Postlicensure vaccine safety monitoring: Australia

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Post-licensure vaccine safety monitoring
Australia

• Glenda Lawrence PhD MPH
• Senior Research Fellow
• National Centre for Immunisation Research and
  Surveillance
• Childrens Hospital and University of Sydney

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Outline

• Background - Australia
• Current post-licensure activities
• passive surveillance
• special AE clinics
• Evaluation
• Issues challenges
• New initiatives
• Vaccine Safety Workshop
• pilot studies - active surveillance

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Population 20 million Annual births 250,000
States Territories 8
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Australian immunisation system -1

• Federal responsibilities
• Funding of all vaccines on national immunisation
  program (NIP)
• Australian Childhood Immunisation Register (ACIR)
  
• Therapeutic Goods Administration (TGA)
• similar functions to FDA - registration,
  regulation, monitoring
• merge with New Zealand July 2007
• TGA and Adverse Drug Reactions Advisory Committee
  (ADRAC)
• passive surveillance - drugs vaccines

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Australian immunisation system - 2

• State and Territory (S/T) responsibilities
• Manage immunisation delivery
• Forward AEFI data to TGA
• National Immunisation Committee
• All 8 S/T represented, Federal Chair
• Forum for funding and program delivery issues,
  AEFI

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Active anti-vaccination network
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Conscientious objectors to immunisation due
to Lifestyle, not Religion
Coverage 90-95 Pockets at 75
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Current post-licensure activities

• Surveillance
• National via TGA blue card
• Regional (sentinel)
• Parent hotlines in 2 S/T
• Specialist AEFI clinics 6 clinics in 5 S/T
• Specialist AE clinics
• Service role consultation and re-immunisation
• Research collaborations

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Passive AEFI surveillance

• Similar to VAERS and other national AEFI passive
  surveillance systems
• notification, review, analysis, publication
• TGA / ADRAC
• medicines and vaccines
• paediatrician with expertise in immunisation

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Notifying AEFI

• National guidelines on what to notify
• Australian Immunisation Handbook
• case definitions
• Other reports also accepted - serious / unusual
• S/T differ in notification processes
• mandatory notification (NSW, Qld, NT, WA)
• notify direct to TGA (Vic, Tas) vs to S/T health
  dept TGA
• Doctors, HCWs, vac companies, public

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Passive AEFI Surveillance System
Public
Vaccine companies
State Territory health departments
Doctors, hospitals, etc
TGA - Adverse Drug Reactions Unit
Publish in CDI 2x yearly other as required
Triage Health Professional
Serious, severe or unexpected reaction
Other reactions
NCIRS data analysis
Health Professional
Medical Officer
Electronic data
Data entry
Follow up as required
Reviewed at ADRAC meeting (6 weekly)
Copy of annotated notification
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Data analysis

• Monitor trends, detect signals
• Interpret data in relation to
• known vaccine adverse reactions
• changes in immunisation programs (e.g. MenC, 4th
  dose DTPa),
• changes in surveillance practices, coding (e.g.
  WHOART-MedDRA)
• Estimate reporting rates of AEFI per doses
  administered
• children lt7 years - ACIR data
• other age groups with known denominator - annual
  influenza coverage survey
• Serious AEFI defined as
• recovery with sequelae, hospitalisation,
  life-threatening, death

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Published reports
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Communication

• Communicable Diseases Intelligence
• 6 monthly reports of summary data
• available via the Internet
• regular communication
• transparency
• information for providers
• ADRAC quarterly bulletin
• GPs of issues, updates
• Peer-reviewed journal
• major new findings
• WHO

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Reporting rate per 100,000 doses
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Reporting rate of DTPa local reactions
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New vaccines in national program
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Reported AEFI for new vaccine
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Immunisation adverse events clinics
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Australian AEFI clinic network

• First clinic established 1994
• concerns about DTPw
• Now 6 clinics
• Major paediatric hospitals
• Some linked with
• State health dept
• Telephone information service
• Regular teleconferences

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Parents Providers MO
Recipients AEFI reports



South Australian Enhanced system
Surveillance Notification
Management Special Immunisation Service
Vaccine safety data linkage (pilot)
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AEFI management

• Examination of risk factors
• Promote continuation of schedule
• Advice to parents immunisation providers
• Re-vaccination in clinic
• Hospitalisation if required
• Short and long-term follow up
• 90 re-vaccinated
• rarely contra-indicated

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Evaluation issues challenges

• Surveillance
• Small population
• Difficult to detect very rare AE
• Dependent on other countries
• National consistency
• Timeliness vs completeness
• Rapid report vs full case investigation
• More active surveillance
• Pilot projects under way

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AEFI reporting rate by S/T
AEFI reporting rate per 100,000 population
Reporting by nurses promoted
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Reporting rates by jurisdiction
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Reporting sources timeliness
between date of onset and date report received
at TGA
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Stakeholders Recommendations

• National AEFI surveillance strategy, priorities
  objectives
• AEFI surveillance committee
• Greater consistency between jurisdictions
• Address weaknesses in passive system
• timeliness, feedback to providers, reporting of
  data
• Supplement passive system with active
  surveillance methods
• Canadian system (IMPACT) data linkage (hospital
  ACIR)
• Introduce no-fault compensation system

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Vaccine Safety Workshop Nov 05

• 40 invited participants broad representation
• AEFI surveillance, clinical management,
  communication
• Recommendations
• Surveillance
• Improve national consistency, timeliness
  investigate active surv.
• Clinical management research
• Resources, common database, clinical management
  protocols
• Communication
• public and providers greater involvement of
  consumers
• AEFI Working Party formed April 2006
• aim to progress recommendations
• DoHA, ADRAC, GP, NCIRS, S/T

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Pilot studies

• Data linkage
• Pilot study conducted in South Australia (Dr M
  Gold)
• Federal (ACIR) and State (hospital, ED)
• National initiative in development pilot
• Other national initiatives in DL and health
  adverse events
• Hospital-based active surveillance
  (modeled on IMPACT - Canada)
• Pilot project 2007 4 sites
• AFP, seizure post vaccination, intussusception,
  pertussis

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Summary

• Surveillance
• Passive surveillance enhanced by
• Expert review of reports
• Additional mechanisms in some S/T
• Denominators from register data
• Pilot studies in more active surveillance
• Data linkage
• Hospital surveillance for severe AEFI
• Clinical management network
• Service and research
• Communication
• Regular reports

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Acknowledgements

• TGA
• Ian Boyd
• ADRAC
• David Isaacs, Mike Gold
• Specialist clinics
• Sydney, Melbourne, Adelaide, Perth, Canberra
• NCIRS colleagues
• Peter McIntyre, Nick Wood, Han Wang

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Byron Bay
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(No Transcript)
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Adverse Reaction Report
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Data quality

• Important information often missing
• age or dob (1)
• serious (9)
• vaccination /or onset dates (12)
• outcome (13)
• dose number (53)
• batch number (55)
• hospitalisation (56)