A vaccine database found a possible link between the Pfizer/BioNTech bivalent COVID-19 vaccine and ischemic strokes in people over 65 who got the shot, the CDC and the FDA said in a joint news release.
, “a near real-time surveillance system,” raised a safety concern about the Pfizer/BioNTech booster.
No higher likelihood of strokes linked to the Pfizer bivalent vaccine had been found by Pfizer/BioNTech, the Veterans Administration, the Vaccine Adverse Event Reporting System maintained by the CDC and the FDA, or other agencies that monitor reactions of vaccines, the news release said. No safety issues about strokes have been identified with the Modera bivalent vaccine.
In a joint statement, Pfizer and BioNTech said: "Neither Pfizer and BioNTech nor the CDC or FDA have observed similar findings across numerous other monitoring systems in the U.S. and globally and there is no evidence to conclude that ischemic stroke is associated with the use of the companies' COVID-19 vaccines.”
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