Global Training Network ProgrammeWorld Health Organization

Global Training Network ProgrammeWorld Health Organization 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

Global Training Network ProgrammeWorld Health Organization AEFI Modern vaccines  Are generally safe  Not entirely without risk  Benefits far outweigh risks

Global Training Network ProgrammeWorld Health Organization AEFI Why monitoring of AEFI are important ?  Upsets people  Refusal for further immunization

Global Training Network ProgrammeWorld Health Organization Adverse drug reaction form AEFI reporting form HOW DOES AEFI REPORTING INTERACT WITH ADR REPORTING?

Global Training Network ProgrammeWorld Health Organization 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

Global Training Network ProgrammeWorld Health Organization MOH goal for establishing AEFI surveillance AEFI surveillance has been started to improve the quality of immunization services

Global Training Network ProgrammeWorld Health Organization 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.

Global Training Network ProgrammeWorld Health Organization Political commitment A circular was distributed in 2003 by MOH for health facilities to report every AEFI to medical universities and CDC.

Global Training Network ProgrammeWorld Health Organization Establishment of National immunization safety committee 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

Global Training Network ProgrammeWorld Health Organization 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.

Global Training Network ProgrammeWorld Health Organization 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.

Global Training Network ProgrammeWorld Health Organization 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.

Global Training Network ProgrammeWorld Health Organization 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

Global Training Network ProgrammeWorld Health Organization 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 u Vaccine reaction - caused by vaccine’s inherent properties u Programme error - caused by error in vaccine preparation, handling, or administration u Coincidental - happens after immunization but not caused by it ( a chance association) u Injection reaction - anxiety or pain of injection not vaccine u Unknown - cause cannot be determined

Global Training Network ProgrammeWorld Health Organization 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

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

Global Training Network ProgrammeWorld Health Organization 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

Global Training Network ProgrammeWorld Health Organization RARE, MORE SERIOUS REACTIONS (1 st dose) 0.17 (subsequent doses) 0.15 (contacts) 4-30 daysVaccine-associated paralytic poliomyelitis (VAPP) Risk is higher for first dose, adults, and immunocompromised OPV days days 0-1 hour Febrile seizures Thrombocytopaenia Anaphylaxis Measles /MMR hour 1-6 weeks Anaphylaxis Guillain Barré syndrome Hep B Nil known Hib months 1-12 months Suppurative lymphadenitis BCG osteitis Disseminated BCG BCG Rate per million doses Onset interval ReactionVaccine

Global Training Network ProgrammeWorld Health Organization RARE, MORE SERIOUS REACTIONS (2) hours 0-3 days 0-24 hours 0-1 hour 0-3 days Persistent (>3 hrs) inconsolable screaming Seizures Hypotonic, hyporesponsive episode (HHE) Anaphylaxis/shock Encephalopathy DTP Nil extra to tetanus reactions Tetanus-diphtheria days 0-1 hour 1-6 weeks Brachial neuritis Anaphylaxis Sterile abscess Tetanus Rate per million doses Onset interval ReactionVaccine

Global Training Network ProgrammeWorld Health Organization 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

Global Training Network ProgrammeWorld Health Organization 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

Global Training Network ProgrammeWorld Health Organization ANAPHYLAXIS Reported less from developing countries Less sensitization? Less reporting? Anaphylaxis is rare (1/ vaccinations) Fainting is common Untrained staff may misdiagnose fainting/dizziness for anaphylaxis or vice versa Administration of adrenaline in a faint may be dangerous PROMPT MANAGEMENT IS VITAL!

Global Training Network ProgrammeWorld Health Organization SEIZURES Particularly associated with measles and DTP vaccination (pertussis component) febrile seizures Temp >38 afebrile seizures Temp normal Febrile seizures more common with pertussis An association with non-febrile seizures has not been proven

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

Global Training Network ProgrammeWorld Health Organization 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 of antituberculous drug systemic Rx is ineffective

Global Training Network ProgrammeWorld Health Organization

Global Training Network ProgrammeWorld Health Organization

Global Training Network ProgrammeWorld Health Organization 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

Global Training Network ProgrammeWorld Health Organization 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

Global Training Network ProgrammeWorld Health Organization 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 vaccination and 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

Global Training Network ProgrammeWorld Health Organization 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. 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

Global Training Network ProgrammeWorld Health Organization 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 hours needs to be reported as possible indicator of programme error

Global Training Network ProgrammeWorld Health Organization 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

Global Training Network ProgrammeWorld Health Organization 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

Global Training Network ProgrammeWorld Health Organization

Global Training Network ProgrammeWorld Health Organization

Global Training Network ProgrammeWorld Health Organization

Global Training Network ProgrammeWorld Health Organization Algeria India Turke y Yemen1997 Programmatic error 70 infants 21 deaths Insulin given to 70 infants instead of DTP vaccine with 21 deaths Insulin vial Vaccine vials T DTP

Global Training Network ProgrammeWorld Health Organization 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 ?

Global Training Network ProgrammeWorld Health Organization 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

Global Training Network ProgrammeWorld Health Organization

Global Training Network ProgrammeWorld Health Organization ____________ ____________ ____________ ____________ ____________

Global Training Network ProgrammeWorld Health Organization 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)

Global Training Network ProgrammeWorld Health Organization 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