“COVID vaccine producers shared over a million adverse effect reports with Health Canada”
As public health officials, lawmakers, legacy media and even government-funded influencers were touting the safety of novel COVID vaccines and urging hesitant Canadians to take the shot, thousands of serious adverse events reports were pouring into Health Canada almost daily.
This is according to ongoing correspondence with Access to Information (ATIP) coordinators at Health Canada over four requests for such disclosures by vaccine producers Pfizer, AstraZeneca, Moderna and Janssen. Food and Drug Act regulations compel drug makers to report all serious adverse events (SAE) that occur anywhere in the world “to the minister…within 15 days after receiving or becoming aware of the information”.
This ATIP correspondence also revealed that from the end of 2020 to December 31, 2022, Health Canada received more than one million such reports: these included 600,000 from Pfizer, 220,000 from AstraZeneca, 160,000 from Moderna and 22,000 from Janssen (Johnson & Johnson).
“A broader interpretation (of your request) could encompass millions of records,” writes an access to information coordinator for the department.
“Given our current processing capacity of about 500 pages per month, handling such a large volume would require a significant amount of time to complete.”
If each serious adverse event report were just a single page, the prescribed pace for Health Canada’s access to information office would take 167 years to see them all processed.
Pfizer’s BioNTech mRNA injection was first to get Health Canada approval on Dec. 9, 2020, followed by Moderna’s mRNA iteration two weeks later. By June 30, 2021, Pfizer’s SAE submissions to Health Canada totaled some 100,700 international reports and another 820 domestic occurrences while Moderna had filed 30,000 international and 40 domestic SAEs. In other words, Canada’s drug regulator and then-health minister Patty Hadju knew about reports of potential harm from the vaccines
AstraZeneca submitted 123,000 international SAE reports and 170 domestic post-jab injury reports during that period for its DNA adenovirus version. All told, there were 1000 serious adverse event reports in Canada for the three vaccines combined in this time span.
Based on these figures, during the first half of 2021 Health Canada was receiving nearly 10,000 SAE reports every week. While the bulk were international, remember that Canada experienced supplier delays – due in part to a botched vaccine deal with China’s CanSino Biologics – so when mass vaccination began in earnest here beginning April 2021, millions of doses had already been administered in the United States, Europe and Israel.
Though Health Canada data indicate slightly more than one serious adverse event for every 10,000 administered doses, regulatory law expert Shawn Buckley suspects that is a conservative figure and the enormous trove of manufacturers’ SAE reports currently under wraps could shed more light on the totality of the harm.
“The numbers for Canada will be much larger than (Health Canada has) reported,” Buckley told True North. “We actually have no idea of the percentage of adverse reactions that get reported in Canada.”
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Jason is based in Ottawa. He is a former Parliamentary Press Gallery reporter. He enjoys public interest journalism. https://tnc.news/author/jasonunrau/
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