The Food and Drug Administration admitted internally it couldn’t assess risk of known COVID-19 vaccine side effect.
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.
Studying subclinical myocarditis, or heart inflammation without clinical symptoms, was also not able to be done with the data “because of the absence of a definition of subclinical myocarditis and unknown background incidence of troponin abnormalities,” the document stated.
Months before the document was prepared, U.S. authorities had learned of a large number of myocarditis cases following Pfizer vaccination in Israel, a fact they hid from Americans. The U.S. military also recorded cases just weeks after the vaccines were rolled out in late 2020. And additional cases were reported to the Vaccine Adverse Event Reporting System (VAERS), which is managed by the FDA and another agency.
“It is shameful that the Sentinel Program electronic database that FDA officials use to monitor reported vaccine side effects appears to have failed to adequately assess the magnitude of risk of heart inflammation (myocarditis and pericarditis) in children and adults aged 12 to 30 that occurred after receipt of Pfizer COVID shots. It also looks like heart inflammation cases were not appropriately followed up to find out how many people suffered permanent heart damage,” Barbara Loe Fisher, co-founder and president of the National Vaccine Information Center, told The Epoch Times in an email.
The FDA declined to comment.
