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Jane Philpott is the dean of the Faculty of Health Sciences at Queen’s University. Kieran Moore is the medical officer of health for Kingston, Frontenac, and Lennox & Addington Public Health. Ethan Toumishey is a public health and preventive medicine resident at Queen’s University.

Health Canada approves Pfizer’s COVID-19 vaccine

We have to use all the tools at our disposal to promote high COVID-19 vaccination rates across the country. It will take about 25 million immune Canadians to lift the patchwork of public health restrictions blanketing our provinces and territories. Here, we recommend an important step Canada should take to ensure that all Canadians who willingly get immunized for the collective benefit have clear medical and legal pathways to address those very rare, unintended or unexpected outcomes after immunization.

Adverse events following immunization (AEFIs) include any unwanted or unexpected health effects that happen after a person receives a vaccine. AEFIs are often mild and, most of the time, clear up quickly and completely. Most Canadians are familiar with mild AEFIs such as redness and swelling at the injection site, headache or fever. Though exceedingly rare, more severe health effects can occur after vaccination such as allergic reactions, neurologic events such as seizures, and, in extremely rare cases, death. We are seeing this play out in the U.K., as adverse reactions are discovered in parallel with the delivery of the COVID-19 vaccine.

The current legal recourse mechanism, outside of Quebec, requires claimants who have suffered injury to demonstrate fault in order for a compensatory award to be granted. In other words, the provider or distributor (often including the practitioner who gave the injection) of the vaccine must be proved to have violated a standard of practice. Unfortunately, those rare but serious AEFIs can occur even when appropriate protocols are followed. People suffering severe AEFIs are left to assume the costs of legal fees, lost wages, uninsured medical services and rehabilitation supports.

No-fault compensation programs are one means by which compensation could be provided differently to better support Canadians. Globally, there are many countries that have national no-fault compensation programs for AEFIs, but Canada is not one of them. In fact, Canada is the only Group of Seven country that has not implemented a national program, though, within Canada, Quebec has had a program for vaccine injury compensation since 1985.

Typically, no-fault compensation programs are the responsibility of a government body that assesses and decides individual cases. Claimants access the process after submission of an AEFI report from an attending physician. Claimants do not require legal representation. A compensation decision is based on an administrative review of eligibility criteria and an independent physician assessment.

In the context of the COVID-19 pandemic, we are concerned that, given the anticipated scale of the COVID-19 immunization campaign and new vaccine technologies employed, mass immunization may result in a small number of Canadians experiencing serious AEFIs, despite adherence to best practices. While AEFIs are possible with routine immunizations, pandemic situations are unique with respect to the speed and scale with which vaccine technologies are developed and distributed. Rare serious AEFIs may not be captured during phases of clinical trials because it may require very large numbers of the population to be immunized for AEFIs to manifest.

The anticipated incidence of serious AEFIs can be estimated at 1 in one million immunizations. Serious adverse outcomes are exceedingly more common with COVID-19 infection itself, but the potential health consequences of adverse events following immunization borne by the few will be for our collective benefit in stopping the deadly spread of the virus. Operating under this estimate, we anticipate 25 Canadians may suffer a serious health outcome following COVID-19 vaccination, or 0.1 per 100,000 doses.

Jurisdictions with no-fault compensation programs have reported cost-savings. By avoiding legal fees, evidence suggests millions of dollars have been saved. In no-fault systems, compensation is needs-based and not punitive. This has allowed for faster payments, quicker resolution and higher levels of complainant satisfaction. A fault-based system is an obstacle to those few who do suffer harm and a concern for those providers who administer the vaccine in good faith.

An appropriate, equitable and fair compensation system with a transparent accountability process for monitoring potential AEFIs associated with COVID-19 immunization could increase public confidence in vaccines and promote uptake. Though none of us want to consider adverse vaccine-related health outcomes while we are enduring the COVID-19 pandemic, given the high vaccination numbers we hope to attain, due diligence requires Canada to ensure no one is left behind as we plan for the vaccine rollout and work to end the pandemic.

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