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National Advisory Committee on Immunization (NACI)

Meetings

  • June 7-8, 2017, Ottawa, Ontario
  • September 27-28, 2017, Ottawa, Ontario
  • February 7-8, 2018
  • June 6-7, 2018
  • September 26-27, 2018
  • February 6-7, 2019
  • June 5-6, 2019
  • September 25-26, 2019

Past Meetings:


Summary of Discussion October 5-6, 2016 Meeting, Ottawa, Ontario

Summary of Discussion October 5-6, 2016 Meeting, Ottawa, Ontario
AGENDA ITEM SUMMARY

Welcome and Introduction

The Chair welcomed participants to the meeting.

Evidence-based Methodology (EBM) Working Group Update

An update was provided on the work done to date and to discuss the role and activities of the Working Group in the context of the expanded mandate for NACI. The short-term and long-term next steps for the Working Group were presented and discussed. A proposal for revised wording for NACI recommendations was presented for discussion, as well as an algorithm developed to provide transparent and logical steps for NACI to consider when deciding to develop guidance in the absence of published peer-reviewed literature.  The Working Group will provide an oversight function for the development of processes and methods for the additional elements of NACI’s expanded mandate.  

Common Guidance Update – Expanded NACI Mandate

An update on the implementation and pilot projects for NACI’s expanded mandate was presented. Pilot projects will be initiated over the next year to assist in the development of new processes and methods for the implementation of the expanded NACI mandate.  A session will be presented at the upcoming Canadian Immunization Conference on what is new with NACI including the implementation of the expanded mandate.

Working Group Update:  Hepatitis B

The Working Group Chair provided a summary of work done to date and the changes made to the Hepatitis B Statement Update since NACI’s first review in August 2016. The statement and recommendations were approved by NACI.

Working Group Update:  HPV

The Working Group Chair provided an update on the work done to date. Pre-release of the current statement on a two dose schedule for the HPV nine-valent vaccine is expected in November.

Working Group Update: Pertussis

The Working Group Chair presented the project plan and timelines for a 3-phased approach. The WG will begin in Phase 1 with a review of the evidence and recommendations for Tdap immunization in pregnancy to prevent pertussis infection in infants. The project plan was reviewed by the Canadian Immunization Committee prior to presentation to NACI. Phase 2 and 3, immunization in children, adolescents and adults will be defined following Phase 1.

Working Group Update: Meningococcal

The Working Group Chair provided an update on the upcoming priority items to be addressed by the Working Group. The Working Group will be focussing its current activities on Meningococcal B vaccine recommendations.

Working Group Update: Influenza  

The Working Group Chair provided a summary of recent web publications, including the two addendums to the 2016-2017 Statement on Seasonal Influenza Vaccine; LAIV use in Egg-Allergic Individuals, and LAIV Use in Children and Adolescents.     

Survey Results: Seasonal Influenza Statement New Format

Highlights of the results of the recent online stakeholder survey on the new format of the Statement on Seasonal Influenza Vaccine were provided.  In general, respondents were satisfied with the new format. Some suggestions for improvement were provided and will be taken into consideration by the Working Group.

Literature Review: Individuals with Neurological Conditions

The Working Group Chair provided a summary of the work completed to date and reviewed next steps and timelines for the Working Group. The Working Group will add this item to their work plan; timeline to be determined.  

Tutorial Session: Primer on Health Economic Evaluations

A presentation was provided on economic evaluations, which included an overview of the type and components of economic evaluations and how conclusions can be drawn from economic models.   

Working Group Update: Pneumococcal

The Working Group Chair provided a summary of the work completed to date and reviewed next steps and timelines for the Working Group. The Working Group is continuing to develop the statement on pneumococcal vaccination in immunocompetent adults 65 years of age and older (population level), in follow-up to the interim statement, which is expected to be published online later in October.

Liaison Representative /Ex-Officio Updates

Updates were provided by liaison and ex-officio representatives including the:  Association of Medical Microbiology and Infectious Disease Canada; Biologics and Genetics Therapies Directorate, Health Canada; Canadian Association for Immunization Research and Evaluation; Canadian Paediatrics Society; Canadian Immunization Committee; Canadian Public Health Association; Centers for Disease Control and Prevention; Canadian Immunization Research Network;  First Nations and Inuit Health Branch, Health Canada; Marketed Health Products Directorate, Health Canada; and National Defense and the Canadian Armed Forces.

Canadian Immunization Guide (CIG) Update

An update on recent updates to the Canadian Immunization Guide (CIG) was provided.  The migration of the CIG to the new Canada.ca web platform is complete. The new platform offers additional features including the ability to view and search entire Parts of the CIG. Following completion of the migration, the plan moving forward is for CIG chapters to be updated on the same day that a Statement is published.

Roles and Responsibilities for NACI members and NACI Secretariat

The NACI Executive Secretary highlighted some elements of the draft roles and responsibilities of the NACI Secretariat as a companion document to the NACI member and liaison and ex-officio representative roles and responsibilities. These documents were developed for internal operational purposes.  

Working Group Update: Vaccine Safety

An update on the status of the Vaccine Safety Working Group was presented.  The Working Group will be revising its terms of reference and bringing them to NACI for approval. The Working Group will also be initiating the review of the safety section of the CIG and developing an engagement approach with other NACI working groups.

General Business

  • Status Report on NACI Activities
  • Vaccine Pipeline Submissions and Notice of Compliance
  • NACI Work plan

The NACI Executive Secretary gave a brief overview of NACI activities in progress, including expected timelines. An overview of the vaccine industry pipeline submissions was provided, highlighting additions since the June meeting.

Adjournment

The Chair thanked members for their contributions and adjourned the meeting.

 

Summary of Discussion June 8-9, 2016 Meeting, Ottawa, Ontario

Summary of Discussion June 8-9, 2016 Meeting, Ottawa, Ontario
AGENDA ITEM SUMMARY

Welcome and Introduction

The Chair welcomed participants to the meeting.

Launch of Common Vaccine Guidance

An expansion in NACI’s mandate was launched to achieve integrated common vaccine guidance.  Through the expanded mandate programmatic elements will be added to the assessment completed by NACI to formulate it’s recommendations, including economic evaluation, and feasibility, acceptability, ethics and equity assessments. The expanded mandate will be implemented over the next few years as methods and processes are developed. The implementation will be informed by several pilots planned for the coming year.  

Canadian Immunization Research Network (CIRN) Update

An update was provided to NACI on the current research activities of CIRN. The presentation included an overview of network objectives, areas of research interest, network structure and capacity, and completed projects.

NACI Research Priorities

Following CIRN’s presentation, NACI discussed committee identified research gaps from previous NACI products and recently requested information from Working Group Chairs.

Canadian Immunization Guide (CIG) Update

 A status update of chapter reviews and revisions was presented to NACI. The review cycle, with each chapter being reviewed at a minimum of every four years, is on track. Working groups have been established for Part 1 and 3 and they are actively reviewing chapters for updates and presentation to NACI as required.

Biologics during pregnancy and immunization

 An update to the CIG chapter, Immunization of Immunocompromised Persons, was presented for approval following discussion at the two previous NACI meetings. The updated text on the immunization of infants exposed to monoclonal antibodies in utero was approved by NACI. This update will be applied to the chapter posted online.  

Canadian Association for Immunization Research and Evaluation (CAIRE) 2.0 – Life After the Scheifele Era

CAIRE is in the process of evaluating its role in the current Canadian context.  NACI members were asked for advice and feedback regarding CAIRE’s role in the increasingly complex Canadian vaccine environment.

Statement: Update Recommendations on Human Papillomavirus (HPV) Vaccines: 9-valent HPV vaccine 2-dose immunization schedule and the use of HPV vaccines in immunocompromised populations

The working group chair presented the draft statement and recommendations for NACI review and discussion. The recommendations for immunocompromised populations are supported by a literature review that will be published as a separate document. Final approval will be sought from NACI following the meeting.

Pertussis Working Group Update

The working group chair provided an update on activities and confirmed next steps with NACI. The project plan and research questions for the literature reviews were presented to NACI and approved. The project plan will be presented to the Canadian Immunization Committee for comment prior to implementation of the plan.   

Hepatitis B Working Group Update

The working group chair provided an update on working group activities and work done to date. The working group is expecting to have the draft statement ready for NACI review by the fall.   

Evidence-Based Methodology Working Group Update

An overview of the work done to date was provided as well as an update on next steps and short term and long term activities. There has been no working group engagement since the fall of 2015. NACI agreed with the proposed approach. Working group meetings will be resumed.

Roles and Responsibilities of NACI Members, Liaison Representatives and Ex-officio Representatives

As per the October 2015 NACI meeting, a draft document outlining roles and responsibilities of NACI members, liaison representatives and ex-officio representatives has been prepared. The document will be finalized following the meeting and additional comments from members and will be used for internal NACI operational purposes.

NACI Statement on Seasonal Influenza Vaccine for 2017-2018

The working group chair presented the changes made to the statement from the 2016-2017 statement. NACI approved the statement. The statement will be disseminated to provincial and territorial governments this fall and will be posted online in the spring of 2017.  

Influenza Working Group Update

An update was provided on the survey developed to evaluate the combined statement format, which was implemented in 2015-2016. The survey was posted with the 2016-2017 statement and will be active for several months.
NACI agreed that the literature review for influenza vaccination in adults with neurological conditions should be revisited by the working group when resources become available. 

Influenza Repeat Vaccinations (I-ReV) effects: Emerging evidence, trends and perspectives

Dr. Danuta Skowronski presented emerging evidence, trends and perspectives on the negative effects of prior vaccination on current influenza vaccine protection. This presentation has been previously presented to the Influenza Working Group. Studies from Canada, the United States and Europe have reported negative effects of prior vaccination on current influenza vaccine effectiveness, including a negative dose response effect with additional doses received.

Impact of prior season vaccination on influenza vaccine effectiveness (VE) in four consecutive seasons (2011-2012 through 2014-2015) and in-camera discussion without the presenters

Dr. Shelly McNeil presented findings on the impact of prior season vaccination on subsequent influenza VE in four consecutive seasons from the Canadian Immunization Research Network (CIRN) Severe Outcome Surveillance (SOS) Network. There was varied impact of prior vaccination on subsequent VE observed from season to season among hospitalized patients. The impact of prior vaccination was larger in some seasons (e.g., 2012-2013 and 2014-2015) than others. It was noted that unmeasured indication bias may have accounted for the observed impact and further study is needed.

Economic Analysis of Pneumococcal Vaccination for Elderly Adults in Canada

A revised presentation was provided as an adjustment was made to model estimates from the presentation provided at the NACI February meeting. The model evaluated the cost-effectiveness of different pneumococcal vaccination strategies: Pneumococcal Polysaccharide 23-valent vaccine (PPV23) at age 65 years, Pneumococcal Conjugate 13-valent vaccine (PCV13) at age 65 years, PPV23 at age 65 years, PCV13 one year later as well as PPV23 at age 65 years and 70 years.

Pneumococcal Working Group Update

The working group chair provided an update on working group activities and discussed next steps. A draft statement incorporating the systematic review presented at a previous meeting and results from the economic analysis will be prepared for NACI review. This will be an early pilot of the incorporation of additional elements into NACI processes and products as per its expanded mandate announced earlier in the meeting.  

Liaison and Ex-Officio Representative Updates

Updates were provided by liaison and ex-officio representatives including the:  Association of Medical Microbiology and Infectious Disease Canada; Biologics and Genetics Therapies Directorate, Health Canada; Canadian Association for Immunization Research and Evaluation; Canadian Paediatrics Society; Canadian Immunization Committee; Canadian Public Health Association; Centers for Disease Control and Prevention; Committee to Advise on Tropical Medicine and Travel; Marketed Health Products Directorate, Health Canada; and Vaccine Safety Section, Public Health Agency of Canada.

National Immunization Technical Advisory Group (NITAG) International Network meeting update

An update was provided on the NITAG International Network meeting that took place in May. The meeting marked the launch of the international NITAG network. General network principles as well as secretariat and other functions were discussed. A meeting report is planned for public release.  

General Business

  • Status Report on NACI Activities
  • Vaccine Pipeline Submissions and Notice of Compliance
  • NACI Work plan

A brief overview was presented on NACI activities in progress, including expected timelines. An overview of the vaccine industry pipeline submission template was also provided, highlighting additions since the February meeting.

Pipeline Day - April 13, 2016

NACI members were informed that the Canadian Immunization Committee discussed the pipeline day at their recent face-to-face meeting. NACI members were asked for additional feedback on the pipeline day.  

Adjournment

The Chair thanked members for their contributions and adjourned the meeting.

Summary of Discussion February 10-11, 2016 Meeting, Ottawa, Ontario

Summary of Discussion February 10-11, 2016 Meeting, Ottawa, Ontario
AGENDA ITEM SUMMARY

Welcome and Introduction

The Chair welcomed participants to the meeting.

Economic Evaluation of Vaccination Against Pneumococcal Disease in Elderly Adults in Canada

An evaluation of the cost effectiveness of different vaccination strategies with PPV23 and PCV13 for elderly adults in Canada was presented. The presenter is planning to release the model and results publicly later this year and publish in a peer-reviewed journal pending acceptance.

