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AEFI

بسم الله الرحمن الرحیم. AEFI. AEFI. What is an AEFI? AEFI is a medical incident after an immunization and is believed to be caused by the immunization Basically two types Avoidable and unavoidable. AEFI. Modern vaccines Are generally safe Not entirely without risk

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AEFI

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  1. بسم الله الرحمن الرحیم AEFI World Health Organization

  2. AEFI What is an AEFI? AEFI is a medical incident after an immunization and is believed to be caused by the immunization Basically two types Avoidable and unavoidable World Health Organization

  3. AEFI Modern vaccines • Are generally safe • Not entirely without risk • Benefits far outweigh risks World Health Organization

  4. AEFI Why monitoring of AEFI are important ? • Upsets people • Refusal for further immunization World Health Organization

  5. HOW DOES AEFI REPORTING INTERACT WITH ADR REPORTING? Adverse drug reaction form AEFI reporting form World Health Organization

  6. BARRIERS TO REPORTING • Not considering the event as related to immunization • Not knowing about reporting system and process • Lethargy, lack of interest or time, inability to find report form • Fear that the report will lead to personal consequences • Guilt about having caused harm and being responsible for the event • Uncertainty about reporting an event when not confident about the diagnosis World Health Organization

  7. MOH goal for establishing AEFI surveillance • AEFI surveillance has been started to improve the quality of immunization services World Health Organization

  8. objective • Estimation of AEFI rates. • Detection, correction, and prevention of program errors . • Early detection of AEFI associated with a specific vaccine lots or brands and early response. • Maintaining the community confidence on immunization services after an AEFI . World Health Organization

  9. Political commitment • A circular was distributed in 2003 by MOH for health facilities to report every AEFI to medical universities and CDC. World Health Organization

  10. Establishment of National immunization safety committee - 2001 The members include: • National EPI manager ,as the head of committee • Pediatric neurologists • Neurologist • Infectious disease specialist • Virologist • Epidemiologist • Immunologist • NRA representative The committee has regular meeting sessions monthly or in necessary intervals World Health Organization

  11. central immunization safety committee activities • Providing a guideline on accurate AEFI definition • Designing a reporting system based on WHO recommendation • Designing and disseminating of AEFI reporting forms. • Providing materials for training of health- care workers, managers and supervisors. World Health Organization

  12. Reportable AEFI It is mandatory to report the following: • All deaths suspected to be related to immunization • All cases requiring hospitalization due to vaccination • All injection sites abscesses • All cases of BCG lymphadenitis • Anaphylactic reactions • Any seizure during one month after vaccination • Hypotonic reactions • Encephalitis • Other severe or unusual medical events DEFINITION OF EACH OF THE ABOVE IS INCLUDED IN THE COUNTRY GUIDELINE. THESE ARE BASED ON WHO GUIDELINES. World Health Organization

  13. How AEFI should be reported • All serious AEFI such as hospitalization, death and abscess should be reported immediately by phone to district, province and CDC. • All mild reactions included in the national AEFI list should be reported to the focal points in the province and then to CDC, monthly. • Zero reporting for measles and polio is mandatory and the AEFI zero reporting is collected with the same form monthly. World Health Organization

  14. How AEFI should be reported(cont‘d ) • All health-care workers have to report any AEFI which occurs during or soon after vaccination to the AEFI focal point, immediately. • All health workers have to report any event suspected to be related to immunization in the monthly report. THE REPORTING SYSTEM IS PASSIVE World Health Organization

  15. WHAT IS AN ADVERSE EVENT FOLLOWING IMMUNIZATION (AEFI)? A medical incident that takes place after an immunization, causes concern, and is believed to be caused by immunization • Vaccine reaction - caused by vaccine’s inherentproperties • Programme error - caused by error in vaccinepreparation, handling, or administration • Coincidental - happens after immunization but notcaused by it (a chance association) • Injection reaction - anxiety or pain of injection notvaccine • Unknown- cause cannot be determined World Health Organization

  16. VACCINE REACTIONS • Common, minor reactions • vaccine stimulates immune system • settle on their own • warn parents and advise how to manage • Rare, more serious reactions • anaphylaxis (serious allergic reaction) • vaccine specific reactions World Health Organization

