Overview of AEFI Overview of AEFI Surveillance and Response Surveillance and Response

Guidelines Guidelines

AEFI Strategic Communication AEFI Strategic Communication Workshop Workshop

Delhi, 9-10 August 2004Delhi, 9-10 August 2004

Dr. Adwoa Bentsi-Enchill, WHO/IVBDr. Adwoa Bentsi-Enchill, WHO/IVB

March 22, 1919 - THE OTTAWA CITIZEN Protest VaccinationIn 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

May 8, 1980 – WHO GENEVAThe eradication of smallpox

Historical perspectivesHistorical perspectives

Current contextCurrent 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 What is an adverse event following immunisation (AEFI)?(AEFI)?

A medical incident that takes place A medical incident that takes place after immunizationafter immunization, causes , causes

concern, and is believed to be concern, and is believed to be caused by the immunization.caused by the immunization.

After immunization After immunization (temporal link)(temporal link) does not equal caused by the does not equal caused by the immunization immunization (causal link).(causal link).

Adverse Adverse EventEvent versus Adverse versus Adverse ReactionReaction

Adverse Adverse eventevent:: undesirable outcome undesirable outcome observed observed without without causality assessment.causality assessment.

Adverse Adverse reactionreaction: : undesirable outcome undesirable outcome caused by vaccine (or caused by vaccine (or drug) when there is drug) when there is evidence supporting a evidence supporting a causal relationship.causal relationship.

5 types of AEFI5 types of AEFI

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

Insulin vial

Vaccine vials

TT DTP

Vaccine reaction - caused by vaccine’s inherent properties e.g., fever, allergic reactions, vaccine associated polio, BCG lymphadenitis

5 types of AEFI5 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 surveillancePrimary Objectives of AEFI surveillance

DetectionDetection of serious or potentially serious of serious or potentially serious AEFIAEFI

Ensure Ensure rapid notification and effective rapid notification and effective evaluationevaluation of information of information

Enable Enable prompt and effective responseprompt and effective response in order to minimize negative impacts on in order to minimize negative impacts on health and immunization programmeshealth and immunization programmes

Core elements of AEFI surveillance (1)Core elements of AEFI surveillance (1)

WhyWhy Importance to immunization program overallImportance to immunization program overall Advocacy messages (targets include decision makers, Advocacy messages (targets include decision makers,

private sector)private sector)

WhatWhat Establish reportable events & case definitionsEstablish reportable events & case definitions Define action for serious (investigation) versus non-Define action for serious (investigation) versus non-

serious eventsserious events Identify and correct programmatic errorsIdentify and correct programmatic errors

How & WhenHow & When Guidelines/SOP; reporting methods, standard forms …Guidelines/SOP; reporting methods, standard forms …

WhoWho Focal points at different levelsFocal points at different levels Roles of regulatory authority, private sector, industryRoles of regulatory authority, private sector, industry Partnerships with academic institutions, Partnerships with academic institutions,

pharmacovigilance etc.pharmacovigilance etc.

Core elements of AEFI surveillance (2)Core elements of AEFI surveillance (2)

Communication within health communityCommunication within health community

Training + tools to handle ongoing questions Training + tools to handle ongoing questions from vaccinees/parentsfrom vaccinees/parents Technical information on AEFI Technical information on AEFI Vaccine informationVaccine information Support to handle crises (communication strategy, Support to handle crises (communication strategy,

spokespersons, multiple stakeholders e.g., EPI, spokespersons, multiple stakeholders e.g., EPI, NRA)NRA)

Communication with public/communityCommunication with public/community

Provide information, particularly in crisis Provide information, particularly in crisis situationssituations Anticipate crisesAnticipate crises Have a planHave a plan Be well-informed and verify factsBe well-informed and verify facts

Communication most critical in …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 surveillanceModels for AEFI surveillance

Establish via routine immunization programmes Establish via routine immunization programmes versus mass vaccination campaignsversus mass vaccination campaigns

Sentinel surveillanceSentinel surveillance

Passive/active (or combination)Passive/active (or combination)

