The government has confirmed that coronavirus vaccine manufacturers are protected from liability when it comes to issues with their doses — but the feds say this is par-for-the-course and has no bearing on vaccine safety.
“Let’s be clear that indemnification clauses in vaccine contracts are standard,” Procurement Minister Anita Anand told reporters, speaking at a Monday press conference in Ottawa.
“All countries, generally speaking, are faced with the issue of indemnification of companies, especially in cases of novel technologies like this.”
When pressed on whether Canada is including these indemnification clauses as part of the contracts that have been drawn up with vaccine manufacturers, Anand confirmed that this is the case.
“Yes we are, and we are definitely not any different than any other country in this world,” Anand explained.
Her comments are in line with government and public health positions that pre-date the pandemic.
In a Public Health Agency of Canada (PHAC) document that lays out planning guidance for vaccines in the event of a pandemic, the agency recommends using indemnity clauses to keep the inoculation process moving.
“To prevent delays in release of the vaccine at time of pandemic, the pandemic vaccine supply contract stipulates that the Government of Canada will indemnify the manufacturer against any claims or lawsuits brought against it by third parties,” the document reads.
That document is from 2017, and was most recently updated in September 2019.
This removal of liability for vaccine manufacturers is an issue that has taken centre stage in some anti-vaccination circles, where individuals cite this lack of liability as a key source of their vaccine hesitancy. The latest incarnation of this argument was seen in an e-petition sponsored by Conservative MP Derek Sloan.
That e-petition, which calls into question vaccine safety and has been condemned by Health Minister Patty Hajdu, claims that “COVID-19 vaccine manufacturers are being granted legal immunity” and cites this as a chief concern driving their call for the vaccine to be voluntary — something that is already the case in Canada.
Global News contacted PHAC to ask about this indemnity last week. While the agency wouldn’t provide details of its contracts with manufacturers at that time, they did emphasize the safety of any vaccine that is approved in Canada.
“Health Canada is committed to protecting the health and safety of Canadians and has a rigorous scientific review system in place to ensure vaccines are safe and effective in preventing the diseases they target,” read the emailed statement from PHAC.
“Once a vaccine is authorized for sale, manufacturers are required to continue submitting information on the safety and effectiveness of the vaccine and monitor and communicate any potential adverse events following immunization. Health Canada will not hesitate to take action if a safety issue is identified.”
Officials from Health Canada have echoed these reassurances. In its published decision regarding the Pfizer coronavirus vaccine, Health Canada wrote that the data confirms the vaccine is roughly 95 per cent effective, and was “well tolerated” with no serious safety concerns.
“I would say to Canadians, we’ve authorized it. If it is their turn to get the vaccine, they absolutely should feel comfortable getting that,” Dr. Supriya Sharma, chief medical advisor with the regulatory branch of Health Canada, told reporters when the vaccine was approved last week.
She added that the reactions observed so far have been “mild,” including pain at the injection site, body chills, a fever or feeling sluggish.
While two allergic reactions to the vaccines took place in the United Kingdom, the individuals both had histories of allergic reactions to other things — and Canada is keeping a close eye on this and any other adverse reactions.
And while the pharmaceutical companies might not be responsible for any adverse reactions to these vaccines, that doesn’t mean Canadians are left in the lurch in the exceedingly rare event that any vaccine — coronavirus or otherwise — causes them harm.
In a Friday press release, the government announced its intention to establish a “pan-Canadian no-fault vaccine injury support program” that provides Canadians with support in the “rare event that they experience an adverse reaction to a vaccine.”
Anand pointed to this compensation program on Monday as she fielded questions about the indemnity that has been granted to vaccine manufacturers.
“The idea that they would get Health Canada approval and therefore be deemed to be safe and effective is fundamentally important to us having this successful vaccine strategy. That’s why you won’t see any rollout of a vaccine until Health Canada approves it,” Anand said.
“By the same token, however, it is important … for Canadians to know that if there is an issue at all with the technology in these novel vaccines, that they do have access to a regime that aims to protect them.”
As of Tuesday, the first Pfizer coronavirus vaccine doses have already been administered in Canada. The milestone comes as cases continue to rise.
There have been 460,743 cases of COVID-19 to date, including 13,431 deaths. There are also 74,059 active cases across the country.
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