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AEFIWkshop BentsiEnchill ppt Global The Communication

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					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                      May 8, 1980 – WHO GENEVA
Protest Vaccination                                        The eradication of smallpox
In trying to enforce the medical fetish of vaccination
on an unwilling public it seems to me that the germ-
huns 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
                       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     DTP




                Insulin        Vaccine vials
                vial
                   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                               Nepal
October 2003                         November 21, 2003
     14 cases with one death              5 cases following measles;
     All cases hospitalized                3 deaths within 19 hrs, 2
     Several children received             recovered after treatment
      three vaccines in one session        Cases were reported within
     Incomplete reporting                  24 hours and investigation
                                            conducted 72 hours after
     No information about                  report
      community concern and
      measures taken                       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.

				
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