1 japanese encephalitis vaccination

Adult Japanese encephalitis vaccinations

1. Adult JE Vaccination 29 th October 2021 Live Attenuated SA 14-14-2 Presented by-Dr Rajesh Pandey

2. Updated Operational Guidelines Ministry of Health & Family Welfare, Govt. of India

3. Outline of the Presentation Outline of the presentation Epidemiology of JE JE Vaccine in RI JE Vaccination Government of India: Strategy Revised Protocol proposal due to COVID situation Micro-planning considerations Team: composition, workload & roles Rapid Convenience Assessment JE vaccine: presentation, storage, administration and contra-indications

4. Japanese encephalitis (JE) is a vector-borne zoonotic viral disease caused by flavivirus JEV is transmitted primarily by Culicine mosquitoes Culex tritaeniorhynchus , the most important vector species, breeds in water pools and flooded rice fields and bites mainly during the night. Also spread by Culex vishnuii and Culex pseudo vishnuii Epidemiology

5. Transmission Cycle of JE Natural hosts of JE virus water birds of Ardeidae family (mainly pond herons and cattle egrets) Pigs play an important role- Amplifier Host . Humans are dead-end host - very low viraemia and no man to man transmission.

6. Disease predominantly found in rural and periurban settings, where humans live in closer proximity to these vertebrate hosts. Majority of infections occur during July and October coinciding with monsoon and post-monsoon period. Disease Burden: JEV - main cause of viral encephalitis in many countries of Asia with an estimated 68K clinical cases every year, with >20K deaths! Symptomatic Japanese encephalitis (JE) is rare, the case-fatality rate among those with encephalitis can be as high as 30% . (COVID-0.5%) Permanent neurologic or psychiatric sequelae can occur in 30% –50% of those with encephalitis. Epidemiology contd ….

7. Global Scenario Source: WHO/CDC Map Production: Public Health Information and Geographic Information Systems (GIS), WHO 2012 24 countries are JE endemic around the world Global JE endemic countries

8. Historical Perspective 1952 - First evidence of JE viral activity VRC (NIV) during sero -surveys for arbo - viruses. 1955 - First human case of JE(suspected case). 1958 - First viral isolation from JE case. 1973 - First outbreak- Bankura and Burdwan in West Bengal. 1976 - Repeat outbreak in Burdwan . 1978 Widespread occurrence of suspected JE cases. National level monitoring initiated by NMEP in 1978. Initiation of immunization using inactivated mouse brain vaccine 2005 Massive JE Outbreak in Eastern UP and Bihar Around 6000 AES/ JE cases /1500 deaths were reported from UP Around 6500 AES/JE cases/1600 deaths from 10 states of India.

9. JE vaccines under UIP Ministry of Health & Family Welfare Govt. of India

10. Adult JE Campaign JE Vaccination States JE campaign completed in 230 districts. *Status as on 23 rd September 2019 Completed District Planned District NA States Districts with JE vaccine in RI States Districts with JE vaccine in RI Andhra Pradesh 4 Manipur 8 Arunachal Pradesh 3 Meghalaya 6 Assam 33 Nagaland 7 Bihar 24 Odisha 17 Chhattisgarh 1 Tamil Nadu 14 Goa 1 Telangana 9 Haryana 6 Tripura 8 Jharkhand 17 Uttar Pradesh 38 Karnataka 11 Uttarakhand 1 Kerala 2 West Bengal 21 Maharashtra 9

11. JE vaccination introduced in UIP in 2006. It is provided only in JE endemic districts.  JE vaccination strategy : Newly identified JE endemic districts by NVBDCP are taken-up for JE vaccination campaign in beneficiaries aged 1-15 years, followed by JE vaccine introduction in Routine Immunization as two doses provided at 9-12 months and 16-24 months of age. Presently, 336 districts across 22 states have been identified as JE endemic districts. Of these, JE vaccine has been introduced in RI in 297 districts across 21 states. Introduction

