After almost a year of enduring the pandemic and its enormous health, economic and social toll, help may be on the way. The world has been encouraged by the promising early results from the Pfizer and Moderna messenger mRNA vaccines. The possibility of a vaccine being available in the early New Year appears realizable. It is an incredible story – a 15-year process of vaccine development compressed into a single year.
Canada is an enviable position – having purchased more vaccines per capita than any other country. But there is a lingering gap in our vaccine policy. What happens in the very rare instance that an individual should suffer an adverse event from the vaccine?
COVID-19 vaccines will go through the rigours of Phase 3 randomized clinical trial evaluations. They will have to meet regulatory standards for safety and efficacy. But there is a possibility that we will not detect extremely rare side-effects in Phase 3 trials.
COVID-19 is far riskier for some populations, yet we will need the majority of the public to participate in vaccination if our goal is to create herd immunity. However, there are real ethical challenges in encouraging everyone to be vaccinated without providing any support for rare adverse events that may occur as a result.
People who sustain harm while contributing to herd immunity should be supported by a national no-fault vaccine injury program that would provide a straightforward path to compensation.
Notably, Canada is alone among G7 nations in not having a vaccine injury compensation program, although the province of Quebec does have one. At least, twenty-five jurisdictions around the world have such programs, including countries such as Vietnam and Nepal.
No-fault compensation programs make sense for several reasons. First, as described, there is typically “no-fault” when someone experiences a rare adverse event. Best practices are in place, the vaccine meets regulatory standards for safety and the events are so rare that even if you are aware they exist, a reasonable person would still proceed to be vaccinated.
Second, these programs also promote vaccine industry innovation. In fact, a major reason for their introduction in the U.S. was that fears and costs of litigation, even if unsuccessful, had pushed many pharmaceutical companies out of the vaccine manufacturing business, creating shortages.
But perhaps most importantly, it’s simply the right thing to do. Vaccines are a public good and we should partake in these programs not only for our benefit but also for the benefit of others — in particular, the vulnerable.
If in the process of partaking in a public good one is injured, they should be provided with just compensation.
Which brings us to the COVID-19 vaccine. A program is needed even more urgently for these vaccines. An initial target group will be front-line workers who care for vulnerable populations. There will be an expectation, a pressure, if not a requirement that they be vaccinated. It would be unjust and antithetical to our current ethos that these workers, if in the rare instance they suffer a possible adverse event, would be left on their own.
This problem will be further magnified as we extend the vaccine roll-out to the broader population with the message to get vaccinated to protect yourself and others. We have provided financial compensation for individuals and businesses throughout the pandemic who have taken measures to help reduce the spread of the virus. We should continue that approach with the release of a vaccine.
How would such a program be designed? We have previously created guidance for such a program to be established in Canada and there are many international examples we could model and multiple jurisdictions which we could emulate.
Will creating a program to address rare injuries create undue anxiety over vaccine safety? There is no evidence either way on their impact on vaccine hesitancy from the jurisdictions we have studied.
Will they be expensive? There is no evidence that run-away costs have overwhelmed any of the programs we have studied precisely because vaccines are so safe.
We are strong supporters of vaccines and have confidence in their safety. It’s not too late for Canada to address this gap in our vaccination policy, first for COVID-19 vaccines, and then extended to all recommended vaccines.
By Kumanan Wilson and Jennifer Keelan
Kumanan Wilson is a Physician/Scientist at The Ottawa Hospital and a member of the University of Ottawa Centre for Health Law, Policy and Ethics. Follow him on Twitter at @canimmunize
Jennifer Keelan, PhD, is the lead author of 2011 Munk School briefing on no-fault vaccine injury compensations.