CDC, FDA investigate possible link between Pfizer vax, stroke risk in 65+
(WXMI) — The Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) have identified a potential safety concern for ischemic stroke in people ages 65 and older who received the Pfizer-BioNTech COVID-19 Vaccine (Bivalent).
The CDC has also emphasized that the data currently suggests that it is very unlikely that the signal in VSD represents a true clinical risk.
The Vaccine Safety Datalink (VSD) is one of the surveillance systems the CDC uses to monitor symptoms people are reporting following a poke.
Recent data in the datalink system met the statistical criteria to prompt additional investigation into whether there actually was a safety concern for ischemic stroke in people who received the most recent version of the Pfizer COVID vaccine.
This preliminary signal has not been identified with the Moderna Vaccine (Bivalent).
The CDC and FDA will continue to evaluate additional data from the Datalink and other vaccine safety systems.
Further data and additional analyses will be discussed at the upcoming Jan. 26 meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee.
Despite this potential concern, the CDC continues to recommend that everyone ages 6 months of age and older stay up-to-date with COVID-19 vaccination.