Health Canada says AstraZeneca vaccine is safe after investigating blood clot reports

Health Canada on Thursday said the benefits of AstraZeneca’s COVID-19 vaccine “continue to outweigh the risks” after investigating reported blood clots in several countries, and encouraged Canadians to receive it if offered.

The agency said an assessment of available data on the reports out of Europe determined no link between the vaccine and an increase in the overall risk of blood clots. Health Canada stressed that the reports themselves were rare, and suggested blood clots “can also be due to COVID-19” itself.

While Health Canada did find one report of a stroke that occurred in an individual who was inoculated with the AstraZeneca vaccine, it was found not to be related to the shot.

“Health Canada will continue to work with international regulators and review data and evidence as it becomes available, including as it pertains to these rare events,” a statement from the department read.

It added that officials are working with AstraZeneca to ensure health-care professionals and Canadians have the safety information they need.

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Earlier Thursday, the European Medicines Agency announced it had come to the same conclusion about the vaccine’s safety. Yet the drug watchdog’s director Emer Cooke said the agency could not definitively rule out a link to blood clot incidents and the vaccine in its investigation into 30 cases of a rare blood clotting condition.

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The agency had been under growing pressure to clear up safety concerns after a small number of reports in recent weeks of bleeding, blood clots and low platelet counts in people who have received the shot.

The agency’s review, covering 5 million people, included 30 cases of unusual blood disorders in people in the European Economic Area (EEA), which links 30 European countries.

At least 13 European countries, including France, Germany and Italy, have stopped administering the shot pending the review, the latest blow to the bloc’s faltering inoculation campaign.

AstraZeneca has also been scrutinized for not providing sufficient data on the vaccine’s efficacy among seniors, prompting Canada and other countries to warn the shot should not be given to people over the age of 65.

Canada’s National Advisory Committee on Immunization reversed its stance earlier this week, announcing that the vaccine was safe for seniors.

The committee cited “real-world evidence” that demonstrates the vaccine is safe and effective in older adults, particularly against severe illness from COVID-19 and hospitalization.

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Still, if there is a choice, NACI says mRNA vaccines — like Pfizer’s and Moderna’s — should be prioritized for use on seniors, but that it no longer recommends against using AstraZeneca for anyone over the age of 65.

Health Canada approved the AstraZeneca vaccine for use in anyone 18 years or older in late February. It became the third COVID-19 shot green-lit in Canada, joining vaccines from Pfizer-BioNTech and Moderna.

Canada’s initial 500,000 doses of the AstraZeneca COVID-19 vaccine have been manufactured by the Serum Institute in India. In total, two million doses will arrive in the country from that agreement.

The initial doses delivered last week have now been spoken for. Another 20 million doses already secured with AstraZeneca aren’t expected until sometime in April, which leaves provinces with time to reconsider how they will roll out the next batch and to whom.

— With files from Hannah Jackson, Rachael D’Amore and Reuters