Booster Shots May Trigger Stroke Incidents, According to CDC and FDA

An Overview of Risk and Prevention

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In addition to cardiac events, another life-threatening side effect has been associated with the Pfizer-BioNTech vaccine. When is the risk period? Does the flu shot play any role in these events? What actions should we take to better protect ourselves?

Summary of Key Facts

• An increased risk of stroke events has been identified with the Pfizer COVID-19 bivalent vaccine, according to a joint statement from the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA).
• The onset time in people aged 65 years and older was 1–21 days after the booster, with a significant cluster of events observed 11–21 days after the booster.
• Sixty-four percent had received the flu vaccine on the same day as the COVID-19 booster.
• The bivalent booster contains the code of the spike protein, contributing to the increased risk of blood clots. High-risk people should avoid the boosters.
• Solution: Remember the five “suddens” of stroke warning signs.
• Advice on preventing other risk factors of stroke is also provided in this paper.

On Jan. 13, 2023, the FDA and CDC issued a joint statement that a new “safety signal” for ischemic stroke had been detected in one of the agency’s vaccine safety surveillance systems.

The statement read, in part: “CDC’s Vaccine Safety Datalink (VSD), a near real-time surveillance system, met the statistical criteria to prompt additional investigation into whether there was a safety concern for ischemic stroke in people ages 65 and older who received the Pfizer-BioNTech COVID-19 vaccine bivalent.”