AEFI Surveillance

8/9/2019 AEFI Surveillance

1/23

AEFIReporting, Investigation

& Management


2/23

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


3/23

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


4/23

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


5/23

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!


6/23

INVESTIGATING ADVERSE eventsfollowing IMMUNIZATION

Respond

Detect Report

Investigate


7/23

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.


8/23

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


9/23

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


10/23

Investigation of Major AEFI

District AEFI Committee

Reporting major AEFIs

Laboratory Investigation

Management


11/23

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


12/23

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


13/23

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.


14/23

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


15/23

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


16/23

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


17/23

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


18/23

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


19/23

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


20/23

Communicate

District Health Officer/Civil Surgeon

ACMO

DIO

DMO


21/23

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


22/23

Your support in AEFI investigation andcoordination at all level is crucial


23/23

Muito Obrigado!Thank You

Dr Dhananjay Singh

Consultant

Kala-azar ProjectJohn Snow Inc.

Cell:94311 05617

Documents

AEFI Surveillance