The FDA did a Rapid Cycle Analysis of CMS Medicare vaccination data.

in fda •  2 years ago 

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It did not detect any elevated stroke risk with the Pfizer bivalent vaccine. The analysis covered 4.25 million vaccinations. See the graph below.

Likewise there was no elevated risk seen in VAERS data. Nor in a Veterans Affairs database. And neither Israel nor Europe has detected a stroke signal in their data either. And Pfizer has not seen it in their global safety database.

As a result of the preponderance of data, the FDA concludes that they believe the stroke safety signal seen in the Vaccine Safety Datalink isn't a real clinical signal.

Out of an abundance of caution the FDA is going to begin a formal epidemiological study to investigate the issue and settle it conclusively.

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