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

The U.S. Food and Drug Administration (FDA) in White Oak, Md., on June 5, 2023. Madalina Vasiliu/The Epoch Times

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.

The document also said that information on post-vaccination myocarditis, pericarditis, and subclinical myocarditis would be coming from studies that Pfizer was conducting, in lieu of FDA surveillance.

Several of those studies have been completed, but the FDA and Pfizer are refusing to release the results to the public. The FDA and U.S. Centers for Disease Control and Prevention (CDC) have confirmed the Pfizer, Moderna, and Novavax vaccines cause myocarditis and pericarditis. Outside research has found myocarditis and pericarditis happen primarily in young males, while a recent study indicated subclinical myocarditis is more prevalent than previously thought.

The document was sent to the Public Health and Medical Professionals for Transparency (PHMPT), which sued the FDA after it refused to release documents relating to its authorization of Pfizer’s vaccine. It was part of the final tranche from the FDA, which the agency was required to produce by a federal court.

Monitoring Systems

The CDC and the FDA have repeatedly claimed the COVID-19 vaccines are closely monitored. The CDC on its website, for instance, says that the vaccines were subject to “the most intense safety monitoring in U.S. history.”

But the failure of Sentinel to provide data on a known risk is just one piece of data that undercuts that claim, according to Elizabeth Brehm, a partner at Siri & Glimstad LLP, which represents PHMPT.

VAERS, for instance, is repeatedly described by officials as being unable to provide vaccines cause any conditions. V-safe, another surveillance system, “doesn’t directly monitor specific adverse events,” Dr. Tom Shimabukuro, a top CDC vaccine safety official, wrote in one email that has been made public. The Vaccine Safety Datalink, run by the CDC, is a closed system, which outside researchers cannot access without approval. A fourth system only has CDC officials and researchers funded by the agency consulting on individual cases. They often encourage patients to receive additional vaccines even if they have experienced an adverse event.

“Without a diagnosis, these types of consultations can be very unfulfilling for the provider and patient; the assessment of causality is typically ‘indeterminate’ as to whether a vaccine caused or contributed to an adverse event,” a CDC official wrote in another email about that system.

“When you really look at the ’system' collectively and what they say about it themselves, the question remains: what is an adequate safety surveillance system used by our authorities that provides reliable data to FDA and CDC concerning vaccines?” Ms. Brehm told The Epoch Times via email.

The CDC has said government systems have been useful, including helping detect the problem of thrombosis with thrombocytopenia syndrome after Johnson & Johnson vaccination and providing information on myocarditis after Pfizer and Moderna vaccination.

Additional documents are still forthcoming in a separate legal case brought against the FDA over documents relating to its authorization of Moderna’s COVID-19 vaccine.

Correction: A previous version of this article inaccurately stated which group sued the FDA. The Epoch Times regrets the error.