  17. COMMON, MINOR REACTIONS Local reaction (pain, swelling, redness) Irritability, malaise & systemic symptoms Vaccine Fever >38oC - 90-95% - BCG - 5-15% 2-10% Hib - 1-6% HepB Adults: 15%; Children: 5% Measles/MMR 5% rash ~10% 5-15% Polio (OPV) <1% - <1%** ~10%* ~10% ~25% Tetanus DTP (pertussis) Up to 50% Up to 50% Up to 55% * Rate of local reactions likely to increase with booster doses, up to 50-85% ** Symptoms include diarrhoea, headache, and/or muscle pains World Health Organization

  18. MANAGEMENT OF COMMON, MINOR REACTIONS • Local reaction • cold cloth at injection site • paracetamol • Fever >38°C • give extra fluids • tepid sponging • paracetamol • Irritability malaise and systemic symptoms • give extra fluids • paracetamol World Health Organization

  19. RARE, MORE SERIOUS REACTIONS Vaccine Reaction Onset interval Rate per million doses BCG Suppurative lymphadenitis BCG osteitis Disseminated BCG 2-6 months 1-12 months 1-12 months 100-1000 1-700 2 Hib Nil known Hep B Anaphylaxis Guillain Barré syndrome 0-1 hour 1-6 weeks 1-2 5 Measles /MMR Febrile seizures Thrombocytopaenia Anaphylaxis 5-12 days 15-35 days 0-1 hour 333 33 1-50 OPV Vaccine-associated paralytic poliomyelitis (VAPP) Risk is higher for first dose, adults, and immunocompromised 4-30 days 0.76-1.3 (1st dose) 0.17 (subsequent doses) 0.15 (contacts) World Health Organization

  20. Vaccine Reaction Onset interval Rate per million doses Tetanus Brachial neuritis Anaphylaxis Sterile abscess 2-28 days 0-1 hour 1-6 weeks 5-10 1-6 6-10 Tetanus-diphtheria Nil extra to tetanus reactions DTP Persistent (>3 hrs) inconsolable screaming Seizures Hypotonic, hyporesponsive episode (HHE) Anaphylaxis/shock Encephalopathy 0-24 hours 0-3 days 0-24 hours 0-1 hour 0-3 days 1000-60 000 570 570 20 0-1 RARE, MORE SERIOUS REACTIONS (2) World Health Organization

  21. ADVERSE EVENTS ASSOCIATED WITH SPECIFIC VACCINES • WHO case definitions are used here • Lack of standardized case definitions in the literature • e.g. fever • The Brighton collaboration • developing case definitions for AEFI • promoting global implementation of these definitions secretariat@brightoncollaboration.orghttp://brightoncollaboration.org World Health Organization

  22. ANAPHYLAXIS • Type 1 hypersensitivity reaction • Circulatory failure • Bronchospasm +/- laryngospasm/laryngeal oedema • respiratory distress • May include pruritis, flushing, angioedema, seizures, vomiting, abdominal cramps & incontinence • Occurs in previously sensitized individuals World Health Organization

  23. ANAPHYLAXIS • Reported less from developing countries • Less sensitization? • Less reporting? • Anaphylaxis is rare (1/1 000 000 vaccinations) • Fainting is common • Untrained staff may misdiagnose fainting/dizzinessfor anaphylaxis or vice versa • Administration of adrenaline in a faint may bedangerous • PROMPT MANAGEMENT IS VITAL! World Health Organization

  24. SEIZURES • Particularly associated with measles and DTP vaccination (pertussis component) • febrile seizures Temp >38 • afebrile seizuresTemp normal • Febrile seizures more common with pertussis • An association with non-febrile seizures has not been proven World Health Organization

  25. ADVERSE REACTIONS TO BCG Disseminated BCG • widespread infection, 1-12 months after BCG • usually in immunocompromised individual • confirm by isolation of Mycobacterium bovisBCG strain • treat with antituberculous regimen including Rifampicin and Isoniazid Osteitis/osteomyelitis • infection of the bone with M bovis BCG strain • management as above World Health Organization

  26. ADVERSE REACTIONS TO BCG Suppurative lymphadenitis • occurs within 2-6 months of BCG vaccination • case definition • 1 lymph node> 1.5 cm in size/draining sinus over a lymph node • usually occurs in the axilla, on the same side as innoculation • Management • heals spontaneously over months • only treat if sticking to skin or draining • surgical drainage and local installation ofantituberculous drug • systemic Rx is ineffective World Health Organization

