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8/9/2019 AEFI Surveillance
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AEFIReporting, Investigation
& Management
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AEFI
AEFI is Adverse Event FollowingImmunization.
AEFI is a medical incident that takesplace within a defined period after animmunization, causes concern, but
may or may not be caused byimmunization
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Frequency of AEFI
Vaccine Estimated rate* BCG1 1 in 1000 to1 In50,000
dosesOPV 1 in 3 million dosesfor the first dose ofOPV
Measles 1 in one million dosesDTP1 in 750,000*Only the rate for severe
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Probable Causes
Vaccine reaction - caused by vaccines 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
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COMPONENTS OF THEVACCINE FORMULATION
Suspending agents e.g. water, saline Preservatives e.g. thiomerosal
Stabilisers e.g. sorbitol and hydrolyzed gelatin - MMR Adjuvants e.g. aluminium Salts
Other substances which may be present
Residuals in the growth medium Antibiotics, e.g. neomycin, streptomycin - IPV, varicellavaccine
consider these components as well
when assessing causality!
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INVESTIGATING ADVERSE eventsfollowing IMMUNIZATION
Respond
Detect Report
Investigate
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Live Attenuated SA14-14-2 JEVaccine
Used since 1988: China Also used in Nepal; S.Korea and India Over 210 Million children vaccinated
WHO Position paper and GACVS report onsafety and efficacy
Independent commission report on AEFI of2006 campaign
no direct causality has been established between thereported illnesses and the live attenuated SA14-14-2 JEvaccine. No stricture on the further use of the vaccineis warranted.
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National Level Committee ofExperts NO PRIMA FACIE EVIDENCE THAT AEFI
HAS CONTRIBUTED EXCESS
MORTALITY
o No Systemic adverse events were seen
o
No consistency in cause of death were noted
o Even statistically there were no anomalies detected
o Strengthening of documentation Hospital Case
records
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Major & Minor AEFI
Minor AEFI: Any vaccinated child presenting withany symptom of illness that is resolved in a shorttime following preliminary care and medication.Hospitalization is not required and the child iscompletely recovered without any sequelae
Mild Fever Rash Tenderness at Injection site Irritability Abdominal discomfort
Major AEFI: Any vaccinated child presenting withany symptom of illness that requireshospitalization and/or the child dies from theillness
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Investigation of Major AEFI
District AEFI Committee
Reporting major AEFIs
Laboratory Investigation
Management
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District AEFI Committee
A district AEFI Committee has beenformed under the chairmanship of theDHO/CS/DIO
The CommitteeoA pediatrician/physicianoA pathologist/microbiologist/MO trained
in pathology
oAnesthesiologisto District Immunization officero District Malaria Officer
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Roles and Responsibilities
Review preparedness of the District hospital andother possible referral centers for management of
AEFI Hold one orientation meeting for all PHC MOs in
management and reporting of AEFI All major AEFI cases will be investigated physically
by at least one member of the committeeimmediately following report ( w/in 24 hours)
Ensure that the investigation is carried out as perNational Guidelines
Brief the official spokesperson of the District formedia update and response
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Forms to be filled up
FIRo To be filled up for all cases by the investigatorimmediately
following investigation of the case. This form may be filled upby the Health worker at the vaccination site, the Medical officerat the PHC, District Hospital and the Medical College
immediately following their investigation of the case. PIR
o To be filled up for all cases by the investigatorwithin 2- 4 daysof investigation of the case. This form may be filled up by theMedical officer at the PHC, District Hospital and the MedicalCollege immediately following their investigation of the case.
DIRo To be filled up for all cases by the investigatorwithin 1 to 3
months following investigation of the case. This form may befilled up by the District Immunization officer, Medical officer atthe PHC, District Hospital and the Medical College immediatelyfollowing their investigation of the case.
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What to collect following amajor AEFI
Vaccine vials: collect the actualopened vial of vaccine and diluentused to vaccinate the child (
wherever possible); collect unopenedvials
Collect syringes and needles
Ensure needles are capped
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Specimens...1
It is mandatory to collect CSF Specimens from allmajor AEFI cases with neurological symptoms
In case CSF collection is not possible at PHC level,
the DIO should ensure that that the CSF is collectedby specialist from the district hospital or elsewhere
If CSF is not collected then paired blood samples
o Ist. on the day of the admission
o IInd. on 10th. day or the day of discharge in case of deathimmediately after death-which ever is earlier
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Specimens...2
Routine: urine, serum
If the child dies-Autopsy and brain specimens collection
All specimens should be collected and transported inreverse cold chain to the designated laboratory(NIV,PUNE) under the supervision of the DIO
Dr Milind Gore, Director I/C
National Institute of Virology,Sus Road Campus, Pashan,Pune 411021, IndiaTel: 91-20-25880982,Fax: 91-20-25883595
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Vaccine vials
Collect the actual opened vial of vaccineand diluents used to vaccinate the child (wherever possible);
Collect unopened vials :o 2 from central storeo Five from ILR of implementing unit (PHC)
These vials will be sent to the laboratory for
testing of any adventitious tissue , adjuvantor sterility
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Expectations from AEFICommittee
Identification of members Communication to the district of all
AEFI cases
Specimens: Routine CSF; bloodand slide for MP; autopsy ( in death) CSF and Serum for apex laboratory One official spokesperson from the Dist.
Completed investigations forms: Form 8 - FIR Form 9 - PIR
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Collection, Storage & Shipment
Samples CSF - 2-5 ml Blood - 5 ml (Centrifuge and segregate
Serum and Cells)
Reverse Cold Chain: Vaccine Carrier/ILR/Cold Box
Within 72 Hrs. of collection
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Communicate
District Health Officer/Civil Surgeon
ACMO
DIO
DMO
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Useful Instruction
Do not vaccinate a child if the child /parentscomplain of any sickness in the child including
mild fever
Not the name and full address of the child
Vaccinate the child once he recovers
In case of doubt, the health worker should consultthe Medical Officer of the PHC
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Your support in AEFI investigation andcoordination at all level is crucial
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Muito Obrigado!Thank You
Dr Dhananjay Singh
Consultant
Kala-azar ProjectJohn Snow Inc.
Cell:94311 05617