1. Transition from JE outbreaks to sporadic cases in
Sri Lanka : a tale of two JE vaccines
Country presentation for the 5th Bi-regional meeting on JE
prevention and control
Dr. Pushpa Ranjan Wijesinghe
National Surveillance Focal Point
Principal investigator- study on safety and immunogenicity
of the LJEV - SA 14 -14-2 in Sri Lankan children
Epidemiology Unit, Ministry of Health

2. Overview
• Campaign of JE immunization with the mouse brain
derived vaccine
• Challenges to the immunization campaign
• An alternative vaccine - the solution to new
challenges
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the decision making
Introduction
Challenges/issues during introduction
Program monitoring and evaluation
AEFI surveillance and challenges

3. Immunization against JE
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Major outbreaks in 1985-1988
Phased introduction in 1988
Campaign approach
Timing - inter epidemic period (Sep-Oct)
Mouse brain derived inactivated JE vaccine
– Nakayama strain
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Target group – children aged 1-10years
Three primary doses and 1 booster
Beijing strain in 1994
High coverage - decreased incidence of JE

4. Challenges to the JE immunisation
programme
• Sporadic cases and outbreaks in districts without
immunization
– Expansion of immunisation to 18 districts
• High rates of AEFI relative to other EPI vaccines
– The highest rates of reported AEFI after DTP
– Role of overall improvement of AEFI reporting ??
– Poor quality of the mouse brain derived vaccine
( Japanese experience)
• Repercussions on the acceptability of the JE vaccine
– Negative feedbacks from paediatricians

5. Challenges to the JE immunisation
programme
• Increasing cost of the JE vaccine over the years
– Annual cost for 4 doses – 9.1 million US $
– ¾ of the entire government budget for all EPI
vaccines
• Prohibitive factor on self funded EPI
– Sustainability of JE immunisation programme
– Sustainability of other EPI vaccines
• Shortage of vaccines for procurement
• high demand and pressure for JE vaccination
– Political, public and media pressure

6. Decision maker’s dilemma
• What was the answer to challenges ?
– Essence of an alternative to the inactivated JE vaccine
• affordable , safe , immunogenic
• Was there an alternative ?
– Availability of LJEV for consideration
• Not considered in 2003 due to lack of information
• Was LJEV the appropriate choice ?
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Evaluation of JE core working group
WHO SAGE recommendation
Translated literature from China by PATH
• Were safety and immunogenicity information available ?
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Empirical evidence from China, Nepal, India
• Was the choice financial ly sustainable ?
– Cost saving potential of the LJEV vaccine with the low price
• At 0.20 US $ ( India) – 8.8 million US $
• 0.40 US $ ( Nepal) – 8.6 million US $
– Cost saving potential with
• The single dose
• ability to deliver through the EPI through out the year
• abandoning the campaign approach

7. Challenges to decision making
• Scepticism of the medical fraternity on safety and
immunogenicity
– Open expression in the annual immunization stakeholder’s meeting
• Demand of the National Advisory Committee on
Communicable Diseases (NACCD) for local evidence
– Local study to assess the safety and immunogenicity
• Mobilizing financial resources for the study
– Involvement of PATH as the sponsor of the study
– MRI’s unwillingness to acquire skills and perform PRNT
• Policy of using only WHO pre qualified vaccines n the EPI
• Sustain the achievements of over 2 decades
– Ensuring access to JE vaccination
– avoiding accumulation of a susceptible population

8. Issues/ Challenges during implementation
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Cost of a vaccine dose > the anticipated price
– Attempt s of direct procurement through government to government
– The role of a middle company
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Operational difficulties with contraindications in the product insertion
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Plan of the WHO/HQ for a detailed analysis at the GACVS
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Untypical contraindications for a pediatric vaccine
Generic nature ( renal, hepatic , cardio-vascular disorders)
Not listed in current WHO position papers
Need of clarifying the scientific rationale from the Chengdou and WHO
WHO’s Dialogue with chengdou
WHO –HQ response to Sri Lanka
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Contra-indications – not clinically revised recently in China
Based on local precautionary practices
Persistence with obsolete Chinese pharmacopeia due to need for complying with Chinese
regulations
No documented risk of immunizing children with mentioned conditions
Sri Lanka to determine contra indication for the NPI
• A local set of pragmatic contra-indications by the NACCD

