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10. AEFI surveillance management-PCV launch (1).pptx
This document provides information on pneumococcal conjugate vaccine (PCV) safety and adverse event following immunization (AEFI) surveillance. It states that PCV is known to be safe with minor and rare AEFIs reported like fever, injection site reactions. It outlines the classification, reporting timelines and roles for minor, severe and serious AEFIs. The last section provides an overview of PCV AEFI reporting from various Indian states from 2011-2021 with most cases reported from Bihar, Uttar Pradesh and Madhya Pradesh.
10. AEFI surveillance management-PCV launch (1).pptx
- 1. Pneumococcal Conjugate Vaccine (PCV) Reportingand management of AEFIs
- 2. Safety profile ofPCV • PCV is known to be a safe vaccine • Minor AEFIs • Local reactions: PCV can cause redness, swelling and tenderness in around 10% of vaccine recipients • Generalized reactions e.g. fever in <1% of vaccine recipients and are rare • Rarely allergic reactions and anaphylaxis
- 3. Safety profile ofPCV • PCV vaccines are safe and have been used in over 146 countries without safety concerns. • Studies have shown PCV to be safe and immunogenic when given along with other childhood vaccines. • PCVs are considered safe in all target groups for vaccination, including immuno-compromised individuals. • Some common and minor adverse events reported are- Irritability, fever, injection site tenderness, redness, swelling, decreased appetite, increased / decreased sleep. These events are found to be generally mild and transient. • No serious adverse events have been linked to the use of PCV. For further reading, refer to WHO fact sheet-http://www.who.int/vaccine_safety/initiative/tools/Pneumococcal_Vaccine_rates_information_sheet.pdf?ua=1 CDC fact sheet- https://www.cdc.gov/vaccinesafety/vaccines/pneumococcal-vaccine.html
- 4. AEFI surveillance andNew Vaccines • Although vaccines are safe, surveillance of adverse events is required to o Detect, correct and prevent immunization errors. o Prevent false blame arising from coincidental adverse events. o Maintain confidence by addressing parent/community concerns, and raising awareness about vaccine risks. • Past experiences from different countries and India shows that reporting of adverse event following new vaccine increases due to improved sensitisation and training. • New vaccine introduction provides an opportunity to strengthen AEFI surveillance.
- 5. What is anAEFI? An adverse event following immunization (AEFI) is any untoward medical occurrence which follows immunization and which does not necessarily have a causal relationship with the usage of the vaccine. The adverse event may be any unfavorable or unintended sign, abnormal laboratory finding, symptom or disease. Types of AEFIs • Minor • Severe • Serious
- 6. Classification of AEFIs MinorAEFIs • Minor reactions following immunization are common and self-limiting e.g. pain & swelling at the site of injection, fever, irritability, malaise, etc. • Record all minor AEFIs in block AEFI register every week and report monthly in HMIS Severe AEFIs • Severity of minor AEFIs increases but not hospitalised • Can be disabling, do not lead to long-term problems, rarely life threatening • Examples of severe reactions include non-hospitalized cases of: anaphylaxis that has recovered, high fever( >102 degree F), hypotonic hypo-responsive episodes • Report and investigate all severe AEFIs immediately!
- 7. Classification of AEFIs SeriousAEFIs Death Hospitalization Persistent or significant disability Clustering Community concern Report and investigate all serious AEFIs immediately! Follow National AEFI Surveillance Guidelines – 2015 Dedicated portal / email address: safe-vac portal
- 8. Response to anAEFI Provide immediate primary management for all AEFIs. • Minor AEFIs – provide symptomatic treatment • Serious/severe AEFIs: Refer immediately to the nearest health facility/AEFI centre, and report to the appropriate authority. • All ANMs/ASHAs/AWWs and MOs must • be sensitized to recognize and notify/report AEFI promptly. • know what to do when an AEFI occurs • be aware of location of the nearest AEFI management centre. • Anaphylaxis Kit must be available at the sessions.
