Published on February 15, 2014
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
Overview • Campaign of JE immunization with the mouse brain derived vaccine • Challenges to the immunization campaign • An alternative vaccine - the solution to new challenges – – – – – the decision making Introduction Challenges/issues during introduction Program monitoring and evaluation AEFI surveillance and challenges
Immunization against JE • • • • • 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 • • • • Target group – children aged 1-10years Three primary doses and 1 booster Beijing strain in 1994 High coverage - decreased incidence of JE
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
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
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 ? – – – Evaluation of JE core working group WHO SAGE recommendation Translated literature from China by PATH • Were safety and immunogenicity information available ? – 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
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
Issues/ Challenges during implementation • Cost of a vaccine dose > the anticipated price – Attempt s of direct procurement through government to government – The role of a middle company • Operational difficulties with contraindications in the product insertion – – – – • Plan of the WHO/HQ for a detailed analysis at the GACVS – • 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 – – – – – 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
Implementation of LJEV • • • • • 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
Issues/ Challenges during implementation • Discrepancy with the product insertion – – – – – 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
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
AEFI surveillance of LJEV • • • • • • • 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
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
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 $
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 • • • • • • • 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
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