Adverse Events following Adverse Events following

Immunization (AEFI) Immunization (AEFI)

Monitoring Monitoring

and Causality Assessment and Causality Assessment

An OverviewAn Overview

Department of Disease Control

Ministry of Public Health

Bureau of Epidemiology

22

“Immunization has been a great public health success story. The lives of millions

of children have been saved, millions have the chance for

a longer, healthier life, a greater chance to learn, to play, to read and write, to

move around freely without suffering.”

(Nelson Mandela 2002, Chair – Vaccine Fund Board)

Robben Island27 years Imprisonment

Released 9/11, 1990.

Robben Island27 years Imprisonment

Released 9/11, 1990.

3

Building on Building on SuccessSuccess

Percent of world's children

receiving 6 basic vaccines (DTP,

polio, measles, BCG):

– <5% in 1975 versus >83% in

2008

3

Immunization program success requires

ongoing public confidence

Adult, Elder, Traveler -VaccinationPolio – distrustedNigeria, 2000s

Case or outbreak following importation (0 - 6 months)Endemic countries The boundaries and names shown and the designations used on this map do not imply

the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. WHO 2010. All rights reserved

Wild virus type 1 Wild virus type 3 Wild virus type 1/3

*Excludes viruses detected from environmental surveillance and vaccine derived polioviruses. 1 WPV1 in Jammu and Kashmir, date of onset of 07 Feb 2010, does not appear on the map.

Wild Poliovirus*, 30 Dec 2009 – 29 Jun 2010Wild Poliovirus*, 30 Dec 2009 – 29 Jun 2010

Distribution of AFP and laboratory-confirmed polio cases, Tajikistan, 2010Distribution of AFP and laboratory-confirmed polio cases, Tajikistan, 2010

= 1 Confirmed wild poliovirus type 1 - Total 129 cases

= Districts with AFP Cases

Data as of 20th May 2010

*Dots are placed randomly within district

Source: Weekly AFP reporting to WHO European Region

= 1 Confirmed Vaccine poliovirus type 1 - Total 1 case

China

Afghanistan

6 I Global Alert and Response

ExposureLocal movement to/from Tajikistan

Vaccine isimportant for disease

prevention and even eradication

7

88

Impact of AEFI on Immunization Programs

Inci

den

ce

Vaccinecoverage

Adverse events(number and/or perception)

Disease

Outbreak

Vaccinationstops

Pre-vaccine Increasing coverage

Loss of confidence

Resumption of confidence

Eradication

Maturity of programme

Adapted from: Chen RT et al, Vaccine 1994;12:542-50

RealityNo Ideal Vaccine,

but close to expectation,and evolutionary vaccines.(with advance technology and Innovation)

9

1010

10 am: 6 ½ month old baby received routine DPT + OPV at a clinic session

How would you deal with the following case?

1:30 pm: baby brought to Hospital with dyspnea, pharyngeal edema, and mottling

– Diagnosed as anaphylactic shock

– given fluids, oxygen, antihistamine, steroids

– Admitted

1111

• 4 pm: cyanosis, respiratory distress, change in state, cool skin with mottling, prolonged capillary refill time, fever– Chest exam: rales and rhonchi but no

evidence of upper airway obstruction– normal pharyngeal examination– given fluids, oxygen; antibiotics started – 10 pm: generalized convulsion, given

phenobarb, followed by apnea, resuscitated with intubation

– pronounced dead at 00.50 am

How would you deal with the following case?

1212

Impact on Patient, Community

What is the possible impact?

Vaccine withdrawal or

not?

National and/or

international implications?

Need for communication?

Need for education?

How urgently is action

needed?

1313

1. Pre-licensure review and approval

2. Good manufacturing procedures

3. Lot assessment before release

4. Post marketing surveillance and AEFI – reporting

5. Causality assessment review: serious AEFI

6. Process for action if vaccine performance issue

7. Vaccine recommendations: epidemiology, vaccine

effectiveness and efficacy (National Committees)

8. International collaboration (WHO/GACVS)

Vaccine Safety System Components

14

POLICY MAKERS

Parents

Patient

ACADEMICINSTITUTIONSCommunity

EPIManufacturer

NRA

Stakeholders

Media

Health care workers

15

1 .เป็�นทู�ต : สนบสน�น ถ่�ายทูอดเรื่��อง AEFI

2. เป็�นพลเมื�องด� :ช่�วยสงสย และแจ้ ง สสจ้ หรื่�อ ส"านกอนามืย กทูมื

3. เป็�นนกส�บ: ให มื�การื่เก%บตวอย�างและทู"า Autopsy

เพ��อหาสาเหต�

4. เป็�นทู��ป็รื่&กษา : ด านคล)น)กให ทู�มืสอบสวนโรื่ค

How Clinicians Contribute to AEFI Monitoring System

Thank You for Your Attention Bureau of Epidemiology

16

Question and Comments (if any)