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. May 8, 1980 – WHO GENEVA The eradication of smallpox 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)

4. 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).

5. 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.

6. Vaccine reaction - caused by vaccine’s inherent properties e.g., fever, allergic reactions, vaccine associated polio, BCG lymphadenitis TT DTP Insulin vial Vaccine vials 5 types of AEFI • Programme error - caused by error in vaccine preparation, handling, or administration

7. 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

8. 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

9. 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.

10. 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

11. 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)

12. 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

13. 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

14. 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

15. 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

16. 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

17. 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)

18. 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

19. 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://brightoncollaboration.org/ • Standardization of case definitions

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