Establishing a cholera stockpile: What do we need? Alejandro Costa Epidemic Readiness and Intervention

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1 Establishing a cholera stockpile: What do we need? Alejandro Costa Epidemic Readiness and Intervention

2 Outline 1. Experience Meningococcal vaccine stockpile Yellow Fever vaccine stockpile 2. Criteria for establishing a cholera vaccine stockpile Number of topics to be considered

3 When do we need a vaccine stockpile? Epidemic response: yellow fever, meningitis, cholera, polio. Unpredictable demand. Reemerging pathogens: smallpox, polio, influenza Security, bioterrorism: smallpox, anthrax Supply shortages, buffer stocks

4 WHO strategy Early detection and confirmation, evidence based decision making process Case management, if treatment is available Reactive vaccinations, if vaccine is available

5 Current global vaccine stockpile: Objectives 1. To ensure rapid access to vaccines bundled with injection materials for countries experiencing epidemics 2. To promote the optimal use of these resources (especially when stocks are limited) 3. To promote injection safety practices and the use of assured quality vaccines 4. To coordinate international efforts in preparing for, and responding to epidemics

6 Basic principles 1. Global stock is managed by an international partnership 2. Timely arrival of vaccine for an effective outbreak response 3. Work with manufacturers to ensure availability of an emergency stock of supplies at global level 4. Established financial mechanism to purchase emergency supplies

7 The overall goal Reactive vaccination: the good timing AR / /wk 1600 Number of Cases Too early! Too late! w1 w2 w3 w4 w5 0 wk1 wk8 wk15 wk20

8 Criteria for obtaining vaccines Evidence of an ongoing outbreak and laboratory confirmation Epidemiological data should demonstrate affected districts have crossed the epidemic threshold (ex: 10 cases/ ) Availability of a plan of action for mass vaccination A vaccination plan is crucial to the success of a mass vaccination campaign and guarantees an optimal use of resources. Availability of standard storage conditions and material resources To ensure safe and effective mass vaccination campaigns, vaccines should be stored, bundled with injection material and handled according to standards

9 Meningococcal vaccine stockpile Managed by the International Coordinating Group (ICG): established in 1997 Partnership between WHO, UNICEF, MSF and IRCF Revolving stock: Men AC + ACW + Men A conj. Over 40 million doses of vaccine have been channelled since 1997 Current stockpile : 45 million doses Financed by GAVI

10 Yellow fever stockpile Managed by the International Coordinating Group (ICG): established in 2001 Partnership between WHO, UNICEF, MSF and IRCF Revolving stock of YFV for outbreak and preventive campaigns 52 million doses of vaccine have been shipped since 2001 Current stockpile : 90 million doses Financed by GAVI

11 ICG mechanism Vaccine stockpile Country request 1- Submission Request more information WHO ICG secretariat IFRC, MSF, UNICEF, WHO ICG 2- Circulation 3- Decision in 48h 4- Approval 7 days max UNICEF SD 5- Procurement Manufacturers 6- Packing and shipment Vaccines in country 7- Arrival

12 Establishing a cholera vaccine stockpile 1. An effective vaccine for epidemic response: Rapid and long lasting immune response to be use in epidemic response = 1 dose schedule but also for EPI/preventive and catch up campaigns Multi-dose presentation, liquid, oral Include all serogroups Heat stable long shelf life ( > 3 years)

13 Establishing a cholera vaccine stockpile Once we have a vaccine we should also think: 2. Revolving stock mechanism: if the vaccine is only for outbreak response, no commercial market Negotiation with manufacturers to renew the stock (shelf life) if the vaccine can be used in EPI or mass campaigns Financial mechanism to support vaccine introduction in EPI and to sustain the demand

14 Establishing a cholera vaccine stockpile 3. Strategy: National stockpile Regional stockpile Global stockpile 4. Governance if global stockpile: WHO (ex: smallpox, Tamiflu, H5N1) International partnerships like ICG (YFV, Men AC)

15 Establishing a cholera vaccine stockpile 5. Management, administration: WHO?, based on the experience gathered with small pox, meningitis and yellow fever 6. Demand forecasting: Techniques to use, target population: risk assessments Type of vaccine: outbreak response or EPI, mass vaccination campaigns, catch up campaigns Responsibility: individual countries or WHO

16 Establishing a cholera vaccine stockpile 7. Storage: Presentation for storage bulk or final product, volume and cold chain requirements Storage location: manufacturer, WHO, national stockpiles, or a combination 8. Logistics: Deployment strategies, responsibilities Shipping time Bundled vaccine other devices or supplies (ex: water and buffers)

17 Establishing a cholera vaccine stockpile 9. Procurement: Procurement agency, procurement strategies (LTAs), tender versus pre-agreement with manufacturers Flexibility, ability to make direct procurement Special specifications: WHO Prequalification, multidose, VVMs 10. Regulatory issues: Licensed product or Investigational New Drug IND, regulatory agreement with the NRA Legal issues, assurances, liability AFEIs surveillance

18 Establishing a cholera vaccine stockpile 11. Distribution: Prioritization mechanisms based on epi data Decision making process by consensus 12. Financing: Who pays Payment methods: prepayment, reserved stocks, incentives for the manufacturers, such as revolving fund

19 What do we need? Managing an international stockpile is not easy A global vaccine stockpile requires: Strong support from the public health and research community to develop an adequate vaccine for epidemic response Effective partnership, agencies, donors and vaccine manufacturers. A well understood mechanism: procedures, but flexibility basic principles and pre-established criteria defined roles and responsibilities always wiliness to discuss

20 Cholera Vaccines Whole cell injectable vaccine: not recommended Whole cell inactivated + CTB: Dukoral from SBL Vaccin AB Oral liquid Monodose vial + buffer to be dissolved in water 2 or 3 doses required Protection: 2 years, 65% Live Oral Vaccine: Orochol from Berna Biotech Oral Lyophilized Monodose double sachet + excipient to be reconstituted in water 1 dose?, Protection: 3-6 months