The Public Health Agency of Canada (PHAC) provided supplemental information requested at the hearing in a letter to the Committee.

In response to questions about the specifics of the Government of Canada’s contractual obligations with vaccine manufactures and Canada’s vaccine supply management, the agency provided the following information:

Q1B. Current Vaccine Supply Management?

Management of Canada’s COVID-19 vaccine supply is complex and must continually pivot and adjust to an uncertain COVID-19 disease trajectory. This includes variants of concern, evolving public health advice based on the latest science, and changes in vaccine demand of individuals and the population as a whole, both domestically and internationally.

The Government of Canada continues to work closely with provincial, territorial, and Indigenous partners to align COVID-19 vaccine supply with Canada’s COVID-19 immunization program requirements, recognizing that provinces and territories (PTs) have jurisdiction over their immunization programs. Canada’s COVID-19 vaccine supply needs are also informed and based on the most recent scientific data on COVID-19 vaccines, COVID-19 epidemiology, surveillance of vaccine coverage in our population and evidence-based expert advice.

The Government of Canada is continuing to support PTs and Indigenous partners in ongoing efforts to support COVID-19 vaccination, with a focus on supporting individuals in Canada in staying up to date on COVID-19 vaccination, including boosters, guided by the latest evidence-based guidance and public health advice. The Government of Canada’s continued efforts in this regard relate to inventory management and distribution of COVID-19 vaccines, development of evidence-based guidance on the use of COVID-19 vaccines, communication and public education efforts, partnerships, and initiatives to support vaccine confidence and uptake. These efforts take a health equity approach and provide supports for healthcare providers, vaccine coverage and safety surveillance.

Additionally, the Public Health Agency of Canada continues to work closely with Public Services and Procurement Canada and vaccine suppliers to adjust COVID-19 vaccine contractual commitments and delivery schedules where possible and is examining options to reduce or adjust contractual commitments in 2023 and 2024 to more closely align with anticipated needs. PHAC also monitors vaccine shelf-life and expiry date extensions and approvals by Health Canada and plans accordingly in order to maximize the use of doses delivered in Canada.

Canada continues to strengthen its ability to monitor COVID-19 vaccine inventory including wastage, in addition to streamlining reporting and data sharing that will facilitate more accurate capture of vaccine wastage in Canada.

To date, the government has donated the equivalent of more than 196 million doses, including at least 41.5 million doses deemed surplus from Canada's domestic supply. The federal government continues to work toward its commitment of donating the equivalent of at least 200 million doses.

In an effort to minimize wastage, the Government of Canada will continue to make vaccine surplus available to other countries for donation. Working multilaterally and bilaterally, in partnership with Global Affairs Canada, the Government of Canada continues to look to place surplus vaccine donations, recognizing that it is more difficult to donate vaccine doses due to global oversupply and diminishing demand.

Q1C. Potential Doses Lost due to Expiration Dates not properly Tracked?

Since the launch of the COVID-19 vaccination campaign, over 103.5 million doses have received an authorized shelf-life extension, allowing greater utilization of COVID-19 vaccine products available to Canadians and through international donations. PHAC closely monitors COVID-19 vaccine product shelf-life and expiration dates and continues to work closely with federal, provincial, and territorial (FPT) partners to track and monitor expirations in the absence of an end-to-end integrated supply chain system across all levels of government and partners involved in COVID-19 vaccination. These steps include regular reports to FPT partners with a line list of all vaccine lot batches distributed in Canada, by lot number and expiry date, with updated expiration dates following shelf-life extensions. To ensure broad dissemination, this information is shared via several communication channels such as weekly logistics reports and FPT Canadian Immunization Committee updates. As the expiration of vaccine product approaches (at least 30 days lead time), PHAC notifies FPT partners to ensure product is being prioritized for use to maximize campaign efficiency, as well as to monitor in respective jurisdictional inventories that expired product is not used.

It should be noted that the shelf life for COVID-19 vaccine products involves both the management of product in the frozen state, for which the original labelled expiry date and any subsequent shelf-life extension must be respected, as well as the shelf life of product once thawed and held in the refrigerated state. This level of inventory management occurs at the local level. Once the product is taken out of the freezer at local vaccine administration sites, there is limited to no visibility of the available shelf life of product at the provincial/territorial and federal levels. Locally, COVID-19 vaccine supply logs are maintained at local clinics (i.e., pharmacies, vaccine clinics, doctor’s offices), including the ability to mark the expiry on the vial based on the product monograph to support use of product.

