Transcript Advanced Course on AEFI* Monitoring and Causality Assessment

Bureau of Epidemiology
Adverse Events following
Immunization (AEFI) Monitoring
and Causality Assessment
An Overview
Department of Disease Control
Ministry of Public Health
“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.”
Robben Island
27 years Imprisonment
Released 9/11, 1990.
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(Nelson Mandela 2002, Chair – Vaccine Fund Board)
Building on Success
 Percent of world's children receiving 6
basic vaccines (DTP, polio, measles,
BCG):
– <5% in 1975 versus >83% in 2008
Immunization program success requires
ongoing public confidence
Polio – distrusted
Nigeria, 2000s
Adult, Elder, Traveler -Vaccination
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Wild Poliovirus*, 30 Dec 2009 – 29 Jun 2010
Wild virus type 1
Wild virus type 3
Wild virus type 1/3
Endemic countries
Case or outbreak following importation (0 - 6 months)
*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.
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
Distribution of AFP and laboratory-confirmed polio cases,
Tajikistan, 2010
China
Afghanistan
= 1 Confirmed wild poliovirus type 1 - Total 129 cases
= 1 Confirmed Vaccine poliovirus type 1 - Total 1 case
= Districts with AFP Cases
*Dots are placed randomly within district
Data as of 20th May 2010
Source: Weekly AFP reporting to WHO European Region
Exposure
Local movement to/from Tajikistan
6 I Global Alert and Response
Vaccine is
important for disease
prevention and even eradication
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Impact of AEFI on Immunization Programs
Pre-vaccine
Increasing Loss of
Resumption
Eradication
coverage confidence of confidence
Disease
Vaccination
stops
Outbreak
Vaccine
coverage
Adverse events
(number and/or perception)
Maturity of programme
Adapted from: Chen RT et al, Vaccine 1994;12:542-50
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Reality
No Ideal Vaccine,
but close to expectation,
and evolutionary vaccines.
(with advance technology and Innovation)
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How would you deal with the following case?
10 am: 6 ½ month old baby received routine DPT
+ OPV at a clinic session
1:30 pm: baby brought to Hospital with
dyspnea, pharyngeal edema, and mottling
– Diagnosed as anaphylactic shock
– given fluids, oxygen, antihistamine, steroids
– Admitted
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How would you deal with the following case?
• 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
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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?
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Vaccine Safety System Components
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)
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NRA
EPI
Manufacturer
POLICY MAKERS
Patient
Stakeholders
Health care
workers
Parents
Community
ACADEMIC
INSTITUTIONS
Media
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How Clinicians Contribute to
AEFI Monitoring System
1. เป็นทูต : สน ับสนุน ถ่ายทอดเรือ
่ ง
AEFI
ั และแจ้ง สสจ หรือ
่ ยสงสย
2. เป็นพลเมืองดี :ชว
สาน ักอนาม ัย กทม
ื : ให้มก
3. เป็นน ักสบ
ี ารเก็บต ัวอย่างและทา Autopsy
เพือ
่ หาสาเหตุ
4. เป็นทีป
่ รึกษา : ด้านคลินก
ิ ให้ทม
ี สอบสวนโรค
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Thank You for Your Attention
Bureau of Epidemiology
Question and Comments (if any)
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