12. JE vaccines under UIP Live attenuated- SA-14-14-2, Chengdu- China(LAJEV). Can be used in beneficiaries and Adult For use in Campaign & RI Two indigenous JE vaccines (Killed/Inactivated) : JenVac (M/s Bharat Biotech) Can be used in beneficiaries and Adult For use in Campaign & RI JEEV (M/s BE Ltd) (Paediatric preparation 1-3 years, 3 µg ) Can only be used in beneficiaries For use in RI only Currently in Chhattisgarh, Odisha, West Bengal only

13.   BE- Jeev   No JE vaccine   Chengdu China JE vaccine under Routine Immunization JE vaccine under RI in 21 states of which BE is currently in 3 states Chhattisgarh, Odisha, West Bengal

14. JE Vaccination Government of Assam: Strategic Target-2021 JE Campaign: Target beneficiaries 15-65 year No of Beneficiary(Assam)-40 Lakhs ( approx ) (47% of Population) Chirang Beneficiary-243000 One doses of JE vaccination At least 88 Sessions per Day for 21 Days 99 JE Endemic Blocks of Assam Both Ballumguri & Sidli BPHC in Chirang District

15. Pre Campaign Planning Timelines and Activities Micro planning Cold chain Training IEC & Social Mobilization Vaccination site Team composition Vaccine safety/ Waste management Adverse Events Following Immunization

16. Micro plan Session site selection – HSC/HWC, AWC & Primary Schools Estimation of beneficiaries Human resource requirements Vaccine, logistics and cold chain Route chart for distribution of vaccine and logistics Supervision, Recording and reporting Training IEC Referral in case of AEFI

17. State District Block 1 PHC 1 PHC 2 SC1 SC2 SC1 SC2 V1 V2 V1 V2 V1 V2 V1 V2 Estimation of beneficiaries Block 2 PHC 1 PHC 2 SC1 SC2 SC1 SC2 V1 V2 V1 V2 V1 V2 V1 V2 Estimation of beneficiaries Participatory bottom up approach Hard to Reach Area Plan and Urban Plan V : Village; SC : Sub center Vaccination Unit : Village Implementation Unit: Sub Centre Planning unit: PHC/Block HR mobilization and formulation of microplan to be ensured in vacant Sub- centres by MO I/c PHC/ DIO

18. Duration of Campaign Target beneficiaries: Adult in the age group of 15-65 years. Planning & IEC from 10 th to 15 th Oct’21 Start Date – 10 th Oct 2021 onwards Total duration of the campaign: 21 Days – may be rationally extended, if needed Timing of activity – 9 AM to 2 PM. State Target ~40 Lakhs Vaccine Available ~42 lakhs

19. Estimation of Beneficiaries All adults between the age group above 15 year and below 65 years should be estimated for vaccination with JE vaccine It is estimated that the Assam average for age group of 15-65 years is 47 % of the population however, headcount/ census is a preferred mode of estimation of beneficiaries The beneficiaries who are vaccinated earlier with JE should be excluded Adults between the age group of 15 to 65 years = 47% of total population

20. Estimation of Vaccines/Logistics JE vaccine doses required = Total Population x 33% x 1.1 (to include 10% vaccine wastage) JE vials (5 dose) required = JE vaccine doses required (S. No. 1/ 5) Diluents required = JE vials (5 dose) required (S. No.2) Disposable syringes required = JE vials (5 dose) required (S. No.2) Auto disabled syringes required = JE vaccine doses required (S. No. 1) Number of Imunization Certificates = JE vaccine doses required (S. No. 1) No. of Hub cutters = 1 per vaccinator Red plastic bags = 1 per 50 syringes Black plastic bags - 2 per session site per day Live Attenuated JE Vaccine 5 dose per vial with diluents

