FDA Stroke Risk Study Suggests No Need To Change COVID-19 Vaccine Administration Strategy

But new study finds increased risk of non-hemorrhagic stroke in those receiving high-dose adjuvanted flu vaccines, and another study detects new signal for seizures/convulsions among younger children who received COVID vaccine. Authors say findings warrant more investigations.

Covid-19 vaccine risks
FDA study assesses risk of stroke with mRNA COVID-19 vaccines • Source: Shutterstock

A study co-authored by researchers at the US Food and Drug Administration’s Center for Biologics Evaluation and Research looking at potential safety issues associated with concomitant COVID and influenza vaccine administration does not indicate a need to change strategy around dosing but does recommend more studies on the safety of influenza vaccines. The study did not find any statistically significant association of stroke following administration of COVID-19 mRNA bivalent vaccines in those aged 65 and older but found a small increased risk of non-hemorrhagic stroke in those receiving high-dose adjuvanted flu vaccines.

A preprint version of the study, “Evaluation of Stroke Risk Following COVID-19 mRNA Bivalent Vaccines Among U.S. Adults Aged ≥65 Years,” was posted by medRxiv on 15 October

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