National Advisory Committee on Immunization (NACI): Methods and process

Canadian Immunization Guide

On this page

• Overview
• Resources on methods and processes
• History of NACI
• Process for industry engagement with NACI
• Contact us

Overview

The National Advisory Committee on Immunization (NACI) provides the Public Health Agency of Canada (PHAC) with ongoing and timely medical, scientific, and public health advice relating to immunization.

NACI's analysis framework includes multiple complementary factors that have been established through consultation with provinces and territories, and are consistent with modern guideline methods including the Grading of Recommendations Assessment, Development and Evaluation (GRADE) Evidence to Decision framework.

PHAC acknowledges that the advice and recommendations set out in Advisory Committee Statements are based upon the best current available scientific knowledge at the time of publication. People administering vaccines should also be aware of the contents of the relevant product monographs, which can be found on Health Canada's Drug Product Database. NACI recommendations for use and other information set out within the Statements may differ from that set out in the product monographs of the Canadian manufacturers of the vaccines. NACI members and liaison members conduct themselves within the context of PHAC's Policy on Conflict of Interest, including yearly declaration of potential conflict of interest.

Resources on methods and processes

• Interpretation Guide – Health Economics, 1st edition (2024)
• Guidelines for the economic evaluation of vaccination programs in Canada, 1st edition (2023)
• Process for incorporating economic evidence into federal vaccine recommendations (2022)
• Navigating inequities: A roadmap out of the pandemic (2021)
• A framework for the systematic consideration of ethics, equity, feasibility, and acceptability in vaccine program recommendations (2020)
• Immunization guidance products: Different levels of detail for different uses (2016)
• Canada's National Advisory Committee on Immunization (NACI): Evidence-based decision-making on vaccines and immunization (2010)
• Evidence-based recommendations for immunization – Methods of the National Advisory Committee on Immunization (2009) [PDF]

History of NACI

• Canada's National Advisory Committee on Immunization: Celebrating 50 years (2015)

Process for industry engagement with NACI

NACI interaction with vaccine manufacturers

NACI is Canada's National Immunization Technical Advisory Group (NITAG). The relationship between NACI, NACI Vaccine-Preventable Diseases (VPD) Working Group members, the NACI Secretariat, and vaccine manufacturers is defined by a clear boundary to maintain the integrity and independence of NACI recommendations. NACI is expected to make decisions based on scientific evidence and public health needs. However, there are instances where the vaccine review process necessitates interaction with vaccine manufacturers because they possess unique information about their products and can provide summaries or overviews of what is available, along with unpublished data that are currently under review or being planned for evaluation.

NACI's engagement with vaccine manufacturers aligns with the committee's ethical procedural values of inclusiveness, responsibility, and accountability. These interactions occur through clearly defined and predictable steps.

Timing and process for vaccine manufacturers to provide information to NACI

Vaccine information should ideally be provided to the NACI Secretariat at PHAC through a standard dossier format concurrently with submission to Health Canada for regulatory review and authorization or once the relevant NACI Working Group (WG) has been established. NACI can typically also access key regulatory submission data via PHAC and Health Canada as needed.

All communications with NACI occur through the NACI Secretariat, and the manufacturer should communicate early with the NACI Secretariat at PHAC to determine when the NACI WG will be established. NACI will prioritize the review of certain vaccines in alignment with the NACI workplan. However, dossier requests can also be made by the NACI Secretariat to aid in planning and future work initiatives.

Dossier submissions by manufacturers are voluntary and not required as part of NACI's development of recommendations for the basis of decision-making, but are expected to facilitate timely recommendations from NACI.

Information provided to NACI

NACI has access to vaccine regulatory submission data as needed, in accordance with subsection 21.1 (3) of the Food and Drugs Act and the Privacy Act. This enables the Committee to start work in parallel to the regulatory review by Health Canada.

The NACI Secretariat also invites vaccine manufacturers to submit shorter clinical dossiers in a standard format on a voluntary basis, to facilitate information sharing between NACI and the vaccine manufacturer.

NITAGs use a manufacturer-submitted dossier as a tool to collate information on vaccines under review as part of a comprehensive evidence profile supporting independent evaluation. Innovators and manufacturers have unique information on products and can provide a summary or overview of what is available, as well as unpublished data that is underway and being planned for review and evaluation. The information provided to NACI includes detailed data on the vaccine's characteristics, safety profile, immunogenicity, efficacy in preventing the target disease, and any additional relevant information. These are submitted in an established dossier format to facilitate the review of the information. NACI and PHAC will use this submission dossier to complement other evidence sources that are collected systematically and independently from the vaccine manufacturer. By integrating information from diverse sources, NACI and PHAC can ensure a robust and well-rounded evaluation of vaccines.

