Transcript Slide 1
Overview of AEFI Surveillance
and Response Guidelines
AEFI Strategic Communication Workshop
Delhi, 9-10 August 2004
Dr. Adwoa Bentsi-Enchill, WHO/IVB
Historical perspectives
March 22, 1919 - THE OTTAWA CITIZEN
Protest Vaccination
In trying to enforce the medical fetish of vaccination
on an unwilling public it seems to me that the germhuns owe it to the public to give a definition of what
vaccination really is.
…the only truthful definition is about as follows:
"Vaccination is the inoculation of the pure blood of
a healthy individual with the filth obtained from the
fostering sore on a diseased calf, with the object of
preventing a possible but altogether improbable
disease, viz. smallpox." ...
…
There is no reliable evidence that vaccination
prevents smallpox, or ever saved a single life.
S.L. Macbean,
57 Victoria Street,
Montreal
May 8, 1980 – WHO GENEVA
The eradication of smallpox
Current context
Number and variety of concerns keeps growing
Rapid spread of safety concerns
Suggestions of a vaccine link easy to "establish" while "no
evidence of association" more difficult to prove.
Growing mistrust of vaccines from developing country
manufacturers
Example of SII vaccines (60-80% of UNICEF supply of DTP,
DT and measles)
What is an adverse event following immunisation
(AEFI)?
A medical incident that takes place
after immunization, causes concern,
and is believed to be caused by the
immunization.
After immunization (temporal link) does
not equal caused by the immunization
(causal link).
Adverse Event versus Adverse Reaction
Adverse event: undesirable
outcome observed without
causality assessment.
Adverse reaction: undesirable
outcome caused by vaccine (or
drug) when there is evidence
supporting a causal
relationship.
5 types of AEFI
Vaccine reaction - caused by
vaccine’s inherent properties e.g.,
fever, allergic reactions, vaccine
associated polio, BCG lymphadenitis
Programme error - caused by error
in vaccine preparation, handling, or
administration
TT
Insulin
vial
DTP
Vaccine vials
5 types of AEFI
Injection reaction - caused by
anxiety or pain of the injection
Coincidental - happens after immunisation but
not caused by it - a chance association e.g.,
diarrhea and vomiting due to food poisoning, fever
from malaria
Unknown - cause cannot be determined
Primary Objectives of AEFI surveillance
Detection of serious or potentially serious AEFI
Ensure rapid notification and effective evaluation of
information
Enable prompt and effective response in order to
minimize negative impacts on health and immunization
programmes
Core elements of AEFI surveillance (1)
Why
Importance to immunization program overall
Advocacy messages (targets include decision makers, private
sector)
What
Establish reportable events & case definitions
Define action for serious (investigation) versus non-serious events
Identify and correct programmatic errors
How & When
Guidelines/SOP; reporting methods, standard forms …
Who
Focal points at different levels
Roles of regulatory authority, private sector, industry
Partnerships with academic institutions, pharmacovigilance etc.
Core elements of AEFI surveillance (2)
Communication within health community
Training + tools to handle ongoing questions from
vaccinees/parents
Technical information on AEFI
Vaccine information
Support to handle crises (communication strategy, spokespersons,
multiple stakeholders e.g., EPI, NRA)
Communication with public/community
Provide information, particularly in crisis situations
Anticipate crises
Have a plan
Be well-informed and verify facts
Communication most critical in …
Serious AEFI
Death
Life-threatening
Hospitalization
Disability
Potential programme error
AEFI clusters
Toxic shock syndrome, sepsis, abscesses
Other toxic exposure suspected
AEFI causing significant public concern
Campaigns (special aspects)
Models for AEFI surveillance
Establish via routine immunization programmes versus
mass vaccination campaigns
Sentinel surveillance
Passive/active (or combination)
Ensuring AEFI surveillance as a National Regulatory
Authority (NRA) function means collaboration between
EPI - reporting function, corrective action for programmatic
errors
NRA – regulatory role, vaccine quality
Challenges & opportunities: Country issues
Recognising importance of AEFI surveillance to
immunization programme
Commitment and ownership
Allocation of resources (personnel, budget)
Impact on resources (e.g., investigation of clusters)
Barriers within the health system; fears that surveillance
leads to:
increased awareness of safety issues with negative impact
potential for assigning blame
increased amount of work
Challenges & opportunities: Global issues
Effective AEFI surveillance critical for regulating
vaccine quality (NRA function)
Potential impact on prequalification and global supply
of some vaccines
Data to combat fears/concerns especially regarding
vaccines from developing countries
Detecting signals of unrecognised adverse reactions
Recent examples of AEFI incidents (1)
Bangladesh
September 03 (Jamalpur District)
Cluster of 6 AEFI cases post-measles vaccination (1 vial)
3 deaths within 22 hours
Investigation suggested toxic shock and other evidence of
unsafe injection practices
June 04 (Khulna District)
Death of 9-mth old post DPT + OPV
Clinical symptoms did not support vaccine link
Investigation suggests coincidental event
Media attention + community concern but no long
term impact
Recent examples of AEFI incidents (2)
Myanmar
October 2003
14 cases with one death
All cases hospitalized
Several children received
three vaccines in one session
Incomplete reporting
No information about
community concern and
measures taken
Nepal
November 21, 2003
5 cases following measles;
3 deaths within 19 hrs, 2
recovered after treatment
Cases were reported within
24 hours and investigation
conducted 72 hours after
report
No information about
community concern and
action undertaken
Strategies to support/strengthen AEFI surveillance (1)
Advocacy for commitment, leadership and resources at
national level
Assessment of AEFI surveillance (NRA is key in
strengthening or establishing systems)
Development of Action Plans incl. communication strategy
Development of norms (guidelines/SOPs, reporting forms)
Strategies to support/strengthen AEFI surveillance (2)
Reference material and technical documents
Background information on AEFI, aide-memoires etc.,
Accessibility (e.g., print + online, language needs)
Training - Global Training Network on AEFI, Sri Lanka
Technical support - investigation & causality assessment
Addressing safety concerns at global level
WHO Global Advisory Committee on Vaccine Safety
http://www.who.int/vaccine_safety/en/
WHO Immunization safety website
http://www.who.int/immunization_safety/en/
Regular updates
Official UN languages
Links to WHO documents
Links to other resources
Brighton Collaboration
http://brightoncollaboration.org/
Standardization of case definitions
Lack of correct and timely response
to rumours and crises creates
potential for wrong information or
miscommunication.