Managing Vaccine Supply The Canadian Perspective

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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

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Presentation Highlights

• National Immunization Strategy and Vaccine Supply
• Managing Vaccine Supply Vaccine Supply Working
  Group
• Case Study Influenza Vaccine 2004-2005

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There are now a range of challenges to
immunization

• 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

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for which governments are responsible

• Vaccine approval
• Vaccine recommendations
• Vaccine purchase
• Vaccine promotion
• Immunization program planning, implementation and
  evaluation
• Surveillance (vaccine preventable diseases,
  coverage and adverse events)

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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

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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

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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/affordability of
  programs
• Ensure security of vaccine supply
• Provide rapid and effective national
  interventions in emergency situations and in
  response to international requests when required

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Key Components

• 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

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NIS Milestones

• 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

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(No Transcript)
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NIS Milestones - II

• 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)

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Equitable Access Collaborative Immunization
Program Planning

• 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

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Meningococcal Conjugate Vaccine Access ( 12 mos
of age) 2003
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Meningococcal Conjugate Vaccine Access ( 12 mos
of age) 2005
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Pneumococcal Conjugate Vaccine Access ( 18 mos
of age) 2003
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Pneumococcal Conjugate Vaccine Access ( 18 mos
of age) 2005
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Varicella Vaccine Access ( 12 mos of age) 2003
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Varicella Vaccine Access ( 12 mos of age) 2005
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Adolescent Acellular Pertussis Vaccine Access
(13-16 yrs of age) 2003
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Adolescent Acellular Pertussis Vaccine Access
(13-16 yrs of age) 2004
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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
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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
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The NIS works in the following way

• CIC/IRID
• Immunization Goals
• Program Planning

Working Groups Vaccine Safety Registries VPD
Surveillance Vaccine Supply
Supporting Activities Public Education Professiona
l Education Approaches to Special
Populations Research
Advice/Input NACI, Consensus Conferences, etc.
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Canadian Immunization Committee

• 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

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Canadian Immunization Committee

• 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

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NIS From Bulk Procurementto Vaccine Supply

• 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

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Vaccine Supply Working Group

• 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

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Vaccine Supply Working Group - II

• Membership F/P/T, including other Federal
  Departments (Public Works, Defence, Correctional
  Services)
• Meets twice a year June and December
• Monthly teleconferences

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Managing Vaccine Supply Issue
Public Health Agency of Canada
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NACI

• 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

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PWGSC

• 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

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Health Product and Food BranchHealth Canada

• 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

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Vaccine Industry Committee

• 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

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Influenza Vaccine Managing a Potential Shortage

• Factors
• Shortages in the U.S.
• Increased awareness
• The addition of a new high risk group
• Early demand
• Unprecedented demand

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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
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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

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Growth of Bulk Procurement

• 1994/1995
• Value of contracts awarded
• 16.1 M

• 2004/2005
• Value of contracts awarded
• 163.1 M

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VSWG Priorities 05/06

• 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

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Questions ?
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Pandemic Vaccine Strategy

• 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)

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Pandemic Vaccine Strategy - II

• 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

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Pandemic Vaccine Strategy - III

• 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
• Canadas 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 Canadas investment (eg,
  expanded markets)
• Currently egg-based production, but provisions to
  work with contractor to implement newest
  technologies

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Use of Vaccines in Short Supply

• 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 gt65 years
• d) children 6 to 23 months of age
• e) pregnant women
• Healthy adults
• Children 24 months to 18 years old