Pfizer Bivalent COVID Shot May be Linked to Stroke, Says CDC

(CTN News) – (This Jan. 13 item has been resubmitted with a headline change to make clear that the connection to a stroke is conceivable but not conclusive.)

According to early data examined by U.S. health regulators, a safety monitoring system warned that the revised COVID-19 injection from American pharmaceutical company Pfizer Inc. (PFE.N) and German partner BioNTech could be connected to a specific form of cerebral stroke in older persons.

The Food and Drug Administration (FDA) and the U.S. Centers for Disease Control and Prevention (CDC) announced on Friday that a CDC vaccine database had revealed a potential safety issue in which people 65 and older were more likely to experience an ischemic stroke 21 days after receiving the Pfizer/BioNTech bivalent shot than they were to do so between days 22 and 44.

Blockages in the arteries that provide blood to the brain cause an ischemic stroke sometimes called brain ischemia.

According to the FDA and CDC, the CDC’s Vaccine Adverse Event Reporting System, other nations’ databases, and Pfizer databases, BioNTech did not identify this safety problem, and more research is needed.

Although the sum of the data indicates that it is improbable that the signal in VSD (Vaccine Safety Datalink) reflects a real clinical danger, the health authorities said that they felt it was vital to communicate this information with the public.

In a statement, Pfizer and BioNTech said that they were made aware of a small number of cases of ischemic strokes in adults 65 and older after receiving their revised dose.

The companies further stated that there was no evidence to support a link between the companies use of the COVID-19 vaccines and ischemic stroke.

“Neither Pfizer and BioNTech nor the CDC or FDA have observed similar findings across numerous other monitoring systems in the U.S. and globally,” they added.

Moderna’s (MRNA.O) bivalent injection has not been linked to this safety issue, and the CDC and FDA continue to advise that everyone aged 6 months and older maintain current COVID-19 immunization records.

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