21. Vaccine Route Chart & Bundling logistics Plan

22. High Risk Areas for 20-21 - Assam High Risk Area Prioritization - Assam : 2020-21 District Old HRA Status - As of 2019 Total HRAs deleted Total HRAs added Status after Revision: 2020 # of Hard to Reach Areas % Hard to Reach areas BARPETA 105 162 267 263 99 KOKRAJHAR 77 27 104 78 75 CHIRANG 317 233 84 82 98 GOALPARA 333 258 75 70 93 BONGAIGAON 30 47 77 43 56 DHUBRI 463 205 258 170 66 DIMA HASAO 174 174 171 98 KARIMGANJ 82 40 104 146 59 40 HAILAKANDI 53 53 6 11 CACHAR 80 25 115 170 36 21 SIBSAGAR 126 95 31 JORHAT 54 103 157 69 44 DIBRUGARH 99 24 75 2 3 TINSUKHIA 560 506 54 14 26

23. High Risk Area Prioritization - Assam : 2020-21 District Old HRA Status - As of 2019 Total HRAs deleted Total HRAs added Status after Revision: 2020 # of Hard to Reach Areas % Hard to Reach areas NALBARI 101 101 83 82 DARRANG 176 59 117 65 56 KAMRUP (M) 419 258 161 KAMRUP 220 50 170 77 45 BAKSA 54 54 45 83 KARBI ANGLONG 112 41 153 16 10 GOLAGHAT 177 62 239 2 1 MARIGOAN 131 10 121 49 40 NAGAON 139 151 290 49 17 UDALGURI 102 12 90 35 39 LAKHIMPUR 47 65 112 63 56 SONITPUR 419 33 386 142 37 DHEMAJI 349 286 63 12 19 TOTAL 4617 2094 1259 3782 1701 45 High Risk Areas for 2020-21- Assam

24. Transportation Vaccine and logistics to be delivered to the health workers at the immunization session sites. Health workers can start the immunization session on time Vaccines and logistics are collected on the same day and unused/ opened vials, session report (tally sheet) and immunization wastes are brought to PHC on the same day

25. IEC & Social Mobilization Advocacy and social mobilization Sensitize general public, community leaders and other volunteers, school principals and teachers, etc., about JE vaccine benefits. The communication planning should address the following issues: Target group/ Time /Place of vaccination Proper media orientation/ Media spokesman Media plan

26. Training MO I/c should train the MOs and other personnel such as Data managers, BPMs and Cold Chain Handlers. Sensitization workshop/meeting for Headmen, Community Leaders, SHGs, school principals & teachers should be held. Both vaccinators in a team and Supervisors must receive training on Guidelines on JE vaccination, JE Vaccines Recording & Reporting coverage AEFI – actions to be taken, referral & reporting Waste disposal following vaccination The Vaccinators will further train the AWWs and ASHAs and other mobilizers

27. Team Composition One vaccinator is sufficient for injection load of: 100-150 (GOI- 200) Team members: 1-2 vaccinators, AWW, ASHA, Volunteer/ link worker & local influencer Injection load ≤ 75-100, one vaccinator per team. Injection load ≤ 100-150, two vaccinators per team. Adequate numbers of teams to be deployed (based on injection load) to cover: whole village in a single day for community based activity.

28. Requirement as per COVID protocol—(1) The Infection Prevention & Control Measures should be strictly adhered.. The Vaccination team members must wear proper facemask Handwashing should be done at a regular interval The beneficiary should enter the room after handwashing; facilities should be made available at each vaccination sites The beneficiaries should wear cloth/locally available face masks The beneficiaries having fever & ILI symptoms to be referred to a COVID screening center The session sites should be cleaned/ disinfected after a regular interval and at the end of the session

29. Requirement as per COVID protocol-(2) The session sites should be cleaned/ disinfected after a regular interval and at the end of the session Social distancing to be maintained at the waiting area before & after the vaccination Maximum 5-7 minutes/ beneficiary to be spent by the vaccination Team considering the contact duration for COVID transmission Gathering of beneficiaries to be strictly avoided Well ventilated rooms to be arranged as vaccination session sites Waiting areas with proper ventilation & social distancing arrangement should be arranged