NACI guidance development process complements Health Canada regulatory review

The Health Canada regulatory review primarily focuses on the safety, efficacy, and quality of a vaccine, ensuring it meets the necessary standards for regulatory approval. The NACI process complements the regulatory review by assessing the vaccine's public health impact and provides recommendations on its optimal use within Canadian immunization programs, often comparing multiple vaccines to recommend the best option for Canadians. NACI considers factors such as the target population, dosing schedule, potential benefits to public health, thereby complementing the regulatory evaluation conducted by Health Canada. The NACI evidence base may include infectious disease modelling and health economics, real world evidence, ethics, equity, feasibility and acceptability analyses, and indirect evidence from other vaccines or other populations.

It is common for NACI to build on the focused Health Canada regulatory assessment to integrate other broader evidence streams. This may result in a NACI off-label recommendation for the vaccine if it promotes health equity that is supported by a public health ethics analysis.

Role of NACI in the vaccine review process

The federal government leads the regulatory review of vaccines through Health Canada and supports provincial and territorial vaccine programs through multiple functions at PHAC. NACI is an external advisory body to PHAC that provides independent, expert advice to the federal government on the optimal use of authorized vaccines in Canada. Provinces and territories often rely on NACI guidance to inform their immunization programs, and ultimately these recommendations guide healthcare professionals, policymakers, and the public in making informed decisions regarding vaccination.

Typical duration of NACI review process

The duration of the NACI review process can vary depending on multiple factors, but typically takes 9-24 months from the establishment of the NACI Working Group to the publication of the NACI Statement. It is generally preferred for NACI to deliberate and issue advice after a regulatory decision from Health Canada, in order to prevent unnecessary off-label recommendations. In rare emergency situations, NACI may issue advice concurrent with Health Canada.

Next steps following completion of NACI review process

Once the review is complete, NACI will provide the recommendations on the use of the vaccine to PHAC. PHAC then translates the recommendations into both official languages and disseminates the advice to the provinces and territories, and eventually publishes the NACI Statement online. Provinces and territories will then consider whether to implement the NACI recommendations. The NACI recommendations are crucial for informing public health policies and vaccination strategies.

Process for vaccine procurement in Canada

Once a vaccine is authorised by Health Canada, it can be marketed for sale. This typically results in availability for purchase on the private market and it can also be sold directly to provinces and territories to support their publicly funded vaccine programs. For most vaccine programs, the Federal government coordinates a Bulk Procurement Program on behalf of provinces and territories where the jurisdictions interested in participating will identify common vaccine requirements then Public Services and Procurement Canada (PSPC), with PHAC, will negotiate a large purchase on their behalf to secure the best price and optimize value to Canadians. NACI recommendations can facilitate procurement by the provinces and territories and the Bulk Procurement Program.

Vaccine manufacturer engagement with NACI during the vaccine development process is planned and consistent

NACI's formal review will not start before a submission to Health Canada is evaluated and approved. Prior to that, the manufacturer is encouraged to contact the NACI Secretariat to share information about anticipated submission timelines, and to inquire about potential timelines and scope of the NACI review (e.g. inclusion or exclusion of health economic evidence). Advice will not be provided on clinical trial design or study goals.

NACI interactions with the vaccine manufacturers are limited and structured to prevent any bias in the independent advisory process and the regulatory review of the submission early in the process, vaccine manufacturers are encouraged to engage with the NACI Secretariat at PHAC.

There are 6 main engagement steps for industry in the NACI process:

1. Contacting the NACI Secretariat at PHAC before Health Canada regulatory submission: This step allows manufacturers to explore the possibility of getting their vaccine on the NACI workplan, which cycles every two years.
2. Notifying PHAC once a vaccine has been submitted to Health Canada: Manufacturers should notify PHAC of their submission to Health Canada, indicating whether it is for priority review or a standard new drug submission (NDS) 300-day review.
3. Submitting a dossier to PHAC for NACI's review: Manufacturers are invited to provide a confidential technical dossier containing evidence for NACI's review through the NACI Secretariat at PHAC. Materials in this dossier may be published in the final NACI Statement, which occurs after authorization of the vaccine by Health Canada and NACI review of all available evidence.
4. Scheduling a technical presentation to the relevant NACI VPD Working Group: This step involves presenting the technical aspects of the vaccine to the relevant NACI VPD WG. The presentation will typically include product characteristics, clinical trial evidence, and in some cases economic evidence. NACI Secretariat will advise on the ideal scope of information to include in the presentation. In rare cases, where there are no new clinical data held by the manufacturer, the NACI Secretariat will not invite a presentation to the NACI VPD WG.
5. Being available for ad hoc information requests throughout the review period: Manufacturers should be prepared to respond to ad hoc information requests from NACI and the Secretariat during the review period, which typically spans 9-24 months.
6. Providing a technical review of the draft NACI evidence summaries and product characteristics to identify factual errors: Manufacturers are encouraged to review and provide input on the draft NACI evidence summaries to identify any factual errors in the description of product characteristics or the summaries of their industry-sponsored clinical trials. This review does not include access to NACI's confidential deliberations or proposed recommendations. In rare cases, where there are no new clinical data held by the manufacturer, the NACI Secretariat will not invite a review for factual errors.

Contact us

Contact the NACI Secretariat for more information at: naci-ccni@phac-aspc.gc.ca.