Statement: Update of PNEU-C-13 Use in Otherwise Healthy Adults – Individual Recommendation

The working group chair provided a status update on the statement. It has been reviewed by the Canadian Immunization Committee and approved by NACI. Next step will be the pre-release, following the Public Health Agency of Canada’s (PHAC) approval. The working group will then focus on the preparation of a new statement on recommendations at a population level with a focus on public health impacts and benefits. The statement will be informed by literature reviews on PCV13 and PPV23. The timelines of the draft population level statement have not been determined at this time.  

Systematic Review – Vaccine Effectiveness PPV23

The results of a systematic review and meta-analyses were presented on the vaccine effectiveness of PPV23 in the prevention of invasive pneumococcal disease (IPD) and community acquired pneumonia (CAP) among the general population 50+ years of age.
The systematic review synthesizes and appraises the published literature in a population comparable to a recent trial of PCV13, Community-Acquired Pneumonia Immunization Trial in Adults (CAPiTA), to enable comparisons of the effectiveness of the two pneumococcal vaccines.
The methods, results, limitations, and conclusions were outlined.  The review included 31 studies. Overall, 5 meta-analyses were performed and funnel plots were included to assess publication bias. The results were stratified according to several different factors, such as method and time since diagnosis.

Statement: HPV Update

The HPV working group chair provided NACI with an update on working group activities. The statement on HPV9 3-dose schedule and minimum intervals will be ready for pre-release following the meeting.
The working group has also completed a literature review on HPV vaccination in immunocompromised populations, which was presented. The working group also discussed 2-dose recommendations for HPV9.

Literature Review: HPV Immunization of Immunocompromised Populations

The methodology and results of a literature review on HPV vaccine use in immunocompromised populations was presented. A scan of recommendations from other National Immunization Technical Advisory Groups (NITAGs) was also completed.  The literature review will be used by the HPV Working Group to support the development of a new statement.

Comparison of immunogenicity of 2-dose and 3-dose regimens of 9-valent HPV vaccine

A presentation was provided to NACI by Merck Canada on the clinical study Protocol V503-010 that was conducted to compare the immunogenicity of 2 doses of 9-valent HPV vaccine administered at a 6- or 12-month interval in girls and boys 9-14 years of age versus 3 doses administered at 0, 2, and 6 months in women 16-26 years of age (i.e., the dose regimen and population used to establish vaccine efficacy). The study demonstrated non-inferior HPV antibody responses in girls and boys who received 2 doses compared with women who received 3 doses. Based on these results, and using the same approach that was previously accepted for licensure of 2-dose and 3-dose regimens of the quadrivalent HPV vaccine and the 3-dose regimen of the 9-valent HPV vaccine in girls and boys, efficacy findings in women who received 3 doses can be extended to girls and boys who received 2 doses of the vaccine.

Statement: HPV 2-dose and immunocompromised draft recommendations

The working group chair presented draft recommendations for immunocompromised populations. NACI agreed in principle with the recommendations included in the statement. NACI’s approval was also requested for an amendment to the February 2015 HPV 2-dose statement for quadrivalent and bivalent formulations; revising the recommendations on minimum intervals and aligning the statement with the current HPV statement update being prepared for release. 
The statement update will also include recommendations on a 2-dose schedule for the 9-valent HPV vaccine. The timelines for the statement will be determined following additional follow-up with the working group.

Statement: Canadian Immunization Guide Chapter on Influenza and Interim Statement on Seasonal Influenza Vaccine for 2017-18

The working group chair presented an outline for today’s meeting, introducing the objectives and upcoming presentations.

A quality assessment of the systematic literature review on adults with neurological conditions and influenza immunization

A draft systematic literature review relating to adults with neurological conditions and influenza immunization presented in October was assessed.  Following the presentation of the assessment, NACI agreed that the review should be repeated to confirm results.

Influenza Working Group Work plan and revised Terms of Reference

The Influenza Working Group (IWG) work plan was presented for NACI’s approval. Proposed revisions to the IWG Terms of Reference were also presented for NACI approval.

Influenza Working Group Update

The Influenza Working Group (IWG) Chair gave an update on the status of the 2016-2017 statement. A brief overview was presented on revisions being considered for the 2017-2018 statement. NACI’s approval on the 2017-2018 statement will be sought at the June 2016 meeting.
The Chair also updated the group on an evaluation of the new format for the combined seasonal influenza statement and Canadian Immunization Guide chapter that is being planned. The survey will be available concurrently with the publication of the 2016-2017 statement.

Canadian Immunization Guide (CIG) Chapter Approval Process

An update was provided on the recently developed levels of approval required for changes to the Canadian Immunization Guide (CIG).  The level of approval is based on the nature of the changes being proposed.  NACI agreed to the proposed approval process.

CIG Part 5: Passive Immunizing Agent

A proposal for the removal of Part 5 was presented to NACI. NACI agreed with the removal of Part 5 with additional mapping of content in consultation with leads for CIG chapters where Part 5 content will be relocated. A chapter on Respiratory Syncytial Virus (RSV) is to be created and added to Part 4 of the Guide.

BCG Chapter Update

NACI agreed that the BCG chapter is an important component of the CIG. When the chapter is reviewed contact should be made with the leads for the Canadian Tuberculosis Standards to discuss potential collaboration and information sharing. 

National Immunization Strategy

An update was provided on the review of the National Immunization Strategy being conducted through the Public Health Network.

Common Guidance

Internal PHAC briefings and approvals are underway on a Common Guidance model through an expanded mandate for NACI, incorporating additional elements into the activities of the committee including economic evaluations.

Liaison Representatives/Ex-Officio and other Updates

Updates were provided by liaison and ex-officio representatives including the:  Association of Medical Microbiology and Infectious Disease Canada; Biologics and Genetics Therapies Directorate, Health Canada; Canadian Paediatrics Society; Canadian Immunization Committee; Canadian Immunization Research Networks; Canadian Public Health Association;  Society of Obstetricians and Gynaecologists of Canada; Canadian Association for Immunization Research and Evaluation; Centers for Disease Control and Prevention; Canadian Paediatrics Society; First Nations and Inuit Health Branch, Health Canada;  and Marketed Health Products Directorate, Health Canada.

Live Vaccines: Biologics & Pregnancy

The methods and results of a recent publication on the use of vaccines for infants exposed to biologicals in utero were presented. The current evidence on this topic is limited and is based to a large extent on case reports.

CIG Immunization of Immunocompromised Persons chapter – Monoclonal Antibodies

During the October 2015 NACI meeting, it was decided to remove breastfeeding as a contraindication and precaution to immunizing infants of mothers receiving monoclonal antibodies. Evidence and proposed CIG text for vaccination of infants born to mothers who received monoclonal antibodies in pregnancy was discussed. Revised text is to be brought back to NACI for further consideration.

General Business

  • Status Report on NACI Activities
  • Vaccine Pipeline Submissions and Notice of Compliance
  • NACI Work plan

The NACI Executive Secretary gave a brief overview of NACI’s business and activities in progress, including expected timelines. An overview of vaccine industry pipeline submissions was provided, highlighting additions since the October meeting. A vaccine pipeline day pilot meeting is being considered for spring 2016.

Working Group Vice-Chairs

Currently none of the working groups have designated vice-chairs. The potential role and need for a working vice-chair were discussed. The appointment of a working group vice-chair will be left to the discretion of the working group chair. The vice-chair can be a NACI voting member of liaison representative.

Vaccine Safety Working Group Update

A general working group update was provided. Additional discussion is required on the role and functioning of the working group.

Statement: Measles

An update was provided on working group’s activities. As previously presented, topics for WG review include: Optimal timing of doses, the administration of MMR(V) following receipt of blood products and natural infection, and post-exposure prophylaxis (PEP).

Members role and responsibilities on a working group for the development of NACI statement and a chapter

As per the discussion at the October 2015 meeting, the Executive Secretary presented a draft template for roles and responsibilities of NACI members, liaison and ex-officio representatives and the PHAC secretariat. The completed draft template will be brought back to NACI for review at an upcoming meeting.

Adjournment

The Chair thanked members for their contributions and the meeting was adjourned.

Summary of Discussion October 5-6, 2015 Meeting, Ottawa, Ontario

Summary of Discussion October 5-6, 2015 Meeting, Ottawa, Ontario
AGENDA ITEM SUMMARY

Welcome and Introduction

The Chair welcomed participants to the meeting.

Evidence-based Methodology (EBM) Working Group Update

An update was provided on the work done to date and to discuss the role and activities of the Working Group in the context of the expanded mandate for NACI. The short-term and long-term next steps for the Working Group were presented and discussed. A proposal for revised wording for NACI recommendations was presented for discussion, as well as an algorithm developed to provide transparent and logical steps for NACI to consider when deciding to develop guidance in the absence of published peer-reviewed literature.  The Working Group will provide an oversight function for the development of processes and methods for the additional elements of NACI’s expanded mandate.  

Common Guidance Update – Expanded NACI Mandate

An update on the implementation and pilot projects for NACI’s expanded mandate was presented. Pilot projects will be initiated over the next year to assist in the development of new processes and methods for the implementation of the expanded NACI mandate.  A session will be presented at the upcoming Canadian Immunization Conference on what is new with NACI including the implementation of the expanded mandate.

Working Group Update:  Hepatitis B

The Working Group Chair provided a summary of work done to date and the changes made to the Hepatitis B Statement Update since NACI’s first review in August 2016. The statement and recommendations were approved by NACI.

Working Group Update:  HPV

The Working Group Chair provided an update on the work done to date. Pre-release of the current statement on a two dose schedule for the HPV nine-valent vaccine is expected in November.

Working Group Update: Pertussis

The Working Group Chair presented the project plan and timelines for a 3-phased approach. The WG will begin in Phase 1 with a review of the evidence and recommendations for Tdap immunization in pregnancy to prevent pertussis infection in infants. The project plan was reviewed by the Canadian Immunization Committee prior to presentation to NACI. Phase 2 and 3, immunization in children, adolescents and adults will be defined following Phase 1.

Working Group Update: Meningococcal

The Working Group Chair provided an update on the upcoming priority items to be addressed by the Working Group. The Working Group will be focussing its current activities on Meningococcal B vaccine recommendations.

Working Group Update: Influenza  

The Working Group Chair provided a summary of recent web publications, including the two addendums to the 2016-2017 Statement on Seasonal Influenza Vaccine; LAIV use in Egg-Allergic Individuals, and LAIV Use in Children and Adolescents.     

Survey Results: Seasonal Influenza Statement New Format

Highlights of the results of the recent online stakeholder survey on the new format of the Statement on Seasonal Influenza Vaccine were provided.  In general, respondents were satisfied with the new format. Some suggestions for improvement were provided and will be taken into consideration by the Working Group.

Literature Review: Individuals with Neurological Conditions

The Working Group Chair provided a summary of the work completed to date and reviewed next steps and timelines for the Working Group. The Working Group will add this item to their work plan; timeline to be determined.  

Tutorial Session: Primer on Health Economic Evaluations

A presentation was provided on economic evaluations, which included an overview of the type and components of economic evaluations and how conclusions can be drawn from economic models.   

Working Group Update: Pneumococcal

The Working Group Chair provided a summary of the work completed to date and reviewed next steps and timelines for the Working Group. The Working Group is continuing to develop the statement on pneumococcal vaccination in immunocompetent adults 65 years of age and older (population level), in follow-up to the interim statement, which is expected to be published online later in October.

Liaison Representative /Ex-Officio Updates

Updates were provided by liaison and ex-officio representatives including the:  Association of Medical Microbiology and Infectious Disease Canada; Biologics and Genetics Therapies Directorate, Health Canada; Canadian Association for Immunization Research and Evaluation; Canadian Paediatrics Society; Canadian Immunization Committee; Canadian Public Health Association; Centers for Disease Control and Prevention; Canadian Immunization Research Network;  First Nations and Inuit Health Branch, Health Canada; Marketed Health Products Directorate, Health Canada; and National Defense and the Canadian Armed Forces.

Canadian Immunization Guide (CIG) Update

An update on recent updates to the Canadian Immunization Guide (CIG) was provided.  The migration of the CIG to the new Canada.ca web platform is complete. The new platform offers additional features including the ability to view and search entire Parts of the CIG. Following completion of the migration, the plan moving forward is for CIG chapters to be updated on the same day that a Statement is published.

Roles and Responsibilities for NACI members and NACI Secretariat

The NACI Executive Secretary highlighted some elements of the draft roles and responsibilities of the NACI Secretariat as a companion document to the NACI member and liaison and ex-officio representative roles and responsibilities. These documents were developed for internal operational purposes.  

Working Group Update: Vaccine Safety

An update on the status of the Vaccine Safety Working Group was presented.  The Working Group will be revising its terms of reference and bringing them to NACI for approval. The Working Group will also be initiating the review of the safety section of the CIG and developing an engagement approach with other NACI working groups.

