Adverse Events following Immunization (AEFI) Monitoring and Causality Assessment An 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 Island 27 years Imprisonment Released 9/11, Robben Island 27 years Imprisonment Released 9/11, 1990.

3 Building on Success  Percent of world's children receiving 6 basic vaccines (DTP, polio, measles, BCG): – 83% in Immunization program success requires ongoing public confidence Adult, Elder, Traveler -Vaccination Polio – distrusted Nigeria, 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 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 2010

Distribution 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 Exposure Local movement to/from Tajikistan

Vaccine is important for disease prevention and even eradication 7

88 Impact of AEFI on Immunization Programs Incidence Vaccine coverage Adverse events (number and/or perception) Disease Outbreak Vaccination stops 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

Reality No Ideal Vaccine, but close to expectation, and evolutionary vaccines. (with advance technology and Innovation) 9

10 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

11 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 am How would you deal with the following case?

12 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?

13 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 ACADEMIC INSTITUTIONS Community EPI Manufacturer NRA Stakeholders Media Health care workers

15 1.เป็นทูต : สนับสนุน ถ่ายทอดเรื่อง AEFI 2.เป็นพลเมืองดี :ช่วยสงสัย และแจ้ง สสจ หรือ สำนักอนามัย กทม 3. เป็นนักสืบ: ให้มีการเก็บตัวอย่างและทำ Autopsy เพื่อหาสาเหตุ 4. เป็นที่ปรึกษา : ด้านคลินิกให้ทีมสอบสวนโรค How Clinicians Contribute to AEFI Monitoring System

Thank You for Your Attention Bureau of Epidemiology 16 Question and Comments (if any)