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

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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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National Immunization Strategy and Vaccine Supply

Managing Vaccine Supply – Vaccine Supply Working Group

Case Study: Influenza Vaccine 2004-2005

Presentation Highlights


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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 …


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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


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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/affordabilityof 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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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


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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


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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


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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










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Public Health Network (proposed) age): 2004

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 - age): 2004Proposed

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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CIC/IRID age): 2004

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.


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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


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FPT committee collaboration for the purpose of providing leadership in immunization through the analysis, development and recommendation of national goals, effective and cost-effective immunization programs,

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


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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


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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


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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


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Managing Vaccine Supply Issue (Public Works, Defence, Correctional Services)

Public Health Agency of Canada


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Advisory committee to Public Health Agency of Canada (Public Works, Defence, Correctional Services)

Linked to the Canadian Immunization Committee

Provides medical, scientific, and public health advice on vaccine use in Canada

NACI


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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


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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


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Dec 2003: Subcommittee of BIOTECanada Inspectorate :

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


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Factors: Inspectorate :

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


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Americans take flu ferry to get vaccine in B.C. Inspectorate :

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 Inspectorate :

  • 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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1994/1995 Inspectorate :

Value of contracts awarded

$ 16.1 M

2004/2005

Value of contracts awarded

$ 163.1 M

Growth of Bulk Procurement


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Develop a national vaccine supply strategy Inspectorate :

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


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Questions Inspectorate :?


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Primary Canadian pandemic strategy Inspectorate :

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


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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


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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


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1. supply of fertilized hen eggs) to reside in CanadaHealth 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


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