Infectious Disease Special Edition (IDSE)CDC, FDA: Risk for Stroke in Seniors Following Updated COVID-19 Vaccine ‘Very Unlikely’

Reports on the Vaccine Safety Datalink flagged the need to investigate a potential increased risk those 65 years of age and older, for ischemic stroke in the first 21 days after receiving the bivalent Pfizer-BioNTech booster. FDA has parallel monitoring systems to confirm or fail to validate a safety signal. In this case, those other systems did not confirm the Vaccine Safety Datalink flag.