Overview of AEFI Surveillance and Response Guidelines

1
Overview of AEFI Surveillance and Response
Guidelines

• AEFI Strategic Communication Workshop
• Delhi, 9-10 August 2004
• Dr. Adwoa Bentsi-Enchill, WHO/IVB

2
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 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
3
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)

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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).
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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.

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5 types of AEFI

• Programme error - caused by error in vaccine
  preparation, handling, or administration

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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

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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

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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.

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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

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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)

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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

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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

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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

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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

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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

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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)

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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

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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 Collaborationhttp//brightoncollaboratio
  n.org/
• Standardization of case definitions

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Lack of correct and timely response to rumours
and crises creates potential for wrong
information or miscommunication.