30. Requirement as per COVID protocol (3) Vaccine & logistics distribution to be done maintaining all COVID related SOPs Supervisors to ensure that all COVID related IPC protocols are followed Training sessions to be held by maintaining all required norms in well ventilated rooms. If feasible, virtual trainings to be conducted at majority of the areas. The web based reporting system will be developed for daily reporting In case of C/O any ILI/SARI symptoms by a member of vaccinator Team – prompt testing & isolation to be done along with replacement of the HR District Task Force to ensure that all IPC measures are adhered in the field

31. Process of Vaccination 1- HWs writing the cards 2- Child would take the card to Vaccinator Vaccinator checks the card and then vaccinates 3- After vaccination Child would get the Vacc . Card, Tally sheet is marked and counterfoil is with vaccinator beneficiaries would wait for half an hour after vaccination 1 2 3 4

32. Ensure that beneficiaries are taken one by one in vaccination room – should be properly segregated from waiting rooms Mark an area for observing beneficiaries after vaccination (keep under observation for 30 minutes) Avoid sending these beneficiaries back home immediately after vaccination. 32 Session site Management…

33. Vaccination Sites Neutral site; acceptable to all The SC/HWC , village primary school, Community Hall/ ICDS center will be the preferred site of vaccination activity a fixed site which is easily identifiable, approachable and acceptable to the community may be selected If two or more teams are required in a village, these should work at separate vaccination sites.

34. Role of vaccinator Develop micro plan for activity in her sub center area (local sub center ANM) Ensure completeness of micro plan Vaccination site selection in the village Identify the all members of the team Orientation of all member Assist in vaccine and logistic transportation planning for her sub center area Vaccinate beneficiaries Give specific instructions to parents on AEFI Take appropriate measures in case of any AEFI Ensure completeness and reporting of day’s activity in the designated format Overall responsible and accountable for planning, training and conducting the activity in the center Planning Stage Activity Day

35. Vaccinators to carry to the Vaccination Site 2 Vaccine carriers and 8 ice packs / team (1 vaccine carrier with 4 conditioned ice packs /ANM) Adequate number of JE Vaccine vials and equal number of JE diluents Adequate number of AD syringes / Syringes for reconstitution Adequate cotton swab Adequate number of vaccination record cards Tally sheets – multiple 1 Hub-cutter/ ANM, i.e. 2 Hub cutters per team Marker Pens – 1 per ANM (2 per team) Red bags and Black bags for waste disposal Banner to mark location site AEFI kit with Emergency medicines

36. Role of other Team Members Member Primary Job Responsibility AWW / ASHA / Link person Before Activity : Social Mobilization – parent’s meeting, IPC etc. in village as awareness campaign Coordinate with school personnel in preparing the vaccination center On day of activity Manage queue Provide logistic support to vaccinators Repeat instructions of the vaccinator to parents before they leave the center After- Activity Mobilize absentee beneficiaries to the PHC for vaccination

37. Role of Volunteers Mobilize beneficiaries from the village to the vaccination center Assist in identification of absentee beneficiaries

38. Types of AEFI ? Types of AEFIs Minor Severe Serious

39. Minor AEFIs Minor reactions – common, self-limiting e.g. pain & swelling at injection site, fever, irritability, malaise, etc. Treat symptomatically – paracetamol , others Assure teachers & parents Record minor AEFIs in block/PHC AEFI register every week; report monthly in HMIS Report and investigate minor AEFIs in clusters as serious AEFIs

40. Severe AEFIs Increased severity of minor AEFIs; do not lead to long-term problems; rarely life threatening; can be disabling Non-hospitalized cases Examples: N on-hospitalized cases of anaphylaxis that has recovered, high fever (>102 degree F), sepsis, etc.

