1. Module 6 Monitoring Events Supposedly Attributable to Vaccination or Immunization (ESAVIs) Training for Inactivated Poliovirus Vaccine (IPV) introduction

2. Monitoring Events Supposedly Attributable to Vaccination or Immunization (ESAVIs) I Module 6 I February 2015 2 |2 | Learning objectives At the end of the module, the participants will be able to: – Identify Events Supposedly Attributable to Vaccination or Immunization (ESAVI) – Explain how to report ESAVIs Duration – 30 minutes

3. Monitoring Events Supposedly Attributable to Vaccination or Immunization (ESAVIs) I Module 6 I February 2015 3 |3 | What is an ESAVI? 1 1 Which ESAVIs do I report? 3 3 Key issues How do I report an ESAVI? 4 4 How likely is an ESAVI after IPV? 2 2

4. Monitoring Events Supposedly Attributable to Vaccination or Immunization (ESAVIs) I Module 6 I February 2015 4 |4 | Events Supposedly Attributable to Vaccination (ESAVI) What is an ESAVI? –It is a clinical symptom that occurs after the administration of a vaccine, that may or may not be related, but may lead to concern if it is perceived to be attributable to vaccination. –While an ESAVI denotes a temporal assosiation, it does not necessarily imply a cause-effect relationship. The causality between the event and the vaccination is determined by the investigation.

5. Monitoring Events Supposedly Attributable to Vaccination or Immunization (ESAVIs) I Module 6 I February 2015 5 |5 | What is the difference between an ESAVI and an ADVERSE REACTION? What is the difference between an ESAVI and an ADVERSE REACTION? ESAVI vs. REACCION ADVERSA An ESAVI is different than an “adverse reaction.” An adverse reaction is harm in which a causal relationship has been established with the vaccine or vaccination.

6. Monitoring Events Supposedly Attributable to Vaccination or Immunization (ESAVIs) I Module 6 I February 2015 6 |6 | How do you classify ESAVIs? By typeBy severity - Coincidental event (not related to the vaccines, but due to another cause) - Vaccine-related reaction Programmatic errors Vaccine product related reaction - Anxiety-related reaction - Inconclusive events - Mild (most common) - Moderate - Severe (least common)

7. Monitoring Events Supposedly Attributable to Vaccination or Immunization (ESAVIs) I Module 6 I February 2015 7 |7 | Difference between “severe” and “serious” A “severe” ESAVI – Describes the intensity of a specific event (ie: mild, moderate, or severe). – Can be a relatively minor medical importance. A “serious” ESAVI – Could result in death – Potentially be life-threatening – Require hospitalization – Result in persistent or significant disability – Require intervention to prevent permanent impairment or damage.

8. Monitoring Events Supposedly Attributable to Vaccination or Immunization (ESAVIs) I Module 6 I February 2015 8 |8 | Coincidental events Occur after vaccination, but not caused by the vaccine or its administration The administration of most vaccines coincides with the period of greatest vulnerability of children when illnesses are common and congenital or early neurological conditions become apparent

9. Monitoring Events Supposedly Attributable to Vaccination or Immunization (ESAVIs) I Module 6 I February 2015 9 |9 | Programmatic errors Errors in the preparation, handling, storage or administration of the vaccine. Not fulfilling the standards set by the National Program. They are preventable. They often represent most ESAVIs. Errors in training It is critical to recognize and correct these errors: – Examples: Unsterile injection. Injection in the wrong place. Administration of vaccine that has passed its expiration date.

10. Monitoring Events Supposedly Attributable to Vaccination or Immunization (ESAVIs) I Module 6 I February 2015 10 | How likely is an ESAVI after IPV? IPV is a very safe vaccine and well tolerated. Adverse reactions are extremely rare. It is an inactivated vaccine – therefore, no risk of vaccine-associate polio Contraindications of polio are: Documented allergy to streptomycin, neomycin, or polymyxin B History of an allergic reaction following a previous IPV injection

11. Monitoring Events Supposedly Attributable to Vaccination or Immunization (ESAVIs) I Module 6 I February 2015 11 | Which ESAVIs should be reported? Any ESAVI that is concern to parents or health-care workers should be reported. In particular, health care workers should report: “Serious” ESAVIs Signals and events associated with a newly introduced vaccine ESAVIs that may have been caused by a programmatic error Significant events of unexplained causes occurring within 30 days after vaccination Unexpected events in which the relation to the vaccination is unclear Clustered events The role of the notifier is to notify and NOT assess causality.

12. Monitoring Events Supposedly Attributable to Vaccination or Immunization (ESAVIs) I Module 6 I February 2015 12 | Report the event within the first 24 hours through existing ESAVI reporting systems established by national authorities National authorities Community, district, and regional levels Signs or symptoms believed to be related to the vaccine When and how to report ESAVI's

13. Monitoring Events Supposedly Attributable to Vaccination or Immunization (ESAVIs) I Module 6 I February 2015 13 | Conducting an ESAVI investigation ESAVIs should be investigated within the first 48 hours of notification of the case Some ESAVIs require further investigation by national authorities and committees ESAVI. Components of ESAVI investigation: – Identify specifications of implicated vaccine – Examine operational aspects of the program which may have led to immunization errors – Determine if case is isolated or if there are related cases – Verify if there are cases in non-vaccinated people – Compare background risk to reported rate of ESAVI – In collaboration with experts, determine if ESAVI was vaccine-related

14. Monitoring Events Supposedly Attributable to Vaccination or Immunization (ESAVIs) I Module 6 I February 2015 14 | What information should an ESAVI report contain? Client information Details about the vaccine – Type – Date – Manufacturer – Lot/expiration date – Site/route of immunization, etc. Description of adverse event(s) Medical and treatment history Reporter details

15. Monitoring Events Supposedly Attributable to Vaccination or Immunization (ESAVIs) I Module 6 I February 2015 15 | Communication with caretakers in case of an ESAVI Reassure the caretakers and keep them informed them on the progress of the investigation. Convey that the ESAVI will be reported and investigated fully. Keep the community and health workers informed on the investigation.

16. Monitoring Events Supposedly Attributable to Vaccination or Immunization (ESAVIs) I Module 6 I February 2015 16 | Key messages ESAVIs are generally mild ESAVIs in rare situations can be serious ESAVIs should be reported through existing ESAVI reporting systems/forms IPV is a very safe vaccine Most infants who get IPV do not experience any side effects. Serious reactions are extremely rare. In case of an ESAVI – Ensure immediate attention to the child – Reassure the caretaker – Investigate fully – Keep the community informed

17. Monitoring Events Supposedly Attributable to Vaccination or Immunization (ESAVIs) I Module 6 I February 2015 17 | End of module Thank you for your attention!