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National Advisory Committee on Immunization (NACI): Terms of reference

Updated and Public Health Agency of Canada Vice President approved: September 16, 2022

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1.0 Background

The National Advisory Committee on Immunization (NACI) was established in 1964 and currently reports to the Vice President (VP), Infectious Diseases Programs Branch, Public Health Agency of Canada (PHAC).

NACI works collaboratively with the Canadian Immunization Committee, the Pan-Canadian Public Health Network, and PHAC's Committee to Advise on Tropical Medicine and Travel, all of which are part of a national structure addressing immunization issues in Canada.

2.0 Mandate

NACI provides ongoing and timely medical, scientific, and public health advice for routine programs and in urgent situations (such as influenza pandemic) related to Canada's use of:

PHAC retains all decision-making authority, policymaking responsibilities and investigatory responsibilities.

NACI carries out its mandate by advising PHAC on:

  1. The use of vaccines and prophylactic agents in humans. To this end, NACI:
    • summarizes the epidemiology of specific vaccine-preventable diseases
    • summarizes information and evidence on specific vaccines and prophylactic agents, including (but not limited to) vaccine efficacy, effectiveness, immunogenicity, and safety
    • makes evidence-based recommendations
    • makes recommendations based on expert knowledge and practice when evidence is lacking
  2. Vaccine research and surveillance. To this end, NACI:
    • recommends phase IV post-marketing assessment and surveillance activities for specific authorized vaccines (including surveillance of vaccine failures, adverse events and immunization coverage)
    • identifies research questions of interest to provincial, territorial and national immunization programs
    • recommends surveillance for specific infections and diseases when available data are insufficient to make a recommendation
  3. Vaccine programs. To this end, NACI provides evidence-based recommendations on
    • vaccine(s) authorized for use "in provincial and territorial immunization programs through a notice of compliance or the Special Access Program, considering programmatic elements such as:
      • Economics: Is the product or program cost effective?
      • Feasibility: Is the program reasonably practicable?
      • Acceptability: Do the public (or providers or other stakeholders) want such a program or product?
      • Ethics: Is the product or program the right thing to do? Are values and ethical principles upheld during the decision-making process? How will conflicts of values be resolved?
      • Equity: Is the product or program accessible to populations who can benefit from them?
    • best practices in immunization (such as record keeping, immunization technique, vaccine cold chain)

NACI advice to PHAC takes into consideration the information needs of both public health decision makers and health care providers. NACI recommendations are intended to supplement regulatory decisions based on disease burden and public health needs in Canada; the Committee, therefore, considers but is not restricted by the contents or indications of product monographs. As such, NACI may make "off-label" recommendations when supported by a public health ethics analysis.

3.0 Membership

NACI is composed of 16 volunteer members. Members will be recruited through an open nomination process and appointed based on, but not limited to, their expertise, knowledge and experience in: immunization; public health; prevention of vaccine-preventable diseases; previous experience on vaccine advisory committees or with paediatric or adult infectious diseases; geriatrics; allergy/immunology; and other health related fields, such as nursing, pharmacoeconomics, social sciences, epidemiology and infectious-disease modelling.

Appointments will reflect PHAC's policy that Committee membership be:

To the extent possible, the Committee will also reflect the diversity and demographics of Canada in such areas as, gender, official language, race, and ethnicity to help ensure a balance of perspectives.

Members cannot be represented by alternates or substitutes.

3.1 Terms of appointment, resignation and termination

Members will be appointed by and serve at the discretion of the VP, Infectious Diseases Programs Branch, normally for a term of 4 years, but may be asked to extend their term for up to an additional 4 years. For a member completing their final term, an additional extension (1 to 2 years) may be considered, upon agreement by the NACI chair, Executive Secretary and working group chair to complete projects for which the member is the lead.

Term and appointment of the Chair:

The Chair will be a NACI member and appointed for a two-year term with the potential of two one-year extensions. Selection will be based on a demonstrated ability to lead and work effectively with members and other NACI participants. The Chair will only vote when there is a 50/50 tie vote among voting members. Six months before the term of the NACI Chair is complete, the VP, Infectious Diseases Programs Branch will seek to appoint a Chair elect.

