# Presentation: 656632

## Post-licensure vaccine safety monitoring: Australia

- Glenda Lawrence PhD MPH
- Senior Research Fellow
- National Centre for Immunisation Research and Surveillance
- Children’s Hospital and University of Sydney

**Notes:**
Thank you.

I’m just going to talk briefly about AEFI surveillance in Australia.

## Outline

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

## Population = 20 million; Annual births = 250,000; States & Territories = 8 

- Population = 20 million; Annual births = 250,000; States & Territories = 8

## 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

## 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

## Active anti-vaccination network

## Conscientious objectors to 

- Conscientious objectors to
- immunisation due to
- Lifestyle, not Religion

- Coverage = 90-95%
- Pockets at 75%

## 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

**Notes:**
What is AEFI?
Adverse event following immunisation.
The key word is actually ‘following’, in that the adverse event and immunisation are associated in time, but are not necessarily causally linked – that linkage requires investigation.

AEFI surveillance in Australia is principally via a passive system. 

We also have specialist AEFI clinics in several states, including one at this hospital. These have a role as sentinel surveillance sites. The SA hot line for parents and doctors can also act as a sentinel system

Active surveillance is conducted on an ad hoc basis - during pre-licensure clinical trials, as part of an epidemiological study to investigate something detected via passive surveillance, and also when large scale vaccination campaigns are conducted - such as the measles control campaign.

Some other active surveillance methods are under investigation, such as using data linkage methods to link immunisation and health records. This is similar to the US - Datalink project. 

## 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

**Notes:**

All passive surveillance systems have a set of common components:
They require detection of the event under surveillance, 
a mechanism for the event to be notified or reported to someone who is collecting the information, 
the information must be reviewed 
 and data needs to be analysed and results be shared with stakeholders, the public etc.

## 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

**Notes:**
The national guideline on what AEFIs to notify are found in the Immunisation Handbook. 
There are about 20 conditions in all, including severe systemic reactions and local reactions. In addition to these 20, vaccination providers are also asked to report on any other serious or unusual event. This is so that new AEFI, not detected in clinical trials might be identified.

States and Territories differ in their regulations on how AEFI should be notified and by whom.
In some juristictions notification is mandatory, most require notification to them, others want notification to go directly to the TGA, some only accept notification from the doctors and health care workers, others accept parent reports.

## Passive AEFI Surveillance System

**Public**** **

**Vaccine companies**

**TGA - Adverse Drug Reactions Unit**

**Triage – Health Professional**

**Other reactions**

**State & Territory health departments**

**Doctors, hospitals, etc**

**Medical Officer**

**Serious, severe or unexpected reaction**

**Follow up as required**

**Reviewed at ADRAC **
**meeting (6 weekly)**

-  **Data entry**** **

**Health Professional**

**Copy of annotated notification**

**Electronic data**

**NCIRS  **
**data analysis**

**Publish in CDI ****2x yearly**** & other as required**

**Passive AEFI Surveillance System**

## 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 <7 years - ACIR data
- other age groups with known denominator - annual influenza coverage survey
- Serious AEFI defined as
- recovery with sequelae, hospitalisation, life-threatening, death

**Notes:**
S/T, the TGA and now NCIRS have roles in analysing data – 
mainly to monitor trends and detect signals. 
We’d like to report the  rates of AEFIs for specific vaccines – for this we need denominator data of doses delivered. 
One source of information will be the ACIR.

Reporting of findings can be found in some S/T reports and bulletins, the TGA monthly bulletin, CDI,  and in the peer-reviewed literature if it’s a major new finding. Also WHO reports AEFI. 

## Published reports

## 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

## Reporting rate per 100,000 doses

## Reporting rate of DTPa local reactions

## New vaccines in national program

## Reported AEFI for new vaccine

## Immunisation adverse events clinics

## 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

- Parents	Providers	            MO         Recipients
- AEFI reports

- South Australian
- Enhanced system

- Surveillance
- Notification

- Management
- Special Immunisation
-           Service

**Vaccine safety data linkage**** (pilot)**

**Notes:**
This slides describes how the AEFI surveillance and management is co-ordinated.  That is reports are reviewed by SA Immunisation Co-ordination (SAICU) and those children requiring review or further vaccination are referred onto the SIS.   
The special immunisation service in SA was established in 1997
Clinics occur twice monthly
The clinic is staffed and FUNDED by a nurse from SA Immunisation Co-ordination unit – the nurse who is involved in the AEFI system and MG who reviews passive AEFI reports and attends the clinic.
SIS located in a tertiary care hospital –OPD- if admissions required then through the hospital system
Data collected “real time” on lap-top computer 

## 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

## 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

## AEFI reporting rate by S/T 

| Practice | S/T | 2004* | 2005* |
| --- | --- | --- | --- |
| Direct to TGA |  Tas, Vic | 1.2 – 2.5 | 3.9 – 4.3** |
| Mandatory to S/T | NSW, Qld, WA | 3.0 – 4.7 | 2.7 – 2.8 |
| Parent report to S/T | SA, ACT | 14.2 – 35.9 | 11.1 – 16.3 |
| Mandatory to S/T
different population | NT | 17.5** | 13.8** |

- *AEFI reporting rate per 100,000 population
- ** Reporting by nurses promoted

## Reporting rates by jurisdiction

## Reporting sources & timeliness

| Reporter | % of reports | Median days* | % rec’d by 90 days* |
| --- | --- | --- | --- |
| S/T health depts | 64 | 68 | 59 |
| Doctors | 25 | 12 | 96 |
| Nurses | 2.8 | 17 | 92 |
| Hospitals | 4.3 | 32 | 76 |
| Vac companies | 1.7 | 19 | 88 |
| Public/parents | 1.4 | 8 | 85 |

- * between date of onset and date report received at TGA

## 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

## 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

## 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

## 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

## Acknowledgements

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

## Byron Bay

## Slide 33

## Adverse Reaction Report

## 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%)