1. Module 6 Inactivated poliovirus vaccine AEFI monitoring Training for Inactivated Poliovirus Vaccine (IPV) introduction

2. Inactivated poliovirus vaccine AEFI monitoring, Module 6 I 03 July 2015 03 July 2015 2 |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 Duration – 30 minutes

3. Inactivated poliovirus vaccine AEFI monitoring, Module 6 I 03 July 2015 03 July 2015 3 |3 | What is an AEFI? 1 1 Which AEFIs do I report? 3 3 Key issues How do I report an AEFI? 4 4 How likely is an AEFI after IPV? 2 2

4. Inactivated poliovirus vaccine AEFI monitoring, Module 6 I 03 July 2015 03 July 2015 4 |4 | 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? TypeSeverity - Vaccine reaction - Programme error - Coincidental - Injection reaction - Unknown - Minor - Severe Serious Non-serious … these are defined soon

5. Inactivated poliovirus vaccine AEFI monitoring, Module 6 I 03 July 2015 03 July 2015 5 |5 | 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

6. Inactivated poliovirus vaccine AEFI monitoring, Module 6 I 03 July 2015 03 July 2015 6 |6 | 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

7. Inactivated poliovirus vaccine AEFI monitoring, Module 6 I 03 July 2015 03 July 2015 7 |7 | 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

8. Inactivated poliovirus vaccine AEFI monitoring, Module 6 I 03 July 2015 03 July 2015 8 |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 – Include seizures and allergic reactions caused by body’s reaction to a particular component in a vaccine

9. Inactivated poliovirus vaccine AEFI monitoring, Module 6 I 03 July 2015 03 July 2015 9 |9 | 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

10. Inactivated poliovirus vaccine AEFI monitoring, Module 6 I 03 July 2015 03 July 2015 10 | 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

11. Inactivated poliovirus vaccine AEFI monitoring, Module 6 I 03 July 2015 03 July 2015 11 | 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

12. Inactivated poliovirus vaccine AEFI monitoring, Module 6 I 03 July 2015 03 July 2015 12 | Which AEFIs should be reported? Any severe events or AEFI that is of concern to the parents or health care worker

13. Inactivated poliovirus vaccine AEFI monitoring, Module 6 I 03 July 2015 03 July 2015 13 | 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

14. Inactivated poliovirus vaccine AEFI monitoring, Module 6 I 03 July 2015 03 July 2015 14 | 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

15. Inactivated poliovirus vaccine AEFI monitoring, Module 6 I 03 July 2015 03 July 2015 15 | What information should an AEFI report contain? Client information Details 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

16. Inactivated poliovirus vaccine AEFI monitoring, Module 6 I 03 July 2015 03 July 2015 16 | 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

17. Inactivated poliovirus vaccine AEFI monitoring, Module 6 I 03 July 2015 03 July 2015 17 | 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

18. Inactivated poliovirus vaccine AEFI monitoring, Module 6 I 03 July 2015 03 July 2015 18 | End of module Thank you for your attention!