The CDC and FDA issued preliminary findings about monitoring the bivalent COVID-19 vaccine’s safety that discusses an initial increase of strokes in their safety monitoring data for the Pfizer bivalent COVID-19 vaccine.
As part of routine surveillance, the CDC detected a preliminary signal for stroke in people ages 65and older who received the Pfizer-BioNTech COVID-19 Bivalent mRNA Vaccine. However, this statistical signal is lower than the signals seen for other issues related to the vaccines.
As a response to the signal, the CDC and FDA examined several large databases including:
- Medicare’s database of 5 million doses.
- The Veterans’ Affairs’ database of millions of veterans.
- Israel’s dose database.
- Various European countries’ dose databases.
To date, the aforementioned organizations have not seen an association or increased risk in stroke from vaccines in these databases. The totality of the data currently suggests that it is very unlikely that the initial signal represents a true clinical risk.
Should a person have concerns, they may also request the Moderna Bivalent Vaccine which did not have an increased signal for strokes.