Policy Considerations for Introduction of Dengue Vaccine in Sri Lanka

Transcription

1 Policy Considerations for Introduction of Dengue Vaccine in Sri Lanka DVI ASIA-PACIFIC DENGUE PREVENTION BOARD April 20, 2011 Epidemiology Unit Ministry of Health Sri Lanka Dr Paba Palihawadana Chief Epidemiologist Dr Ananda Amarasinghe Senior Consultant Epidemiologist Dr Hasitha Tissera Consultant Epidemiologist

2 Policymaker Survey - Sept 08 Conclusions Well poised to become an early adopter of dengue vaccines Number of enabling factors include: - very high awareness of the disease - country s highly-functioning EPI - EPI s extensive schedule beyond infancy Main potential obstacle - price of vaccine to the public sector and soliciting donors support for introduction

3 Policymaker Survey - Sept 08 Recommendations Sri Lanka should be strongly considered as a site for a post marketing (Phase IV) surveillance study of dengue vaccines; PDVI (DVI) should continue the policy dialogue with the Sri Lankan government and keep the National Advisory Committee on Communicable Diseases (NACCD) informed of developments with the vaccine candidates and clinical trials, since it is a strong contender as an early adopter of a dengue vaccine; PDVI (DVI) should consider funding locally-initiated denguerelated studies, including a dengue cost-of-illness study. Source: Denise DeRoeck & Don Douglas. Sept 2008, Report on the Findings of the Policymaker Survey in Sri Lanka on Dengue and Dengue Vaccines, PDVI.

4 NACCD: participatory decision-making Ministry of Health Secretary of Health Annual Immunization Stakeholders Forum (Immunization Summit) Ministry of Finance and Planning Department of National Planning Director General Health Services Deputy Director General Health Services (Public Health) Chairperson National Advisory Committee on Communicable Diseases (NACCD) (recommends introduction of new vaccines) Members meet every Quarter 1) Ministry of Health ex-officio 2) Representatives from professional bodies 3) Representatives from Academia 4) Co-opted members Chief Epidemiologist Manager EPI (Expanded Program on Immunization) Secretary External Observers WHO & UNICEF NACCD provides Guidance to MoH on prevention and Control of communicable diseases for > 40 years

5 Required data and considerations of the NACCD in making decisions about the introduction of a new vaccine. Data from the disease surveillance system Data from disease burden studies Estimates of disease burden Does the Burden warrant introduction of a vaccine? Are the Global data of Safety and Immunogenicity of available vaccines conclusive? Is there a need to conduct safety and Immunogenicity study in Sri Lanka Can the Vaccine be incorporated into the Sri Lankan Immunization schedule? Are the suggested vaccine/s cost-effective? Will the EPI of Sri Lanka be able to financially self-sustain the suggested vaccine in the long run? Reproduced from Wijesinghe et al; Vaccine 28S (2010) A96-A103

6 Key factors influencing decisions Consistent with the national policy of universal free health care for all WHO pre-qualification certification Safety and immunogenicity studies conducted in Sri Lankan population (even small) Feasibility of incorporating into NPI (EPI) Economic analysis can the country sustain long-term financing

7 Sri Lanka North-east monsoon Island Republic off South India Land area 62,705 sq.km Population 20 million (~20% urban) Density 319/persons/sq/km (Colombo District 3,633/per/sq/km) GDP per capita $2399 (poor 22.7%) Colombo South-west monsoon Total Life Expectancy at Birth 73.0 Adult Literacy 90.7 (Total); 89.2 (F) ; 92.2 (M) Per capita health expenditure $2.5 Universal free healthcare since early 1940 s EPI DTP3/OPV3 coverage 97%

8 New vaccine introductions into NPI Vaccine Year Introduced Scope and Target Population Japanese encephalitis (JE) 1988 Children 1-10 years old in high-risk districts through campaigns and routine EPI (now in 19/26 districts) Funding Source Central government Rubella 1996 (monovalent vaccine for women) 2001 (MR vaccine for children) Monovalent vaccine: women years old ( ) MR vaccine: all 3 year olds nation-wide (2001 to date) Central government Hepatitis B (using tetravalent DPThepB) Haemophilus influenzae b (Hib) (using pentavalent DPT-hepB-Hib) Live JE SA Infants nation-wide 2008 Infants nation-wide (suspended in June due to AEFI reports) 2010 Children 1-10 years old GAVI funding (up to 2007) GAVI with government cofinancing Central government MMR 2011/12 Children 1 & 3 years nation-wide Central govt.