Term and appointment of Vice-Chair:

A Vice-Chair will be appointed for a two-year term with the potential of two one-year extensions upon mutual agreement. Selection will be based on a demonstrated ability to work effectively with NACI members and other NACI participants. The Vice-Chair will normally be considered first for the position of Chair when the Chair's term is complete, although the appointment of the Chair remains the prerogative of the VP.

The Chair, Vice-Chair or other delegated NACI member (as determined by the VP, Infectious Diseases Programs Branch in consultation with the Chair) will be NACI's representative on the Canadian Immunization Committee, the Advisory Committee on Immunization Practices, and the Canadian Immunization Conference Planning Committee and serve in a liaison role with other National Immunization Technical Advisory Groups (NITAGs) internationally.

Requirement before appointment

Before being appointed as a member, a nominee will:

  1. submit a personnel screening, consent, and authorization form for security clearance and receive the security clearance appropriate to the mandate of NACI (see Section 7.0)
  2. sign a confidentiality agreement (see Section 7.0)
  3. complete and sign an affiliations and interests declaration form and, if participation is permitted despite a direct financial interest, accept limitations on participation (see Section 6.0)
  4. provide a brief autobiography (see Section 6.0)
  5. review and accept a summary of his or her affiliations and interests that might be made public, including in media releases (see Section 6.0)

Resignation process

A member may resign from NACI by writing to the Executive Secretary, with a copy sent to the NACI Chair, including the effective date of the resignation.

Reasons for termination

A member's appointment may be terminated for a variety of reasons, including the:

  1. member's term is complete
  2. member resigns
  3. member becomes a federal government employee
  4. mandate of NACI changes and the member's knowledge, experience, or expertise is no longer relevant to the revised mandate
  5. advisory body's mandate or terms of reference or both is rescinded by PHAC
  6. member violates their confidentiality obligations
  7. the member misses three consecutive meetings of the advisory body without a satisfactory reason
  8. member acts in a way that jeopardizes the integrity of the advisory body
  9. member consistently fails to meet their commitments to NACI

The Executive Secretary will notify a member in writing about the termination and will provide the member with the reason for concluding the appointment and the date of termination.

3.2 Roles and responsibilities

Members have a responsibility to:

  1. participate in Committee meetings, including virtual meetings (teleconferences, videoconferences, etc.) and email exchanges, and be prepared to discuss the advisory body's recommendations, advice, or reports to PHAC
  2. declare any changes in their affiliations or interests related to the Committee's mandate prior to every meeting and notify the Secretariat and Chair in writing (email) of any such changes
  3. direct any inquiries from the media or the public to the Secretariat
  4. respond promptly to email requests or other communication from the Secretariat
  5. review and provide input into all NACI statements and the Canadian Immunization Guide chapters
  6. vote on NACI recommendations when required
  7. assist in the preparation of responses to inquiries from the public and provincial, territorial, municipal or regional governments on the interpretation or implementation of NACI recommendations
  8. serve as chair or a member of NACI working groups for the development of NACI statements and revisions of the Canadian Immunization Guide as required

Members cannot identify an alternate should they be unable to attend meetings.

With the exception of 3.2.(h), the Chair has the same responsibilities as members as well as additional responsibilities, including, but not limited to:

  1. providing input to PHAC on the selection of members and the Vice-Chair
  2. chairing advisory body meetings
  3. inviting members to make a presentation at a meeting, when relevant and appropriate
  4. facilitating a full and frank discussion among committee members in fulfillment of the committee's mandate
  5. seeking consensus on advice among all committee members, and, if there is no agreement, ensuring that this diversity of opinion is noted in meeting records or the report
  6. delivering the committee's advice to PHAC and ensuring the preparation of the meeting records and report
  7. supporting the fulfillment of the committee's mandate in other ways
  8. participating in the NACI Executive Committee and meetings with the VP
  9. sitting on other advisory committees at the request of the VP
  10. coordinating and chairing a rapid response committee of NACI members and others at the request of the VP
  11. participating in meetings that further the work of NACI, including those of the Global NITAG Network and chairs of provincial and territorial immunization committees
  12. speaking to the media on behalf of NACI, upon PHAC's request

The Vice-Chair, at the request of the Chair or in the case of the Chair's absence, can chair the meeting(s) and take on other tasks or responsibilities as required or delegated by the Chair. The Vice-Chair will participate in the NACI Executive Committee and meetings with the VP, Infectious Diseases Programs Branch as required. In addition, the Vice-Chair will support the upkeep of the Canadian Immunization Guide.