- 9. AEFI surveillance: roles •The district AEFI committee should be • Aware of introduction of pneumococcal vaccine in UIP • Prepared to support DIO in investigating serious AEFIs • Involved in managing media during times of crises as secondary spokesperson
- 10. • Maintaining ofPHC-wise AEFI reporting registers for recording of all Minor, serious and severe AEFI cases by the ANM. • These registers should be weekly reviewed by the concerned MO for identifying the repetition of events and potential signal detection. • All serious and severe AEFIs are to be investigated on CRF, PCIF and FCIF other supporting documents as per guidelines. • District AEFI committee need to be revived & updated Strengthening of AEFI surveillance
- 11. Formats and timelinesfor reporting serious/severe AEFI cases Type of Report Responsible Timeline CASE REPORTING FORM(CRF) MO 24 hours of notification DIO 48 hours of notification CASE INVESTIGATION FORM (CIF) DIO 10 days of notification
- 12. STATE (No. of districts) Introductio nDate 2017 2018 2019 2020 2021 Reason For Reporting REMARKS HOSPIT ALIZED DEATH CLUSTER SEVERE HIMACHAL PRADESH 1-Jun-17 0 6 8 1 2 8 6 2 1 6 cases from District Sirmaur, Mandi-4, Kangra-2, Shimla-2, Kullu-1, Solan-1 & Kinnaur-1 UTTAR PRADESH 10-Jun-17 3 6 8 16 12 2 43 0 0 4 -Balrampur, 4-Lucknow, 4-Agra, 3- Gonda, 2-Bahraich, 2-Bijnor 2-Bulandshahar, 2-Etawah, 2- Kheri, 2-Shahjahanpur, 2-Siddharthnagar, 2-Sitapur and one each from Amroha, Badohi, Deoria, Furrakhabad, GB Nagar, Jaluan, Kanpur nagar, Kaushambi, Mathura, Moradabad, Pilibhit, Raebareli, Unnao & Maharajganj BIHAR 19-Jul-17 22 68 80 48 6 21 195 3 5 14 cases from Begusarai, 14-Munger, 13-Muzaffarpur, 13-Samastipur, 12- Madhepura, 12- Supaul, 12- Vaishali, 11-Darbhanga, 11-Saran, 10-Purnia, 9-Khagria, 8-Madhubani, 8-Nanlda, 8- Saharasa, 6-Jamui, 5-Gopalganj, 5-Sitamarhi, 5-Champaran west, 4-Gaya, 4-Katiar, 4-Nawada, 4- Rohtas, 4-Bhagalpur, 4-Champaran East, 3-Kishanganj, 3-Sheikhpura, 3-Patna, 2-Araria, 2- Aurangabad, 2-Banka, 2-Bhojpur, 2-Jehananbad, 2-Siwan and one each from Arwal, Kaimur & Lakhisarai. MADHYA PRADESH 07-APR-18 0 12 31 20 3 16 42 5 3 12- Bhopal, 6-Satna, 5-Anuppur, 5- Indore, 4-Sehore, 3- Ujjain, 2-Ashoknagar, 3-Bhind, 2-Jhabua, 2-Mandla, 2-Morena, 2-Seoni, 2-Sagar and one each from Betul, Chhindwara, Devas, Dindori, Gwalior, Harda, Jabalpur, Mandsaur, Panna, Rajgarh, Ratlam, Rewa , Shajapur, Sidhi & Umariya. RAJASTHAN 07-APR-18 0 2 1 7 1 7 4 0 0 Jhalawar-2, Udaipur-2 and one each from Barmer, Bhilwara, Chittaurgarh, Dungarpur, Nagaur & Rajsamand HARYANA 03-Oct-18 0 4 10 13 4 12 18 0 1 9-Panchkula, 6-Sirsa, 3-Sonepat, 3-Ambala, 2-Panipat, 2-Kaithal- 2-Yamunanagar and one each from Bhiwani, Hisar, Karnal & Palwal. KERALA 3 0 3 1 1 6 1 0 1 2 cases from Kozhikode, 2-Ernakulamand 1 case each from Thrissur, Palakkad, Kannur & Pathanmtitta (private health facility) MAHARASHTRA 0 2 2 1 0 4 0 0 1 2-Thane & 3- GR. Mumbai (private health facility) WEST BENGAL 1 2 1 0 0 3 1 0 0 Asansol (pvt. health facility) & 1 from Hugli, 2 Kolkata TAMIL NADU 0 1 3 4 2 7 3 0 0 5 from Channai & one each from THIRUVALLUR, Nagapattinam & Vellore (Pvt. facility) GUJARAT 0 3 0 1 0 0 1 3 0 3 cases from District Kheda and one from GIR SOMNATH) TRIPURA 0 1 0 0 0 1 0 0 0 Tripura West, Agartala Hospital & Research Centre Pvt Ltd CHANDIGARH 0 0 2 0 0 2 0 0 0 Chandigarh Govt health facility (Pvt Supply) KARNATAKA 0 0 3 0 0 3 0 0 0 1-Mysoue, 1- Banglore & 1- Uttar Kannad (Govt health facility) GOA 0 0 1 0 0 1 0 0 0 south Goa-Private Practitioner PUNJAB 0 0 1 0 0 1 0 0 0 Indus Hospital Mohali (Pvt) JAMMU & KASHMIR 0 0 0 1 2 1 2 0 0 2 cases from Badgam & One from Jammu JHARKHAND 0 0 0 0 1 0 1 0 0 1 Bokaro NAGALAND 0 0 0 0 1 1 0 0 0 1 Mokokchung ODISHA 0 0 0 0 4 2 2 0 0 One each from Dhenkanal, Ganjam, Puri & Bhadrak TOTAL 29 107 154 113 39 98 319 13 12 Serious/severe AEFIs reported following PCV vaccination (co- administered) in 2017-21* * Rajasthan -Vaccination started in all 33 districts from Feb 2020 & Uttar Pradesh started in all 75 districts from Aug 2020 Causality Assessment status: documents incomplete for causality assessment – 183 cases. (BI- 83, MP-47, UP-32, HR-8 RJ-6 & HP-7 ) *Data as on 31-Jul-2021 (as per DOV) Total 442 cases
- 13. Overview of AEFISurveillance A&N Islands, D&N Haveli, Daman & Diu, Gujarat, Lakshadweep & West Bengal
- 14. A & NIsland Data as on 31-July-2021 0 0 0 0 0 0 0 0.5 1 2011 2012 2013 2014 2015 2016 AEFI cases reported year 2011-16 0 0 2 0 0 0 0 2 0 0 0 0 2 0 0 0 0 1 0 0 0 0 1 0 0 0 1 2 3 2017 2018 2019 2020 2021 AEFI reporting status year 2017-21 TOTAL AEFI CRF PCIF FCIF STATE CA REPORT Overview of State AEFI Surveillance A & N Island -2011-2021* A & N Island Data as on 31-July-2021
- 15. Silent District Reporting District SILENTDISTRICTS ON AEFI SURVEILLANCE 2019-2021* A & N Island Data as on 31-July-2021 2019 2021 REPORTING DISTRICT- 1 SILENT DISTRICT- 2 REPORTING DISTRICT- 0 SILENT DISTRICT- 3 2020 REPORTING DISTRICT- 0 SILENT DISTRICT- 3 N IC OBAR N ORTHANDMIDD LEAN DAM AN SO UTHAND AMAN N IC O BAR N O R THAN DMIDD LEAN DAM AN SO UTHAND AMAN N IC OBAR N ORTHANDMIDD LEAN DAM AN SO UTHAND AMAN
- 16. D & NHaveli Data as on 31-July-2021 0 0 0 0 0 3 0 1 2 3 4 2011 2012 2013 2014 2015 2016 AEFI cases reported year 2011-16 0 2 3 2 1 0 2 3 2 1 0 2 3 2 1 0 2 3 2 1 0 2 3 2 1 0 1 2 3 4 2017 2018 2019 2020 2021 AEFI reporting status year 2017-21 TOTAL AEFI CRF PCIF FCIF STATE CA REPORT Overview of State AEFI Surveillance D & N Haveli -2011-2021* 2 CRF received and cross notified in 2017