9 Number of years taken to reach over 90% coverage following introduction of selected vaccines DPT3 Measles MR

10 Addressing safety concerns Hib Pentavelent HHE & temporally associated infant deaths 2008 Rubella Anaphylaxis Death Temporary suspension NACCD independent investigations (supported by external experts from WHO) Reintroduction with number of policy changes All immunization related deaths mandatory postmortem by consultant JMO using standardized protocol Date of manufacture & expiry to be printed on all vaccine vials used in NPI Emergency tray & mandatory training for all staff on treatment of anaphylaxis

11 Dengue in Sri Lanka Serologically confirmed 1962; first outbreak 1965 First major epidemic reported in 1989 Endemic since 1989 with occurrence of DHF Became a notifiable disease in 1996 Temporal and Spatial Spread, N=1294 N=15463 N=5994 N=11980 N=35007 Reported Cases

12 Dengue Trends in Sri Lanka 2009 CFR 0.99% 2010 CFR 0.71% 2011 CFR %

13 Geographic Expansion : 7 districts > : 13 districts >100 Incidence 80/100,000 Incidence 170/100, : 21 districts >100 Incidence 209/100,000

14 Overall Sero-prevalence among children < 12 52% study supported by PDVI

15 Dengue cases by age groups Sri Lanka and Number < 1 year >60 Age group No. of cases analysed N= Number <1year >60 Agegroup No.ofcasesanalysedN=5553 Reported Source: mean Epidemiology age changed Unit Sri Lanka from 10-15yrs to 20-25yrs between 1996 & 2006 Dataas22/01/2008

16 Highest Political Commitment Ministries Health Local Govt. Environment Education Media

17 Statistics LRH Ward % Total Dengue Patients : 333 (Jan-Aug 2009) 37% 13% 49% DF DF DHF I & II I & II DHF III III DHFIV IV * Source: Infection Control Unit LRH + Ward 04 records Dr. Padmakanthi Wijesuriya

18 Saving Lives: through strengthened Case Management National Guidelines Professors Suchithra & Siripen from Thailand were in Sri Lanka for a week in April 11

19 Important safety concerns (?) 1)whether the vaccine itself would lead to antibody-enhanced disease (ADE), especially if people are exposed to infection before they are fully immunized (i.e., between doses). 2)whether there will be interference between the dengue vaccine and Japanese encephalitis (JE) antibodies induced either by natural infection or by JE vaccination.

20 Antibody Dependent Enhancement (ADE) After primary vaccination -? boosters every 5 years support for long term studies When vaccine Ab level starts to wean 10 years down the line what are the available options Those with known history of Dengue Haemorrhagic Fever (DHF) -? vaccinate Long term follow-up plan -? finance

21 Vaccinate or not Sri Lanka has both childhood and adult disease Do we have enough justification for use in Adults as trials on kids (vice versa) Co circulation of multiple sero-types with new strains -2009/10 New DEV 1 strain (in press EID) Colombo has already immune population where as in South/North majority naïve whom to chose Pre-vaccination screening do we need to select recipients

22 Introduction strategy Might be premature to introduce into NPI targeted introduction, phase-in manner - intensely follow up for several years (is it ethical) Long term monitoring a must as no data on vaccinees (chickenpox, Hib many years of data) Most convenient age of introduction months 3 dose schedule 6 months apart Depending on availability and affordability a catch-up programme to be considered few years later

23 Post-Infancy Immunization Schedule Age Vaccine 1 year+ JE 18 months DPT 4 and OPV 4 3 years * Measles-rubella (MR) 5 years (school entry) DT and OPV years Adult Td 13 years Rubella *From 2011 MMR at 1 & 3 years and JE at 9 months

24 Anticipated pvt. sector demand: Huge Ex: media hype with Bti There will be very high private sector demand that will certainly include both children and adult population

25 Cost implications Current spending on Dengue prevention and health service organization - SL Govt. spent US$ 5 mil in 2010 Cost of vaccine, storage and logistics Comparison with JE cost per dose

26 Regular update on dengue situation Thank You!