module 6 inactivated poliovirus vaccine aefi monitoring training for inactivated poliovirus vaccine...

Module 6

Inactivated poliovirus vaccine AEFI monitoring

Training for Inactivated Poliovirus Vaccine (IPV) introduction

Inactivated poliovirus vaccine AEFI monitoring, Module 6 I 19 April 2023

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Learning objectivesLearning 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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What is an AEFI ?11

Which AEFIs do I report?

33

Key issues

How do I report an AEFI ?

44

How likely is an AEFI after IPV ?

22


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Adverse Event Following Immunization (AEFI)

Adverse Event Following Immunization (AEFI)

What is an AEFI?– A medical incident– Takes place after an immunization– Causes concern– Is believed to be caused by immunization

How are AEFIs categorized? Type Severity

- Vaccine reaction- Programme error- Coincidental- Injection reaction- Unknown

- Minor- Severe

• Serious• Non-serious

… these are defined soon


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Programme errorsProgramme 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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Coincidental eventsCoincidental 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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Injection reactionsInjection 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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Vaccine reactions can be classified into two levels of severity

Vaccine reactions can be classified into two levels of severity

Minor reactions

– 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

Severe reactions- require timely and appropriate management– Usually do not result in

long-term 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


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Some severe events can be SERIOUS

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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The difference between serious and severe adverse events

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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How likely is an AEFI after IPV?How likely is an AEFI after IPV?

IPV is a very safe vaccineNot associated with serious systemic

AEFIsInactivated vaccine – therefore, no risk of

vaccine-associate polioCan safely be administered with other recommended childhood vaccines, including OPV and other injectable vaccines


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Which AEFIs should be reported?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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Report the event through existing AEFI reporting systems established by national immunization programs

National authorities

Community, district, and regional levels

Signs or symptoms

believed to be related to the

vaccine

Where to report AEFI's Where to report AEFI's


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Conducting an AEFI investigationConducting 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

vaccine-related


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What information should an AEFI report contain?

What information should an AEFI report contain?

Client informationDetails about the vaccine

– 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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Communication with caretakers in case of an AEFI

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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Key messagesKey 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 excellentMost infants who get IPV do not experience any

side effects In case of an AEFI

– Reassure the caretaker– Admit uncertainty– Investigate fully– Keep the community informed


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End of moduleEnd of module

Thank youfor your attention !

module 6 inactivated poliovirus vaccine aefi monitoring training for inactivated poliovirus vaccine...

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