Mr. Speaker, in response to (a), "Adverse Reaction Reporting and Health Product Safety Information: Guide for Health Professionals" outlines the submission methods available to health care professionals and anyone living in Canada wishing to voluntarily report adverse reactions, ARs, including adverse events following immunization, AEFIs, with vaccines, such as COVID-19 vaccines, and medical devices incident reports to the Canada vigilance program, CVP.

There have been no changes since December 2020 to the process for health care professionals and -consumers to voluntarily report to the CVP on AEFIs, including AEFIs for COVID-19 vaccines.

At the provincial and territorial level, legislation is in place that requires AEFIs to be reported by health care professionals to local provincial health units. These reports are shared with PHAC via the Canadian adverse events following immunization surveillance system, CAEFISS. Health Canada and PHAC collaborate to continuously monitor AEFIs with vaccines, including the COVID-19 vaccines, received through the CVP and the CAEFISS.

Following a December 2019 provincial/territorial, P/T, request, changes were made in December 2020 to the “Report a side effect” web page. The changes pertained only to the online reporting form and did not impact the ability for consumers and health professionals to voluntarily report AEFIs directly to Health Canada by telephone, mail, fax, or email.

The purpose of these changes was to minimize confusion due to the co-existing CVP and CAEFISS reporting paths and to acknowledge AEFI reporting through the long-standing public health route. As a result, consumers and health care professionals were directed to report AEFIs with COVID-19 vaccines to local public health authorities. These changes were supported by and authorized by senior officials within Health Canada and the Public Health Agency of Canada, PHAC.

The response to (b) is N/A.

In response to (c), following the December 2020 update to the vaccine section of the “Report a side effect” web page, comments were received from some health professionals and consumers seeking to more easily report AEFIs directly to Health Canada. Comments from health professionals and consumers indicated a need for Health Canada to restore the ability to voluntarily report AEFIs online to the Canada vigilance program.

To address this, in February 2023, Health Canada reinstated the direct link to Health Canada’s online reporting form on the “Report a side effect” web page. This change aimed to make direct AEFI reporting to Health Canada easily accessible to those who were unable to report AEFIs through other submission methods, e.g., fax, phone, mail.

In response to (d), PHAC was informed and had no objections to the web page update that reinstated the direct link to Health Canada’s online reporting form, as it co-leads AEFI surveillance along with Health Canada. Other stakeholders were not notified, as it is not standard practice to announce web page changes.

In response to (e), as noted in (a), (b) and (c), the updates to the “Report a side effect” web page did not change the protocol of reporting AEFIs. Voluntary reporting of AEFIs online directly to the CVP by health care professionals and consumers has been available before and after these website updates.

Yasir Naqvi

$503,232.00