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AEFIADVERSE EVENT FOLLOWING
IMMUNIZATION
http://www.slideshare.net/haqinaam
Contents of this lecture
• Definition of AEFI
• Classification of AEFIs
• Serious AEFI
• Examples of AEFIs
• Reporting and...
Definition
• An AEFI is any untoward medical occurrence
which follows immunization and which does
not necessarily have a c...
AEFI Frequency Terminology
Very common* > 1/10 > 10%
Common
(frequent)
> 1/100 and < 1/10 > 1% and < 10%
Uncommon
(infrequ...
Classification of AEFIs
Module B | May 2013 | 6AEFI Basic concepts
1
Vaccine
product-
related
reaction
An AEFI that is
caused or
precipitated by
a...
Module B | May 2013 | 7AEFI Basic concepts
1
Vaccine
product-
related
reaction
EXAMPLE
Extensive
limb swelling
following D...
Vaccine Reactions
Two types of vaccine reactions-
Minor and Severe
Two types of vaccine reactions-
Minor and Severe
Two types of vaccine reactions-
Minor and Severe
Antigen
[Live, Killed,
Purified,
Inactivated
toxin]
Stabilizers
(help the...
AEFI Reporting and Surveillance
Module B | May 2013 | 16AEFI Basic concepts
Vaccine safety terminology: Serious adverse event/reaction
• Death
• Hospitali...
Module B | May 2013 | 17AEFI Basic concepts
"A cluster of AEFIs is
two or more cases of
the same adverse event
related in ...
Module B | May 2013 | 18AEFI Basic concepts
Vaccine safety terminology: AEFIs needing special attention
• e.g. bacterial a...
Module B | May 2013 | 19AEFI Basic concepts
Serious AEFI Potential
immunization
error
Cluster
Parental
concern
Community
c...
Module B | May 2013 | 20AEFI Basic concepts
AEFI RECORDING AND
REPORTING IN INDIA
Module B | May 2013 | 21AEFI Basic concepts
CASES TO BE REPORTED
Serious AEFI
Severe AEFI
Minor AEFI
Which AEFIs should be notified to health system?
Any AEFI that is of concern to the parents or to the health care worker s...
Reporting formats and channels
CASE REPORTING FORM (CRF)
CASE INVESTIGATION FORM(CIF)
- Preliminary
- Final
Serious/severe...
Case Reporting Form- Routing, timeline, actions
Medical Officer
Pvt Practitioner
District
Immunization
Officer
State
Immun...
Case Investigation Form- Routing, timeline, actions
District
Immunization
Officer
Preliminary
CIF
State
Immunization
Offic...
Serious AEFI Cases (formats and timelines)
Type of Report Responsible Time line
CASE REPORTING
FORM(CRF)
MO
24 hours of
no...
http://www.slideshare.net/haqinaam
Adverse Events Following Immunization (AEFIs)
Adverse Events Following Immunization (AEFIs)
Adverse Events Following Immunization (AEFIs)
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Adverse Events Following Immunization (AEFIs)

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Adverse Events Following Immunization (AEFIs)

