Recent results from a database maintained by the U.S. Centers for Disease Control and Prevention (CDC) suggest an association between older persons who received an upgraded Pfizer COVID-19 bivalent shot and an increased risk of stroke. However, Health Canada (HC) reports that there is currently “no indication” linking mRNA bivalent vaccinations to ischemic strokes.
Ischemic stroke is the most prevalent type of stroke, according to the website of Health Canada. It entails an abrupt loss of brain function caused by a sudden blockage of a brain blood artery. This can be caused by smoking, high blood pressure, obesity, diabetes, and high blood cholesterol levels.
Health Canada and the Public Health Agency of Canada (PHAC) “are aware” of the recent announcement regarding the “possible preliminary COVID-19 vaccine safety signal between the Pfizer-BioNTech bivalent COVID-19 vaccine and strokes in people aged 65 and older.” Still, the CDC is not recommending any changes to vaccination practices at this time.
As of January 1, over seven million mRNA bivalent vaccines have been administered in Canada, the agency said in an email to Global News on Friday. However, PHAC or HC “have not observed an elevated risk or any signals for thromboembolic events or vascular events” after the administration of these vaccines.
The statement said that other international regulatory services have not noticed a possible link between bivalent Pfizer injections and strokes in elderly persons.
As is the case with all licensed vaccinations in Canada, “Health Canada and PHAC continue to monitor the safety of COVID-19 vaccines approved in Canada to ensure that their benefits continue to outweigh their risks,” the document stated.
As the CDC and Food and Drug Administration (FDA) continue to study if there is a link between ischemic stroke and the Pfizer bivalent vaccine for older individuals, U.S. health officials stated on Thursday that the signal is weaker than what the CDC had indicated in January. Officials from the U.S. Food and Drug Administration stated that they had not discovered a link between the injections and strokes in two other safety monitoring databases.
Less than five reports of ischemic stroke have been received to PHAC and HC in Canada following receipt of an mRNA bivalent vaccine to date, according to an email from Canada’s health agency. Of those, “just one followed the Pfizer-BioNTech bivalent vaccine” for a “person aged 65 years or older.”
“At this time, there is no indication of a link between ischemic stroke and bivalent mRNA vaccinations in Canada,” the report stated.
“A preliminary signal was found by the CDC’s Vaccine Safety Datalink surveillance system, but not by their Vaccine Adverse Event Reporting System,” the agency stated in an email. The dissemination of this information proves that the global post-market surveillance mechanism for vaccinations is effective.
The organization confirmed that Canada has a “strong vaccine safety surveillance system in place, involving healthcare professionals, vaccine manufacturers, and provincial and territory health authorities.” As safety concerns are investigated, Health Canada will take “necessary action,” according to the statement.
PHAC reported this week that over 50,000 Canadians have perished as a result of catching COVID-19 since the beginning of the pandemic emergency over three years ago. The death toll at that time was 50,135.
Quebec, the only province that continues to provide COVID-19 data daily, has witnessed the most confirmed deaths of any jurisdiction to date, with 17,865 deaths. The second-highest provincial death toll as of January 20 is 15,786 in Ontario, followed by 5,470 in Alberta as of January 18.