PHAC is actively coordinating with PTs to monitor vaccine wastage and expiry. Vaccine wastage, both avoidable and unavoidable, is expected and planned for at all levels of the immunization supply chain. Avoidable closed vial wastage is due primarily to cold chain excursions or expiry, and this is where controls can be exercised.

Furthermore, the Government of Canada will work with PTs to support advancement in systems for tracking and monitoring distribution to have real time inventory and wastage data, and for this data from PTs to be collected and shared at the federal level.

PHAC is actively working to advance the implementation and data quality procedures of the three modules of VaccineConnect. VaccineConnect provides information and support to PTs for planning, management, and reporting on COVID-19 vaccine supply orders, inventory management, as well as vaccine safety monitoring and surveillance. Some of its features allow FPT officials to: process vaccine orders; manage the full cycle of scheduling, vaccine administration, recording, and reporting; and track inventory and logistics in real time. VaccineConnect also provides analytics to enhance population health management.

PHAC will continue to actively engage jurisdictional partners on the identification of service and data quality needs and gaps in order to support future integration of the systems to support vaccination.

In response to a questions about the quantity of COVID-19 vaccines procured, the amounts in storage, and what has been discarded, the agency provided the following information:

Q2B. What has been purchased physically?

The cumulative supply of all doses/types received into Canada as of January 1, 2023 is 164.3M.

Q2C. What is the current inventory?

As of January 31, 2023, there were 22.6M COVID-19 vaccine doses in federal inventory and approximately 7.2M doses in PT inventory [both DEL (drug establishment license) facilities and non-DEL facilities]. The table below shows the breakdown of doses in federal inventory as of January 31, 2023.

Table A—COVID-19 Vaccine supply in federal inventory by type

Q2D. What has been discarded?

Overall, approximately 25.6M doses have expired to date. As of December 31, 2022, a total of 12,061,760 doses held domestically in federal inventory have been disposed of and/or are awaiting disposal due to expiry, and a total of 13.6M doses held off-shore (AstraZeneca) have been disposed of due to expiry. The table below shows the breakdown of doses held domestically in federal inventory that have been disposed of or are waiting disposal due to expiry.

Table B—Detailed breakdown of Canada’s expired COVID-19 vaccine doses,

Table C provides information about the COVID-19 vaccine supply currently in Canada, by manufacturer as of January 30, 2023. This includes all formulations for the manufacturer (monovalent, bivalent, adult, pediatric and infant pediatric formulations).

Table C—Detailed Breakdown by COVID-19 Vaccine Manufacturer

*Other:          This section refers to doses that expired in the provincial / territorial (PT) system at any level. Includes both closed vial (expired frozen or thawed; discarded due to cold chain excursions) and open vial wastage (vial punctured and not all doses used). In the OAG audit, this is referred to as “unknown status” as the responsibility for tracking / disposal is at the PT level. Federal tracking / visibility is dependent on availability of PT data and reported federally.

**Expired:    This section is reflective of doses that have expired while in the Federal inventory.

***DEL:         Drug establishment licensing.

Donations

Doses donated by Canada?

Canada has donated the equivalent of more than 196 million doses to-date. This includes at least 41.5 million doses deemed surplus from Canada's domestic supply and donated to COVAX, as well as more than 3.7 million doses donated directly to countries through bilateral agreements.

AstraZeneca: 22.5 million doses have been donated to COVAX and bilaterally and 8.9 million doses were delivered to recipient countries.

Janssen: 9.8 million doses have been donated to COVAX and 9.8 million were delivered to recipient countries.

Moderna: At least 10 million doses have been donated to COVAX and 7.1 million were delivered to recipient countries.

Pfizer: 3 million doses were donated bilaterally to a recipient country. Including both COVAX donations and bilateral donations, 28.8 million of Canada’s donated doses have been delivered to 36 recipient countries.

Table D—Donated COVID-19 Vaccines

Doses offered by Canada and waiting for donation

When global vaccine supply became more abundant, the COVAX allocation mechanism moved from a supply-driven approach to a demand and absorption capacity-driven approach. This meant that COVAX began only accepting donation offers following requests from recipient countries. Canada has adapted its supply management to fit this model and has since provided doses to COVAX on an as-requested basis. Specific lots are no longer pre-emptively committed for donation and doses are pulled from Canada’s surplus supply once a recipient (through COVAX or bilateral engagement) is confirmed.

Doses expired waiting for donation

13.6 million AstraZeneca doses held at the manufacturer expired due to lack of demand.