# Presentation: 933159

## 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

## Presentation Highlights

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

**Notes:**
Immunization is one of the most effective ways to promote health ...
Preventive rather than curative:
Immunization saves more lives and prevents more suffering every day than any other medical intervention
Sometimes prevention is the ONLY way
Reduces pressures on the health care system
Prevents outpatient visits, hospitalizations and long term disabilities
Responds to growing concerns about antimicrobial resistance

## 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

## ... 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)

## 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

## 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

## 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

## 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

## 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

## Slide 10

##  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)

## 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

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

**Notes:**
 NACI recommendation for Mening. Conj. Vaccine = 2,4,6 mths

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

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

**Notes:**
 NACI recommendation for Mening. Conj. Vaccine = 2,4,6 mths
 New or expanded programs as of Jan. 2005:
	ON=12 yr olds, 15-19 yr olds, high risk of all ages
NS=1 yr olds, 14-16 yr olds

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

**Notes:**
NACI recommendation for Pneumo. Conj. Vaccine = 2,4,6, 12/15 mths
 denominator used is 2 yrs, not 12 mths as requested

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

**Notes:**
NACI recommendation for Pneumo. Conj. Vaccine = 2,4,6, 12/15 mths
denominator used is 2 yrs, not 12 mths as requested
 New or expanded programs as of:
   Jan 2005:	ON=children born on or after Jan 1/04
NS=children born on or after Jan 1/05
  Apr 2005:	SK= 2,4,6,18 mths
NB= 2,4,6,18 mths

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

**Notes:**
NACI recommendation for Varicella Vaccine = 12 mths

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

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

**Notes:**
NACI recommendation for Varicella Vaccine = 12 mths
New or expanded programs as of Jan 2005:
BC=12 mths
SK=12 mths, Gr. 6
MB=12 mths
ON=5 yr olds, high risk
NS=2,3,4,6 yr olds 

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

**Notes:**
- NACI recommendation for Adol. Acell. Pertussis Vaccine = 14-16 yrs
- Vaccine offered by age group (14-16 yrs)

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

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

**Notes:**
 NACI recommendation for Adol. Acell. Pertussis Vaccine = 14-16 yrs
 Vaccine offered by school grade (ranging from Gr. 8 to Gr. 10 – majority of PT’s offering vaccine in Gr. 9), except for Ontario which is still offering vaccine by age (14-16yrs)
For 2005, Yukon reported that it is waiting for authorization to implement its program this year.

## Public Health Network (proposed)

**Council**
- FPT members (14)

**Issue Groups**

**Expert Groups**
**(permanent expertise)**

- Canadian Public Health Laboratory

- Emergency Preparedness & Response

- Communicable Disease Control

- Surveillance and Information

- Disease and Prevention

- Health Promotion & Disease Prevention

- CIC

- PIC

- Issue Group

- Issue Group

- Issue Group

- Issue Group

- Issue Group

- Issue Group

- Issue Group

- Issue Group

- Issue Group

- Issue Group

- Task Group

- Is accountable to

**Task Groups**
**(time limited)**

**Public Health Network (proposed)**

**FPT  Conference of Deputy Ministers of Health**

## Public Health Network - Proposed

*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

**PHAC**

**Non-Government Organisations and Industry**

**CDMH**

**Council**

**CDCN**

**PIC**

**CIC**

**NACI**

**PEWG**

**RAC**

**CIRN**

**VSEWG**

**IRISWG**

**CNCI**

***Expert ***
***Groups***

***Issues ***
***Groups***

***Sub-Issue***
***Groups***

***Task ***
***Groups***

**Public Health Network - *****Proposed***
*Immunization and Respiratory Infections*

**VSWG**

**PHMWG**

**TGs**

**CWG**

**AVWG**

**TGs**

**TGs**

**TGs**

**ICWG**

## 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
- Professional Education
- Approaches to Special Populations
- Research

_**Advice/Input**_
- NACI, Consensus Conferences, etc.

**Notes:**
CIC - 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
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

- 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

- 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

## NIS:  From Bulk Procurementto 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

## 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

## 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

## Managing Vaccine Supply Issue

- Public Health Agency of Canada

## 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

## 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

## Health Product and Food BranchHealth 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

## 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

**Notes:**
Mission Statement
Foster full access to and ensuring availability of all vaccines including, existing, new and innovative vaccines for all Canadians.
Promoting the value of immunization to all Canadians.
Promoting high quality nature of Canadian Research, development, manufacturing and distribution of vaccines.

## 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

**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 ...**

## 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

**Notes:**
 For the Influenza season of 2004/05, the Public Health Agency of Canada, provinces and territories developed a national plan to ensure an adequate supply of the Influenza vaccine for people in highest risk groups.

These measures include:

Identify and target certain groups at higher risk of complications from the Influenza. 

2.	Purchase additional doses from the suppliers.

3.	Re-allocate and re-distribute surplus vaccines to ensure adequate supplies in all provinces and territories and,

4.	Explore options for purchasing additional doses from Canadian and international vaccine manufacturers.  

## Growth of Bulk Procurement

- 1994/1995
- Value of contracts awarded
- $ 16.1 M

- 2004/2005
- Value of contracts awarded
- $ 163.1 M

## 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

## Questions ?

## 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)

## 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

## 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
- 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

## 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 >65 years
- 		d)	children 6 to 23 months of age
- 		e)	pregnant women
- Healthy adults
- Children 24 months to 18 years old