Federal compensation not ready yet for vaccine injuries, deaths

Federal compensation not ready yet for vaccine injuries, deaths-Milenio Stadium-Canada
Alex Smirnov gets a COVID-19 vaccination from Annie Halinka Sanson at a demonstration of a drive-through vaccination site, Tuesday, May 4, 2021 in Montreal. (Ryan Remiorz/The Canadian Press)

With cases emerging of rare but serious blood clots following vaccination with the AstraZeneca-Oxford COVID-19 vaccine, the compensation program announced by the federal government last December still isn’t ready to consider any claims. 

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In a statement to CBC News, the Public Health Agency of Canada said a third party will administer its vaccine injury support program but it’s still in negotiations with the prospective supplier. The agency said the goal is for the program to be ready for applications “later this spring.”

“All claims will be eligible for retroactivity to the beginning of the immunization campaign,” Health Minister Patty Hajdu said Wednesday.

“My heart is with families that have been affected by vaccination in any way, but I can reassure those families as well that those claims will be considered as inclusive.”

The federal government agreed to assume liability for injuries or deaths as a condition in its contracts with vaccine suppliers, protecting these manufacturers from potential litigation.

Vaccine injury compensation programs are in place in 19 other countries, including every G7 member except Canada.

The province of Quebec implemented one of its own in 1985 after a young girl developed viral encephalitis shortly after receiving a measles vaccination. Her family sought damages but couldn’t prove the manufacturer was negligent in court, highlighting the need for another path to compensation.

AstraZeneca vaccines-Milenio Stadium-Canada
Pharmacist Barbara Violo arranges all the empty vials of the Oxford-AstraZeneca COVID-19 vaccines that she has provided to customers at the Junction Chemist in Toronto on April 19, 2021. (Nathan Denette/The Canadian Press)

Federally, questions about the provinces’ jurisdiction over health care have been a barrier to establishing a national system. But with the federal government purchasing all of Canada’s COVID vaccines — and with vaccine manufacturers requiring the same protections they have in other jurisdictions for that supply — the need to get a system in place for both pandemic vaccinations and future needs became obvious.

Although the exact language in Canada’s COVID-19 vaccine contracts has not been released, it’s neither new nor unusual for governments to help mitigate a company’s financial risk to encourage innovative technologies.

Such compensation programs also assure the public that someone has their back in the event of serious or permanent injury.

‘Embarrassing’ Canada doesn’t compensate

Personal injury lawyer Jasmine Daya has three clients from different parts of Canada who are reporting long-term health issues following their Pfizer and Moderna shots.

While those health issues are not life-threatening, they go well beyond aches and pains, she said; two found it difficult to continue to work, for example.

Daya said she had to tell her clients the likelihood of a successful lawsuit for damages was basically nil — the government has given the manufacturers immunity and adverse events are usually more about an individual’s specific health circumstances than supplier negligence — because vaccine manufacturers adhere to strict quality controls.

She said she’s been advocating for a no-fault compensation scheme on their behalf. Even if what’s implemented isn’t perfect, she said, “something is better than nothing … it’s embarrassing that Canada has not had this program for all these years.”

She rejects the argument that having a compensation program would increase vaccine hesitancy.

“I believe people are smarter than that,” she said. “They know that people are having adverse effects. It’s being reported. Why don’t we give people peace of mind and give them something?”

Clinical trials miss rare adverse events

Epidemiology researcher and medical professor Kumanan Wilson of the Ottawa Hospital Research Institute has studied vaccine confidence. He said he’s found compensation programs don’t have an impact either way.

He’s argued forcefully in favour of compensation, calling the lack of a program a serious gap in Canadian immunization policy. Experts on the government’s task force consulted his work last fall before the new injury support program was announced.

“There’s been a lot of uncertainty during this pandemic, but probably one of the most predictable things was an unpredictable adverse event,” he said, recalling examples like the swine flu outbreak in 1976, when cases of Guillain-Barré syndrome, a rare neurological disorder, emerged during the vaccination campaign.

Clinical trials typically only pick up adverse events with a likelihood of one in 10,000 cases, Wilson said. Clinical trials may not have caught the more rare events now emerging, he said, as tens of millions of doses of multiple types of vaccines go into arms worldwide.

The government should have had such a program in place before the pandemic began, he said.

“Yes, you’re getting the vaccine to protect yourself, but you’re also getting the vaccine to protect others,” he said. “If in the process of doing something to help others you’re hurt, then it’s part of the social contract that the government should assist you.”

Financial liability ‘not a consideration’

In its December announcement, PHAC said serious adverse reactions to a vaccine are “extremely rare — less than one in a million — and we have a duty to help if this occurs.”

As the vaccine rollout continues, however, adverse reactions haven’t been as rare as officials anticipated.

As of Wednesday evening, Canada is reporting 15 confirmed cases of serious blood clots, out of the more than 2.3 million doses of AstraZeneca injected so far. Three of those people have died — one each in Quebec, Alberta and New Brunswick.

In response to an inquiry from CBC News last week, Health Canada said it works with manufacturers to monitor which vaccine batches from which production facilities are linked to adverse events. No patterns have emerged so far in the doses linked to blood clots or low blood platelets, the department said.

Ontario’s eight serious blood clot cases so far translate into a rate of about one in every 60,000 AstraZeneca shots administered, provincial Chief Medical Officer David Williams said Tuesday as he announced the province would pause administering first doses of the vaccine.

On Wednesday, Public Health Ontario clarified that the rate of vaccine-induced immune thrombotic thrombocytopenia (VITT) is approximately 1 in 80,000.

Hajdu couldn’t say how much the federal government has set aside for its injury compensation program. She said the government’s financial liability is “not a consideration” in decisions about which vaccines Canada authorizes. Those decisions, she said, have been led by experts on the government’s immunization task force.

The federal government put out its call for potential administrators of a no-fault injury support program in February. The contract was set for five years but could be extended.

Interested applicants were told the financial support offered must “align with accepted industry practices” and be “consistent with other public and private sector compensation regimes.”

“Financial support will include income replacement; death benefits; reimbursement of eligible costs such as otherwise uncovered medical expenses; and injury indemnities,” the call for proposals said, without providing potential dollar figures. The supplier will be in charge of processing applications, adjudicating claims and implementing an appeal process for rejected claims.

“It is anticipated that information on when the third party will begin to accept applications for support will be available later this spring,” the agency told CBC News in a statement. Because it’s still negotiating its funding arrangement, it would not provide further details, it said.

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