What is the definition of Adverse Events Following Immunisation (AEFIs)?
Any untoward medical occurrence which follows immunisation and which does not necessarily have a causal relationship with the use of the vaccine.
AEFIs may include any unfavourable or unintended sign, abnormal laboratory finding, symptom, or disease.
Are AEFIs notifiable conditions in all jurisdictions?
No - statuatorily notifible (Public Health Acts) in ACT, NSW, NT, QLD, WA
Encouraged but not legally required in VIC, Tas,SA
What is the role of TGA in AEFI surveillance?
TGA conducts passive monitoring of AEFIs.
This monitoring is supplemented by active surveillance via AusVaxSafety (NCIRS) and various jurisdictional approaches.
What does SAEFVIC do in Victoria?
SAEFVIC conducts passive AEFI surveillance and investigation of vaccine safety signals, reports to TGA, and provides expert immunisation safety advice.
They also offer clinical services for those who have experienced an AEFI.
What types of events should be reported following immunisation?
- Any significant event felt to be following immunisation
- Expected symptoms that have not resolved after a few days
- Side effects requiring clinical assessment
- Suspected shoulder injury related to vaccine administration (SIRVA)
- Immunisation administration errors
- Reactions affecting confidence in future immunisation
Reporting helps in monitoring vaccine safety.
What constitutes a serious AEFI?
- Death
- Hospitalisation
- Persistent disability
- Non-common reaction
- Congenital anomaly or birth defect
What are non-serious AEFIs?
Common/expected adverse events known to be associated with a vaccine and do not pose a potential risk to health.
E.g. injection site reactions and systemic symptoms.
Define low level AEFI classification.
Common and/or unlikely to be causally related to immunisation.
This classification indicates minimal concern about the relationship with the vaccine.
Define high level AEFI classification.
Uncommon and serious with a potential relationship with recent immunisation.
This classification indicates a significant concern that requires further investigation.
What does a high level of significance AEFI classification indicate?
Uncommon and significant with a likely causal link to immunisation or significant media/community concern.
These events may require urgent public health responses.
What are vaccine errors?
Errors that occur when a vaccine is incorrectly stored, prepared, or administered, potentially resulting in an AEFI.
What are some examples of vaccine errors?
- Administering an expired vaccine or diluent component
- Cold chain breached vaccine administered
- Vaccine contraindicated for an individual.
What is the cold chain in vaccine storage?
The requirement to keep vaccines between +2 and +8 degrees Celsius.
Maintaining the cold chain is crucial for preserving vaccine potency.
What are the national guidelines for vaccine storage?
Strive for Five
Strive for 5C (between +2C to +8C)
What key issues does the strive for 5 guidelines include?
- Safe vaccine storage - cold chain and breaches
- Vaccine refrigeration - type, positioning, power supply (+backup),
- Vaccine temperature monitoring - data loggers, thermometers, cold chain monitors, alarm systems
- Maintaining equipment and auditing
What does the term ‘Strive for 5’ refer to?
National vaccine storage guidelines for maintaining the cold chain.
True or False: Lower temperatures generally affect vaccine potency more than slightly elevated temperatures.
True
What should be done in case of a cold chain breach?
- Report all exposures outside the temperature range (DH)
- Isolate vaccines and label “do not use”
- Thorough documentation
- May be advised to discard affected vaccines
Proper handling after a breach is essential to ensure safety.
True / False: Ice packs and gel coolers can be used to maintain temperatures for mobile or outreach vaccination.
True - seek guidance from Strive for 5 guidelines
What are key components for maintaining the cold chain?
- Correct refrigerators
- Reliable thermometers
- Staff training
- Policies/procedures/protocols
- Regular audits and servicing
- Reliable power source
- Plans for power failures
These components help ensure vaccine safety and efficacy.
Fill in the blank: Vaccines should be monitored at all times to maintain a temperature between _______.
+2 and +8 degrees Celsius.
True or False: Injection site reactions are considered serious AEFIs.
False.
Injection site reactions are classified as non-serious AEFIs.
