AEFI data management training course

1. Basic Concepts to understand AEFI Data AEFI data management training course

2. Aspects discussed

3. Definition of AEFI …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 unfavorable or unintended sign, abnormal laboratory finding, symptom or disease.

4. Definition of AEFI (previous) (previously used) WHO Aide Memoire: AEFI Investigation, 2004 www.who.int/immunization_safety/en/

5. AEFI Frequency Terminology * Optional categories Source: Council for International Organizations of Medical Sciences (CIOMS), 1995

6. CIOMS/ WHO cause specific definition of AEFIs

7. CIOMS/ WHO cause specific definition of AEFIs 1955- IPV- 120,000 injected 40,000 mild polio 200 paralysed 10 died

8. Vaccine reactions 1Vaccine product-related reaction 2Vaccine quality defect-related reaction 3Immunization error-related reaction 4Immunization anxiety-related reaction 5Coincidental event MINOR REACTIONS EXAMPLE Extensivelimb swelling following DTP vaccination. EXAMPLE Failure by the manufacturer to completely inactivate a lot of inactivated polio vaccine leads to cases of paralytic polio. SEVERE REACTIONS

9. Vaccine reactions 1Vaccine product-related reaction 2Vaccine quality defect-related reaction MINOR REACTIONS SEVERE REACTIONS • Usually occur within a few hours of injection. • Resolve after short period of time and pose little danger. • Local (includes pain, swelling or redness at the site of injection). • Systemic (includes fever, malaise, muscle pain, headache or loss of appetite).

10. MINOR REACTIONS SEVERE REACTIONS Minor vaccine reactions, treatments and rates associated with childhood vaccines

11. Vaccine reactions 1Vaccine product-related reaction 2Vaccine quality defect-related reaction MINOR REACTIONS SEVERE REACTIONS • Usually do not result in long-term problems. • Can be disabling. • Are rarely life threatening. • Include seizures and allergic reactions caused by the body's reaction to a particular component in a vaccine.

12. Vaccine reactions 1Vaccine product-related reaction 2Vaccine quality defect-related reaction MINOR REACTIONS SEVERE REACTIONS Severe vaccine reactions, treatments and rates associated with childhood vaccines * Reactions (except anaphylaxis) do not occur if already immune (90% of those receiving a second dose); children >6 years unlikely to have febrile seizures.  ** VAPP risk higher for first dose (1 in 750 000 compared with 1 in 5.1 million for subsequent doses), and for adults and immunocompromised clients. *** Seizures are mostly febrile. The risk of having a seizure depends on the persons age. The risk is much lower in infants <4 months of age. * Reactions (except anaphylaxis) do not occur if already immune (90% of those receiving a second dose); children >6 years unlikely to have febrile seizures.  ** VAPP risk higher for first dose (1 in 750 000 compared with 1 in 5.1 million for subsequent doses), and for adults and immunocompromised clients. *** Seizures are mostly febrile. The risk of having a seizure depends on the persons age. The risk is much lower in infants <4 months of age.

13. Difference between serious and severe reactions Severe reactions(Not regulatory term) • Can be disabling and, rarely, life threatening. • Must be reported. • Most do not lead to long-term problems. • Severe reactions include serious reactions but also include other severe reactions. Subset of severe • Any untoward medical occurrence that at any dose: • Results in death. • Requires inpatient hospitalization. • Results in persistent or significant disability. • Is life-threatening. • Congenital Anomaly Serious reactions (Regulatory term)

14. Serious AEFI ‘Serious’ is not synonymous with ‘severe’ (i.e., intensity or severity of the event) Source: report of CIOMS/WHO Working Group on Vaccine Pharmacovigilance, 2012

15. AEFI surveillance The ongoing systematic collection and analysis of data and the provision of information which leads to action

16. AEFI Case selection for Reporting* ALL AEFI cases brought to the notice of the health care system should be reported Reporter should NOT assess causality * Events to be reported according to context - Routine surveillance, new vaccine, mass campaign etc

17. Cluster Aggregation of relatively uncommon events or diseases in space and/or time in frequency that are believed or perceived to be greater than could be expected by chance.** * WHO Aide Memoire: AEFI Investigation, 2004 ** Last, John M. 2001. A Dictionary of Epidemiology, 4th ed, R. A. Spasoff, S.S. Harris and M.C. Thuriaux eds. Oxford: Oxford University Press

18. Signal Reported information on possible causal relationship between an adverse event and vaccine • Important considerations • seriousness of the event • quality of the information. Source: WHO International Drug Monitoring Programme, 1991

19. AEFIs needing special attention

20. Causality and Causality assessment • *A direct cause is a factor in absence of which the effect would not occur (necessary cause). • *Sometimes, there are multiple factors that can precipitate or function as co-factors for the effect (event) to occur.

21. AEFI Case selection for detailed investigation and causality assessment: Mandatory • As decided by reviewing team / committee • If immunization error is suspected  • Significant events of unexplained cause within 30 days of vaccination • Events causing significant parental or community concern (e.g. HHE, febrile seizures)

22. Why apply these concepts & terminology to AEFI?