  1. 1. AEFIADVERSE EVENT FOLLOWING IMMUNIZATION http://www.slideshare.net/haqinaam
  2. 2. Contents of this lecture • Definition of AEFI • Classification of AEFIs • Serious AEFI • Examples of AEFIs • Reporting and Surveillance of AEFIs
  3. 3. Definition • An 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 unfavorable or unintended sign, abnormal laboratory finding, symptom or disease.
  4. 4. AEFI Frequency Terminology Very common* > 1/10 > 10% Common (frequent) > 1/100 and < 1/10 > 1% and < 10% Uncommon (infrequent) > 1/1,000 and < 1/100 > 0.1% and < 1 % Rare > 1/10,000 and < 1/1,000 > 0.01% and < 0.1% Very rare* < 1/10,000 < 0.01% * Optional categories
  5. 5. Classification of AEFIs
  6. 6. Module B | May 2013 | 6AEFI Basic concepts 1 Vaccine product- related reaction An AEFI that is caused or precipitated by a vaccine due to one or more of the inherent properties of the vaccine product. 2 Vaccine quality defect-related reaction An AEFI that is caused or precipitated by a vaccine that is due to one or more quality defects of the vaccine product including its administration device as provided by the manufacturer. 3 Immunization error-related reaction An AEFI that is caused by Inappropriate vaccine handling, prescribing or administration. 4 Immunization anxiety-related reaction An AEFI arising from anxiety about the immunization. 5 Coincidental event An AEFI that is caused by something other than the vaccine product, immunization error or immunization anxiety CIOMS/ WHO cause specific definition of AEFIs
  7. 7. Module B | May 2013 | 7AEFI Basic concepts 1 Vaccine product- related reaction EXAMPLE Extensive limb swelling following DTP vaccination. 2 Vaccine quality defect-related reaction EXAMPLE Failure by the manufacturer to completely inactivate a lot of inactivated polio vaccine leads to cases of paralytic polio. 3 Immunization error-related reaction EXAMPLE Transmission of infection by contaminated multidose vial. 4 Immunization anxiety-related reaction EXAMPLE Vasovagal syncope in an adolescent following vaccination. 5 Coincidental event EXAMPLE A fever after vaccination (temporal association) and malarial parasite isolated from blood. CIOMS/ WHO cause specific definition of AEFIs
  8. 8. Vaccine Reactions
  9. 9. Two types of vaccine reactions- Minor and Severe
  10. 10. Two types of vaccine reactions- Minor and Severe
  11. 11. Two types of vaccine reactions- Minor and Severe Antigen [Live, Killed, Purified, Inactivated toxin] Stabilizers (help the vaccine maintain its effectiveness during storage) [MgCl2, MgSO4] Adjuvants (improve the immune response to vaccine antigens, most often in killed vaccine) [Aluminium salts] Antibiotics (to prevent bacterial contamination of the tissue culture cells in which the viruses are grown) [Neomycin] Preservatives (added to multidose vaccines to prevent bacterial and fungal growth) [Thiomersal, Formaldehyde]
  12. 12. AEFI Reporting and Surveillance
  13. 13. Module B | May 2013 | 16AEFI Basic concepts Vaccine safety terminology: Serious adverse event/reaction • Death • Hospitalization or prolongation of existing hospitalization (e.g., encephalopathy, seizures, aseptic meningitis) • Persistent or significant disability or incapacity (e.g., paralysis) • Congenital anomaly/birth defect • Life-threatening Serious AEFI Source: report of CIOMS/WHO Working Group on Vaccine Pharmacovigilance, 2012 ‘Serious’ is not synonymous with ‘severe’ (i.e., intensity or severity of the event)
  14. 14. Module B | May 2013 | 17AEFI Basic concepts "A cluster of AEFIs is two or more cases of the same adverse event related in time, place or vaccine administered".* * WHO Aide Memoire: AEFI Investigation, 2004 ** Last, John M. 2001. A Dictionary of Epidemiology, 4th ed, Vaccine safety terminology: 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.**
  15. 15. Module B | May 2013 | 18AEFI Basic concepts Vaccine safety terminology: AEFIs needing special attention • e.g. bacterial abscess, severe local reaction, high fever or sepsis, BCG lymphadenitis, toxic shock syndrome, clusters of AEFIs) If immunization error is suspected Significant events of unexplained cause occurring within 30 days after a vaccination Events causing parental or community concern
  16. 16. Module B | May 2013 | 19AEFI Basic concepts Serious AEFI Potential immunization error Cluster Parental concern Community concern Unexpected relationship with vaccination Unexpected frequency AEFI Case selection for Reporting* Reporter should NOT assess causality * Events to be reported according to context - Routine surveillance, new vaccine, mass campaign etc
  17. 17. Module B | May 2013 | 20AEFI Basic concepts AEFI RECORDING AND REPORTING IN INDIA
  18. 18. Module B | May 2013 | 21AEFI Basic concepts
  19. 19. CASES TO BE REPORTED Serious AEFI Severe AEFI Minor AEFI
  20. 20. Which AEFIs should be notified to health system? Any AEFI that is of concern to the parents or to the health care worker should be notified In particular, health workers should notify: Serious AEFIs (death, hospitalization, cluster, disability) Signals and events associated with a newly introduced vaccine. AEFIs that may have been caused by an immunization error. Significant events of unexplained cause occurring within 30 days after a vaccination. Events causing significant parental or community concern. Swelling, redness, soreness at the injection site IF it lasts for more than 3 days or swelling extends beyond nearest joint.
  21. 21. Reporting formats and channels CASE REPORTING FORM (CRF) CASE INVESTIGATION FORM(CIF) - Preliminary - Final Serious/severe AEFIs
  22. 22. Case Reporting Form- Routing, timeline, actions Medical Officer Pvt Practitioner District Immunization Officer State Immunization Officer DC Immunization Division MoHFW, Govt.of India • Confirm AEFI • Complete Case Reporting Form • Assign EPID number, complete additional details • Dist level planning meeting on investigation • Send copy of CRF to local drug inspector, team conducting autopsy & other stakeholders • Initiate collection of vaccine, logistic samples, CSF, Serum (or biological products), if indicated • Start collecting data for completing CIF • Inform if necessary  State/regional AEFI committee  State Drug Controller • If necessary, convene State AEFI Committee Meeting to plan course of action State District National 24 Hours 24 Hours Site Immediate Health Worker
  23. 23. Case Investigation Form- Routing, timeline, actions District Immunization Officer Preliminary CIF State Immunization Officer DC Immunization Division MoHFW, Govt.of India Inform DCG(I) & senior officers in the MoH&FW Inform the Vaccine manufacturers and review GMP Final CIF 10daysofNotification • Convene district AEFI committee meeting and finalize action • If indicated and recommended, ship specimens to appropriate labs • Site (s) visit and investigation • Collect additional details  Vaccine/logistic distribution and utilization  Other AEFI in the area  Other details such as pre-existing health, medical and environmental condition • Inform state AEFI committee & State Drug Controller • Request for additional information if necessary • Do a causality assessment within 100 days of notification 70daysofNotification State National District
  24. 24. Serious AEFI Cases (formats and timelines) Type of Report Responsible Time line CASE REPORTING FORM(CRF) MO 24 hours of notification DIO 48 hours of notification CASEINVESTIGATION FORM(CIF) Preliminary DIO 10 days of notification Final AEFI investigation team 70 days of notification
  25. 25. http://www.slideshare.net/haqinaam

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