Training for Inactivated Poliovirus Vaccine (IPV)
introduction
Module 6
Inactivated poliovirus vaccine
AEFI monitoring
Learning objectives
 At the end of the module, the participants will be
able to:
– Identify adverse events following immunization (AEFIs)
– Explain how to report AEFIs
 Duration
– 30 minutes
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Inactivated poliovirus vaccine AEFI monitoring, Module 6 I 24 July
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Key issues
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2
3
What is an AEFI?
How likely is an AEFI after
IPV?
Which AEFIs do I report?
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How do I report an AEFI?
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Inactivated poliovirus vaccine AEFI monitoring, Module 6 I 24 July
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Adverse Event Following Immunization
(AEFI)
 What is an AEFI?
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–
–
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A medical incident
Takes place after an immunization
Causes concern
Is believed to be caused by immunization
 How are AEFIs categorized?
Type
- Vaccine reaction
- Programme error
- Coincidental
- Injection reaction
- Unknown
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Severity
-
Minor
Severe
• Serious
• Non-serious
… these are defined soon
Inactivated poliovirus vaccine AEFI monitoring, Module 6 I 24 July
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Programme errors
 Errors in vaccine preparation, handling, storage, or
administration
 Preventable
 Often constitute the greatest proportion of AEFIs
 Identification and correction are of great importance
 Examples:
– Non-sterile injection
– Injection at incorrect site
– Administration of frozen vaccine
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Inactivated poliovirus vaccine AEFI monitoring, Module 6 I 24 July
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Coincidental events
 Occur after vaccination, but not caused by the vaccine or its
administration
 Occur during infancy when illnesses are common and
congenital or early neurological conditions become apparent
 Onset temporally associated with vaccination, and inevitable
when vaccinating these age groups
 Applying normal incidence of disease and death in these age
groups along with coverage allows estimation of expected
numbers of coincidental events after immunization
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Inactivated poliovirus vaccine AEFI monitoring, Module 6 I 24 July
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Injection reactions
 Immunization anxiety-related reactions in anticipation
to and as a result of an injection of any kind
 Not related to the vaccine but to fear of the injection
 You may encounter 4 types of injection reactions :
– Fainting
– Hyperventilation
– Vomiting
– Convulsions
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Inactivated poliovirus vaccine AEFI monitoring, Module 6 I 24 July
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Vaccine reactions can be classified into two
levels of severity
 Minor reactions
 Severe reactions- require
timely and appropriate
management
– Usually occur within few
hours
– Resolve quickly
– Pose little danger
– Local: pain, swelling, redness
at injection site
– Systemic: fever, malaise,
muscle pain, headache, or loss
of appetite
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Inactivated poliovirus vaccine AEFI monitoring, Module 6 I 24 July
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– Usually do not result in longterm problems
– Can be disabling
– Are rarely life threatening
– Include seizures and allergic
reactions caused by body’s
reaction to a particular
component in a vaccine
Some severe events can be SERIOUS
A serious AEFI- Any untoward medical
occurrence that at any dose:
– Results in death
– Is life threatening
– Requires in-patient hospitalization or prolongation
of existing hospitalization
– Results in persistent or significant disability or
incapacity
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Inactivated poliovirus vaccine AEFI monitoring, Module 6 I 24 July
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The difference between serious and severe
adverse events
 A severe reaction is a broader term which includes SERIOUS
reactions + reactions that do not necessarily lead to long term problems.
 Severe reactions must be reported
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Inactivated poliovirus vaccine AEFI monitoring, Module 6 I 24 July
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How likely is an AEFI after IPV?
IPV is a very safe vaccine
Not associated with serious systemic AEFIs
Inactivated vaccine – therefore, no risk of
vaccine-associate polio
Can safely be administered with
other recommended childhood
vaccines, including OPV and
other injectable vaccines
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Inactivated poliovirus vaccine AEFI monitoring, Module 6 I 24 July
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Which AEFIs should be reported?
 Any severe events or AEFI that is of concern to the parents
or health care worker
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Inactivated poliovirus vaccine AEFI monitoring, Module 6 I 24 July
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Where to report AEFI's
 Report the event through existing AEFI reporting systems
established by national immunization programs
Signs or symptoms
believed to be related
to the vaccine
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Community, district, and
regional levels
Inactivated poliovirus vaccine AEFI monitoring, Module 6 I 24 July
2016
National
authorities
Conducting an AEFI investigation
 Some AEFI reports will need further investigation by
the immunization programme managers
 Components of AEFI investigation:
– Identify specifications of implicated vaccine
– Examine operational aspects of the programme which may have
led to immunization errors
– Search for other potential AEFI cases/clustering
– Compare background risk to reported rate of AEFI
– Confirm (or propose) the diagnosis and determine outcome
– In collaboration with experts, determine if AEFI was vaccinerelated
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Inactivated poliovirus vaccine AEFI monitoring, Module 6 I 24 July
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What information should an AEFI report
contain?
 Client information
 Details about the vaccine
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–
–
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Type
Date
Manufacturer
Lot/expiration date
Site/route of immunization, etc.
 Description of adverse event(s)
and any associated events
 Medical and treatment history
 Reporter details
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Inactivated poliovirus vaccine AEFI monitoring, Module 6 I 24 July
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Communication with caretakers in case of
an AEFI
 Reassure the caretaker
 Admit uncertainty
 Convey that the AEFI will be reported and
investigated fully
 Keep the community informed with follow-up
information
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Inactivated poliovirus vaccine AEFI monitoring, Module 6 I 24 July
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Key messages
 AEFIs can be minor or severe (which include serious events)
 AEFIs should be reported through existing AEFI reporting
systems/forms
 The safety profile of IPV is excellent
 Most infants who get IPV do not experience any side effects
 In case of an AEFI
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–
–
–
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Reassure the caretaker
Admit uncertainty
Investigate fully
Keep the community informed
Inactivated poliovirus vaccine AEFI monitoring, Module 6 I 24 July
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End of module
Thank you
for your attention!
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Inactivated poliovirus vaccine AEFI monitoring, Module 6 I 24 July
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