41. Serious AEFIs Deaths Hospitalizations Clusters Disability Media reports/ Community/ parental concern Report all serious and severe AEFIs immediately in Case Reporting Formats (CRFs)

42. AEFI surveillance in JE campaign – Preparations All ANMs/ASHAs/AWWs and MOs must: be sensitized to recognize and notify/report AEFI promptly. know what to do when an AEFI occurs and be aware of location of the nearest AEFI management centre. Conduct 2 hours Virtual training on AEFI surveillance & case management for medical officers

43. AEFIs due to immunization errors and anxiety reactions are preventable

44. Preventing immunization errors during JE campaign During monitoring and supervision activities, check ILRs/DFs for presence of drugs other than vaccines Ask health workers to check expiry date, VVM and name of the diluent and vaccine before loading vaccine carriers and before administration Ensure adequate supply of reconstitution syringes to prevent re-use Ensure reconstituted vaccines are used within 4 hours and are not carried to another session Maintain cold chain throughout Ensure clean septum

45. Do not panic Arrange to provide immediate treatment for all AEFIs Minor AEFIs – provide symptomatic treatment Serious/severe AEFIs Contact the nearest designated AEFI Management Centre as per micro-plan If supervisor is a medical officer with AEFI treatment kit, contact him immediately Arrange for transportation (108/ other means) Inform the nodal officer of the AEFI management centre and supervisor Response to an AEFI in MR campaign

46. Anaphylaxis management at the Session Site One AEFI kit should be made available at every session site/team. In Case there is a reaction the child should be placed on the couch lying down with the foot end elevated. Immediately call the ambulance-108 / vehicle / mobile AEFI team . Contact the Medical Officer and follow his/her instructions Inform the AEFI management centre so that they may be ready to receive the child Shift the child at the earliest to the already identified AEFI management centre

47. Waste Management As in Routine Immunization, Waste management guidelines of CPCB/ SPCB to be followed.

48. Reporting Campaign: Daily campaign reports should be submitted to District and State. State needs to submit daily district wise consolidated report to immunization division of the Ministry of Health and Family Welfare, GoI & ITSU and at end of campaign final signed report to be submitted. Email id for submitting daily reports: [email protected]

49. Immunization Field Volunteers (IFVs) IFVs to uncover pockets of un-immunized beneficiaries and take corrective actions. Qualitative and quantitative assessment on the immunization activity, during campaign and RI sessions, also Can be utilized For - Planning Training of FLWs Monitoring Mid-course corrective actions – e.g. Re-training the vaccinators, review of micro-plans, etc. Immediate corrective actions – Repeat immunization activity in areas where significant number of unimmunized beneficiaries are found after completion of activity.

50. Rapid Convenience Assessment (RCA) An extremely useful tool to uncover pockets of un-immunized beneficiaries and take corrective actions. Qualitative and quantitative assessment on the immunization activity by the observers/ monitors Utilized For - Mid-course corrective actions– e.g., Re-training of the vaccinators, review of micro-plans etc. Immediate corrective actions– Repeat immunization activity in an area where significant number of unimmunized beneficiaries are found after completion of activity.

51. Methodology Standardized monitoring format (Form 16) should be used for making rapid convenience assessments of the quality of activity in an area. Simple tool – can be used by National/ State/ District/ Partners/ Supervisors of variable level of expertize. The RCA is to be conducted in areas where Session under JE campaign has been completed. High risk areas, hard to reach areas, hamlets etc. should be taken up on priority.

52. Steps to conduct the RCA Step-1: Identify areas through microplan /discussion with Medical Officer/health workers where JE campaign activity has been completed. Focus should be to identify areas where quality of campaign is suspected to be sub-optimal. Step 2: The RCA should be started from a central location and any direction may be randomly chosen to visit the households. Step 3: Start assessment with the first house facing yourself. Identify and tally 20 target-age beneficiaries in 20 households. The no. of households visited may be more than 20 to verify the desired no. of beneficiaries .

