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.