4.0 Other participants

4.1 Ex-officio representatives

Ex-officio representatives will support the work of NACI and PHAC by:

Ex-officio representatives may include representatives from the:

Ex-officio representatives shall have no voting status. They may have substitutes, however.

4.2 Liaison representatives

Representatives of national or professional associations or committees may be invited by the VP, Infectious Diseases Programs Branch, to participate in NACI's activities in the capacity of liaison representatives, who have no voting status. Each group identified by the VP, Infectious Diseases Programs Branch will be invited to nominate a representative who can support the work of NACI by:

Liaison representatives may include persons from the:

Similar to NACI members, liaison representatives will need to declare any new affiliations and interests related to the committee's mandate at working group or NACI meetings and will notify the Secretariat and Chair in writing (email) if any changes in their affiliations and interests occur during the time they are representative on the advisory body.

4.3 Presenters, invited guests, and observers

PHAC may invite certain individuals who are not members of the advisory body or participating representatives to provide input on a specific topic or agenda item. As well, these individuals may ask to speak to NACI on a given topic or agenda item or may ask to observe all or part of a meeting. Such requests will be considered by PHAC in consultation with the Chair and Executive Secretary.

5.0 Secretariat and Executive Committee

PHAC will maintain a Secretariat, an Executive Secretary, and a NACI Executive Committee to provide organizational, technical, project-management and administrative support to NACI.

5.1 Secretariat

The Secretariat will consist of project officers who organize NACI meetings, Working Group meetings and travel for NACI members and distribute materials to participants as needed. While PHAC is committed to openness and transparency, confidentiality rules may prevent the release of some materials.

The Secretariat will also consist of technical leads (for example epidemiologists, scientific project coordinators, medical advisors) who provide technical leadership and support to NACI and the working groups. A senior manager will provide overall coordination for NACI and the Secretariat.

5.2 NACI Executive Committee

The NACI Executive Committee will consist of the NACI Chair, Vice-Chair, Executive Secretary, Deputy Executive Secretary, and Executive Director of the PHAC Division of Immunization Programs. The Executive Committee will meet monthly, via teleconference. The Executive Secretary will chair Executive Committee meetings. Other attendees may be invited to attend, as required.

5.3 Executive Secretary

The Executive Secretary will support NACI's mandate by providing leadership, guidance and strategic advice, including guidance and advice on the committee's management. This individual will work closely with the NACI Chair, Secretariat and NACI Executive to ensure NACI's mandate is met in an effective and efficient manner. This individual will also provide advice to PHAC on NACI-related issues and inform NACI of issues that may impact its operation.

The Executive Secretary will chair the NACI Executive Committee. After NACI submits advice to PHAC, the Executive Secretary will report back to the committee on how that advice was used.

5.4 Deputy Executive Secretary

The Deputy Executive Secretary will support the Executive Secretary in committee business and serve as a substitute in all functions of the Executive Secretary during a period of absence.

5.5 Executive Director, Division of Immunization Programs

The Executive Director of the Division of Immunization Programs is responsible for the operations and oversight of NACI and the NACI Secretariat as well as liaison to PHAC Senior Management on NACI and its activities. The Executive Director will also support the Executive Secretary in engagements with provinces and territories, strategic leadership, and issues management within PHAC, and may serve as a substitute for stakeholder relations and leadership functions of the Executive Secretary during a period of absence.

6.0 Affiliations and interests

Members, liaison representatives and ex-officio representatives (NACI participants) are expected to conduct themselves in an appropriate manner, i.e., such that their actions as NACI members cannot be reasonably construed to be for their private gain or that of any other person, company, or organization; they must refrain from any real or perceived conflict of interest.

Recognizing that people with affiliations and interests related to NACI's mandate may have valuable insights to contribute to the committee's work, PHAC will not prevent such individuals from becoming NACI members. After consultation with the Chair and Vice-Chair, the agency may limit the participation of a NACI participant with respect to an agenda item or meeting topic, however. That decision will be taken depending on the nature of the participant's affiliations or interests.

