Methods Working Group (2009) Guidelines for collection, analysis and presentation of vaccine safety data into surveillance systems. Vaccine 27(16):2289-2297.

Lawrence G. for the National Immunisation Committee (2006) National Vaccine Safety Workshop: Summary and draft recommendations. Communicable Diseases Intelligence 30(3):378-380.

Dixon et al (2010) Lessons from the first year of the WAIVE study investigating the protective effect of influenza vaccine against laboratory confirmed influenza in hospitalised children aged 6-59 months. Influenza and Other Respiratory Viruses 4:231-234.

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Media Analysis – 2010 Seasonal Influenza

Gardasil Expert Panel – Report to the National Manager, Therapeutic Goods Administration on the safety and efficacy of Gardasil – TGA – February 2009.

Gold M et al (2010) Febrile Convulsions after 2010 seasonal trivalent influenza vaccine: implications for vaccine safety surveillance in Australia. Medical Journal of Australia 193(9): 492-493.

Email Correspondence between Office of Product Review (TGA), WA Health and SA Health. (April 2010)

Log, line listings and case reports of suspected adverse events following influenza vaccination received by the TGA 2010

Email advice from the World Health Organization Collaborating Centre for Reference and Research on Influenza in Melbourne (Professor Anne Kelso) regarding yearly trivalent vaccine strain selection and vaccine manufacture - November 2010.

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