Adverse events following immunization presentation

AEFI

1. AEFI Surveillance: Overview, Recording and Reporting

2. Plan of presentation Overview and significance of AEFI Objective of AEFI Steps of AEFI Surveillance Recording and Reporting of AEFI Data flow in AEFI Surveillance Council for International Organizations of Medical Sciences (CIOMS)  / WHO cause specific definition of AEFIs

3. Overview of AEFI Surveillance

4. Objectives of AEFI surveillance Identify problems, if any, with vaccine lots/brands leading to vaccine reactions caused by vaccine Detect, correct and prevent immunization errors Prevent false blame arising from coincidental adverse events Reduce incidence of injection reactions from anxiety or fear/pain through education and messaging Maintain confidence by addressing parent/community concerns, and raising awareness about vaccine risks Estimate rates of AEFI occurrence in local population compared with clinical trials and international data

5. Scope of AEFI surveillance Important component of Universal Immunization Programme (UIP), part of the National Regulatory Authority (NRA) Passive surveillance system Covers AEFIs following ALL vaccines administered for prevention Routine and campaign non-UIP and adult vaccines Private and public sector International travel, anti-rabies, Kyasanur Forest Disease, etc. Includes monitoring of minor AEFIs AEFIs can be reported on mere suspicion that vaccine caused event No time limit between vaccination and onset; vaccination/onset and reporting Global Vaccine Action Plan (GVAP) vaccine safety indicator - minimal capacity if at least 10 serious/severe cases per 100,000 surviving infants per year are reported

6. AEFIs – Definition and Types Minor – low grade fever, local pain, swelling, redness, resolves within 2-3 days Severe – Increased severity of minor AEFIs; do not lead to long-term problems; rarely life threatening, can be disabling e.g. Injection site swelling beyond nearest joint, fever >102 degrees F Serious Deaths Hospitalizations Clusters Disability Congenital anomalies/birth defects Community/ parental concern Any untoward medical occurrence following immunization and which does not necessarily have a causal relationship with the usage of the vaccine

7. AEFI Surveillance System Initiated in 1988-89; AEFI guidelines developed and updated in 2005, 2010, 2015 & 2024 National, state and district AEFI committees formed Regular trainings on AEFI reporting, recording and causality assessments National and state AEFI technical collaborating centres established Software based system for reporting serious/severe AEFIs NRA assessment conducted in 2017 – maturity level of 4

8. Immediate notification of serious/severe AEFIs by health worker in person or phone Recording of minor, serious and severe AEFIs in AEFI registers at PHCs and other health facilities Case visit for confirmation and reporting by the medical officer AEFI case investigation , report submission and action at the local level by district Causality assessment by the State AEFI committee and submission Taking action at state and national level Programmatic action – capacity building, monitoring, supervision, stimulated reporting, etc. Regulatory action – pharmacovigilance, GMP inspections, PSUR reviews, etc. Signal management for vaccines Steps in AEFI surveillance

9. Importance of Reporting Reporting helps in identification and rectification of program errors Reporting of AEFIs helps in identifying rare adverse events which were not detected during clinical trials due to limited number of subjects In Europe, more than 4 lakh AEFI cases were reported following Covishield (AstraZeneca vaccine) After analysis of these cases, Thrombosis with Thrombocytopenia Syndrome (TTS) was detected as safety signal of Covishield Reporting of known adverse events (fever, pain, bodyache etc ) is equally important to monitor their frequency

10. AEFI reporting system

11. Sources of Reporting of AEFI Universal Immunization Program AEFI surveillance system: Primary reporting of AEFI cases from rural & urban areas: ANM, MO-PHC Medical colleges, private practitioners, media reports Immediate reporting of all AEFI cases into SAFE-VAC / Co-WIN SAFE-VAC and TB-WIN HMIS Report: Monthly reporting of all AEFIs (numbers only) through HMIS VPD Surveillance: Weekly reporting (severe & serious cases) from all reporting unit in form of VPD H002 & its compilation in D001 forms Pharmacovigilance Program of India (PvPI) Individual Case Safety Report ( ICSRs) generated by ADR Monitoring centres established as a part of PvPI Central Drugs control and Standards Organization Monitoring of post marketing safety updates from market authorization holder (MAH) IAP’s http://www.idsurv.org/ portal for private Paediatricians

12. Primary reporting of AEFI cases from rural & urban areas: ANM, MO-PHC

13. Safe Vac

14. HMIS Report for AEFI

15. IAP’s portal for private Paediatricians

16. Cases to be reported

17. REPORTING OF SEVERE AND SERIOUS AEFIs

18. Important Terminology in AEFI Surveillance Notification : Health care system becomes aware of an AEFI. Usually by ANM to the MO Reporting : Informing of the AEFI to the district and documentation of the same in the CRF. Usually by MO to the district (DIO) Investigation : Site visit and documentation in the CIF by the district AEFI committee (DIO is convener of investigation) Causality Assessment : Systematic assessment of information to determine the likelihood of the vaccine/s causing the event. Conducted by State/ National AEFI Committee.

