1. Module 6 AEFI monitoring
Training for the introduction of Inactivated Poliovirus Vaccine, Fractional Dose (fIPV)
Module 6
AEFI monitoring

2. 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
Explain which AEFI should be reported and how
Fill in an AEFI reporting form and identify to whom the report should be sent
Duration
30 minutes

3. How likely is an AEFI after IPV?
Key issues
What is an AEFI? 1
How likely is an AEFI after IPV? 2
Which AEFIs do I report? 3
How do I report an AEFI? 4
To the facilitator:
Explain to the participants the key issues raised in this module.
It is important to monitor and report AEFIs so that the community continues to have confidence in the immunization program.
We will provide you with answers to the following questions:
What are the AEFIs of inactivated poliovirus vaccine?
How to report an AEFI?
Is it OK to give multiple injections at the same visit?

4. Adverse Event Following Immunization (AEFI)
What is an AEFI?
A medical incident
Takes place after an immunization
Does not necessarily have a causal relationship with the usage of the vaccine
May be any unfavorable or unintended sign, abnormal lab finding, symptom or disease
Why monitor AEFI ?
To timely detect, identify and investigate safety concerns in a timely manner
For appropriate and timely response to prevent reoccurrence
To maintain confidence in the immunization programme
To the facilitator:
Explain to the participants the adverse event following immunization of inactivated poliovirus vaccine.
An adverse event following immunization (AEFI) is any untoward medical occurrence which follows immunization and which does not necessarily have a causal relationship with the usage of the vaccine. The adverse event may be any unfavourable or unintended sign, abnormal laboratory finding,
The safety profile of the inactivated poliovirus vaccines currently available is good. Most infants who get the inactivated poliovirus vaccine do not experience any side effects.
These AEFIs are described in the following slides

5. WHO cause specific definition of AEFIs
Vaccine product-related reaction
Vaccine quality defect-related reaction
Immunization error-related reaction
Coincidental event
AEFI caused or precipitated by a vaccine due to one or more of the inherent properties of the vaccine product.
AEFI caused or precipitated by a vaccine due to one or more quality defects of the vaccine product including its administration device as provided by the manufacturer.
AEFI caused by inappropriate vaccine handling, prescribing or administration.
AEFI caused by something other than the vaccine product, immunization error or immunization anxiety
EXAMPLE after IPV:
Transient minor local erythema (0.5-1%)
Induration (3-11%)
Tenderness (14-29 %)
EXAMPLE
Failure by the manufacturer to completely inactivate a lot of IPV, leading to cases of paralytic polio.
Transmission of infection by contaminated multi-dose vial.
A fever after vaccination (temporal association) and malarial parasite isolated from blood.
Explain to the participants what Vaccine product-related reactions are:
-is an individual’s reaction to the inherent properties of the vaccine, even when the vaccine has been prepared, handled and administered correctly
- IPV is considered very safe given alone or in combination with other vaccines; Known IPV reaction are Transient minor local erythema (0.5-1%)
Induration (3-11%) Tenderness (14-29 %)
Explain to the participants what Vaccine quality defect-reactions are:
-due to a defect in a vaccine (or its administration device) that occurred during the manufacturing process.
-such a defect may have an impact on an individual’s response and thus increase the risk of adverse vaccine reactions. Insufficient inactivation of wild-type vaccine agent (e.g. wild polio virus) during the manufacturing process or contamination introduced during the manufacturing process could cause the vaccine quality defect-related reactions.
- In the early years of immunization programmes, some major vaccine quality defect-related reaction incidents were reported. However, since the introduction of good manufacturing practice (GMP) manufacturing defects are now very rare. Since vaccine manufacturers have started following GMP, and NRAs have been strengthened, the potential risk of such quality defects is now rare.
Explain to the participants what Immunisation errors are and the importance to report them to take appropriate action to prevent recoccurence:
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
Administering frozen vaccine
Explain to the participants what Coincidental events are
Events occur after vaccination but not caused by the vaccine or its administration
Vaccinations given in infancy when illnesses are common and congenital or early neurological conditions become apparent.
Coincidental events are inevitable when vaccinating in 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

6. How likely is an Adverse reaction 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
IPV vaccine is very safe, and Known IPV reaction are minor : Transient minor local erythema (0.5-1%)
Induration (3-11%) Tenderness (14-29 %)
Latest review of safety of IPV vaccine by GACVS:
However, as explained earlier other type of AEFI can be encountered and need to be reported.

