Federal compensation not ready yet for vaccine injuries, deaths

With cases emerging of rare but serious blood clots following vaccination with the AstraZeneca-Oxford COVID-19 vaccine,thecompensationprogram announcedbythe federal governmentlast December stillisn't ready to consider any claims.

In a statement to CBC News, the Public Health Agency of Canada said a third party willadminister itsvaccine injury support programbut it's still in negotiations with the prospective supplier. The agency said thegoal is for the program to beready 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 governmentagreed to assume liability forinjuries or deaths as a condition in itscontracts with vaccine suppliers,protecting these manufacturersfrom potential litigation.

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

The province of Quebec implementedone of its ownin 1985after a young girldeveloped viral encephalitis shortly after receiving a measles vaccination. Her family soughtdamages but couldn't prove the manufacturer was negligent in court, highlighting the need for another path to compensation.

Federally, questions aboutthe provinces' jurisdiction over health carehave been a barrier to establishing a national system. But with the federal government purchasing all of Canada's COVID vaccines and with vaccinemanufacturers requiring the same protections they have in other jurisdictions for that supply the needto get a system in place for bothpandemic vaccinations andfuture 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'sfinancial risk to encourageinnovative technologies.

Such compensation programsalso assurethe public thatsomeone has their back in the event of serious or permanent injury.

'Embarrassing' Canada doesn't compensate

Personal injury lawyer Jasmine Dayahas three clientsfrom different parts of Canada who are reporting long-termhealth issues following their Pfizer and Moderna shots.

While those health issues arenot life-threatening, they gowell beyond aches and pains, she said;two foundit difficult to continue to work, for example.

Dayasaid she had to tell her clientsthe likelihood of a successful lawsuitfor damages was basically nil the government has giventhe manufacturers immunityand adverse events are usually more about anindividual's specific health circumstances than suppliernegligence because vaccinemanufacturers adhere to strict quality controls.

She said she's been advocating for a no-fault compensation scheme on their behalf. Even if what'simplemented 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 wouldincrease 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'sfoundcompensation programs don'thave 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 thegovernment'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 outbreakin 1976, when cases ofGuillain-Barrsyndrome, a rare neurological disorder, emerged duringthe vaccination campaign.

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Clinical trials typically only pick up adverse events with a likelihood ofone in 10,000cases, Wilsonsaid. Clinical trials may not have caughtthemore rare eventsnow emerging, he said,as tens of millions of doses of multiple types of vaccines go into arms worldwide.

The government should have had such aprogramin 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, PHACsaid seriousadverse 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 reactionshaven't been as rare as officials anticipated. (Canada's database of reported side effects from COVID-19 vaccination is here.)

As of Wednesday evening, Canada is reporting15confirmed cases of serious blood clots, out of the more than2.3 million doses of AstraZenecainjected 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 toblood 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, provincialChief Medical Officer David Williams said Tuesdayas heannouncedthe province would pauseadministering first doses of the vaccine.

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Dr. David Williams, Ontarios chief medical officer of health, said the province made the decision due to an increase in the rare blood clotting condition linked to 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" indecisions about whichvaccines 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 yearsbut could be extended.

Interested applicants were told thefinancial 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; andinjury indemnities," the call for proposals said, without providing potentialdollar figures. The supplier will be in charge of processing applications, adjudicating claims and implementingan 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 astatement. Because it's stillnegotiating its funding arrangement, it would not provide further details, it said.