General Business

  • Status Report on NACI Activities
  • Vaccine Pipeline Submissions and Notice of Compliance
  • NACI Work plan

The NACI Executive Secretary gave a brief overview of NACI activities in progress, including expected timelines. An overview of the vaccine industry pipeline submissions was provided, highlighting additions since the June meeting.

Adjournment

The Chair thanked members for their contributions and adjourned the meeting.

Summary of Discussion June 10-11, 2015 Meeting, Ottawa, Ontario

Summary of Discussion June 10-11, 2015 Meeting, Ottawa, Ontario
AGENDA ITEM SUMMARY

Welcome and Introduction

The Chair, Dr. Ian Gemmill, welcomed participants to the meeting. The Chair acknowledged that this will be the last meeting for NACI members Dr. Blair Seifert and Dr. Deepali Kumar and ex-officio representative for the Agency, Dr. Barbara Law. Their dedication and commitment to the field of immunization and their work on NACI was acknowledged.

Members were informed that the NACI Chair, Vice-Chair and Executive Secretary are in the process of assessing the applicants who put their names forward in the call for membership that was completed in May 2015.

The Executive Secretary, Robert Lerch informed the committee of changes within the Agency’s senior management, as well as changes within the Centre for Immunization and Respiratory Diseases. Dr. Theresa Tam has taken on the role of Assistant Deputy Minister of the Infectious Disease Prevention and Control Branch and Rhonda Kropp has taken on the role of Director General of Centre for Immunization and Respiratory Diseases. Dr. John Spika will be taking on the role of Senior Medical Advisor for the Infectious Disease Prevention and Control Branch.

HPV Working Group

Updated Recommendations on Human Papillomavirus (HPV) Vaccines: 9-valent vaccine and clarification of minimal intervals between doses in the HPV immunization schedule

Dr. Shelley Deeks, Chair of the HPV Working Group provided an update on the activities of the Working Group. The analysis of HPV immunization of immunocompromised populations has been postponed to focus on the 9-valent statement. The 9-valent statement and recommendations were reviewed by NACI. The statement also includes recommendations on the minimum intervals between doses. This was the first review of the statement and recommendations by NACI.

Measles, Mumps and Rubella Working Group (MMR-WG) Update

Dr. Marina Salvadori, Chair of the MMR-WG provided an overview of the key themes and issues discussed during the Working Group meeting on June 2, 2015. The 5 key issues discussed as priorities were: (1) Review of the evidence on long-term immunity following immunization prior to 12 months of age; (2) Review of the optimal timing for routine MMR vaccine administration; (3) Administration of intravenous (IV) versus intramuscular (IM) immunoglobulin (lg) to pregnant and immunocompromised individuals for post-exposure prophylaxis; (4) Review of current travel recommendations; and (5) Review of the Canadian Immunization Guide (CIG) measles chapter.

Federal Led Action Plan on Vaccine Research, Innovation Development: Vaccine Priorities

Dr. Erling Rud, Senior Science Advisor for the Centre for Immunization and Respiratory Infectious Diseases provided a presentation on a draft Federal-Led Action Plan on Vaccine Research, Innovation and Development. The purpose of the presentation was to share the findings from consultations with the academic sector, industry, provinces and territories, medical experts, and other stakeholders on priority human and animal pathogens for vaccine research and development and to provide a status update on the draft Action Plan. The timeline and process for the finalization and release of the Action Plan has not been set at this time.

Evidence-based Methodology Working Group (EBM WG)

Survey on Evaluation of NACI Products and Processes Update

An update on the Evidence-Based Methodology Working Group’s activities, timelines and next steps was provided. The results of a critical appraisal of NACI statements using the AGREE II (Appraisal of Guidelines for Research & Evaluation) Assessment Tool were reviewed. Overall the appraisal indicated that NACI guidance products have improved over time and are comparable in quality to other similar guidance documents. NACI products scored highest in the “scope and purpose” and “clarity and presentation” domains.

The preliminary results of a survey on NACI Products & Processes (April 14, 2015 to May 19, 2015) were reviewed. A total of 656 people responded to the survey. The majority of respondents rated NACI statements and the Canadian Immunization Guide trustworthy and of high quality.

GRADE information sessions are being organized to support the EBM WG activities by providing an overview the steps and procedures used in the GRADE process.

Liaison and Ex-officio Representative Updates

Updates were provided by liaison and ex-officio representatives including the: Association of Medical Microbiology and Infectious Disease Canada, Canadian Immunization Committee, Biologics and Genetic Therapies Directorate (Health Canada), Canadian Association for Immunization Research and Evaluation, Canadian Paediatric Society, Canadian Public Health Association, US Centers for Disease Control and Prevention, Committee to Advise on Tropical Medicine and Travel, College of Family Physicians of Canada, Council of Chief Medical Officers of Health, First Nations and Inuit Health Branch, Health Canada, Marketed Health Products Directorate (Health Canada) and the Vaccine Safety Section (Public Health Agency of Canada).

Vaccinating Against Pain

Dr. Anna Tadio from the University of Toronto presented on research findings and clinical practice guidelines on pain and vaccination. The presentation reviewed the following topics: (1) rationale for reducing pain during vaccine injections, (2) methods used to develop and update clinical practice guidelines for reducing pain and fear during vaccine injections across the lifespan, and (3) recommendations.

CIG Part 1 Vaccine Administration Practices

Dr. Caroline Quach-Thanh presented a comparison between the recommended interventions against vaccine pain in HELPinKIDS and the Canadian Immunization Guide (CIG) text. Further review and comparison will be undertaken as part of the overall review of the CIG Vaccine Administration Practices chapter currently listed on the work plan.

Vaccine Safety Working Group (VS WG) Update

Dr. Blair Seifert, Working Group Chair provided an update on the VS WG activities. Several teleconferences of the VS WG were held to review and provide comments on the CIG Vaccine Safety Section and review and prioritize the NACI work plan safety-related topics.

Canadian Immunization Guide Vaccine Safety section

Dr. Barbara Law proposed revisions to the presentation of vaccine safety information in the CIG, Part 2 and 4, using the HPV chapter as an example, including the use of terms for AEFI frequency reporting (i.e., very common, common, uncommon, rare, very rare). NACI agreed to the general direction for the revisions. The VS WG will continue to map out the presentation of vaccine safety information in the CIG.

NACI Executive Secretary, General Business

The NACI Executive Secretary gave a brief overview of NACI business and activities in progress, including expected timelines. In regards to the recent call for membership to fill existing vacancies, applications have been received and are being reviewed with the NACI Chair and Vice-Chair. An overview of the vaccine industry pipeline submissions was also provided, highlighting additions and changes since the February meeting. The NACI Executive Secretary noted that as previously discussed the activation of the meningococcal and pertussis working groups are the next priorities, following the completion of products by currently active working groups.

Update on Live Attenuated Influenza Vaccine (Astra Zeneca)

Astra Zeneca provided an update on Live Attenuated Influenza Vaccine (LAIV) effectiveness.

Live Attenuated Influenza Vaccine

Dr. Deepali Kumar, Chair of the ad-hoc Live Vaccine Administration Working Group, presented three options for text to be included in the 2015-2016 seasonal influenza vaccine statement regarding the optimal intervals for the administration of LAIV and other live vaccines. The Ad-hoc working group reviewed evidence on potential immunologic interference following concomitant and sequential (less than 4 weeks apart) administration. NACI approved text will be incorporated into the 2015-2016 seasonal influenza vaccine statement.

Statement of Seasonal Influenza Vaccine for 2015-16

Dr. Nadine Sicard presented seven items and editorial changes for the 2015-2016 seasonal influenza statement for NACI review and approval: (1) inclusion of Fluad PediatricTM, (2) Choice of product for children 6-23 months, (3) Paediatric considerations for choice of product in regards to Influenza B, (4) Recommendation for LAIV and Children with cystic fibrosis, (5) Recommendation for Q-LAIV using evidence from trivalent LAIV, (6) Update on decreased LAIV effectiveness seen in the USA, and (7) Optimal interval for administration of LAIV and other live vaccines (as per agenda item above).

Statement: Hepatitis A

Dr. Bonnie Henry provided an update on the Hepatitis Working Group. The Hepatitis A statement update was presented for NACI review. The statement update will be revised and NACI approval will be sought following the meeting. The Hepatitis B statement has been delayed pending results from an HBV study currently underway in British Columbia.

National Immunization Strategy (NIS)

Ms. Gina Charos, Centre for Immunization and Respiratory Infectious Diseases provided an update on the Public Health Network review of the NIS.

Common Vaccine Guidance

The Executive Secretary , Robert Lerch provided an update on the work underway since the February 2015 meeting on Common Vaccine Guidance including the integration of additional elements into one vaccine guidance process (i.e. acceptability, economic evaluation). The development of a common vaccine guidance process will be continuing over the summer and fall.

Adjournment

The Chair thanked members for their contributions.


Summary of Discussion February 4-5, 2015 Meeting, Ottawa, Ontario

Summary of Discussion February 4-5, 2015 Meeting, Ottawa, Ontario
AGENDA ITEM SUMMARY

Welcome and Introduction

The Chair, Dr. Ian Gemmill, welcomed participants to the meeting. The Chair introduced two new Ex-officio representatives, Althea House, Acting Director, Influenza and Other Respiratory Infectious Diseases Division, Public Health Agency of Canada (the Agency) and Dr. Tom Wong, First Nationals and Inuit Health Branch, Health Canada.

Dr. John Spika, Director General, Centre for Immunization and Respiratory Infectious Diseases provided a short debrief from the recent Canadian Immunization Conference. He alerted NACI to the recently completed revision of the resource, A Parent's Guide to Immunization (first published in 2009), which is now ready for distribution. Dr. Spika also informed NACI that as part of a pilot regarding collaboration among immunization guidance producers, a liaison representative from the Comité sur l'immunisation du Québec (CIQ) has been invited to join NACI.

Developing an analytical framework for the post-implementation evaluation of Immunization Programs in Canada

Dr. Maria Eugenia Espinoza provided a presentation on a standardized logic model for the post-implementation of Canadian immunization programs, identifying vaccination program objectives, resources, activities, outputs and outcomes at different levels, as well as their interrelations. The model can assist in optimizing planning, implementation and communication and capacity building activities.

The model is currently being validated, looking at its overall structure, components, level of complexity, and value in regards to monitoring and evaluation purposes. As part of a consultative process, the framework has been previously presented to various stakeholder groups across Canada, as well as to the Agency. The framework can be helpful in the identification of deficiencies and areas for improvement in immunization programs. Following validation there are plans to undergo pilot testing of the model.

Evidence-based Methodology Working Group (EBM WG)

An update was provided on the progress of the EBM working group, which was initiated to review NACI's methodology and provide recommendations for improvement. A project charter summary was presented, which included the objectives, activities (phases) and deliverables. The critical appraisal of select NACI products with the AGREE II tool is underway. A draft survey questionnaire to collect stakeholder views/opinions on NACI's methodology and products was presented for discussion, including the distribution strategy. The survey is expected to be ready for dissemination in a couple of months.

Statement: Update on Measles-Mumps-Rubella-Varicella Vaccine (MMRV) and Febrile Seizures

The MMRV and Febrile Seizures statement was initially presented and discussed at the October 2014 meeting. The statement has been updated following the October meeting with input from the Vaccine Safety Working Group. The goal of the statement is to update the available evidence on MMRV and febrile seizures. The statement was approved in principle with some suggested changes but requiring final statement approval be completed via email following the meeting.

Statement: Rotavirus Vaccines and Intussusception

A short statement update discussing risks and benefits of rotavirus vaccination was presented to NACI as per the decision at the June 2014 meeting. The statement includes a review of recent data on intussusception as well as a discussion on benefits of vaccination. The statement was approved in principle with final statement approval following minor changes, to be completed via email following the meeting.

National Immunization Strategy (NIS) Update

The Associate Director General, Centre for Immunization and Respiratory Infectious Diseases provided an update on the Public Health Network review of the NIS.

Vaccine Safety Working Group (VSWG)

As a standing item on the agenda, the Working Group Chair informed NACI that the Working Group will be reviewing, refining and prioritizing safety items from the Canadian Immunization Guide (the Guide)/NACI work plan. The working group continues to meet regularly to review and discuss any new safety evidence/information, including Adverse Event Following Immunization and Canadian Adverse Events Following Immunization Surveillance System data.

Pharmacovigilance Information Session

Dr. Blair Seifert provided a presentation to NACI on pharmacovigilance. The presentation was intended to provide members with general information on pharmacovigilance, safety assessment, tools and specific issues related to immunization including the World Health Organization Global Vaccine Safety Initiative.

Hepatitis A-B Working Group Update

The Working Group Chair provided NACI with an update on activities in progress and next steps. There are currently two statements under working group review. Five issues are under review; the off label use of the Hepatitis A vaccine in infants 6-11 months, the need for / timing of a Hepatitis B (HB) booster in adolescents vaccinated in infancy, the need for a Hepatitis B booster in immunocompromised persons, the risk of Hepatitis B infection in diabetics, and the timing and indications of HBIg. Two additional items will be reviewed by the working group, following NACI discussion during the meeting: (1) Post-exposure prophylaxis in individuals ≥50 years of age and those with chronic liver disease; and (2) Optimal timing of primary HB vaccine and recommendations of a birth dose.