- 17. Silent District Reporting District SILENTDISTRICTS ON AEFI SURVEILLANCE 2019-2021* 2020 REPORTING DISTRICT- 1 SILENT DISTRICT- 0 D &NH AVELI 2021 REPORTING DISTRICT- 1 SILENT DISTRICT- 0 2019 REPORTING DISTRICT- 1 SILENT DISTRICT- 0 D &NH AVELI D &NH AVELI D & N Haveli Data as on 31-July-2021
- 18. 0 0 5 0 3 0 0 2 4 6 2011 20122013 2014 2015 2016 AEFI cases reported year 2011-16 0 0 1 0 0 0 0 1 0 0 0 0 1 0 0 0 0 1 0 0 0 0 0 0 0 0 0.5 1 1.5 2017 2018 2019 2020 2021 AEFI reporting status year 2017-21 TOTAL AEFI CRF PCIF FCIF STATE CA REPORT Overview of State AEFI Surveillance Daman & Diu -2011-2021* Daman & Diu Data as on 31-July-2021
- 19. Silent District Reporting District SILENTDISTRICTS ON AEFI SURVEILLANCE 2019-2021* 2019 2021 2020 REPORTING DISTRICT- 0 SILENT DISTRICT- 2 REPORTING DISTRICT- 0 SILENT DISTRICT- 2 REPORTING DISTRICT- 1 SILENT DISTRICT- 1 Diu Daman & Diu Data as on 31-July-2021
- 20. 8 23 8 15 22 73 0 20 40 60 80 2011 20122013 2014 2015 2016 AEFI cases reported year 2011-16 56 83 92 46 22 56 82 92 46 22 56 67 75 38 5 55 65 68 38 5 56 75 20 6 0 0 50 100 150 2017 2018 2019 2020 2021 AEFI reporting status year 2017-21 TOTAL AEFI CRF PCIF FCIF STATE CA REPORT Overview of State AEFI Surveillance Gujarat -2011-2021* Gujarat Data as on 31-July-2021
- 21. Silent District Reporting District SILENTDISTRICTS ON AEFI SURVEILLANCE 2019-2021* 2021 REPORTING DISTRICT- 11 SILENT DISTRICT- 30 REPORTING DISTRICT- 20 SILENT DISTRICT- 21 2019 2020 REPORTING DISTRICT- 15 SILENT DISTRICT- 26 DANGS RAJKOTCORPN. JAM NAGARCORPN. BHAVNAGARCOR PN. BANASKAN THA PATAN M EH SANA SUREND RANAGAR ANAND SABARKANTHA KHED A DAH OD PANCHM AHALS RAJKOT JAM NAGAR PO RBANDAR JUNAGADH AM RELI BHAVNAGAR BHARUC H VADODARACORPN. VADODARA NAR MADA SU RAT CORPN. NAVSARI VALSAD KUTC H AHM EDABAD AHM EDABADCORPN. SU RAT TAPI G ANDHINAGARC ORPN. G ANDHINAGAR JU NAGADHCORPN. DANGS RAJKOTCORPN. JAMNAGARCORPN. BHAVNAGARCOR PN. BANASKAN THA PATAN MEH SANA SUREND RANAGAR ANAND SABARKANTHA KHED A DAH OD PANCHMAHALS RAJKOT JAMNAGAR PO RBANDAR JUNAGADH AMRELI BHAVNAGAR BHARUC H VADODARACORPN. VADODARA NAR MADA SU RAT CORPN. NAVSARI VALSAD KUTC H AHM EDABAD AHMEDABADCORPN. SU RAT TAPI G ANDHINA G ARC ORPN. G ANDHINAGAR JU NAGADHCORPN. DANGS RAJKOT CORPN. JAMNAGAR CORPN. BHAVNAGAR CORPN. BANASKANTHA PATAN MEHSANA SURENDRANAGAR ANAND SABARKANTHA KHEDA DAHOD PANCHMAHALS RAJKOT JAMNAGAR PORBANDAR JUNAGADH AMRELI BHAVNAGAR BHARUCH VADODARA CORPN. VADODARA NARMADA SURAT CORPN. NAVSARI VALSAD KUTCH AHMEDABAD AHMEDABAD CORPN. SURAT TAPI GANDHINAGAR CORPN. GANDHINAGAR JUNAGADH CORPN. Gujarat Data as on 31-July-2021
