TORONTO — Canada may be at the forefront of the race to develop an effective COVID-19 vaccine, with a clinical trial already approved, but experts warn we have fallen short in developing a fund to compensate those who may be injured by vaccinations.
With immense political and public pressure to develop a vaccine, a process that can take years, researchers are carrying out trials at an unprecedented pace in efforts to bring a successful vaccine to market in a matter of months.
And although vaccine-related reactions are rare, experts say a new vaccine — especially one developed using new technology — may come with unknown risks.
At least 19 countries already have programs in place that compensate individuals injured by vaccines, but Canada does not.
In fact, it is the only G7 country without such measures in place, and experts are now calling on the federal government to prepare in advance of the COVID-19 vaccination program.
“If you do suffer an adverse event, a serious adverse event, one of those very rare events, you should be compensated,” said Jennifer Keelan, a retired researcher who worked at the University of Toronto’s Department of Public Health, told CTV News.
“An ideal process is to think about these things before you implement the mass vaccine program, rather than reacting.”
Adverse reactions to vaccines are rare, but have had deadly repercussions in the past.
In 1976, the U.S. government rushed to develop a swine flu vaccination over fears of the next big pandemic. The immunization program was halted after 10 weeks due to reports that the vaccination increased the risk for Guillain-Barre syndrome (GBS), a rare form of paralysis that starts in the feet and creeps up the body.
Though the associated risk was approximately one in 100,000, more than 450 people developed GBS after receiving the vaccine. Of those, 25 died.
Similarly, in 2009, the H1N1 influenza vaccine, while largely deemed safe, was linked with cases of narcolepsy in Europe.
Experts warn that vaccine manufacturers may demand legal protection against lawsuits regarding adverse reactions to a new vaccine.
In 2009, the Canadian government put forth an emergency process to release the H1N1 vaccine without waiting for Health Canada to review the results of clinical trials concerning the vaccine’s efficacy.
According to the Canadian Medical Association Journal, Canada agreed to indemnify the vaccine’s manufacturer, Glaxo-SmithKline, from potential lawsuits.
At the time, the federal government was said to be considering a no-fault compensation scheme, or a vaccine injury compensation program. However, no such program was ever created.
Quebec is the only province that offers such a plan for adverse reactions stemming from immunizations.
In other provinces and territories, any healthcare costs associated with an adverse vaccine reaction would be covered through the public health system or, if disability occurred, through disability income.
According to the Canadian Vaccination Evidence Resource and Exchange Centre, the only other recourse would be through litigation. However, there is a limited understanding of the number of vaccine-injury related lawsuits in Canada.
CTV News contacted the federal government to see if there was any consideration for such a program in light of the circumstances surrounding COVID-19. A request for comment was not returned.
“Some of these individuals may actually be front-line workers, personal support workers, health-care workers, or those working in long-term care centres who will be asked to receive this vaccine not only for their benefit, but to protect the patients, the people they are caring for,” Dr. Kumanan Wilson, senior scientist at the Ottawa Hospital Research Institute, told CTV News.
“Despite best practices being taken, if these individuals are harmed, we need a system in place to help compensate them in the event of injury.”
Wilson and Keelan have been calling for Canada to implement a vaccine injury compensation program for nearly 10 years.
In a 2011 report for the University of Toronto’s Munk School of Global Affairs, the researchers noted that, “the history and experience with vaccine-related injuries in many other western countries also suggests that it is highly probable that Canada will be faced with circumstances.”
At the time, Keelan noted that a no-fault compensation program for vaccine-related injuries would not only benefit people who suffer harm, it might also give those who are waffling about whether to get a vaccine the incentive they need to go ahead.
“We want people to be vaccinated. Vaccines are incredibly safe and they are one of the most effective public health measures that we have for preventing vaccine-preventable diseases,” she said in a 2011 interview with CTVNews.ca.
“We want them to have confidence in our publicly funded vaccine.”
In a report to the World Health Organization in December 2018, the Global Advisory Committee on Vaccine Safety wrote that no-fault vaccine injury compensation programs are considered a measure to maintain confidence in immunization programmes.
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