Human Papillomavirus (HPV) Working Group Update

The Working Group Chair presented an update on work plan activities and progress to date including: (1) 2-dose schedule recommendations, (2) minimum intervals for 3-dose schedule (3) immunocompromised patients and (4) nonavalent vaccine. The HPV 2-dose statement is expected to be posted online in the following weeks. The Guide HPV chapter will also be updated based on the 2-dose statement.

Adult Immunization Continuing Medical Education (CME) Update

Information was provided on an online adult immunization CME developed by mdBriefCase with support from the Agency. The eCME, directed to health care workers, highlights new/updated NACI recommendations and provides practical strategies and tips to manage and counsel patients.

Statement: Seasonal Influenza Vaccine 2015-2016

The Working Group Chair presented a literature review on Fluad™ Paediatric for NACI discussion, summarizing the available evidence on the vaccines efficacy, effectiveness, immunogenicity and safety in children 6 to 72 months of age. Resulting recommendations for the vaccine to be included in the 2015-2016 seasonal influenza vaccine statement, expected to be released in summer 2015. The 2015-2016 seasonal influenza statement and remaining items for discussion were presented to NACI.

Recommended Intervals for administration of live vaccines

Following the October 2014 meeting an ad-hoc working group was established to review the evidence and recommendations on the intervals for non-concomitant live vaccine administration. The working group will begin by reviewing intervals for live attenuated influenza and other vaccines. The working group is expected to present to NACI during the June meeting.

Canada Communicable Disease Report (CCDR)/Knowledge Translation

Dr. Patricia Huston, CCDR Scientific Editor, provided an update on the revitalization of CCDR. The CCDR is a peer-reviewed, online, open access journal on infectious diseases in Canada published by the Agency. The CCDR provides regular communications to clinicians, public health professionals and others including national surveillance summaries on infectious diseases and public health guidance. Subscriptions rates have doubled since the work on the revitalisation of the CCDR began.

Currently, NACI statement summary tables are posted on the Agency website with a link to the full statement on publications.gc.ca. As an additional knowledge translation tool, a CCDR summary for NACI statements was discussed and agreed to by members. The CCDR summary will provide key information from the full statement, outlining the methods, results and final recommendations.

General Business

NACI members were provided with a status update on current NACI activities and the overall work plan items.

Liaison and Ex-Officio Representative Updates

Updates were provided by liaison and ex-officio representatives including the: Association of Medical Microbiology and Infectious Diseases Canada (AMMI), Biologics and Genetic Therapies Directorate (Health Canada), Canadian Association for Immunization Research and Evaluation (CAIRE), Centers for Disease Control and Prevention (CDC), Committee to Advise on Tropical Medicine and Travel (CATMAT), Council of Chief Medical Officers of Health (CCMOH), College of Family Physicians of Canada (CFPC), Canadian Immunization Committee (CIC), Canadian Public Health Association (CPHA), Canadian Paediatrics Society (CPS), National Defence and the Canadian Armed Forces (DND), First Nationals and Inuit Health Branch (Health Canada), Marketed Health Products Directorate (Health Canada), and the Society of Obstetricians and Gynaecologists of Canada (SOGC).

Adjournment

The Chair thanked members for their contributions and adjourned the meeting.


Summary of Discussion October 1-2, 2014 Meeting, Ottawa, Ontario

Summary of Discussion June 4-5, 2014 Meeting, Ottawa, Ontario
AGENDA ITEM SUMMARY

Opening Remarks

The Chair, Dr.  Ian Gemmill, welcomed participants to the meeting. The Chair introduced a new liaison representative, Dr. Catherine Mah from the Canadian Public Health Association, and two new ex-officio representatives from Health Canada, Dr. Jim Gallivan from Marketed Health Products Directorate and Dr. Gina Coleman from Biologics and Genetic Therapies Directorate.

Dr. John Spika, Director General, Centre for Immunization and Respiratory Infectious Diseases acknowledged the appointment of Dr. Gregory Taylor as the new Chief Public Health Officer. Dr Spika also informed NACI members that  Dr. Caroline Quach-Thanh will be the incoming NACI Vice-Chair, with her two year term beginning immediately following the meeting.

NACI’s 50th anniversary was acknowledged as well as the important role it has played in Canada since 1964.

Prevalence of  HPV genotypes in HPV-related cancers and cervical pre-cancers in Canada and overview of 9-valent (9vHPV) vaccine program – key results

The presentation by Merck assessed the current evidence on the prevalence of HPV 6, 11, 16, 18, 31, 33, 45, 52 and 58 genotypes in Canada for HPV-related cancers as well as cervical precancerous lesions. The investigational 9-valent HPV VLP vaccine (9vHPV) includes the 4 HPV types (6, 11, 16, 18) in the 4vHPV vaccine and 5 additional oncogenic types (31, 33, 45, 52, 58). The 9vHPV vaccine has the potential to broaden protection for cervical cancer and precancers, as well as for other HPV-related cancers and precancers. An overview of the 9vHPV vaccine clinical development program and results from the clinical trials were provided.

Statement: Human Papillomavirus  2-dose Schedule

An update of the progress to date and draft recommendations were provided to NACI. NACI approved the recommendations with minor edits. Final Chair approval to be sought following the meeting.

Statement on Seasonal Influenza Vaccine for 2015-16

The Influenza Working Group Chair gave a brief description of the agenda item. The following presentations were provided to NACI for consideration in the 2015-16 influenza vaccine statement, as appropriate.

  • Findings of a literature review on Pediatric Fluad® Influenza Vaccine Use in Children 6-72 Months of Age.
  • Findings of a literature review on Fluzone® High-Dose vaccine.
  • A review of evidence on reduced immunogenic responses in young children, 6-72 months, as a potential factor related to differences in product use.

Following the presentations, the new format for 2015-16, combining the Canadian Immunization Guide Chapter on Influenza and the annual statement on seasonal influenza vaccine was presented.

Concomitant Administration of Live Vaccines

NACI members discussed the current recommendation for LAIV administration with other live vaccines and decided that a review of the evidence should be conducted to inform a future committee discussion. An ad-hoc working group is to be established to complete the evidence review and present the findings to NACI.

Risk of febrile seizures following MMRV

A review of the current NACI recommendations and a recent evidence review were presented to NACI. A draft statement update will be completed with the NACI Vaccine Safety and other relevant working groups for further review and consideration by NACI during the February meeting.

Statements: Hepatitis A and B

The Hepatitis A & B Working Group provided an overview of their activities from May to September 2014, including proposed next steps. Five issues were discussed by the working group; the off label use of the Hepatitis A vaccine in infants 6-11 months, the need for / timing of a Hepatitis B (HB) booster in adolescents vaccinated in infancy, the need for a Hepatitis B booster in immunocompromised persons, the risk of Hepatitis B infection in diabetics, and the timing and indications of HBIg. An update and presentation of draft items, if available, will be provided to NACI during the February meeting.

Statement: Varicella Immune Globulin (VarIg) Update

Current NACI recommendations were reviewed as well as drat text for a statement update for an expanded time period for post-exposure management in susceptible persons; 10 days versus 96 hours in the current recommendations. The draft recommendations and statement update will be presented to NACI for final approval either before or during the February meeting.

Statement: Re-Immunization with Polysaccharide 23-Valent Pneumococcal Vaccine (Pneu-P-23)

Recommendations in the Pneu-P-23 statement, approved by NACI in July 2014, were reviewed and confirmed by NACI. The statement will be submitted for the Chair’s final approval following the meeting.

ACIP PCV13 Recommendation for all adults ≥65 years of age

NACI discussed the ACIP approved PCV13 recommendations for all adults ≥65 years of age, which were voted on during an ad-hoc meeting in August 2014. The initiation of a NACI work plan item to be further discussed with the Pneumococcal Working Group.

Liaison and Ex-officio Representative  Updates

The following liaison and ex-officio representatives provided updates from their host organization, if available.

Liaison Representatives: Association of Medical Microbiology and Infectious Disease Canada (AMMI); Canadian Association for Immunization Research and Evaluation (CAIRE); Canadian Immunization Committee; Canadian Paediatric Society (CPS); Canadian Public Health Association (CPHA); Centers for Disease Control and Prevention (CDC); College of Family Physicians of Canada (CFPC); Council of Chief Medical Officers of Health (CCMOH); and Society of Obstetricians and Gynaecologists of Canada (SOGC).

Ex-officio Representatives:  Biologics and Genetic Therapies Directorate (BGTD), Health Canada; Marketed Health Products Directorate, Health Canada; National Defence and the Canadian Armed Forces; Centre for Immunization and Respiratory Infectious Diseases, Public Health Agency of Canada.

Canadian Immunization Guide (the Guide)

An update was provided on the Guide review process and revisions in progress. Feedback was sought from NACI on a proposed review schedule, 2014 to 2018, based on comments received at the NACI June 2014 meeting.

Canadian Communicable Disease Report (CCDR) Canadian Immunization Guide (the Guide) Commentary

A CCDR commentary was published in April 2014 to inform readers of key changes in Part 4 of the Guide, Active Vaccines. NACI agreed that this would be a useful knowledge translation tool going forward to inform readers of future changes in the Guide.

Vaccine Safety Working Group Update

The working group chair provided an update on their activities, including discussion and review of evidence on rotavirus and influenza vaccination and the collection of data on vaccine administration errors.  

Tdap discussion on question regarding vaccination of medical students

PHAC received an inquiry pertaining to the vaccination of medical school students, seeking clarification on the current Tdap recommendations in the Guide. This issue was discussed at the June meeting and brought back to NACI for further discussion and decision. NACI confirmed the interpretation of the recommendations in the Guide; young adult health care workers should be vaccinated when starting clinical work if they have not previously received Tdap in adulthood, regardless of when Tdap was given in adolescence. NACI also noted that there is a need to review the evidence on the timing of the adolescent booster dose at a future meeting.  

General NACI Business

NACI members were provided with a status update on current activities / timelines. NACI members also discussed the committee’s work plan item list and future priorities.

National Immunization Strategy (NIS)

The Associate Director General, Centre for Immunization and Respiratory Infectious Diseases provided an update on the Public Health Review of the NIS.

Summary of Discussion June 4-5, 2014 Meeting, Ottawa, Ontario

Summary of Discussion June 4-5, 2014 Meeting, Ottawa, Ontario
AGENDA ITEM SUMMARY

Opening Remarks

The Chair, Dr. Bryna Warshawsky, welcomed participants to the meeting. The Chair introduced the new Liaison Representative, Ms. Elaine Sartison, from the Canadian Immunization Committee and welcomed back Dr. Jason Brophy, the Liaison Representative from the Canadian Association for Immunization Research and Evaluation. The Chair also welcomed Dr. Shelley Deeks, who has been appointed as a NACI voting member.

As today's meeting marked the end of Dr. Bryna Warshawsky's term as Chair of the committee, Dr. John Spika, Director General of the Centre for Immunization and Respiratory Infectious Diseases expressed his appreciation for the dedication and efforts of Dr. Warshawsky over the past 3 years as Chair. He also informed the group that Dr. Ian Gemmill will be the incoming NACI Chair.

CAPiTA (Community-Acquired Pneumonia Immunization Trial in Adults)

CAPiTA results were presented. The primary outcome of the trial  was to establish the efficacy of Prevnar™13 in the prevention of a first episode of confirmed, vaccine-serotype, pneumococcal community-acquired pneumonia in adults 65 years and older.

Epidemiology of Community Acquired Pneumonia (CAP) in Canada

Dr. Shelly McNeil, Canadian Centre for Vaccinology, Dalhousie University, Nova Scotia, presented data on community acquired pneumonia and invasive pneumococcal disease among hospitalized adults from a Canadian active surveillance network, the Serious Outcomes Surveillance (SOS) network of PCIRN. The data were collected from a subset of SOS network sites, 9 hospitals/facilities; December 2010 to December 2013.

Evidence-based Methodology Working Group (EBM WG)

The NACI EBM WG has been activated to assess and recommend improvements to NACI's current evidence-based methodology and product templates. A draft project charter was presented. The goal of this project is to improve and update NACI's current evidence-based methodology and products by:  identifying and prioritizing key issues and areas for improvement, developing strategies to address priority issues and areas for improvement, and drafting revised templates and processes for improved NACI products. The EBM WG will further develop its membership and timelines, returning to NACI in October with an update.

Facilitated Discussion on Proposals for Common Guidance (CVG)

NACI discussed the Common Vaccine Guidance which is part of the National Immunization Strategy review. The goal of the discussion was to seek insights and suggestions regarding key qualities and features of the common guidance process and products/outputs.

Tdap discussion on the question regarding vaccination of medical students

PHAC received an inquiry pertaining to the vaccination of students entering medical school. The inquirer is seeking clarification on the current Tdap recommendations in the Canadian Immunization Guide (the Guide): all health care and child care workers, regardless of age, should receive a single dose of Tdap vaccine for pertussis protection if not previously immunised in adulthood, even if they are not due for a tetanus and diphtheria booster. Additional information will be sought from NACI members not in attendance at the meeting prior to clarifying the recommendations in the Guide.