9. Implementation of LJEV
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NACCD approval - 07.03.2008
Implemented - 01.07.2009
Public sector- Live JE vaccine - SA 14-14 -2
Private sector- inactivated and LJEV
Single dose at the completion of 12 months
– Shifting to 9 months with MMR introduction
• Through the EPI program in all districts
– Through the immunization clinics in the primary
health care network

10. Issues/ Challenges during implementation
• Discrepancy with the product insertion
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Potential legal repercussions/media interest
Repercussions on the NIP
Discussion with Chengdou Biologicals
Local insertion to be prepared and enclosed
Permission from the Drug evaluation Sub-committee
of the NDRA
• Chengdou’s inability to supply the required
amount
– Inability to cover those needing boosters
– Inability to cover all districts

11. Programme monitoring and
evaluation
• At the national, district and
divisional level
• Integrated with the MIS of the
EPI
• Quarterly review with 26
regional epidemiologists (RE)
• Quarterly review at the NACCD
• Monthly review at the districts
by RE
• Annual EPI review meetings in
districts
• Annual EPI survey of a selected
district
Field staff
Divisional Level / MOH
District Level/
DPDHS/ RE/ MOMCH
National Level/
Epid Unit, FHB
National Expert Committee on AEFI

12. AEFI surveillance of LJEV
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Integrated with other EPI activities
Field and clinic based activated
passive notification to the Medical
officer of Health
Consolidated AEFI returns to the
district and center
All serious AEFI – detailed
investigations
Deaths following a vaccine – AEFI
advisory committee
Recommendations to the NACCD for
policy decisions
Challenges
–
more involvement of the private sector
in reporting
– Pacifying the effects of adverse media
publicity to AEFI
– Risk benefit communication skills of
the PHC staff
– Anaphylaxis management capabilities
for the PHC staff

13. Year
No of doses
Solicited AEFI
Allergic
reactions
seizures
Severe local
reactions
Fever > 38 C
Others
2009
249758
285
172
20
14
56
23
Rate/
100 000
doses
2010
114
2011
453175
Rate/
100 000
doses
Total
Rate/
100 000
doses
1281940
5.6
22.4
9.0
674
379
31
28
137
99
65.5
5.4
4.8
23.7
17.0
470
272
36
11
112
39
103.7
Rate/
100 000
doses
8.0
116.4
579007
68.9
60.0
7.9
2.4
24.7
8.6
1429
823
87
53
305
161
111.5
64.2
6.8
4.1
23.8
12.6

14. Evaluation of the JE immunization
campaign with the killed vaccine
• A collaborative project by the JE immunization focal
point and a doctoral student in 2005-6
• Financial support by the PATH/USA
• Area of study – the epicenter of former major
outbreaks
• Effectiveness of the immunization campaign
– Cases prevented -97%
– Deaths prevented – 100%
– Disabilities prevented – 98%
• Incremental cost per averting a
– JE case = 315 US $
– Death= 2437 US $
– Disability = 1072.5 US $

15. Acknowledgement
• For the far seeing vision of Dr Nihal Abeysinghe ( Regional
Advisor/IVD –SEAR ) whose leadership as the Chief Epidemiologist
/Sri Lanka made LJEV a reality amidst many challenges …..
• All former epidemiologists for bold decisions in
– Establishing surveillance and initiating vaccination
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Dr. Paba Palihawadana – Chief Epidemiologist
Dr. Sudath Peiris – EPI focal point
Dr. Nayana De Alwis for evaluating the program
PATH for a long standing partnership in many endeavors
Julie , Susan, Chris and Mansur of the PATH team
Cyril, Twinkle , Chesmal and the Quintiles/Singapore team
Sri Lankan parents for the faith in JE vaccination