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  29. TETANUS VACCINE Brachial neuritis • Presents with pain in shoulder and upper arm • Followed by weakness +/- wasting of arm and shoulder muscles • Sensory loss not prominent • Occurs 2-28 days after vaccination • Possibly a manifestation of immune complex disease • Management is symptomatic World Health Organization

  30. ENCEPHALOPATHY AND ENCEPHALITIS Possibly associated with measles & pertussis vaccine • Case definition of encephalopathy • 2 out of 3 of • seizures • alteration of consciousness lasting for one day or more • distinct change in behavior for one day or more • Temporal relationship • within 48 hrs with DTP • within 7-12 days after measles or MMR World Health Organization

  31. HYPOTONIC HYPOTENSIVE EPISODE (HHE OR SHOCK-COLLAPSE) • Mainly associated with DTP • Case definition • Event of sudden onset occurring within 48 (usually less than 12) hours of vaccinationand lasting from one minute to several hours • In a child < 10 years of age • ALL of the following must be present • limpness (hypotonic) • reduced responsiveness • pallor or cyanosis - or failure to observe/recall • Transient, self-limiting, NOT a contraindication to further vaccination World Health Organization

  32. POLIO VACCINE - ACUTE FLACCID PARALYSIS Vaccine associated paralytic poliomyelitis • Occurs within 4-30 days of receipt of OPV or 4-75 days after contact with vaccine recipient Case Following a national immunization day in 1996, cases of paralysis were reported after receiving OPV. On laboratory analysis, the wild virus was found, showing that the children had been infected with wild poliovirus before immunization. The cases of poliovirus were coincidental, and not caused by the vaccine. World Health Organization

  33. TOXIC SHOCK SYNDROME • Case definition: Abrupt onset of fever, vomiting and watery diarrhoea • Occurs within a few hours of immunization • Often leads to death within 24-48 hours • needs to be reported as possible indicator of programme error World Health Organization

  34. UNPROVEN ASSOCIATIONS AND PUBLIC CONCERNS • Influenza vaccine and Guillaine Barré Syndrome • MMR and autism, Crohn’s disease • Polio and HIV • Hepatitis B and multiple sclerosis • DTP and permanent brain damage • DTP and increased risk of mortality • Aluminium and macrophagic myofasciitis • Bovine spongiform encephalopathy (BSE) • Thiomerosal • Multiple vaccines given simultaneously World Health Organization

  35. PROGRAMME ERRORS • Non-sterile injection • infection • Incorrect preparation • abscess (inadequate shaking) • drug effect (use of drug instead of vaccine/diluent) • Injection in wrong site • local reaction/abscess (wrong tissue level) • nerve damage • Vaccine frozen • local reaction • Contraindication ignored • avoidable severe reaction World Health Organization

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  39. Programmatic error Insulin given to70 infantsinstead of DTPvaccine with21 deaths DTP T T Insulin vial Vaccine vials Turkey India Algeria Yemen 1997 World Health Organization

  40. CLUSTER • >=2 cases of the same adverse event following immunizations related in time, geography or in the vaccine administered • Why is it important to monitor for clustering? World Health Organization

  41. WHICH EVENTS TO REPORT? • Death, hospitalization, or other severe/unusual events • Toxic shock syndrome • Severe local reaction • Sepsis • Injection site abscess (bacterial/sterile) • BCG lymphadenitis • AEFIs causing concern or suspicion of vaccine involvement World Health Organization

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  44. SERIOUS EVENTS • Anaphylactoid reaction (acute hypersensitivity reaction) • Anaphylaxis • Persistent (more than 3 hours) inconsolable screaming • Hypotonic hyporesponsive episode • Seizures, including febrile seizures(6-12 days for measles/MMR; 0-2 days for DTP) • Encephalopathy (6-12 days for measles/MMR; 0-2 days for DTP) World Health Organization

  45. SERIOUS EVENTS (CONTINUED) • Acute flaccid paralysis • (4-30 days for OPV recipient; 4-75 days for contact) • Brachial neuritis • (2-28 days after tetanus containing vaccine) • Thrombocytopaenia • (15-35 days after measles/MMR) • Disseminated BCG infection • Osteitis/osteomyelitis World Health Organization

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