LOS ANGELES, Jan. 13 (Xinhua) -- The U.S. Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) announced on Friday that their surveillance system flagged a possible link between the new Pfizer-BioNTech bivalent COVID-19 vaccine and strokes in people aged 65 and older.
Following the availability and use of the updated vaccine, CDC's Vaccine Safety Datalink, a near real-time surveillance system, met the statistical criteria to prompt additional investigation into "whether there was a safety concern" for ischemic stroke in people aged 65 and older who received the updated vaccine, according to a statement on the CDC website.