Seasonal Influenza

The Influenza Working Group (IWG) Chair provided an update on the 2014-2015 Seasonal Influenza Vaccine Statement.  The Chair of the IWG informed NACI that the statement would be finalized and disseminated to stakeholders this summer, with web publication to follow.

The IWG Chair proposed a new format for the influenza statement and the chapter in the Canadian Immunization Guide (the Guide) following discussions with the IWG and staff within the Agency. The new format is meant to make the products more user-friendly, as well as to make their development more efficient. There are two major stakeholder groups with different needs, which we are trying to meet with the NACI influenza products: 1) the Guide influenza chapter for clinicians who want a resource which is short, summarized, and is easy to use; and 2) the statement for users who require more detailed information and evidence. The proposed format will be used to draft the 2015-2016 statement in order for NACI to decide on whether this is the best approach going forward.

Validity of self-reported history of varicella disease as proof of immunity

A literature review was presented to NACI for their review/discussion. A statement will be drafted by the Varicella Working Group for NACI review and approval.

Canadian Immunization Guide (the Guide) Update

A brief update on the Guide was provided, including the new subscribe feature. This feature will be used to alert subscribers by email when new information or updates have been completed for the Guide and other NACI products. This feature, in addition to the Table of Updates for the Guide, will be used to keep readers up-to-date on NACI recommendations and the evergreen edition of the Guide.

An ongoing review process and schedule to ensure regular updates for the Guide was presented to NACI. Following a transition year, an ongoing cycle of chapters review will be implemented. It was proposed that, in addition to periodic updates to a chapter following the release of a NACI statement/update, chapters will be reviewed on a 4 year cycle. Following further refinement, the process and schedule will be finalized by NACI.

Human papillomasvirus (HPV) Working Group Update

The Working Group Chair for HPV vaccine presented a proposal to have the WG draft a statement update on a 2-dose vaccination schedule, to be completed this summer/fall. NACI agreed to the proposal.

Vaccine Safety Working Group (NACI-VS WG) Update

A status update was provided on the NACI-VS WG. The WG Vice-Chair presented a review of recent data on intussusception following Rotavirus vaccination. This information will be used to inform a short statement update on Rotavirus vaccination for review/approval by NACI. The timing of this review/approval to be determined following the meeting and discussion with the Rotavirus WG Chair.

National Immunization Strategy (NIS)

The Associate Director General, Centre for Immunization and Respiratory Infectious Diseases provided an update on the Public Health Network review of the NIS.

Liaison and Ex-Officio Representative  Updates

Updates were provided by liaison and ex-officio representatives including the: Council of Chief Medical Officers of Health (CCMOH), Canadian Public Health Association (CPHA), Canadian Paediatrics Society (CPS), Association of Medical Microbiology and Infectious Diseases Canada (AMMI), Canadian Immunization Committee (CIC) and the College of Family Physicians of Canada (CFPC).

Adjournment

The Chair thanked members for their contributions and members congratulated the retiring Chair, Dr Warshawsky, for her tireless leadership over the last three years.  The meeting then was adjourned.


Summary of Discussion February 5-6, 2014 Meeting, Ottawa, Ontario

Summary of Discussion February 5-6, 2014 Meeting, Ottawa, Ontario
AGENDA ITEM SUMMARY

Opening Remarks

The Chair, Dr. Bryna Warshawsky, welcomed participants to the meeting. Dr. John Spika, Director General, Centre for Immunization and Respiratory Infectious Diseases (CIRID), Public Health Agency of Canada (the Agency), expressed his appreciation, on behalf of the Agency, for all the hard work and accomplishments of NACI. Dr. Judith Bossé Assistant Deputy Minister was introduced and gave a brief background on herself. Gina Charos, was introduced as the new Director of the Immunization Program and Promotion Division, CIRID. The Chair presented the new Liaison Representatives, Dr. Martin Lavoie, Council of Chief Medical Officers of Health, Dr. Julie Emili, College of Family Physicians of Canada. The Chair also introduced a new Ex-officio, Dr. Diego Garcia, First Nations and Inuit Health Branch, Health Canada, and welcomed them to their first NACI face to face meeting.

Fluzone® High Dose Vaccine and FIM12 Efficacy Trial Results

Sanofi Pasteur presented their data on a randomized controlled trial of Fluzone® High Dose (HD) vaccine compared to standard-dose Fluzone® vaccine. Additionally, Sanofi Pasteur is working on an economic analysis.

Update on the Quadrivalent Influenza Vaccines

An update was given to the group in regards to the procurement process, status update and future plans for the  Quadrivalent Influenza Vaccines.

Cervarix® 2-dose schedule - GlaxoSmithKline

GlaxoSmithKline presented their data on immunogenicity and safety of Cervarix® 2-dose schedule in girls aged 9 to 14 years old.

Presentation of the systematic review on the need for boosting with PPV23

A McGill University Masters student gave a presentation on the systematic review of the literature conducted in order to determine if the optimal timing for the 23-valent pneumococcal vaccine booster for high-risk groups could be established.

Statement: Update on Quadrivalent meningococcal Vaccines available in Canada

An update of the progress to date and the next steps and timelines were provided to NACI. Members then discussed a few key issues which arose during the statement review process.

NACI Work plan

NACI was presented with a revised list of items to be considered for the NACI work plan as well as key activities that should be considered a priority for NACI in the upcoming future. The revised and prioritized list will be further refined with the input received from participants at the meeting.

General NACI Business

NACI members were provided with a status update on current NACI activities.

Liaison and Ex-Officio Representative  Updates

The following liaison and ex-officio representatives provided updates from their organization if updates were available: Council of Chief Medical Officers of Health (CCMOH), U.S. Centers for Disease Control and Prevention (CDC), Canadian Public Health Association (CPHA), Canadian Paediatrics Society (CPS), Association of Medical Microbiology and Infectious Diseases Canada (AMMI), Canadian Association for Immunization Research and Evaluation (CAIRE), The Agency's Canadian Immunization Committee (CIC), College of Family Physicians of Canada (CFPC), Health Canada's First Nations and Inuit Health Branch (FNIHB), The Agency's Committee to Advise on Tropical Medicine and Travel (CATMAT), and Health Canada's Biologics and Genetic Therapies Directorate (BGTD) and Marketed Health Products Directorate (MHPD).

National Immunization Strategy (NIS)

The Associate Director General, Centre for Immunization and Respiratory Infectious Diseases provided an update on the Public Health Network review of the NIS.

Update on the Canadian Immunization Guide (the Guide)

NACI was presented with the current status of the Canadian Immunization Guide (the Guide) renewal.  Recent page views for the the Guide revised chapters were provided, along with an update on the status of the PDFs for each chapter. NACI members were invited to send in feedback requesting other web statistics to help inform how the Guide is being accessed and used.Moving forward with the online version, the plan is to update all chapters by February 2016. The Working Group Chairs and NACI Chair will be reviewing the chapters as they are prepared.

A short presentation was also given in order to inform NACI on how the Agency and Centre is approaching a strategic and streamlined approach to managing web published information.  NACI was given a live demonstration of how the Centre products will be presented on the Agency web site.

Facilitated Discussion on Common Guidance Development

NACI discussed the Meningococcal B statement and process as an example of guidance that includes both scientific and programmatic recommendations.

Manufacturers Guidelines comments from Vaccine Industry Committee

This agenda item was deferred.

Literature Review Process and Approval

An issue discussed at the last NACI Executive meeting regarding the ownership, review and approval of literature reviews was brought forth to NACI and subsequently discussed by the group.

Evidence-based Medicine Working Group brainstorming

This agenda item was rescheduled and is to be discussed at the June 2014 NACI face to face meeting.

Adjournment

The Chair thanked members for their contributions and the meeting was adjourned.


Summary of Discussion October 9-10, 2013 Meeting, Ottawa, Ontario

Summary of Discussion October 9-10, 2013 Meeting, Ottawa, Ontario
AGENDA ITEM SUMMARY

Opening Remarks

The Chair, Dr. Bryna Warshawsky, welcomed participants to the meeting. Dr. John Spika, Director General, Centre for Immunization and Respiratory Infectious Diseases (CIRID), Public Health Agency of Canada (the Agency), expressed his appreciation, on behalf of the Branch, for all the hard work and accomplishments of NACI. He informed participants of the significant increase in Agency web page views for the revised Canadian Immunization Guide chapters posted to date. Dr. Spika also informed NACI members that a call is being prepared to solicit applicants for the current vacancy on the committee as well as other upcoming vacancies over the next few years.

Statement: 2014-15 Seasonal Influenza Vaccine Statement and Literature Review

The Influenza Working Group (IWG) chair provided members with some background information on the discussion that occurred on the previous NACI teleconference on the preferential recommendation for LAIV use in children and adolescents 2-17 years of age. Two options for revised wording for the recommendation were presented to the committee for a vote. The revised recommendation will be finalized following the meeting, and following Agency approval, it will be disseminated to immunization stakeholders.

Recommendations for healthy 5-18 and 19-64 year olds were discussed based on two literature reviews which were presented to NACI during a recent teleconference. The recommendations and the draft 2014-2015 statement will be discussed in November, with the final statement expected to be ready for dissemination to immunization stakeholders in early 2014. During the November meeting, a literature review on quadrivalent influenza vaccines will also be presented and discussed.

Project Update: Advice for the Use of Four Component Meningococcal Serogroup B (4CMENB) Vaccine

An update of the progress to date and the next steps and timelines were provided to NACI. The NACI relevant components of the statement will be brought back to NACI for final vote pending market authorization. Further discussion on next steps and the overall approval process will be confirmed and shared at an upcoming NACI meeting. The Task Group leading the development of the vaccine guidance document will be meeting later in October to review additional components of the document and discuss process issues.

General NACI Business

NACI members were provided with a status update on current NACI activities. Members agreed on the current format for the status update going forward.

With regard to the Advisory Committee on Immunization Practices (ACIP) meetings, notes are prepared following the meeting and shared with NACI. Members agreed that it would be useful for the ACIP meeting agenda to be shared with the committee when it becomes available. Additionally, members agreed that the notes prepared following the meeting were useful and should be continued.

Voting Process/NACI working groups and voting members on working groups

Issues were raised with regards to the number of NACI members that should be on each working group. During a recent NACI Executive meeting a minimum of 2, in addition to the Chair, was proposed for consideration by NACI. Some members pointed out that some working groups are mainly composed of external experts.

The current Terms of Reference for NACI indicate that a quorum of 2/3 of NACI members is required to authenticate a vote. Although a quorum of 7 members is needed to vote, for a vote to stand in favour of a recommendation 6 members (50% of the full NACI membership) must vote in favour. For working group consensus, a quorum of 2/3 of members is also required.

Another point raised surrounded the need for an objective and fair process to recruit external experts. It was suggested and agreed that a periodic open call be made for external experts for all NACI working groups.

NACI Work plan

NACI was presented with a revised list of items to be considered for the NACI work plan, following presentation of the original list in June 2013. The revised and prioritized list will be further refined with input from within the Agency and external partners/committees.

Statement: Update on the Use of Conjugate Pneumococcal Vaccine for Asthmatics

The draft statement and recommendations was presented to NACI for discussion. Final approval of the statement and its recommendations will take place via email following the meeting.

Statement: Update on the Use of Quadrivalent Conjugate Meningococcal Vaccines

The draft statement and recommendations were presented to NACI for their first review/discussion. The Working Group will be revising and recirculating the draft statement to NACI following the meeting.

Update on the Evergreen Canadian Immunization Guide (CIG)

Recent page views for the CIG revised chapters were provided, noting the significant increase in web traffic since the new chapters have begun to be posted. Individual chapter page statistics will be prepared for an upcoming NACI meeting.

It was proposed to the committee that for some chapters in the Guide, the epidemiology section could be refined and refer readers to epidemiological information posted on other pages on the Agency website. This approach will be piloted and further reviewed. An update schedule for the Guide will be prepared for NACI for future consideration. A feedback mechanism for users of the Guide would be useful. Further consideration will be given to this item.

NACI Methodology and Template

The discussion from the previous NACI meeting on its methodology was continued during the current meeting. It was agreed that there is the need to review and assess the NACI methodology to determine where improvements could be made. As a part of this work, the NACI template will also be reviewed. The item will be added to the list of NACI work plan items for further consideration. The NACI Evidence-Based Working Group will be the vehicle for completing this work.

It was proposed that NACI literature reviews could be published as articles in the Canadian Communicable Disease Report (CCDR) instead of publishing the full review document. NACI members agreed that publishing the full literature review document online is needed in addition to any other knowledge translation and transfer activities.

It was acknowledged that the web publishing of NACI products on the Agency's web site has been delayed due to the new Government of Canada web renewal and accessibility standards. It was proposed that as a short term solution, a summary of a NACI statement could be posted as a CCDR supplement with access to the full document upon request. NACI members again agreed that access to the full document is needed online in addition to any other knowledge translation and transfer activities undertaken.