7. GVAP vaccine safety indicator
AEFI reporting rate in surviving infants from a country per year.
Number of AEFI cases reported from a country per year
AEFI reporting rate per 100,000 surviving infants per year =
X 100,000
Total number of surviving infants in the country per year
The performance of an AEFI surveillance system is measured by the number of AEFI reported. The target proposed is at least 10 reports per 100,000 surviving infants per year. The sub-national area/country is defined according to the functional requirements and setup of the national AEFI surveillance system   
This is a general indicator, not vaccine specific. The message to convey: although vaccines are very safe, AEFI are expected to occur. As explained earlier the AEFI are not necessarily due to the vaccine; vaccines are normally administered early in life when infections and other illnesses are common, including manifestations of underlying congenital or neurological conditions
A country has minimal capacity if it reports at least 10 cases per 100,000 surviving infants per year.

8. 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
Some severe events can be serious
Include seizures and allergic reactions caused by body’s reaction to a particular component in a vaccine
To the facilitator:
Explain to the participants what “Vaccine Reactions” are:
Minor reactions
Usually occur within few hours
Resolve after short period
Pose little danger
Local (includes pain, swelling, redness at site of injection
Systemic: fever, malaise, muscle pain, headache, or loss of appetite
Severe reactions
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

9. Some severe events can be SERIOUS
A serious AEFI is 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
To the facilitator:
Explain to the participants that some severe events can be serious:
An AEFI will be considered serious, if it:
Results in death
Is life threatening
Requires in-patient hospitalization or prolongation of existing hospitalization
Results in persistent or significant disability/incapacity

10. Which AEFIs should be reported?
Any severe event or AEFI that is of concern to the parents or health care worker
To the facilitator:
Explain to the participants what AEFIs should be reported

11. Where and when 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
Community, district, and regional levels
National
authorities
To the facilitator:
Explain to the participants what should be done for adverse events following immunization (AEFIs).
Similar to all other vaccines, inactivated poliovirus vaccine needs to be monitored for safety and adverse events following immunization.
Health workers should ask parents to immediately report any reaction following the vaccination that may be of concern.
Reporting the AEFI through the existing AEFI reporting systems established by national immunization programs must be made as quickly as possible, so that an immediate decision can be made on the need for action and investigation. Refer to the national AEFI guidelines, and ensure that the each HCW is aware to who to report to. 11

12. What information should an AEFI report contain?
Client information
Details about the vaccination, and 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
To the facilitator:
Explain to the participants what information should be included in an AEFI report.
An AEFI report should contain:
Client – unique identifier, date of birth, gender, location
Immunization event(s) – province where given, date, all vaccines given including name, manufacturer, lot number, administration site and route, as well as the number in series of vaccine doses if relevant
Adverse event(s) – description, including time of first onset following immunization, duration, health care utilization, treatment and outcome
Outcome of the event; seriousness
Relevant medical and treatment history – underlying disease, known allergies, prior AEFI, concomitant medication
Associated event(s) – acute illness, injury, exposure to environmental toxins
Reporter details
If time permit, give them a form to fill in with a fake case.

13. 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 vaccine- related
To the facilitator:
Explain to the participants what an AEFI investigation entails and its purpose
Some AEFI reports will need further investigation by the immunization programme managers
The purpose of this investigation may include:
Confirm (or propose) the diagnosis and determine outcome
Identify specifications of implicated vaccine
Examine operational aspects of the programme which may have led to the immunization errors
Justify the search for other potential AEFI cases/clustering
Compare background risk to reported rate of AEFI

14. 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
To the facilitator:
Explain to the participants how to communicate 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

15. 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
Reassure the caretaker
Admit uncertainty
Investigate fully
Keep the community informed
To the facilitator:
Explain to the participants that this is the main information to keep in mind.
The current safety profile of inactivated poliovirus vaccines is very good
Most infants who get the inactivated poliovirus vaccine do not experience any side effects
AEFIs can be minor or severe (which include serious events)
AEFIs should be reported through the existing AEFI reporting systems/forms
Reassure the caretaker- Admit uncertainty, investigate fully, and keep the community informed

16. End of module for your attention! Thank you To the facilitator:
This is the end of the module.
You have been introduced to “Inactivated poliovirus vaccine AEFI monitoring” module. The following module is titled “Inactivated poliovirus vaccine communication with caretakers”.
Thank you for your attention!