6.1 Conflicts of interests

Situations where a conflict of interest exists and the individual should not serve as a NACI member include:

Potential conflict of interest that should be disclosed but do not limit participation of the individual on the committee:

* NACI participants who are members of a safety data monitoring board will be bound to all the same requirements as above.

6.2 Declarations and assessments process

In order to avoid undue influence or a real or perceived conflict of interest in NACI decisions, screening for potential conflicts must be accomplished and is viewed as a shared responsibility between NACI Executive together with the NACI Chair and Vice-Chair and the individual members. This is accomplished in three ways:

  1. NACI members and liaison representatives are asked to complete an Affiliations and Interests Disclosure Form and they must update this form in writing whenever their situation changes. Members are required to submit changes to their affiliations and interests to the NACI Secretariat.

    PHAC will review disclosure forms before making appointments and at least on an annual basis as well as any time the external advisory body mandate is changed.

    As a condition of membership, NACI members will be asked to permit PHAC to publish on its website a summary of expertise, experience, and affiliations and interests declaration, which will be based on the completed declaration form. NACI members will be asked to review the content of the summary for accuracy before it is released.

  2. Members and liaison representatives will know their own personal situation best, and so it is their personal responsibility to:

    1. Disclose any real or perceived conflicts of interest at the earliest possible time and, in any event, prior to any discussion and decision-making on any related subjects.
    2. In situations where conflict of interest or the appearance thereof arises in the course of NACI discussions, members must declare the existence of the conflict of interest and may be required to recuse themselves from participation in the discussions on that subject matter, or from further participation on the full committee.
    3. A standing item for each NACI meeting will include the opportunity for those voting members with conflict(s) of interest in relation to the content or questions on the agenda to declare the conflict(s) and the member may be required to recuse themselves from participation in the discussions and voting on that subject matter if/when applicable. Any disclosure and measures taken in connection with a real, potential or apparent conflict of interest should be captured in the record of any meeting in which a disclosure is made or measures taken.
  3. Following consultation with the NACI Chair and Vice-Chair, PHAC may limit the participation of a member with respect to an agenda item or meeting topic, depending on the nature of the member's affiliations or interests.

7.0 Confidentiality agreement commitments and security

NACI members as well as any observers or invitees, if applicable, will be required to sign confidentiality agreements. NACI participants are expected to hold in confidence and not disclose any confidential information obtained as a result of their participation on NACI, except as permitted under the terms of the confidentiality agreement.

PHAC will mark information according to the level to which it is protected under the Policy on Government Security.

The Chair and/or NACI Secretariat will ensure that everyone participating in the meeting, telephone discussion, email exchange, or other form of communication has received clear instructions on the confidentiality of the proceedings.

7.1 Security clearance

As a condition of appointment, all NACI members will undergo security clearance at the reliability level.

8.0 Legal assistance and indemnification

PHAC undertakes to provide its volunteer advisory body voting members with protection against civil liability, provided the volunteer member acts in good faith and within the scope of their volunteer duties and does not:

NACI voting members shall give prompt notice to PHAC of any claim, action, suit or proceeding brought against them. If the member is eligible for protection against civil liability, PHAC will, at its own expense, participate in the conduct of the defense of any such claim, action, suit or proceeding and any negotiations for the settlement of the same.

As part of its onboarding package/paperwork, PHAC will provide all NACI voting members with a standard indemnification letter.

9.0 Travel and accommodation expenses

Members who travel for authorized committee purposes will have their travel and accommodation expenses reimbursed according to the National Joint Council Travel Directive. Liaison representatives and ex-officio representatives will be expected to pay for their travel expenses. One exception is when the liaison member is serving as a working group chair, in which case expenses will be reimbursed for travel to NACI meetings.

10.0 Media and communications

All media requests related to NACI should be directed to the Secretariat for direction and response from PHAC's Communications and Public Affairs Branch before any other action is taken.

If appropriate, PHAC may request the Chair, Vice-Chair or a member to address a question raised by the media, in which case PHAC will provide guidance to the individual on how to respond.

