Managing Vaccine Supply – The Canadian Perspective

1. Managing Vaccine Supply – The Canadian Perspective Arlene King, MD, MHSc, FRCPC Director, Immunization and Respiratory Infections Division 2nd NVAC Workshop on Strengthening the Supply of Vaccines in the United States January 24-25, 2005

2. National Immunization Strategy and Vaccine Supply Managing Vaccine Supply – Vaccine Supply Working Group Case Study: Influenza Vaccine 2004-2005 Presentation Highlights

3. Security of supply of vaccines is not assured Lack of availability of immunization records Equitable access to publicly funded programs Unanswered questions that require research Increased costs particularly of new vaccines Public and professional communication There are now a range of challenges to immunization …

4. Vaccine approval Vaccine recommendations Vaccine purchase Vaccine promotion Immunization program planning, implementation and evaluation Surveillance (vaccine preventable diseases, coverage and adverse events) … for which governments are responsible

5. There are critical decisions to be made on immunization… • An organized approach is required • Cutting edge programs are needed to match technologic advances • Governments must lead on immunization issues • Shared problems – cannot be addressed by one government, or even one country, alone

6. National Immunization Strategy (NIS) • A comprehensive, collaborative, progressive strategy to meet the current and future immunization needs of all Canadians • A means for governments and other key stakeholders to work in partnership to address immunization issues with a national perspective

7. Goals of the NIS • Ensure equitable and timely access to recommended vaccines by NACI for all Canadians • Optimize program safety and effectiveness • Improve coordination and efficiency of immunization programs • Optimize cost-effectiveness/affordabilityof programs • Ensure security of vaccine supply • Provide rapid and effective national interventions in emergency situations and in response to international requests when required

8. National Goals and Objectives Equitable Access: Collaborative Immunization Program Planning Vaccine Supply Immunization Registries Immunization Safety Supporting Activities Immunization Research Public Education Professional Education Approaches to Special Populations Vaccine Preventable Disease Surveillance Key Components

9. 2003 Federal Budget: $45M over the next five years to assist in the continued pursuit of a national immunization strategy Final Report: National Immunization Strategy submitted to the Conference of Deputies Ministers of Health (CDMH) in June 2003 was accepted as advice in moving forward with immunization issues in Canada NIS Milestones

11. 2004 Federal Budget: $300M for Provinces and Territories over the next three years to support a National Immunization Strategy Support the introduction of new and recommended childhood and adolescent vaccines, as proposed by the National Advisory Committee on Immunization (NACI) In particular, the following 4 new recommended vaccines: meningococcal conjugate, pneumococcal conjugate, varicella and acellular pertussis for adolescents (TdaP) NIS Milestones - II

12. Due in part to the NIS federal funding announcement in Budget 2004, equitable access to publicly funded progress across Canada has increased tremendously as new P/T immunization programs have been launched, expanded or announced Equitable Access: Collaborative Immunization Program Planning

13. Meningococcal Conjugate Vaccine Access (≤ 12 mos of age): 2003

14. Meningococcal Conjugate Vaccine Access (≤ 12 mos of age): 2005

15. Pneumococcal Conjugate Vaccine Access (≤ 18 mos of age): 2003

16. Pneumococcal Conjugate Vaccine Access (≤ 18 mos of age): 2005

17. Varicella Vaccine Access (≤ 12 mos of age): 2003

18. Varicella Vaccine Access (≤ 12 mos of age):2005

19. Adolescent Acellular Pertussis Vaccine Access (13-16 yrs of age): 2003

20. Adolescent Acellular Pertussis Vaccine Access (13-16 yrs of age): 2004

21. Public Health Network (proposed) Issue Groups CIC Expert Groups (permanent expertise) PIC Issue Group Communicable Disease Control Issue Group Canadian Public Health Laboratory Issue Group FPT Conference of Deputy Ministers of Health Emergency Preparedness & Response Issue Group Council FPT members (14) Issue Group Surveillance and Information Is accountable to Issue Group Disease and Prevention Issue Group Health Promotion & Disease Prevention Issue Group Task Groups (time limited) Issue Group Task Group Issue Group

22. Public Health Network - Proposed Immunization and Respiratory Infections PHAC PHAC – Public Health Agency of Canada CDMH – Conference of Deputy Ministers of Health Expert Group (EG) CDCN – Communicable Disease Control Network Issues Group CIC – Canadian Immunization Committee PIC – Pandemic Influenza Committee TGs – Task Groups Sub-Issue Groups AVWG – Anti-virals WG CIRN – Canadian Immunization Registry Network CNCI – Canadian Nurses Coalition on Immunization CWG – Communications WG ICWG – Infection Control WG IRISWG – Immunization and Respiratory Infections Surveillance WG NACI – National Advisory Committee on Immunization PEWG – Professional Education WG PHMWG – Public Health Measures WG RAC – Research Advisory Council VSEWG – Vaccines Safety Expert WG VSWG – Vaccine Supply WG Sub-Issue Groups NACI TGs Issues Groups PEWG Expert Groups TGs RAC CIRN TGs VSEWG TGs CIC CDMH Council VSWG CDCN CNCI PIC IRISWG Task Groups CWG ICWG AVWG PHMWG Non-Government Organisations and Industry

23. CIC/IRID Immunization Goals Program Planning The NIS works in the following way … Working Groups Vaccine Safety Registries VPD Surveillance Vaccine Supply Supporting Activities Public Education Professional Education Approaches to Special Populations Research Advice/Input NACI, Consensus Conferences, etc.

