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FDA Knew COVID Vaccine Safety Monitoring System Was ‘Not Sufficient,’ Latest Pfizer Documents Confirm

The U.S. Food and Drug Administration this week released its last batch of files related to the licensing of Pfizer’s COVID-19 vaccine for ages 16 and up. The files reveal the agency knew its product safety monitoring system was “not sufficient” for assessing the risk for myocarditis and pericarditis following vaccination.

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