If NACI members are asked a question by the media that relates to the mandate of NACI, they may respond to the question in their personal/professional capacity (for example, an academic professor may speak about his/her research). NACI members may also, in their personal/professional capacity, speak to information that has been published by PHAC. However, NACI members will avoid expressing any opinions on behalf of NACI or PHAC, and will refrain from providing information that would be considered confidential under the confidentiality agreement. If asked by the media to discuss NACI or how NACI examined certain issues, NACI members will refer the media to the Secretariat.

11.0 Transparency

PHAC is committed to transparency as an operating principle. Transparency of NACI is served by posting NACI materials (excluding confidential and personal information) on PHAC's web site. These materials include:

Members will receive, based on their preference, NACI materials in French or English or both official languages.

12.0 Meetings

For planning and conducting meetings of NACI, working groups or other related meetings, the Secretariat will follow PHAC's "Green Meeting Guide".

In keeping with the federal Official Languages Act, advisory body members have the right to receive documents and participate in discussions in the official language of their choice.

12.1 Meeting frequency and location

NACI will meet three times a year, face-to-face, in the National Capital Region. Additional face-to-face meetings may be held on an as-needed basis at the direction of PHAC, in consultation with the NACI Chair. Virtual meetings will also be held as needed, at the discretion of the Chair, including during pandemic contexts where face-to-face meetings may not be practical.

12.2 Quorum, recommendations and voting

The committee provides advice to PHAC as a group, by achieving consensus whenever possible. If members cannot come to a consensus, then the meeting record must note that there is a diversity of opinion with respect to the recommendations or advice.

Where unanimous consensus cannot be achieved, the NACI Executive Committee can proceed to use one of two voting standards to facilitate decision-making. The preferred option is a 2/3 majority consensus, this method was dominantly used during the COVID-19 pandemic vaccine response where votes were common.

Where a 2/3 majority consensus cannot not be achieved, the Executive Committee can defer decisions in order to allow further discussion or develop revised recommendation options working towards a 2/3 majority consensus. Alternatively, the Executive Committee can consider using a 50%-plus-one majority as a last resort if a decision is urgently required or the committee is fundamentally split and unable to move forward. Where there is a 50/50 tie, the Chair will cast the deciding vote to achieve a 50%-plus-one majority.

Vote ratios will be calculated based on the number of voting members available to vote within the prescribed timeframe, not based on the total membership of the committee.

A quorum of at least 2/3 of members must be participating to in order to authenticate a vote. Votes are ideally collected during meetings, but can also be collected via an electronic process. With a total voting membership of 15, quorum will be a minimum of 10 voting members. Members who have been absent for all discussions and have not been able to review all background documentation will not be permitted to vote. An abstention will count as a neutral vote. During a public health emergency, quorum may be adjusted in order to facilitate urgent decision-making.

Key principles of the recommendations will be voted on by NACI, and the final recommendation wording will be elaborated by PHAC (NACI Secretariat) and approved by the Chair on behalf of the Committee.

12.3 Deliberations and reports

The Secretariat will prepare a non-attributable record of decision that includes the recommendations and advice resulting from each committee meeting. This includes in-person meetings, virtual meetings, conference calls, and videoconferences. If parts or all of this record are confidential, the document will indicate this.

Once reviewed by the Chair and Executive Secretary (or the working group chair and PHAC medical / technical lead, for working group meetings), the draft record will be provided to NACI participants in a timely manner. As soon as is possible, the committee will then confirm the draft as an accurate record or will correct it.

For each meeting, a Summary of Discussion that does not contain confidential information will be prepared by the Secretariat. The Chair and Executive Secretary will then review the summary and distribute it to NACI participants for comments within one month following the meeting. Once approved by members, the Summary of Discussion can be used for information sharing and will be posted on PHAC's website.

12.4 Publication and restriction of the committee recommendation

The committee's recommendations may be published on PHAC's website when they do not contain any information that must remain confidential. Information from these publications may include links to information on other websites.

When applicable, PHAC will include specific guidelines for the publication of information and recommendations by the committee.

After approval by the VP, Infectious Diseases Programs Branch or Chief Public Health Officer or both, NACI recommendations may be published on PHAC's website and in the Canadian Immunization Guide. Summaries are typically published in the Canada Communicable Disease Report and occasionally in other publications. Reporting structures may vary during organisational restructurings, for instance during a pandemic response.

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