Auditor General’s Recommendation 9.80:

The Public Health Agency of Canada (PHAC), in collaboration with Health Canada (HC) and the provinces and territories, should resolve barriers to

• 1)      better share vaccine surveillance information among themselves;
• 2)      provide access to the Canadian Adverse Events Following Immunization Surveillance System (CAEFISS) to Health Canada; and
• 3)      provide surveillance data, including case-level details as needed, to the World Health Organization and vaccine companies in a timely manner.^[1]

Milestones From the Public Health Agency of Canada’s Management Response And Action Plan

Goal of Outcomes

Governance documentation and processes for vaccine safety data and information-sharing, which were enhanced in response to the COVID-19 pandemic, will be strengthened through formalization between the Agency and relevant partners.

Milestones:

Part 1

1.1 PHAC will lead a review and update of governance documentation and work plan for the Vaccine Vigilance Working Group, the Federal/Provincial/Territorial (F/P/T) governance table for vaccine safety monitoring and information sharing, to reflect lessons learned from the safety surveillance of COVID-19 vaccines and the identified needs of members. (November 30, 2023)

1.2 PHAC will collaborate with Health Canada on review and update of governance documentation for PHAC-HC vaccine safety collaboration and information sharing, to reflect lessons learned from the safety surveillance of COVID-19 vaccines and the identified needs of members. (November 30, 2023)

Part 2

2.1 PHAC will complete a series of P/T consultations first initiated by the Agency on February 24, 2022 through a presentation to Canadian Immunization Committee (CIC), on a proposal to provide Health Canada staff access to CAEFISS and obtain from each P/T written assent or an articulation of persisting barriers to implementation. (Completion date December 1, 2023) P/T consent is required for any use of case-level data beyond national public health monitoring. P/Ts have cited concerns related to risk of public disclosure of personal information on AEFIs and lack of related patient consent.

2.2 PHAC will continue to share CAEFISS data per the parameters of the Letter of Agreement between HC and PHAC on CAEFISS data sharing, which was extended beyond its October 2022 expiry date for an additional ten years. (Ongoing)

2.3 PHAC will develop a new Letter of Agreement between HC and PHAC to include any new parameters established during the engagement discussions with P/Ts around access to CAEFISS for HC staff (Completion date: 12 months following the completion of 2.1 above)

2.4 Should parameters remain at status quo following these discussions, PHAC will work with HC to identify avenues that may address any persisting barriers.

Part 3

3.1 PHAC will continue to share aggregate vaccine surveillance data with the World Health Organization (WHO) per their requests, and to provide tailored presentations and/or updates to relevant committees (e.g. the Global Advisory Committee on Vaccine Safety). (Ongoing)

3.2 PHAC will review and update (as necessary) the process for sharing of case-level data on identified safety issues with vaccine manufacturers, inclusive of target performance/timelines standards. (March 31, 2023)

3.3 PHAC will facilitate consultations with HC and F/P/T immunization programs on options to share more granular vaccine safety data with the WHO and vaccine manufacturers, with a focus on addressing barriers identified by F/P/T immunization programs. PHAC will report on the results of consultations held. (Report date: March 31, 2024)

3.4 Should parameters remain at status quo following these discussions, PHAC will work with HC to identify avenues that may address any persisting barriers.^[2]