In response to presentations at the last NACI face-to-face meeting and to letters from NACI to the CPHO, Keith Pritchard, Acting Director of  Immunization Programs at PHAC, and André LeVasseur, Executive Director of the Centre for Immunization and Respiratory Infectious Diseases, expressed their sincere appreciation on behalf of, the Agency and the CPHO for the work of this committee, and provided an outline of PHAC organization, PHAC resourcing for NACI and challenges faced by the Agency and NACI in meeting NACI objectives. They are trying to plan for the future by making linkages with other PHAC partners to ensure the availability of expert resources to NACI.

In discussion of the option of resourcing PHAC medical/technical leads from outside the NACI secretariat, it was noted that it would be difficult for a PHAC employee from a different area of PHAC to understand the NACI processes, how to write statements, follow protocols. Timeliness of statements remains a NACI priority. Any new processes should not put up any barriers to the work that now depends to a great deal on good will. It was noted that liaison members are important contributors to NACI meetings and working groups.

The Centre remains committed to NACI and looks forward to further discussions and feedback. Dr Rainer Engelhardt, ADM of the branch, has expressed interest in attending the next face-to-face NACI meeting.

The draft recommendations on the Cervarix vaccine were reviewed.  The Working Group will be revising and recirculating the draft statement.

A clinical overview was given on the Novartis Fluad vaccine, including its properties as an oil-in-water emulsion, its immunogenicity, and safety data.

This update is being done to integrate recommendations for the PCV-13 vaccine and previous recommendations for conjugate pneumococcal vaccines. It was noted that the degree of benefit conferred by PCV13 and PCV10 depends on the epidemiology (which serotypes are prevalent) in a given jurisdiction. The products have different costs, however, NACI mandate does not currently include cost evaluation. Revised wording of some recommendations was approved; further recommendation votes are needed and will be circulated for discussion via email.

A presentation was given on a proposed template process for presenting statements at  face to face NACI meetings (e.g. purpose of this discussion, previous work done etc). The development of this template process was recommended by the NACI Executive. The process will be piloted with statement presentations at the October NACI meeting.

The draft for the 2010/2011 seasonal influenza statement was presented. The format from previous seasonal influenza statements has been slightly modified to make the influenza statement format closer to the new NACI statement template. There has been no opportunity this year for an extensive literature review. It was agreed that the epidemiology section would focus on the entire H1N1 pandemic (first and second wave). Discussion focussed on potential additional recommended groups for vaccine in 2010-2011: obese, children 2-4 years of age and Aboriginal people.

Outgoing NACI members Allison McGeer and Ben Tan were thanked for their many years of outstanding contributions to NACI.

a) Progress update: A presentation was given on the progress to date with the evergreen CIG, which will be an online, downloadable, user-friendly guide. The goals are for this guide to be timely, accessible, efficient, accurate and effective, which collectively require a balance between the ideal (in terms of perfection and comprehensiveness) and the realistic (in terms of timelines and resources). Overall timelines are tight (completion within 3 years), but it is hoped to launch some Part 4 (Active Immunizing Agents) chapters at the Canadian Immunization Conference in December 2010.  The online CIG will include flags and email alerts for updates and PDA accessibility. Communications plans include creating a dialogue with end users, mitigating the impact of the transition to the new format and improving the uptake of the new format over time. Evaluation will be ongoing. A template has been developed for Part 4 chapters, which is much the same as in the past, as requested by stakeholders, but expands some subheadings. So far, the rabies chapter has been reviewed by the Rabies Working Group, and the Zoster and Varicella chapters are being reviewed by PHAC Medical Leads and Working Group Chairs.  Measles, mumps and rubella chapters are being drafted. All background information for all chapters in Part 4 has been collected. The editor is working on the updates and rewrites for these chapters. After she highlights outstanding technical issues, the revisions go to the epidemiology, immunization coverage, and vaccine safety experts in PHAC, and then to the PHAC Medical Lead and Working Group chair. After as many issues are addressed as possible, the Working Group as a whole reviews the chapter and addresses any outstanding issues.  Final drafts will be reviewed and approved by NACI.

b) New immunization schedule format: Ben Tan presented a new table format for the different immunization schedules (which reverses the listing of vaccines and timing whereby vaccines are listed vertically on the left hand side of the table and timing of vaccinations are listed horizontally on the top of the table). He has used these tables successfully with his medical students. In general the new tables were very well received.  CIRID offered to explore graphic design options to ensure printability, user-friendliness, etc.

c) Adverse events sections: A draft of the new format for the Vaccine Safety section of CIG chapters was presented by PHAC Vaccine Safety staff. For adverse events, the new format will include four components: expected adverse events; rare and unexpected adverse events; events of special interest; and allegations and evidence (if necessary/applicable). These will all be defined. In addition to the adverse events section, Vaccine Safety will include contraindications and precautions.

d) Rabies chapter: The rabies chapter for the CIG has been revised based on the background materials. The Working Groups has gone through about half the revisions. The chapter goes beyond immunizations to describe how to manage rabies. There are a number of outstanding issues, but the Working Group will be looking at these and hoping to resolve most issues before the October NACI meeting. At that time, a cleaner version of the chapter will be circulated, with the outstanding issues highlighted for discussion.

Menveo has just been authorized for use in Canada by BGTD. Work was already underway on NACI recommendations and it is hoped they will be finished soon. One remaining issue is the booster dose/reimmunization. It was agreed that the language needs to be revised to clarify that people in a high risk group AND at high risk of exposure should be considered for revaccination. (Also, laboratory workers and people travelling to or staying for the Hajj should be considered for revaccination.)  NACI members were asked to review recommendations 2 and 3 as well as tables 11 and 12 and to get comments in to the Working Group Chair.

A clinical trial update was presented for CervarixTM, SynflorixTM, and the ArepanrixTM H1N1 vaccine. An update on the seasonal influenza vaccine (Fluviral^® ) was also provided.

As the result of questions from providers, PHAC has prepared recommendations for the use of pH1N1 monovalent unadjuvanted vaccine from the 2009/2010 season for persons who have not yet been vaccinated with pH1N1 and are travelling to areas where the virus is still circulating. This vaccine is not being recommended for persons who are not travelling, and the recommendations would apply until the seasonal trivalent vaccine becomes available. NACI was not asked to endorse the recommendation, but simply to give their advice.

The RSV Working Group has had one teleconference. A literature search has been done and is being reviewed by the WG chair. A draft of the statement will be circulated to NACI members later this summer, with a presentation to be given at the October meeting. 

None were given in person at this meeting. The NACI executive will be following up with AMMI and CAIRE to discusss representation from those organizations.

Next meetings:
October 5-7, 2010, Ottawa
February 8-10, 2011, Ottawa