adverse events following immunization (aefis)
TRANSCRIPT
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 Surveillance of AEFIs
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.
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
Classification of AEFIs
Module B | May 2013 | 6AEFI Basic concepts
1Vaccine 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.
2Vaccine 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.
3Immunization error-related
reaction
An AEFI that is caused by
Inappropriate vaccine
handling, prescribing or
administration.
4Immunization
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
Module B | May 2013 | 7AEFI Basic concepts
1Vaccine product-related
reaction
EXAMPLE Extensive
limb swelling following DTP vaccination.
2Vaccine quality defect-related
reaction
EXAMPLE
Failure by the manufacturer to completely
inactivate a lot of
inactivated polio vaccine leads to cases
of paralytic polio.
3Immunization error-related
reaction
EXAMPLE
Transmission of infection by contaminated
multidosevial.
4Immunization
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
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 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]
AEFI Reporting and Surveillance
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)
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,
R. A. Spasoff, S.S. Harris and M.C. Thuriaux eds. Oxford: Oxford University Press
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.**
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
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
Module B | May 2013 | 20AEFI Basic concepts
AEFI RECORDING ANDREPORTING 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 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.
Reporting formats and channels
CASE REPORTING FORM (CRF)CASE INVESTIGATION FORM(CIF)
- Preliminary- Final
Serious/severe AEFIs
Case Reporting Form- Routing, timeline, actions
Medical Officer
Pvt Practitioner
District
Immunization
Officer
State
Immunization
Officer
DC ImmunizationDivisionMoHFW,
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
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
10
day
s o
f N
oti
fica
tio
n• 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
70
days o
f No
tification
State
National
District
Serious AEFI Cases (formats and timelines)
Type of Report Responsible Time line
CASE REPORTING FORM(CRF)
MO24 hours of notification
DIO48 hours of notification
CASE I
NVESTIG
ATIO
N
FO
RM
(CIF
) Preliminary DIO10 days of notification
Final AEFI investigation team 70 days of notification
http://www.slideshare.net/haqinaam