Debunking the Safety Signal: Influenza and COVID-19 Vaccines Pose No Increased Risk of Stroke

2023-10-17 19:38:41

At a time when Quebec is in the middle of a seasonal vaccination campaign once morest influenza, which has been combined with the administration of a booster dose once morest COVID-19 to people considered at risk, we learn that the safety signal launched last winter by an American organization was unfounded.

In January 2023, the Vaccine Safety Datalink (VSD) issued a safety signal following detecting what appeared to be a link between the combination of the influenza vaccine and the bivalent COVID-19 vaccine and an increased risk of stroke in people aged 65 and over.

This signal, which had been communicated to the public, led to the launch of an investigation by American health authorities and the INSPQ. On both sides, we came to the conclusion that this risk was unfounded. This information is therefore timely to reassure people who want to participate in the current vaccination campaign.

Scientific advisor specializing in vaccine safety at the INSPQ, Isabelle Rouleau considers it “reassuring to know that this risk is not there”.

The epidemiologist, who co-signed the report made public last week by the INSPQ, explains that the warning signals emitted by surveillance systems often result from preliminary data. “It’s really just to alert other jurisdictions to do their homework,” she explains, adding that this is what she did in collaboration with her colleague Gaston De Serres.

At the time of triggering its alert, the American organization was banking on data containing inconsistencies, but it would still have chosen to warn the scientific community and the public “out of concern for precaution,” believes Ms. Rouleau.

After analyzing the data in depth, both the US Centers for Disease Control and Prevention (CDC), the US Food and Drug Administration (FDA) and the INSPQ all concluded that the alert was not founded.

Although this investigation focused on the bivalent ComirnatyMD vaccine, administered last winter, and not on the monovalent mRNA vaccine XBB.1.5, currently recommended by the Quebec Immunization Committee, Isabelle Rouleau sees no reason to fear for the safety of the vaccine.

“We always stay on the lookout for what might happen. But when we look, historically, whether for the bivalent vaccine or for the monovalent vaccines for the first, second or third doses, we have not seen an increase in risk,” analyzes the epidemiologist.

According to the Heart+Stroke Foundation, ischemic stroke is the most common type of stroke. These occur when blood flow to part of the brain is blocked due to occlusion of an artery.

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