53. Steps to conduct the RCA Step 4: Check the vaccination status of the eligible child in every household. If a household has more than one eligible child, include only one randomly selected child from each household. Step 5: If a child is found to be unvaccinated, ascertain the reason for it and select appropriate option. Step 6: In any child is found with serious/severe AEFI , record appropriate code same on the format and direct him/her to nearest PHC/AEFI Mgmt Centre.

54. Outcome of RCA Unvaccinated beneficiaries : If the number of un-vaccinated beneficiaries is ≤ 3, request guardians to take their beneficiaries to the nearest session site. In the number of un-vaccinated beneficiaries is 4 or more, plan for repeat Immunization activity in that area. Reasons for Un-vaccination: The reasons for unimmunized beneficiaries needs to be collated and analyzed - identify the gaps in implementation – take corrective measures.

55. Methodology Standardized monitoring format (Form 16) should be used for making rapid convenience assessments of the quality of activity in an area Simple tool – can be used by National/ State/ District/ Partners/ Supervisors of variable level of expertize The RCA is to be conducted in areas where Session under JE campaign has been completed High risk areas, hard to reach areas, hamlets, etc. should be taken up on priority

56. Outcome of RCA Unvaccinated beneficiaries : If the number of un-vaccinated beneficiaries is ≤ 3, request guardians to take their beneficiaries to the nearest session site. In the number of un-vaccinated beneficiaries is 4 or more, plan for repeat Immunization activity in that area. Reasons for Un-vaccination: The reasons for unimmunized beneficiaries needs to be collated and analyzed - identify the gaps in implementation – take corrective measures. (RCAs important for this activity)

57. Cold chain space requirement for J E vaccine LAJEV(Chengdu China) : Primary packing 5 doses/ vial Secondary packing 10 vials/ box. Vaccine vial Box  size 83 mm x 43.5 mm x 38.5 mm. Diluent Diluent box size - 84 mm x 53 mm x 38 mm. 10 diluent vials/ box

58. Example: Cold chain space requirement for J E vaccine 30/42 JE Campaign- LAJEV Total cold chain space need (in litres) for storage of Live JE vaccine = No. of vaccine doses required X 4.2 /1000 Total cold chain space need (in litres) for storage of JE diluent= No. of vaccine doses required X 3.4 /1000 Total space required (in litres) = Total space for JE vaccines + Total space for Diluents Number of ILRs required = Total space required (in litres)/ Capacity of ILRs (in litres) Dry Cold chain storage space requirement 0.5 ml AD Syringe = 56.7 ml 5 ml reconstitution syringe = 66.3 ml Dry cold chain space required for AD syringes and reconstitution syringes. Per dose dry space requirement = 57.6+ (66.3/5) = 71 ml Hub Cutters - 2 hub cutters / team

59. Cold Chain Vaccine vial and diluents should be stored and transported at 2-8°C in a vaccine carrier with 4 conditioned ice packs Planning for replenishment of icepacks is an essential component of micro plan Alternate transportation plan/ vehicles– as per GOI guidelines Separate route chart plan for each vaccination site Micro plan to determine requirement of vehicles

60. Storage To be stored between +2°C and +8°C in the lower basket of ILR VVM is present on the cap of vial No open vial policy for Live JE vaccine Return all used/ unused vials after completion of session 60

61. Cold chain: Key Actions…… Assess cold chain capacity at District and PHC level JE vaccine can be safely stored during campaign? Verify functioning ILRs, DFs, ice packs and cold boxes These equipment can support campaign? Identify ice factories/Cold storage for ice/freezing of ice packs Orient all cold chain handlers They should understand their role in this campaign Vaccine transportation and distribution plan Vaccine to be delivered on site on every day of the campaign

62. Vaccine Supply Cold chain points would have only one type of JE vaccine. JE campaign is one time activity. The left-over vaccine to be used in RI.

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