Ensuring AEFI surveillance as a National Ensuring AEFI surveillance as a National Regulatory Authority (NRA) function means Regulatory Authority (NRA) function means collaboration between collaboration between EPI - reporting function, corrective action for EPI - reporting function, corrective action for

programmatic errorsprogrammatic errors NRA – regulatory role, vaccNRA – regulatory role, vaccine quality ine quality

Challenges & opportunities: Country issuesChallenges & opportunities: Country issues

Recognising importance of AEFI surveillance Recognising importance of AEFI surveillance to immunization programmeto immunization programme Commitment and ownership Commitment and ownership Allocation of resources (personnel, budget)Allocation of resources (personnel, budget)

Impact on resources (e.g., investigation of Impact on resources (e.g., investigation of clusters) clusters)

Barriers within the health system; fears that Barriers within the health system; fears that surveillance leads to:surveillance leads to: increased awareness of safety issues with negative increased awareness of safety issues with negative

impactimpact potential for assigning blamepotential for assigning blame increased amount of work increased amount of work

Challenges & opportunities: Global issuesChallenges & opportunities: Global issues

Effective AEFI surveillance critical for regulating vaccine quality (NRA function) Potential impact on prequalification and Potential impact on prequalification and

global supply of some vaccinesglobal supply of some vaccines Data to combat fears/concerns especially Data to combat fears/concerns especially

regarding vaccines from developing countriesregarding vaccines from developing countries

Detecting signals of unrecognised Detecting signals of unrecognised adverse reactionsadverse reactions

Recent examples of AEFI incidents (1)Recent examples of AEFI incidents (1)BangladeshBangladesh

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)Recent examples of AEFI incidents (2)

MyanmarOctober 2003October 2003

14 cases with one 14 cases with one deathdeath

All cases hospitalizedAll cases hospitalized Several children Several children

received three received three vaccines in one vaccines in one sessionsession

Incomplete reportingIncomplete reporting No information about No information about

community concern community concern and measures takenand measures taken

NepalNovember 21, 2003November 21, 2003

5 cases following 5 cases following measles; 3 deaths measles; 3 deaths within 19 hrs, 2 within 19 hrs, 2 recovered after recovered after treatmenttreatment

Cases were reported Cases were reported within 24 hours and within 24 hours and investigation investigation conducted 72 hours conducted 72 hours after reportafter report

No information No information about community about community concern and action concern and action undertakenundertaken

Strategies to support/strengthen AEFI surveillance Strategies to support/strengthen AEFI surveillance (1)(1)

AdvocacyAdvocacy for commitment, leadership and for commitment, leadership and resources at national levelresources at national level

Assessment Assessment of AEFI surveillance (NRA is key in of AEFI surveillance (NRA is key in strengthening or establishing systems)strengthening or establishing systems)

Development of Action Plans incl. Development of Action Plans incl. communication communication strategystrategy

Development of Development of normsnorms (guidelines/SOPs, reporting (guidelines/SOPs, reporting forms)forms)

Strategies to support/strengthen AEFI surveillance Strategies to support/strengthen AEFI surveillance (2)(2)

Reference materialReference material and technical documents and technical documents Background information on AEFI, aide-memoires etc.,Background information on AEFI, aide-memoires etc., Accessibility (e.g., print + online, language needs) Accessibility (e.g., print + online, language needs)

TrainingTraining - Global Training Network on AEFI, Sri - Global Training Network on AEFI, Sri LankaLanka

Technical supportTechnical support - investigation & causality - investigation & causality assessmentassessment

WHO Global Advisory Committee on WHO Global Advisory Committee on Vaccine Safety Vaccine Safety http://http://www.who.int/vaccine_safety/enwww.who.int/vaccine_safety/en//

WHO Immunization safety website WHO Immunization safety website http://http://www.who.int/immunization_safety/enwww.who.int/immunization_safety/en// Regular updatesRegular updates Official UN languagesOfficial UN languages Links to WHO documents Links to WHO documents Links to other resources Links to other resources

Brighton Collaborationhttp://brightoncollaboration.org/ Standardization of case definitions

Addressing safety concerns at global levelAddressing safety concerns at global level

Lack of correct and timely Lack of correct and timely response to rumours and crises response to rumours and crises

creates potential for wrong creates potential for wrong information or miscommunication.information or miscommunication.