Timeframes for the development of NACI statements

The addition to the NACI statement review process of an early Canadian Immunization Committee (CIC) review, prior to pre-release, was presented. This was in response to a CIC request for an earlier review of NACI statements. NACI members agreed that a high level review by CIC would be beneficial to CIC as well as NACI. An early review by CIC will be undertaken on a trial basis with clear direction on the type of review and timelines to be included.

Liaison and Ex-Officio Representative Updates

Updates were provided by liaison and ex-officio representatives including the: Council of Chief Medical Officers of Health (CCMOH), Canadian Public Health Association (CPHA), Canadian Paediatrics Society (CPS), Association of Medical Microbiology and Infectious Diseases Canada (AMMI), Canadian Association for Immunization Research and Evaluation (CAIRE), Canadian Immunization Committee (CIC), College of Family Physicians of Canada (CFPC), Department of National Defence (DND), Health Canada's First Nations and Inuit Health Branch (FNIHB), Committee to Advise on Tropical Medicine and Travel (CATMAT), and Health Canada's Biologics and Genetic Therapies Directorate (BGTD).

National Immunization Strategy (NIS)

The Associate Director General, Centre for Immunization and Respiratory Infectious Diseases provided an update on the Public Health Network review of the NIS.

Adjournment

The Chair thanked members for their contributions and the meeting was adjourned.


Summary of Discussion June 5-6, 2013 Meeting, Ottawa, Ontario

Summary of Discussion June 5-6, 2013 Meeting, Ottawa, Ontario
AGENDA ITEM SUMMARY

Opening Remarks

The Chair, Dr. Bryna Warshawsky, welcomed participants to the meeting. Dr. Ian Gemmill was introduced as the new Vice-Chair for NACI. New Liaison representatives, Dr. Shelley Deeks from CPHA and Dr. André Corriveau from CCMOH were introduced and welcomed to NACI. New ex-officio representative, Dr. Paul Eagan from the Department of National Defense and Canadian Forces was introduced and welcomed to NACI. As this was Dr. Shelly McNeil's last NACI meeting, she was thanked for her significant contributions and commitment to NACI over the past 8 years.

Canadian Immunization Guide (CIG) Planning

A status report on the CIG revision was provided. The seven remaining chapters are to undergo second and final NACI review at this meeting. Following the final revisions, the chapters will be sent to Working Group Chair and NACI Chair for approval. The significant effort and commitment of NACI and the CIG team were acknowledged.

The web posting strategy for the CIG was also discussed and members were given an update on the progress and schedule for chapters being posted. Several suggestions were provided on alerting readers to updates including the use of an RSS feed. The NACI/CIG Team will continue to develop the Evergreen plan and circulate to NACI and/or present it at an upcoming meeting for additional input.

First review Part 1 CIG Chapter: Basic Vaccinology

This was NACI's second and final review of the Basic Vaccinology chapter. Members reviewed the issues raised during the first review of the chapter. The chapter was approved with identified edits and changes.

First Review Part 1 CIG Chapter: Storage and Handling

This was NACI's second and final review of the Storage and Handling chapter. Members reviewed the issues raised during the first review of the chapter. The chapter was approved with identified edits and changes.

First Review Part 1 CIG: Recent Administration of Human Ig

This was NACI's second and final review of the Recent Administration of Human Immune Globulin Products chapter. Members reviewed the issues raised during the first review of the chapter. The chapter was approved with identified edits and changes.

Final review Part 5 CIG Chapter: Passive Immunization

CIG Chapter: Passive Immunization This was NACI's second and final review of the Passive Immunization chapter. Members reviewed the issues raised during the first review of the chapter. The chapter was approved with identified edits and changes.

Final Review Part 4 CIG Chapter/CATMAT: Typhoid

The Committee to Advise on Tropical Medicine and Travel (CATMAT) and NACI reviewed the chapter. This was the second and final review of the Typhoid chapter. Members reviewed the issues raised by NACI and CATMAT during the first review of the chapter. The chapter was approved with identified edits and changes.

Final Review of Part 1 CIG Chapter: National Guidelines

This was NACI's second and final review of the National Guidelines chapter. Members reviewed the issues raised during the first review of the chapter. The guidelines were included in previous editions of the CIG. When these were first created they were developed in consultation with a number of organizations. The chapter will be reviewed to ensure that it aligns with the policy directions of the National Influenza Strategy (NIS) renewal prior to finalization.

Final review Part 1 CIG Chapter: Immunization Records

This was NACI's second and final review of the Immunization Records chapter. Members reviewed the issues raised during the first review of the chapter. The chapter was approved as presented.

CIG Evergreen Process

A process to update/keep up-to-date CIG chapters was presented. Small changes, such as the correction of information, would include a simple review and approval process. Larger changes would require more extensive review and approval processes. The proposed CIG chapter changes would be incorporated by the NACI/CIG Team and approved by the working group and NACI Chair and Vice-Chair. A plan for regular updates to chapters was also included in the strategy. The NACI/CIG Team will further refine the Evergreen plan and circulate to NACI and/or present it at an upcoming meeting for additional input.

Case example: CIG Influenza Chapter

During the last NACI Executive meeting several options for the influenza chapter were discussed. The proposed approach from the Executive meeting was brought forward to NACI for further input. Members agreed that the chapter will follow the CIG template taking text directly from the influenza statement where appropriate. Additionally, the chapter will be approved in tandem with the statement so that they are ready at the same time.

Statement: 2013-2014 Seasonal Influenza Vaccine Statement

The Influenza Working Group (IWG) Chair led the discussion. The definition of health care workers was discussed with members agreeing that the intent of this section in the statement was to be all inclusive of those within the health care setting. Issues surrounding vaccine administration, Guillain Barré Syndrome, vaccine effectiveness evidence, duration of immunity and co-administration with mucosal vaccines were also discussed. The statement will be revised accordingly and circulated to the committee for approval following the meeting.

2013-14 NACI Work Plan Items

In order to inform the 2013-14 work plan, several documents were reviewed to create a list of items for consideration, including the NACI running list of items from the CIG revision. The list of work plan items will be sent to NACI for comment / refinement following the meeting. Once the key questions and issues are identified the work plan items will be prioritized. Once the NACI work plan has been further refined, it will be shared with the Priorities Committee, identified in the NACI Terms of Reference, for comment/input.

NACI General Business

The Status Report on NACI Activities was reviewed. Members were updated on the web posting of CIG chapters and future NACI Statements and Updates.

National Immunization Strategy (NIS)

The Associate Director General, Centre for Immunization and Respiratory Infectious Diseases provided an update on the Public Health Network review of the NIS.

Developing Evidence-based Vaccine Recommendations (DEVR)

An update was provided on the work of the DEVR Committee, the special advisory committee to the ADM-IDPC. The committee, including members from NACI and the Committee to Advise on Tropical Medicine and Travel (CATMAT) assessed different approaches to developing evidence-based recommendations within and external to the Agency. NACI members were asked for feedback on the use of a modified GRADE approach for immunization recommendations. Members did not feel that a modified GRADE approach is needed. They felt that what is needed for NACI is a review of its current methodology and identification of potential elements that could improve current practices.

Statement: Update on the Use of Conjugate Pneumococcal Vaccine for Asthmatics

A literature review and a draft statement were presented to NACI for feedback and comments. The statement will be finalized and approved via email following the meeting.

Statement: Advice for the Use of the Four Component Meningococcal Serogroup B (4CMENB) Vaccine

An update on Meningococcal B Pilot Project Task Group activities and the common guidance document was provided. With the preliminary vote completed by NACI on the scientific recommendations, the task group will now be focusing on the programmatic elements of the document. NACI will be provided with additional updates at an upcoming meeting.

Statement: Update on the Use of Quadrivalent Conjugate Meningococcal Vaccines

A presentation was provided on the issues and products which the NACI Meningococcal working group will be considering. A working group meeting is being planned for the summer to develop a work plan and timeline.

Pertussis in Pregnancy and Post-Partum

As per the discussion at the February 2013 NACI meeting, a brief pertussis statement has been drafted. The statement was presented to NACI for comments and feedback. NACI was asked to consider the development of a two pager which summarizes the statement. Further comments and NACI approval of the statement will be sought via email.

Statement: Update on the Use of Herpes Zoster Vaccine

Following the last review of the statement update by NACI, there were changes made in the recommendations of the statement. The revised recommendations were presented to NACI for comment/feedback. NACI members are to send in any additional comments following the meeting. The statement will be revised and sent to NACI for final approval via email.

Statement: Update on Human Papillomavirus (HPV) Vaccines

A summary of the recent NACI HPV working group meeting was provided. The working group meeting included two presentations on a 2-dose versus a 3-doses vaccine series. The working group would like to proceed with the evaluation of the evidence and the development of a statement update on a 2-dose series. The proposed HPV statement update will be assessed and prioritized as part of the overall NACI work plan items.

Biologics and Genetic Therapies Directorate (BGTD)

An overview was provided on the Canadian Regulatory process. Although there is a product monograph template, NACI members felt that the presentation of the information could be improved.

Liaison Representatives/Ex-officios Updates

Updates were provided by liaison representatives and ex-officio members including the: Association of Medical Microbiology and Infectious Disease Canada (AMMI), Canadian Association for Immunization Research and Evaluation (CAIRE), Canadian Immunization Committee (CIC), College of Family Physicians of Canada (CFPC), First Nations and Inuit Health Branch (FNIHB), Canadian Public Health Association (CPHA), Council of Chief Medical Officers of Health (CCMOH), Canadian Paediatrics Society (CPS), Centers for Disease Control and Prevention (CDC), College of Family Physicians of Canada, Department of National Defense and Canadian Forces, Marketed Health Products Directorate (Health Canada), Vaccine Safety Section (the Agency).

Ajournment

The Chair thanked members for their contributions and the meeting was adjourned.


Summary of Discussion February 6-7, 2013 Meeting, Ottawa, Ontario

Summary of Discussion February 6-7, 2013 Meeting, Ottawa, Ontario
AGENDA ITEM SUMMARY

Opening Remarks

The Chair, Dr. Bryna Warshawsky, welcomed participants to the meeting. New NACI member, Dr. Ian Gemmill was welcomed to the committee. New Liaison representative, Dr. Anne Pham-Huy from CAIRE was introduced and welcomed to NACI. She will be replacing Dr. Jason Brophy during his absence. New Ex-officio representatives, Dr. Carole Légaré from Marketed Biologicals, Biotechnology and Natural Health Products Bureau, Health Canada and Dr. Maureen Carew from First Nations and Inuit Health Branch, Health Canada were welcomed to NACI.

Canadian Immunization Guide (CIG) Planning

A status of the CIG revision was provided. Twenty-one of the Part 4 chapters are now web posted. Part 3 chapters are NACI approved and all Part 2 chapters are on the agenda for review during the meeting. Part 5 and 1 are the remaining chapters requiring NACI approval. An operational plan is being developed for the evergreen process. The management of ongoing updates and changes will be considered as part of the operational plan.

First review of CIG Chapter: Vaccine Administration Practices

This was NACI's first review of the Chapter. Members reviewed, discussed and resolved issues raised by the Working Group. The chapter will be revised to incorporate changes from this review and presented to NACI for 2nd/final review at the March 25, 2013 teleconference.

First Review of CIG Chapter: Timing of Vaccine Administration

This was NACI's first review of the Chapter. Members reviewed, discussed and resolved issues raised by the Working Group. The chapter will be revised and presented to NACI for 2nd/final review at the March 25, 2013 teleconference.

Second review of CIG Chapter: Vaccine Safety

This was NACI's second review of the Chapter. Issues which were previously raised by NACI and the Working Group have been resolved in consultation with the Biologics and Genetic Therapies Directorate (BGTD). The purpose of this review was to address new issues. Following todays review the chapter will be further reviewed by the designated Working Group and NACI reviewers and then sent to the Working Group and NACI Chair for approval.

Second review of CIG Chapter: Contraindications and Precautions

This was NACI's second review of the chapter. The purpose of the chapter is to orient the end user so they are able to find the information they need on contraindications and precautions. Following todays review the chapter will be further reviewed by the designated Working Group and NACI reviewers and then sent to the Working Group and NACI Chair for approval.

Second review of CIG Chapter: Early Vaccine Reactions including Anaphylaxis

This was NACI's second review of the chapter. Following incorporation of the changes suggested today, the chapter will be further reviewed by the designated Working Group and NACI reviewers and then sent to the Working Group and NACI Chair for approval.

Second review of CIG Chapter: Anaphylaxis hypersensitivity to egg chapter

This was NACI's second review of the chapter. Following incorporation of the changes suggested today, the chapter will be further reviewed by the designated Working Group and NACI reviewers and then sent to the Working Group and NACI Chair for approval.

Second review of CIG Chapter: Smallpox

This was NACI's second review of the chapter. Following incorporation of the changes suggested today, the chapter will be sent to the Working Group and NACI Chair for final approval.

