Principles and practice of vaccine introductions in Thailand

Transcription

1 Principles and practice of vaccine introductions in Thailand Supamit Chunsuttiwat Department of Disease Control, MOPH 14 July 2011

2 Smallpox vaccination in 1838, Bangkok Thailand

3 Immunization in Thailand Private sector immunization Public sector immunization Basic immunizations (EPI) for children, pregnant women and people of certain high risk groups. Public sector immunization Immunizations for specific purposes such as disease elimination and eradication, disease prevention for pilgrims on Hajj, and rabies post exposure prevention.

4 Basic immunization - EPI Established since 1977 Target populations: New born babies & children Pregnant women High risk groups Vaccines: BCG, DTP, dt, OPV, HBV, DTP-HB, M / MMR, JE, influenza Under technical and strategic advisory of the National Advisory Committee on Immunization Practice (NACIP) Fully subsidized in public sector Integrated in MCH services Over 90% coverage nationwide, except in border areas & high terrains.

5 Timeline of vaccine introduction in Thai EPI since BCG BCG x 1 DTP DTPx 2 OPV OPVx 2 M R HB JE TT Typhoid Influenza DTP x 3 OPV x 3 Typhoid R x 1 TT x DTP x 4 OPV x 4 M R x 2 JE x 2 TT x BCG x 2 DTP x 5 HB x 3 OPV x MMR DTP-HB x 3 M or MMR JE x 3 dt x 3 HB x 1 Flu in HCW H1N Flu in HR* Source: EPI / DDC / MOPH, 14 July 2011 (A) HR* High risk groups

6 Timeline of vaccine introduction in Thai EPI since BCG BCG x 1 DTP DTPx 2 OPV OPVx 2 M R HB JE TT Typhoid Influenza DTP x 3 OPV x 3 Typhoid R x 1 TT x DTP x 4 OPV x 4 M R x 2 JE x 2 TT x BCG x 2 HB x MMR JE x Higher vaccine cost DTP x 5 Limited national budget OPV x 5 Need for systematic and M or MMR careful decision making DTP-HB x 3 dt x 3 HB x 1 Flu in HCW H1N Flu in HR* Source: EPI / DDC / MOPH, 14 July 2011 (A) HR* High risk groups

7 Current vaccines in EPI BCG DTP OPV HB JE TT / dt DTP-HB M MMR Influenza

8 Vaccines expected for introduction vaccines under the development Dengue Malaria HIV New TB New JE Chikungunya Leptospirosis RSV Pandemic flu Smallpox / BT Other?

9 Vaccines expected for introduction Licensed / Registered vaccines Pneumo Hib Rotavirus Hepatitis A IPV HPV Varicella Typhoid DTP-HB-Hib DTP-HB-Hib-IPV Cholera Other

10 Decision making process for introduction of new vaccines in Thai EPI The disease is a major burden. Vaccination is a priority intervention. Vaccination is a good investment. Cases/ deaths/ disability Social & economic impacts Safe & efficacious vaccine Vaccine effectiveness Other interventions less promising Cost benefit /cost-effectiveness/cost saving Financing feasibility 4 5 Vaccination is programmatically feasible. Programmatic feasibility is proven in a pilot. Operation and logistic feasibility under existing health infrastructure Public acceptance & political will Pilot program conducted with the feasibility for sustenance if pilot outcome is promising. 18 June 2010

11 Steps for introduction of HB vaccine in Thai EPI Recommendation of National Committee on Viral Hepatitis, 1985 ACIP Recomm Extended to 12 prov Disease Burden review Cost - Benefit review Cost - Effective- Ness study Model Program In CM, CB National Program Beginning 1992 Policy Making by CDC / MOPH Planning (plan7) Budgeting

12 Major events in development of JE vaccination in Thailand Clinical & epidemio. studies Clinical features and consequences of illness at Chinagmai and children s Hosp. (More studies) Vaccine Trials Model JE Vaccination JE vaccination Programs Chiangmai (Sarapee) KPP Ratchaburi Chiangmai (Fang, Mae-ai) Chiangrai (whole province) EPI-based Number of provinces Catch-up Local vaccine development & production Techno transfer from Osaka Univ. to DMSc for lab scale production Techno transfer from DMsc to GPO for pilot scale production, R&D supported by Nat Research Council GPO scaling up production of Nakayama strain vaccine R &D for production of Beijing strain with Biken support Source: Division of GCD, CDC, MOPH Annecy, June 2002

