Seasonal flu vaccine: Overview of vaccine regulation and safety monitoring and investigation into adverse events following 2010 seasonal influenza vaccination in young children

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8 October 2010

Attachment A: Timeline of the investigation into febrile reactions in young children following 2010 seasonal trivalent influenza vaccination

This is Attachment A to the Overview of vaccine regulation and safety monitoring and investigation into adverse events following 2010 seasonal influenza vaccination in young children.

Date Who/what Action
19 March 2010 WA Health Seasonal influenza vaccination commences in Western Australia (WA).
31 March 2010 CDCD WA Health First cluster of reports of febrile convulsions received by WA Health but are not passed on to the TGA
13 April 2010 CDCD WA Health Advises the TGA it has reports of febrile convulsions in children. TGA requests documentation be provided.
20 April 2010 CDCD WA Health Sends first tranche of AEFI reports to the TGA. No clinical case records provided at that time.
22 April 2010 WA Health WA announces suspension of its childhood vaccine program.
23 April 2010 CMO CMO announces temporary suspension of seasonal influenza vaccine to children 5 years of age and under.
23 April 2010 TGA The TGA convenes expert scientific advisory panel to review available information
24, 25 April 2010 ATAGI ATAGI - TGA working group develop data collection templates for epidemiological investigation
26 April 2010 AHPC / CDNA Data collection templates circulated to state and territory members.
27 April 2010 TGA Review of batch release data commences.
27 April 2010 ATAGI ATAGI Chair and TGA National Manager meet with WA Health to request provision of data from WA to the TGA to allow investigation.
29 April 2010 TGA Laboratory analysis of field and retention samples begins
30 April to
early May 2010
Department ATAGI Working Party and NCIRS continue to collate and analyse the data being provided by jurisdictions.
4 May 2010 TGA Meets with NCIRS to review epidemiological analyses.
4 May 2010 TGA TGA expert panel on vaccine testing convened, chaired by Prof Peter Doherty
10 May 2010 TGA TGA reviews distribution and ADR data with vaccine sponsors
11 May 2010 TGA TGA pharmacoepidemiology expert panel reconvened by teleconference to review planned and completed epidemiological analyses; endorses planned analyses
13 May 2010 Department ATAGI-TGA Working Party, NCIRS, and Department meet to review the evidence being provided by jurisdictions.
13,14 May 2010 TGA TGA GMP audit of CSL manufacturing facilities
14 May 2010 TGA TGA expert panel on vaccine testing meets
20 May 2010 ATAGI ATAGI-TGA working party interim report to the CMO recommends continued suspension of vaccination in children < 5 years while laboratory testing, manufacturing inspections and epidemiological analyses continue.
1 June 2010 TGA Samples sent to NIBSC for further in vitro analyses.
2 June 2010 TGA TGA's Advisory Committee on the Safety of Medicines (ACSOM) meets to review issues with 2010 seasonal TIV.
7 June 2010 TGA Samples sent to CDC in vitro and in vivo analyses.
10 June 2010 Department ATAGI meets.
18,21-23 June 2010 TGA TGA inspection of CSL manufacturing facilities.
2 July 2010 TGA TGA issues interim report on the investigations to date.
27 July 2010 CMO Advises resumption of vaccination, using Influvac and Vaxigrip.
24 September 2010 TGA TGA updates interim report of investigation.

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