Pfizer COVID-19 shot safety signal in seniors under investigation by CDC, FDA
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The CDC and US FDA are looking into whether Pfizer (NYSE:PFE) and BioNTech's (NASDAQ:BNTX) updated, bivalent COVID-19 vaccine is associated with a higher ischemic stroke risk in those 65 and older.
The investigation is due to a safety signal found in the CDC's Vaccine Safety Datalink (VSD), an almost real-time surveillance system. However, the CDC and FDA's Vaccine Adverse Event Reporting System (VAERS) has not seen an increase in strokes related to the Pfizer (PFE)/BioNTech (BNTX) jab.

CDC and FDA said that the potential stroke signal has not been seen with Moderna's (MRNA) updated vaccine.
"Although the totality of the data currently suggests that it is very unlikely that the signal in VSD represents a true clinical risk, we believe it is important to share this information with the public...when one of our safety monitoring systems detects a signal," the agencies said.
They added that no changes in vaccination practices is warranted at this time.