Bivalent boosters not linked to stroke risk, federal agencies say

Pfizer's updated COVID-19 booster does not increase the risk for ischemic stroke in patients 65 and older, according to a CDC and FDA review of multiple studies, reporting databases and other countries. 

After being alerted to a potential safety issue about the bivalent shot in November, the two agencies investigated whether ischemic strokes were more likely to happen within 21 days post-vaccination versus between 22 and 42 days, the CDC said in a statement. 

The CDC listed five analyses to confirm the lack of a risk:

  • A large study of updated bivalent vaccines using the CMS database revealed no increased risk of ischemic stroke.
  • A preliminary study using the Veterans Affairs database did not indicate an increased risk of ischemic stroke following an updated vaccine.
  • The Vaccine Adverse Event Reporting System managed by CDC and FDA has not seen an increase in reporting of ischemic strokes following the updated vaccine.
  • Pfizer-BioNTech's global safety database has not indicated a signal for ischemic stroke with the updated vaccine.
  • Other countries have not observed an increased risk for ischemic stroke with updated vaccines.

The CDC said it will continue tracking data on vaccine safety.


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