First review of CIG Chapter: Tick-Borne Encephalitis

This was NACI's first review of the chapter. Members from the Committee to Advise on Tropical Medicine and Travel (CATMAT) participated in the agenda item via teleconference. The chapter will be revised and sent for second review and approval by email.

Vaccine Safety Working Group (VS WG)

The purpose of this item was to review and obtain comments on the working group's draft Terms of Reference (ToR). The draft ToR are to be updated as per NACI's feedback, and following these reviews and revisions, the document will be sent to the NACI-VSWG and the NACI Chair for further comments and approval.

Liaison Representative and Ex-officio Updates

Updates were provided by liaison representatives and ex-officio members including the: Association of Medical Microbiology and Infectious Disease Canada (AMMI), Canadian Association for Immunization Research and Evaluation (CAIRE), Canadian Immunization Committee (CIC), College of Family Physicians of Canada (CFPC), First Nations and Inuit Health Branch (FNIHB), Canadian Public Health Association (CPHA), Council of Chief Medical Officers of Health (CCMOH), Canadian Paediatrics Society (CPS), Centers for Disease Control and Prevention (CDC), College of Family Physicians of Canada, Biologics and Genetic Therapies Directorate (BGTD - Health Canada), First Nations and Inuit Health Branch (Health Canada), Marketed Biological, Biotechnology and Natural Health Products Bureau (Health Canada), Pandemic Preparedness Division, Centre for Immunization and Respiratory Infectious Diseases (PHAC), Vaccine Preventable Diseases, Centre for Immunization and Respiratory Infectious Diseases (PHAC).

NACI Statement: 2013-14 Seasonal Influenza Vaccine Interim Statement Swine and Poultry Workers

The Influenza Working Group (IWG) Chair provided additional background information on influenza vaccination and swine and poultry workers since the October 2012 NACI meeting in addition to options for inclusion of specific recommendations in the 2013-2014 statement.

The Chair presented the 2013-2014 interim seasonal influenza statement. The timing of the influenza interim and full statements was discussed. The 2013-14 Interim statement will be adjusted as per the decisions made and a revised draft will be sent to NACI for final approval. The Working Group Chair presented the IWG ToR, which were recently revised based on the approved NACI ToR, for approval. The IWG ToR was approved and NACI members were advised to send any additional comments to the IWG chair following the meeting.

NACI Statement: Pertussis / Polio / Addressing the Quadracel® Shortage

The focus of this agenda item was to update NACI on the progress of the statement update and to obtain general feedback on the current draft. The final statement, which will include the recommendations, is expected to be ready for NACI review and approval in March. The focus of the work group, as per the request from CCMOH, is on the pertussis and polio vaccine components and not specifically diphtheria or tetanus.

Pertussis - Potential approach to more timely NACI products

At the October 2013 meeting, NACI requested that the Pertussis Working Group consider the issues of vaccination in pregnancy, recommendations for and effectiveness of cocooning strategies and waning immunity in adolescents and adults. The priority issue for the working group is to review vaccination in pregnancy as this is the higher priority at this time. The working group will aim to have the first draft of the statement ready for the June meeting.

NACI Terms of Reference (TOR)

The Associate Director General informed the Committee that the updated NACI ToR has been approved by the Assistant Deputy Minister, Infectious Disease Prevention and Control Branch. Following the meeting, the selection process for the Vice-Chair will be initiated. As per the approved NACI ToR, the Vice-Chair will be appointed for a 2 years term with the potential for a one year extension.

General NACI Business

The Status Report on NACI Work Plan Activities was provided to members for their information.

Update on Meningococcal B Pilot Project

A status update on the Meningococcal B pilot project was provided. The updated literature review and the draft NACI statement and recommendations were presented to NACI. NACI members are to review and provide additional comments on the literature review and the draft statement following the meeting.

NACI Statement: Update on Herpes Zoster

The focus of this agenda item was to provide an update on work to date and to present a draft of the herpes zoster statement update for review and comment. The statement will be sent to NACI for a second review and approval via email following the meeting.

National Immunization Strategy (NIS)

The Associate Director General, Centre for Immunization and Respiratory Infectious Diseases provided an update on the Public Health Network review of the NIS.

Adjournment

The NACI Chair thanked members for their contributions and adjourned the meeting.


Summary of Discussion October 3-5, 2012 Meeting, Ottawa, Ontario

Summary of Discussion October 3-5, 2012 Meeting, Ottawa, Ontario
AGENDA ITEM SUMMARY

Opening Remarks

The Chair, Dr. Bryna Warshawsky, welcomed participants to the meeting. Dr. John Spika, Director General (DG), Centre for Immunization and Respiratory Infectious Diseases (CIRID), Public Health Agency of Canada, introduced the NACI team from CIRID.

Canadian Immunization Guide (CIG) Planning

Part 4, disease specific chapters of the Canadian Immunization Guide, are planned for release at the Canadian Immunization Conference, December 3-5, 2012 in Vancouver, BC. Following this, revised and new chapters will continue to be posted incrementally as they are completed.

CIG Wording for "No known allergies" (consistency issue across chapters)

Where applicable, Part 4 chapters will specify that there are no known allergens for specific vaccines. This will be applied to chapters is progress and will be revised in chapters already approved when they undergo future changes/updates.

First review of CIG Chapter: Chronic Diseases Chapter

The chapter was reviewed. Following discussion it was decided that further details/clarification should be provided on influenza immunization and specifically around the use of live attenuated influenza vaccine. The chapter will also need to clarify the best practices around intramuscular injections for patients with bleeding disorders or taking long-term anticoagulant therapy.

First Review of CIG Chapters: Typhoid

Members of the Committee to Advise of Tropical Medicine and Travel (CATMAT) participated in the discussion via teleconference. The chapter was reviewed and included a discussion on when typhoid vaccine is indicated for travellers. Following the discussion it was decided that further clarity is required around vaccine effectiveness in young children, minimum age for vaccination, decreased gastric secretions, antibiotics and the oral vaccine, and the time interval for boosting with the oral vaccine.

First Review of CIG Chapters: Travellers

Members of the Committee to Advise of Tropical Medicine and Travel (CATMAT) participated in the discussion via teleconference. The chapter was reviewed. The following items were discussed: measles vaccination for infants traveling to an endemic country, need to distinguish between an infant who is going to an endemic country and an infant who is in an endemic area and is coming to Canada, and the need to emphasize the increased risk for varicella with travel.

NACI Statement: 2013-14 Seasonal Influenza Vaccine Statement

Literature was presented on influenza vaccination and commercial swine and poultry workers. This item was added to the February NACI meeting agenda to allow further evidence to be gathered.

NACI Statement: Pneumo 13 Adult Indication

A preliminary review of the recommendations was completed with further discussions and review of the draft statement to occur following the meeting.

Liaison Representative and Ex-Officio Updates

Updates were provided by liaison members including the: Canadian Immunization Committee (CIC), Department of National Defence (DND), Health Canada's First Nations and Inuit Health Branch (FNIHB), Canadian Public Health Association (CPHA), Canadian Association for Immunization Research and Evaluation (CAIRE), Committee to Advise on Tropical Medicine and Travel (CATMAT), Council of Chief Medical Officers of Health (CCMOH), Association of Medical Microbiology and Infectious Diseases Canada (AMMI), Canadian Paediatrics Society (CPS), US Centers for Disease Control and Prevention (CDC), and Health Canada's Biologics and Genetic Therapies Directorate (BGTD).

Canadian Immunization Committee (CIC) Two-Dose Varicella Statement

The CIC sought NACI feedback on whether Canadian varicella recommendations would be impacted by a US article on universal varicella vaccination. It was decided that at this time there is no need to adjust the current NACI recommendations.

Zoster Vaccine and Low Dose Immunosuppressive Therapy

NACI currently recommends that herpes zoster vaccine should not be given to individuals taking most immunosuppressive medications, while ACIP has specific recommendations related to immunosuppressive medication which permits vaccination with herpes zoster vaccine when the patient is taking some low dose immunosuppressive agents. It was decided that an updated to the zoster statement should be completed and brought to the NACI February 2013 meeting. The update would review the issue of low dose immunosuppressive medication and zoster immunization, as well as vaccination following an episode of herpes zoster, herpes zoster ophthalmicus in those with a previous episode of herpes zoster ophthalmicus, and concomitant administration of herpes zoster vaccination and pneumococcal vaccine.

Pertussis Vaccination in Pregnancy

In 2011, ACIP made a recommendation on the use of pertussis-containing vaccines in pregnancy, with further discussion to take place at their upcoming October 2012 meeting. The NACI Pertussis Working Group is to consider the available evidence and the need for a NACI statement at this time.

NACI and CIC Statement: Meningococcal B Pilot Project

A presentation was provided to update NACI on the Meningococcal B Pilot Project. The pilot is still in its early stages so it is evolving. The pilot is being led by the Meningococcal B Task Group which reports to the Communicable and Infectious Disease Steering Committee (CID-SC) of the Public Health Network. As part of the pilot project, an evaluation will be completed and provided to CID-SC. A meeting with Ontario (PHO), Quebec (INSPQ) and PHAC occurred in August, with a meeting of the full Task Group project team being planned for this fall. The proposed plan is to have NACI review the burden of illness, efficacy/effectiveness and safety of the vaccine as per usual NACI process.

Meningococcal B Literature Review

A presentation was provided on a Meningococcal B literature review conducted by Public Health Ontario.

Issues Arising out of Quadracel® Shortage

A CCMOH task group identified several questions related to longer-term issues surrounding the Quadracel® shortage, which NACI was asked to review. A literature review and draft statement will be completed by NACI and provided to CCMOH.

First Review of Part 3 CIG chapters: Patients with Inadequate Records; New to Canada; and Healthcare Institutions

The chapter, Patients with Inadequate Records, was reviewed. Following revisions, including additional text on repeat immunizations, the chapter will be submitted for approval.

The chapter, New to Canada, was reviewed. Following clarification/additional text on assessing HIV status prior to administration of live vaccines, TB skin testing and BCG vaccination, the global epidemiology of varicella, and vaccination for rubella, the chapter will be submitted for approval.

The chapter, Healthcare Institutions, was reviewed. Following clarification/additional text on influenza vaccination and pregnancy, TB skin testing, avoidance of live vaccines during pregnancy, immunization of children in healthcare institutions according to age, the administration of live vaccines in health care settings, adverse event reporting, and pneumococcal vaccination in long term care facilities, the chapter will be submitted for approval.

Second Review of Part 3 Chapters: Immunocompromised

The chapter was reviewed. Following clarification/additional text on varicella and herpes zoster vaccination, vaccines contraindicated for those with B-cell deficiency and known intact T-cells, and influenza vaccination for those with an isolated IgA deficiency with no concomitant defects in T-cells, the chapter will be sent to NACI for final approval.

Second review of Part 3 CIG Chapters: Adults; and Workers

The Adults chapter was reviewed. Following clarification/additional text on PCV-13 (following completion of the statement on pneumococcal 13-valent vaccine for adults), the distinction between healthy adults at low risk and adults with risk factors, measles vaccination, and opportunistic immunization for polio, the chapter is to be submitted for approval.

The Workers chapter was reviewed. Following clarification/additional text on polio vaccination and travel, influenza vaccination and healthcare workers, hepatitis B vaccination for workers in shelters for the homeless, varicella vaccination, and diphtheria and BCG vaccination for humanitarian relief workers, additional comments will be sought following the meeting.

Other CIG Updates: Anaphylaxis; BCG; and Pregnancy and Lactation

Status updates and outstanding issues were discussed including: administration of epinephrine in the Anaphylaxis chapter; TB skin testing in the BCG chapter; and consideration to changing the name of the Pregnancy and Lactation chapter.

Executive Summary

An update was provided on the status of the Terms of Reference, NACI work plan, Guidelines for Manufacturer Presentations to NACI and NACI Working Groups, and the joint NACI / CATMAT committee on developing evidence-based vaccine recommendations.

Improved National Structures and Processes for Making Immunization Recommendations (INSPIR) and the National Immunization Strategy Task Group (NIS-TG) Updates

The need for improved coordination and efficiencies and reduced duplication in the development of immunization recommendations was emphasized, as per the INSPIR report. NACI was also provided with an update on work to date of the NIS-TG.

Vaccine Industry Committee (VIC) Feedback on INSPIR Report Recommendations

Mr. John Dorsey, outgoing Chair of the Vaccine Industry Committee (VIC), introduced his colleagues and presented VIC's feedback on the INSPIR report recommendations. NACI and VIC discussed issues/solutions. VIC will take the issues raised by NACI back to the full committee to discuss and respond as necessary.


Summary of Discussion May 23-25, 2012 Meeting, Ottawa, Ontario

Summary of Discussion May 23-25, 2012 Meeting, Ottawa, Ontario
AGENDA ITEM SUMMARY

Please note that the NACI Statement on Seasonal Influenza Vaccine for 2012-2013 was approved during a teleconference prior to the May 23-25th meeting.