24. The means to effect Federal-Provincial-Territorial (FPT) collaboration for the purpose of providing leadership in immunization through the analysis, development and recommendation of national goals, effective and cost-effective immunization programs,frameworks, practices, guidelines and best practices to: Prevent and control vaccine preventable diseases; Promote the harmonization of immunization programs in Canada; and, Meet the goals of the National Immunization Strategy Canadian Immunization Committee

25. FPT committee Members are public health officials who are responsible for making recommendations on immunization programs to their governments Supported by working groups Develop recommendations and information, based on sound research to submit to either CIC or NACI Respond to CIC or NACI questions and requests for additional information or analysis Provide expert advice and input on new topics and practices in immunization Canadian Immunization Committee

26. FPT Procurement Committee becomes Vaccine Supply Working Group (VSWG) Focus shifts from a limited mandate of managing bulk procurement of vaccines to an expanded mandate to develop strategies for managing and enhancing supply of vaccine Improved / updated chain of authority and FPT reporting relationships NIS: From Bulk Procurementto Vaccine Supply

27. Goal: Strengthen the ability to proactively address vaccine supply issues by: Monitor vaccine supply and prices Develop strategies to address security and quality of supply Conduct studies to determine best procurement practices, addressing jurisdictional needs Involved in reviewing and assessing Canadian vaccine supply issues and making recommendations to vaccine manufacturers and the Canadian Immunization Committee Vaccine Supply Working Group

28. Membership: F/P/T, including other Federal Departments (Public Works, Defence, Correctional Services) Meets twice a year: June and December Monthly teleconferences Vaccine Supply Working Group - II

29. Managing Vaccine Supply Issue Public Health Agency of Canada

30. Advisory committee to Public Health Agency of Canada Linked to the Canadian Immunization Committee Provides medical, scientific, and public health advice on vaccine use in Canada NACI

31. Mandate for the procurement of goods on behalf of the federal government Provides procurement services for vaccines on behalf of the P/Ts on a voluntary basis through a bulk purchasing program Member of and takes direction from the VSWG Responsibility for contract administration; for enforcing contract performance; and for formal negotiations with industry Assists in the development of vaccine allocation plans during shortages PWGSC

32. Biologics and Genetic Therapies Directorate; HPFB Inspectorate : Federal regulator with responsibility for approval of vaccines sold in Canada; licensing of manufacturing facilities; and for the release of each individual lot of vaccine Health Product and Food BranchHealth Canada

33. Dec 2003: Subcommittee of BIOTECanada Formed “to create a vaccine environment conducive to the goals of public health and the manufacturers.” Voting members: GSK, MSD, IDBiomedical, Aventis-Pasteur, Wyeth, Baxter Vaccine Industry Committee

34. Factors: Shortages in the U.S. Increased awareness The addition of a new high risk group Early demand Unprecedented demand Influenza Vaccine: Managing a Potential Shortage

35. Americans take flu ferry to get vaccine in B.C. CTV.ca News Staff Hundreds of Americans are driving and ferrying their way to Canada to get their flu shots. A shortage of the vaccine in the U.S. means Americans are taking matters into their own hands. The Victoria Clipper will ferry more than 600 U.S. residents …

36. National Response to Ensure Adequate Public Supply • Identify and target populations at high risk • Purchase additional doses of vaccine • Re-allocate and re-distribute surplus vaccine • Explore options for purchasing additional doses from Canadian and international vaccine manufacturers • Post mortem review and apply lessons learned

37. 1994/1995 Value of contracts awarded $ 16.1 M 2004/2005 Value of contracts awarded $ 163.1 M Growth of Bulk Procurement

38. Develop a national vaccine supply strategy Develop a protocol of collaboration with Health Products and Food Branch (Regulator) Review Industry Canada and Patented Medicine Prices Review Board contributions to security of supply for vaccines in Canada VSWG – Priorities 05/06

39. Questions ?

40. Primary Canadian pandemic strategy Other interventions – antivirals, public health measures – will buy us time until vaccine available Goal: to provide sufficient infrastructure and capacity to produce 100% of domestic supply needs in the event of a pandemic (enough vaccine for all Canadians) Pandemic Vaccine Strategy

41. Contractor: ID Biomedical Corp. (formerly Shire BioChem Inc.), Québec Contract Duration: 10 years – 2001 to 2011 (option to extend subject to mutual agreement) Requirements: Annual vaccine – minimum of 50% of public market (75% this year) Pandemic preparedness (production capacity and raw materials to produce a minimum 8M monovalent doses/month for 4 months) Production of pandemic vaccine Pandemic Vaccine Strategy - II

42. Production capacity and necessary raw materials (including supply of fertilized hen eggs) to reside in Canada Sharing of infrastructure costs (contractor/Government of Canada) for pandemic production capacity Canada’s investment protected by contract security Firm prices (based on volume & year) for annual and pandemic vaccine for full period of contract Annual “Pandemic Readiness Fee” payable by Government of Canada Cost reductions if Contractor can benefit from alternative uses of Canada’s investment (eg, expanded markets) Currently egg-based production, but provisions to work with contractor to implement newest technologies Pandemic Vaccine Strategy - III

43. 1. Health care workers, including paramedics and public health Essential service providers / government leaders 3. Persons at high risk of severe or fatal outcomes a) persons in nursing homes and long-term care facilities b) persons with high-risk medical conditions c) persons >65 years d) children 6 to 23 months of age e) pregnant women Healthy adults Children 24 months to 18 years old Use of Vaccines in Short Supply