CDC, FDA Identify Covid Vaccine Safety Signal for 65 and Older

 The FDA and CDC said their safety monitoring system met the statistical criteria to prompt additional investigation into whether there was a safety concern for ischemic stroke in people ages 65 and older who received the bivalent Pfizer-BioNTech COVID-19 vaccine.

• Detected signal raised a question about likelihood of stroke in this population in the 21 days following vaccination
• FDA and CDC say it is “very unlikely” that signal represents true clinical risk but will continue to evaluate data
• Signal has not been detected in Moderna vaccine
• No other safety systems have shown a similar signal and multiple subsequent analyses have been performed.

https://news.bloomberglaw.com/pharma-and-life-sciences/cdc-fda-identify-covid-vaccine-safety-signal-for-65-and-older