13 Introduction of MMR in EPI Approximate Timeline Recommen -dation by NACIP Urabe MMR introduced for school children 1997 JL-MMR introduced for children < 5 years 2010 Delay due to inadequate budget Vaccine safety study during Several unsuccessful attempts to purchase Jeryl Lynn MMR vaccine (inadequate budget, lack of supply, marketing competition by non-jl- MMR producers) Urabe MMR pending due to high aseptic meningitis report

14 Geographic expansion of HB, DTP-HB and JE in EPI No. provinces HB JE DTP-HB Influenza Policy & strategy development under national strategic plan (NVC) Technical development & consultation (ACIP / NVC) Research and development (EPI & technical partners) Programmatics Training / orientation / supervision/ Procurement / storage / transport / distribution / Cold chain / Public information / Monitoring / Evaluation Disease surveillance / outbreak control AEFI surveillance and responses In consideration of disease burden, socioecon omics & internatl standards For nationwide health service infra., in public & private sector

15 DDC roles in vaccine introduction Licensed or registered Decision to introduce in EPI Private sector Promote / monitor vaccine use in private sector Policy process Pilot project Expansion Nationwide Public sector Verify disease burden Establish CB / CE Ensure programmatic feasibility Ensure affordability & sustainability Obtain policymaker advocacy Based on experience with introduction of HB ( ), JE (1990 s), DTP-HB (since late 1990 s)

16 DDC roles in vaccine introduction Licensed or registered Decision to introduce in EPI Hib, Pneumo, HPV, Rota, HA, Varicella, Private sector Promote / monitor vaccine use in private sector Policy process Pilot project Expansion Nationwide Hib, Pneumo, HPV, Rota Flu MMR DTP-HB JE Public sector Verify disease burden Establish CB / CE Ensure programmatic feasibility Ensure affordability & sustainability Obtain policymaker advocacy Based on experience with introduction of HB ( ), JE (1990 s), DTP-HB (since late 1990 s) NA 26 Dec 07

17 Drive toward secure access to pandemic vaccine Pandemic vaccine Build essential capacities Increase use of seasonal flu vaccine Initiate / establish flu vaccine production Assess disease burden / justify flu investment 15 Aug 08

18 Projected use of influenza vaccine in Thailand, : a favorable scenario Pre-AI period AI response period Pandemic preparedness period Pandemic response Vaccine production project Increased use of flu vaccine Capacity building Scale up to produce pandemic vaccine Technology: Cell-culture Adjuvant LAIV xx 2020 Note: figures -- from Simmerman et al figures initial projection 15 Aug 08

19 Projected use of influenza vaccine in Thailand, : a favorable scenario โครงการป องก น Pre-AI period โรคไข หว ดใหญ ในบ คลากรสาธารณส ข Note: figures -- from Simmerman et al figures initial projection AI response period 2008 Vaccine production project Increased use of flu vaccine Capacity building 2010 โครงการขยายบร การ ว คซ นไข หว ดใหญ ในประชากรกล มเส ยง Pandemic preparedness period Planning and decision made under the condition of preparedness for threats of influenza pandemic National security / Health economic Pandemic response Scale up to produce pandemic vaccine Technology: Cell-culture Adjuvant LAIV xx Jul 11

20 Reported influenza cases, H1N cases & H1N deaths in Thailand in 2009 and 2010 (as of 20 Nov 2010) Number of cases จ านวนผ ป วย(ราย) Number of deaths 3 จ านวนผ เส ยช ว ต(ราย) death H1N influenza (รง. 506) H1N Source: Bureau of Epidemiology, MOPH ส ปดาห เร มป วย Week of on set H1N cases H1N deaths Reported influenza

21 Pandemic H1N1 introduction 2 million doses Campaign launched since Jan 2010 Target groups: Frontline HCWs pregnant women Obesity Handicapped Chronic diseases Public concern over vaccine safety, enhanced by media, resulting in low vaccine uptake

22 Media are great partners in public health service, treat them with care. Public communication should not be underestimated MOPH covers up flu deaths Miss-guided MOPH gets lost in fighting deadly flu Health ministers competing for publicity in flu fight. Deadly H1N1 vaccine kills babies

23 Background rates strike back Challenge of back ground rates, eg. 10% spontaneous abortion 7 intrauterine deaths per 1,000 live births The public had not been well communicated about background rates and vaccine safety before the launch of H1N1 vaccination. Therefore, the need for sufficient risk communication. Importance of well established and effective AEFI surveillance (PMS) Crucial role of independent experts to verify causes of AEFIs and the association with vaccine.