19. Steps in AEFI Case Detection Immediate AEFI case notification by the health worker in person or phone Case visit for confirmation and reporting by the medical officer Decision on investigation by the District AEFI case investigation , report submission and action at the local level Causality assessment by the State AEFI committee and conclusion of the investigation Submission of Causality assessment report by State AEFI Committee Taking action at State and National level

20. AEFI formats Reporting Formats Case Reporting Form (CRF) Case Investigation Form (CIF) Hospital Records - discharge summary, clinical lab / diagnostic reports Verbal Autopsy in case of death Postmortem Reports, if done Reporting channels SAFE-VAC Co-WIN SAFE-VAC

21. Timelines and Information Flow 24 hours 48 hours Day 21 Day 100 Day 0 State Causality Assessment Report Case Investigation Form ( CIF) Case Reporting Form (CRF) Causality Assessment SEVERE & SERIOUS AEFI CASES Case investigation – district reports to state District decision on investigation and informs state Medical officer visits and reports to district Case Notification Hospital Records- discharge summary, clinical lab/ diagnostic reports; In case of deaths Postmortem Reports/Verbal Autopsy

22. Minor AEFI Reporting

23. Reporting of Minor AEFI AEFI registers: at health facilities - PHC and above SAFE-VAC: DIO and vaccinator can report all AEFIs (minor, severe, serious) into SAFE-VAC through U-WIN HMIS Co-WIN SAFE-VAC: for AEFIs after Covid-19 vaccines TB-WIN SAFE-VAC: for AEFIs after BCG vaccination for adults

24. Reporting formats for Serious / Severe AEFI

25. Case Reporting Format (CRF) Two Parts with total 5 sections: To be filled at session site/facility level by MO: Reporter and notifier details Patient details Details of vaccine(s) and diluent(s) Details of adverse event(s) These include: Details of notifier, reporter, patient, session site, vaccine details, reason for reporting, status, hospitalization, postmortem, event signs and symptoms To be filled at DIO office Decision making details These include: Details of date and time of receipt of CRF at district, DIO details, date of forwarding of CRF to State and National level

26. Case Investigation Format (CIF) Ten sections: Basic details of the session site, place of vaccination, investigator, date and time of investigation, vaccination date Patient personal information and address , information on pregnancy for woman in reproductive age group Vaccine details, description of AEFI event, hospitalization, post-mortem, date and time of first symptoms, Relevant patient details prior to vaccination – past history, family history, birth details, congenital disorders, pre-existing illnesses, treatment details, birth details of infants

27. Case Investigation Format (CIF) Clinical assessment details- Only if hospitalization records are not available or their details are not mentioned in the hospital records. Similar to a case history (includes treatment details and provisional/ final diagnosis) Investigation at vaccination site- Details of vaccines provided at the session site (when was the vaccine given), information to document evidence of possible programme error, cluster details (if relevant), vaccination practices at session site (syringes, needles, vaccine handling, reconstitution, diluent details) Cold chain and transportation details- last cold chain point, status of vaccine storage (VVM, temperature charts, storing of drugs other than vaccines and diluents, vaccine carriers and AVD etc.)

28. Case Investigation Format (CIF) Community investigation- similar events in vaccinated and unvaccinated persons District AEFI Committee review/investigations- meeting dates, provisional diagnosis, details vaccine diluent/ syringe/ needle samples / biological products sent for testing, hospital records, lab reports, post-mortem reports, etc. attached with CIF, details of members of District AEFI Committee which investigated case Details of documents attached , name, designation, and signatures of district AEFI committee members

29. SAFE-VAC 2019 - First version rolled-out across the country 2024 - Integration with U-WIN Reporting of All types of AEFIs – Minor, Severe, Serious For all vaccines except Covid-19 and adult BCG Reporting by DIO, vaccinator

30. Data Flow of AEFI Cases All AEFIs (minor, severe and serious) Persons with access to U-WIN Persons without access to U-WIN DIO Vaccinator Basic information entered into U-WIN (CNF) Data automatically transferred to SAFE-VAC SAFE-VAC Serious / Severe Minor DIO to investigate and complete CRF, CIF All AEFIs (minor, severe and serious) must be entered into AEFI registers at planning units also MOs, private practitioners, other health staff

31. Data Flow of AEFI Cases AEFI reporting initiated in U-WIN by DIO, vaccinator Categorization by DIO DIO initiate CRF and submit CIF form generated automatically, to be filled and submitted by DIO CA form submission by state user Minor/severe/serious SAFE-VAC Case Notification Form (CNF) Case Reporting Form (CRF) Case Investigation Form (CIF) Causality Assessment Form (CA) Case Investigation Verification by DIO Severe/Serious Minor

32.   Council for International Organizations of Medical Sciences (CIOMS)  / WHO cause specific definition of AEFIs

33.   Council for International Organizations of Medical Sciences (CIOMS)  / WHO cause specific definition of AEFIs

34. THANK YOU

35. Reference: Government of India. AEFI Surveillance and Response-Operational Guidelines 2024. New Delhi: Ministry of Health and Family Welfare; 2024.