- 22. 0 0 00 0 0 0 0.5 1 2011 2012 2013 2014 2015 2016 AEFI cases reported year 2011-16 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0.5 1 2017 2018 2019 2020 2021 AEFI reporting status year 2017-21 TOTAL AEFI CRF PCIF FCIF STATE CA REPORT Overview of State AEFI Surveillance Lakshadweep -2011-2021* Lakshadweep Data as on 31-July-2021
- 23. Silent District Reporting District SILENTDISTRICTS ON AEFI SURVEILLANCE 2019-2021* 2019 2020 2021 REPORTING DISTRICT- 0 SILENT DISTRICT- 1 REPORTING DISTRICT- 0 SILENT DISTRICT- 1 REPORTING DISTRICT- 0 SILENT DISTRICT- 1 Lakshadweep Data as on 31-July-2021
- 24. 30 30 113 72 84 182 0 50 100 150 200 20112012 2013 2014 2015 2016 AEFI cases reported year 2011-16 340 219 398 170 45 339 219 395 170 45 296 180 324 119 24 281 156 301 117 8 192 110 281 83 10 -100 100 300 500 2017 2018 2019 2020 2021 AEFI reporting status year 2017-21 TOTAL AEFI CRF PCIF FCIF STATE CA REPORT Overview of State AEFI Surveillance West Bengal -2011-2021* West Bengal Data as on 31-July-2021
- 25. Silent District REPORTING DISTRICT-26 SILENT DISTRICT- 01 2019 Reporting District SILENT DISTRICTS ON AEFI SURVEILLANCE 2019-2021* 2020 REPORTING DISTRICT- 23 SILENT DISTRICT- 04 MALDAH UTTAR DINAJPUR KOCH BIHAR DAKSHINDINAJPUR MURSHIDABAD NADIA HOWRAH DARJILING PURULIA KOLKATA HUGLI JALPAIGURI A LIPURDUAR 24-PARGANAS NORTH BASIRHA T BANKURA BISNUPUR DIAMOND HARBOUR 24-PARGANAS SOUTH JHARGRAM PASCHIM MEDINIPUR NANDIGRAM PURBA MEDINIPUR BIRBHUM RAMPURHAT A SANSOL BARDHAMAN MALDAH UTTAR DINAJPUR KOCH BIHAR DAKSHINDINAJPUR MURSHIDABAD NADIA HOWRAH DARJILING PURULIA KOLKATA HUGLI JALPAIGURI A LIPURDUAR 24-PARGANAS NORTH BASIRHA T BANKURA BISNUPUR DIAMOND HARBOUR 24-PARGANAS SOUTH JHARGRAM PASCHIM MEDINIPUR NANDIGRAM PURBA MEDINIPUR BIRBHUM RAMPURHAT A SANSOL BARDHAMAN REPORTING DISTRICT- 14 SILENT DISTRICT- 13 2021 MALDAH UTTAR DINAJPUR KOCH BIHAR DAKSHINDINAJPUR MURSHIDABAD NADIA HOWRAH DARJILING PURULIA KOLKATA HUGLI JALPAIGURI A LIPURDUAR 24-PARGANASNORTH BASIRHA T BANKURA BISNUPUR DIAMOND HARBOUR 24-PARGANASSOUTH JHARGRAM PASCHIM MEDINIPUR NANDIGRAM PURBA MEDINIPUR BIRBHUM RAMPURHAT A SANSOL BARDHAMAN West Bengal Data as on 31-July-2021
- 26. Summary • PCV isknown to be a very safe vaccine. • Strengthen AEFI surveillance before PCV introduction. • Manage, report promptly and completely investigate all serious and severe AEFI cases in time. • Ensure all health workers and medical officers are trained and sensitized on AEFI reporting and management. • District AEFI Committee meeting should be held just before introduction of PCV to orient members on AEFI surveillance and introduction of PCV vaccine in the UIP schedule.
Editor's Notes
- #13 Data as per vaccination year