24 Shifts in EPI management N H S O National Health Security Office During , EPI was managed by the Ministry of Public Health (MOPH), from policy to technical support, vaccine logistics and supply, vaccine deliver, to monitoring and evaluation. Since 2000, EPI program has undergone major shifts, under Universal Coverage (UC) scheme of national health care reform, with NHSO as major funding partner.

25 Planning and budgeting for national immunization program Review, prioritize & further put forward Prepare plans & budget proposal with justification Scrutinize Budget Bureau MOPH & NHSO Propose Propose & defend Parliament Approval Scrutinize Cabinet NACIP Advice EPI & DDC Procurement and supply by NHSO Budget approved

26 Prospects for program sustainability Disease prevention is stipulated as basic right of the citizens. Basic immunization is always ranked among high priority national health programs NHSO s UC financing promises higher ceiling and flexibility for immunization. Under government s populist policy, financial sustainability of national immunization program, as a UC component, is reasonably secure.

27 EPI under UC Clear areas NHSO takes care of financing for vaccines and vaccine delivery, including procurement and supply of vaccines to all health care providers. MOPH is responsible for: Policy / strategy development and guidance, as well as technical support to health care providers Vaccination service

28 EPI under UC Gray areas Many areas of work require close collaborations between MOPH and NHSO, as well as other partners, however, clear task differentiation is needed: Program management supervision Cold chain maintenance & monitoring Vaccine coverage & performance evaluation Public information & communication Manpower development & capacity building

29 EPI under UC Challenge of vaccine introduction Introduction of new vaccines is a high-cost and high-impact endeavor; therefore, requires careful policy and financial scrutiny. Policy on vaccine introduction is developed by MOPH, under the advice of NACIP. Main decision criteria include disease burden, public health impact, vaccine safety and efficacy; although with the consideration of cost implications. Decision on financing is made by NHSO, whose main decision criteria include cost-benefit, cost effectiveness and budget burden. Harmonized decision is crucial.

30 (ร าง)แนวทางประสานการพ จารณาน าว คซ นใหม เข า EPI คณะกก. ว คซ นแห งชาต (NVC) คณะอน กก. สร างเสร มภ ม ฯ (NACIP) แนะน า แผนงานสร าง เสร มฯ (EPI) กรมคร.(DDC) เสนอแผน และงบฯ กระทรวง สธ. (MOPH) เสนอต ง งบประมาณ

31 (ร าง)แนวทางประสานการพ จารณาน าว คซ นใหม เข า EPI คณะกก. ว คซ นแห งชาต (NVC) คณะอน กก. สร างเสร มภ ม ฯ (NACIP) แนะน า แผนงานสร าง เสร มฯ (EPI) กรมคร.(DDC) เสนอแผน และงบฯ กระทรวง สธ. (MOPH) เสนอต ง งบประมาณ คณะ กก. บ ญช ยาหล ก แห งชาต Common criteria & guideline: Essential drug CEA / CBA / BIA สปสช (NHSO) Other as agreed หน วยงานและ สถาบ นต างๆ ม โอกาสเสนอให พ จารณาว คซ น เข า EPI HITAP researchers เสนอผล ว เคราะห คณะอน กก. ส ทธ ประโยชน

32 (ร าง)แนวทางประสานการพ จารณาน าว คซ นใหม เข า EPI คณะกก. ว คซ นแห งชาต (NVC) คณะอน กก. สร างเสร มภ ม ฯ (NACIP) แนะน า แผนงานสร าง เสร มฯ (EPI) กรมคร.(DDC) เสนอแผน และงบฯ กระทรวง สธ. (MOPH) เสนอต ง งบประมาณ คณะ กก. บ ญช ยาหล ก แห งชาต Common criteria & guideline: Essential drug CEA / CBA / BIA Other as agreed สปสช (NHSO) หน วยงานและ สถาบ นต างๆ ม โอกาสเสนอให พ จารณาว คซ น เข า EPI HITAP researchers เสนอผล ว เคราะห คณะอน กก. ส ทธ ประโยชน

33 ขอบค ณคร บ