FDA System Unable to Identify Risk of Heart Inflammation After COVID-19 Vaccination: Agency

The U.S. Food and Drug Administration could not provide information on a confirmed side effect of the Pfizer COVID-19 vaccine, according to a newly disclosed document. FDA staffers said in the document, from 2021, that one of the agency’s top surveillance systems was unable to provide details on heart inflammation after Pfizer vaccination. The FDA’s Sentinel program was described in the document as “NOT sufficient to identify the outcomes of myocarditis and pericarditis due to reasons identified.” Pericarditis is inflammation of the pericardium, or the membrane around the heart. There weren’t enough people in the program to assess the risk for 12- to 30-year-olds, the population discovered to be most at-risk from post-vaccination myocarditis, or heart inflammation, FDA staffers said. Assessing whether people who suffered from the condition had recovered, and following them long-term, was also not feasible because the program’s data sources “do not have sufficient longitudinal data on patients,” they said....