Opening Remarks

The Chair, Dr. Bryna Warshawsky, welcomed participants to the meeting. The Committee was informed of the resignation of one member, the completion of two terms by another NACI member, and the departure of the Committee to Advise on Tropical Medicine and Travel liaison member. The contributions of these members were acknowledged. Dr. Rainer Engelhardt, the Assistant Deputy Minister (ADM), Infectious Disease Prevention and Control Branch, informed the Committee of the development of the Public Health Agency of Canada's policy on External Advisory Bodies. The policy was developed to ensure transparency and consistency in the approaches used by advisory bodies to provide advice to the Public Health Agency of Canada.

NACI Operational work plan

Resource needs and solutions to support NACI were discussed. There was a decision to develop a detailed operational plan, including resource requirements.

Common Evidence - Based Recommendation Framework

Dr. Ken Scott, the Chair of the Special Advisory Committee (SAC) on the Development of Evidence-Based Vaccine Recommendations (DEVR), provided an update on the committee's activities, which have been focused on completing environmental scans of evidence-based strategies used by other groups.

NACI Statement & Chapter Review Process

NACI review and approval processes were discussed for the Canadian Immunization Guide (CIG). Revised processes were established.

NACI Fall/Winter Teleconference Schedule

A fixed, bi-weekly teleconference schedule was agreed to in order to facilitate the review of the CIG chapters, and discuss other NACI items as required.

Terms of Reference (TOR)

The NACI Terms of Reference (TOR) are being revised so that they align with the Public Health Agency of Canada's policy on External Advisory Bodies. Following further considerations and potential revisions, the TOR will be brought back to NACI for review.

Update on the selection process for NACI Vice Chair

The process for the selection of the NACI Vice-Chair was discussed and will be reflected in the NACI TOR.

Meningococcal B Statement

A presentation was provided to inform NACI members about the progress of the working group to date. The literature review is expected to be ready for review by the working group in June. A draft statement will be brought forward to NACI at an upcoming meeting.

Pneumococcal 13 in Adults

An evidence review is in progress for PNEU-C- 13, including a review of the literature for adult subgroups. Evidence on the efficacy and safety of pneumococcal vaccines in individuals with transplants (liver, kidney, bone marrow, stem cell), persons with HIV infection, and in the elderly were reviewed and discussed. A statement will be prepared by the Working Group for NACI review. Data on the immunization of asthmatic individuals for the prevention of invasive pneumococcal disease (IPD) was also presented.

Improved National Structures and Processes for making Immunization Recommendations (INSPIR) and National Immunization Strategy- Task Group

The NIS-TG is assessing the mechanisms and processes for the development of immunization statements in Canada. The Meningococcal B statement was identified as a pilot project.

Liaison Member Updates

Updates were provided by Liaison members including: the Canadian Immunization Committee, Department of National Defence, Health Canada's First Nations and Inuit Health Branch, College of Family Physicians of Canada, Canadian Public Health Association, US Advisory Committee on Immunization Practices, Canadian Association for Immunizations Research and Evaluation , Committee to Advise on Tropical Medicine and Travel Health, Council of Chief Medical Officers of Health, Association of Medical Microbiology and Infectious Diseases Canada and Canadian Paediatric Society.

Exacerbation of Herpes Zoster Ophthalmicus following Zoster virus vaccination

A presentation summarizing available information was provided. It was decided that an updated Herpes Zoster statement should be prepared to provide an update on information on herpes zoster ophthalmicus following vaccination in those with previous herpes zoster ophthalmicus.

The frequently asked question, when to give zoster vaccine to those who want it after an episode of zoster, was also discussed. Based on expert opinion, it was decided that if vaccination is given after zoster, an interval of a year is recommended. In addition to including this in the updated statement, it will need to be included in the CIG.

CIG: Meningococcal Chapter

Following a discussion of booster doses for high-risk groups and re-vaccination following an exposure or during an outbreak situation, the chapter was revised and approved by NACI.

CIG: HPV Chapter

Vaccination of the following groups/indications was discussed: girls and women, boys and men, immunization after the onset of sexual activity and during breastfeeding. Following discussion and voting by NACI members, the chapter was approved with changes.

CIG: Immunocompromised Persons Chapter

This was the first review of the chapter by NACI. The following topics were discussed: Isolated IgA deficiency and live vaccines, dosing for Human papillomavirus vaccine, Hepatitis B virus vaccine, and immunosuppressive medications. All NACI WG chairs were asked to check for consistency with their specific chapter. The immunocompromised chapter will be revised based on input from the meeting and will be presented to NACI for final review this fall.

CIG: Hepatitis A Chapter

Discussion included risk factors, yeast protein, haemophilia, and travel-related vaccinations. The chapter was approved with the changes.

CIG: Hepatitis B Chapter

Discussion included the assessment of hepatitis B immune status, and the timing of administration of Hepatitis B immunoglobulin following sexual contact and needlestick injuries. The chapter was approved with changes.

Vaccine Safety Working Group

NACI reviewed and discussed the roles of different committees working on vaccine safety-related issues. A NACI Vaccine Safety Working Group was proposed and feedback was provided on a draft Terms of Reference (TOR). Following approval of the revised NACI Terms of Reference, the Vaccine Safety Working Group TOR will be revisited.

CIG: Vaccine Schedules

The immunization tables in the chapter were reviewed, with specific issues discussed for: Table 1: Routine Immunization Schedule for Infants and Children; Table 2: Routine Immunization Schedule for Children less than 7 Years Not Previously Immunized; Table 3: Routine Immunization for Children > 7 Years of Age up to 17 Years; Table 4: Immunization Schedule for Children at Risk; Table 5: Adults Not Previously Immunized; Table 6: Adults Previously Immunized - Additional Doses; and Table 7: Adults at Risk. Following revisions to the tables they will be sent to NACI members for review.

CIG: Chronic Disease Chapter

Discussion included the scope and depth of the chapter, and the list of chronic conditions to be included. The chapter will be revised based on the discussion and a new version will be sent to NACI for review this fall.

CIG: Rotavirus Chapter

Discussion included the timing of doses and intussusception. The chapter was approved by NACI with changes.

Guidelines for Manufacturer Presentations to NACI and NACI Working Groups

A presentation was provided on the revised Guidelines for Manufacturer Presentations to NACI and NACI Working Groups. Issues identified by the Vaccine Industry Committee were discussed. Following additional changes, based on the items discussed during the meeting, the Guidelines will be sent for approval within the Public Health Agency of Canada.


Summary of Discussion February 8-10, 2012 Webex Meeting, Ottawa, Ontario

Summary of Discussion February 8-10, 2012 Webex Meeting, Ottawa, Ontario
AGENDA ITEM SUMMARY

National Immunization Strategy Task Group (NISTG) - Improved National Structures and Processes for Making Immunization Recommendations (INSPIR)

The Immunization Director, Danielle Poulin, advised members that the recommendations of the INSPIR report will be considered in the context of the NISTG recommendations anticipated on or before July 2013. However, the NISTG target date to implement outcomes of the INSPIR and NISTG strategy is unknown at this time. There are many strategies being considered - some that may affect the spectrum of factors that NACI will be expected to consider when making evidence-based recommendations.

Influenza Literature Review, Draft Interim Statement & Full Statement on Seasonal Influenza Vaccine for 2012-13

The NACI Influenza Working Group is actively working on a literature review of healthy children 24-59 months of age. The literature review will inform the 2012-13 statement with the inclusion of healthy children 24-59 months as recommended recipients of the seasonal influenza vaccine. The draft Interim Statement is in progress and the e-version is anticipated to be ready for distribution to stakeholders by February 17, 2012 to inform vaccine procurement and programs for 2012-13. The full statement is expected to be posted on the Public Health Agency of Canada (PHAC) web site in the summer of 2012. A draft will be presented to NACI in May 2012.

Meningococcal B Statement

The NACI Meningococcal Working Group has met by teleconference. They have received presentations from PHAC and some provinces regarding epidemiology, as well as a presentation on a candidate vaccine. They are scheduled to meet several times this winter/spring to discuss and work on statement development. A literature review is planned.

Canadian Immunization Guide (CIG): Meningococcal Chapter

The draft Meningococcal Chapter was reviewed. The key issues discussed were:

  1. Recommendations and schedules for high risk children and adults, including the need for booster vaccination;
  2. Re-vaccination of contacts of cases;
  3. Whether those with HIV should be included in the high risk group; and
  4. Vaccination of infants.

The Meningococcal chapter has been consistency checked and a chronic disease section has been included. The working group met on January 16, 2012 and the subsequent revised draft has been reviewed by the Working Group Chair.
The NACI Meningococcal Working Group will make relevant revisions in the NACI Statement Update on Conjugate Quadrivalent Meningococcal Vaccines (already reviewed and approved by NACI) and will circulate these changes to NACI for final review upon Working Group approval.

Canadian Immunization Guide: Bacille Calmette-Guérin (BCG) Chapter

The draft BCG chapter was reviewed. A PHAC tuberculosis expert will review the chapter.

Canadian Immunization Guide: The Human Papillomavirus (HPV) Chapter

The draft HPV chapter was reviewed.

CIG Progress and Update

The schedule for the remainder of the Part 4 Chapters was presented to NACI. Although ambitious, NACI agreed to the schedule due to the importance of these chapters to healthcare providers in Canada.

In the meantime, work has begun on the Immunocompromised and Chronic Diseases Chapters in Part 3.

A plan for completion of the guide will be presented at the NACI meeting in May 2012.

NACI Statement Products

The NACI Executive Secretary presented a proposal for NACI products which include: 1) Literature Reviews 2) Interim Statements; 3) NACI Statements; and 4) NACI Statement Updates. The products are intended to share NACI recommendations with stakeholders with differing needs in a timely and user friendly way. An in depth description of each product, timelines for release, and target audiences was presented. It was noted that the Canadian Immunization Guide will be maintained as an evergreen document by incorporating changes as they arise from these NACI products.

There was a suggestion to ensure products are flexible enough to accommodate new indications for old vaccines as well as new vaccines.

Evidence-Based Recommendations

A subcommittee for Developing Evidence-based Vaccine Recommendations (DEVR) has been formed to develop options for a common approach for developing evidence-based vaccine recommendations. This sub-committee is chaired by Dr. Ken Scott, Senior Medical Advisor to the Assistant Deputy Minister of The Infectious Disease Prevention and Control Branch, and includes membership from NACI and the Committee to Advise on Tropical Medicine and Travel (CATMAT). The expected outcomes of this group are that: 1) Evidence-based immunization recommendations from PHAC's expert advisory committees on immunization should reflect the advances in evidence-based medicine and take into account any resource implications associated with these approaches, and 2) The subcommittee will develop and present options and recommendations for the revision of the processes to develop evidence-based immunization recommendations to be reviewed and discussed by NACI and CATMAT. It was confirmed that NACI and CATMAT will be kept informed of the progress of the subcommittee, and proposed changes to current processes will be discussed with the committees before any changes are made.

Liaison Member Update

The Canadian Association for Immunization Research and Evaluation (CAIRE) has held recent meetings in Ottawa relevant to NACI. At a two-day education session regarding education of vaccine providers, there was discussion as to how NACI statements could better serve end users. At a one-day meeting entitled "Smoothing the Path to New Vaccine Development", various stakeholders including PHAC, the Biologics and Genetic Therapies Directorate (BGTD), provinces, CAIRE, and industry came together to identify how to improve collaboration and smooth the pathway for new vaccines. Summary reports of both meetings are being prepared. Finally, CAIRE will host a 'Vaccine Science Day' prior to the beginning of the Canadian Immunization Conference in December, highlighting Canadian vaccine research.

Canadian Paediatric Society (CPS) The HPV statement will be updated to include a recommendation for vaccination of boys. The FluMist and Influenza vaccine notes will be updated when the NACI statement is available.

The Canadian Public Health Association (CPHA) The CPHA annual meeting for 2012 is June 11-14 in Edmonton. There will be an environmental theme but there are immunization sessions in the program as well that may be of interest.

In addition, the Immunization Competencies Education Program, sponsored by CPS, was held in Banff in early December 2011. This workshop teaches medical residents and other health professionals about immunization competencies, based on the PHAC document. It is a good way to develop young health professionals as ambassadors for immunization. CPS subsidized the program heavily this year, and it may not be able to continue without unrestricted educational grants from government or other sources.

The Committee to Advise on Tropical Medicine and Travel (CATMAT) is currently working on revising the Evidence Based Medicine process and the Typhoid Statements (using a systematic review process based on GRADE). CATMAT continues to review Canadian Immunization Guide chapters related to travel as they are revised.

The Canadian Immunization Committee (CIC) is currently working on the Rotavirus, Herpes Zoster, 2-dose Varicella, and Human Papillomavirus statements. These may be the last statements developed by CIC.

Wrap up and Future NACI Meetings

The next NACI meeting is scheduled for May 23-25, 2012.
A teleconference focused on the influenza statement is scheduled for May 1, 2012 at 1 p.m. Eastern time.
The fall NACI meeting is tentatively scheduled for October 3-4, 2012.

Additional meetings are scheduled for the following dates:

  • February 6-7, 2013
  • June TBC, 2013
  • Oct TBC, 2013