Posted on 12/10/2023 7:54:16 PM PST by SeekAndFind
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.
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.
Ping for your interest
The Hunter’s Laptop method of health protection!
Deny
Blame on Russian disinformation (this is literally what Dr. Peter Hotez did in his editorial in Nature)
Claim “There’s no evidence”
YOU ARE HERE
Thank you for the PING.
The FDA has blessed, collaborated with, and profited from the creation of the Covid 'vaccine'. They actively hide information that they find inconvenient.
The FDA has had stats and ignored them, while telling everyone they are monitoring and there are no signals which indicate a problem with Covid 'vaccine' safety. The VAERS database has been collecting adverse events reports for 30+ on all vaccines, but 63% of all adverse events reported to VAERS are for the Covid 'Vaccine.' 78% of all reports of death are for the Covid 'vaccine'.
Notice anything in the table below? If you do, you are more perceptive than the
Below, the latest stats that the CDC and FDA selected to publish to VAERS. Most instances are not reported to CDC in the first place, especially now that censorship is expected. So these stats are just the tip of the iceberg. Thomas Renz has a few whistle blowers who say that 40,000 deaths in the CMS system never made it into VAERS as intended, and that CMS system is just one of 12 databases that feed VAERS.
VAERS COVID Vaccine
Adverse Event Reportssource: OpenVAERS.com
Reports from the Vaccine Adverse Events Reporting System. Our default data reflects all VAERS data including the "nondomestic" reports.
All VAERS COVID Reports
US/Territories/Unknown
1,615,020 Reports Through November 3, 2023
36,726 Deaths
212,294 Hospitalizations
153,281 Urgent Care
240,624 Doctor Office Visits
10,706 Anaphylaxis
17,575 Bell's Palsy
5,071 Miscarriages
21,155 Heart Attacks
27,832 Myocarditis/Pericarditis
68,819 Permanently Disabled
9,008 Thrombocytopenia/Low Platelet
38,959 Life Threatening
46,529 Severe Allergic Reaction
15,960 Shingles
PING
All alphabet government agencies are in on it.
Also, side-effects from peanut butter.
To be expected when it pretty much filtered the VARS to death when it came to Covid.
I can’t see them admitting that they killed millions of people.
HUGE CYHA happening.
FResearch has shown 17 million deaths world wide caused by mRNA inniculation.
Abandon this crap!
Ivermectin is your friend.
See:
https://covid19criticalcare.com/
( dosage and supply)
>I can’t see them admitting that they killed millions of people.<
True dat. They developed a study, made sure they didn’t have enough people in the study to develop a data point, then claim they could not find any evidence because the study group was too small.
I would love to hear their excuses for not having a book report in 8th grade. It probably sounds similar.
EC
Your assessment is GENIUS.
Based on the high rate of global immunity and currently available data, the State Surgeon General recommends against the COVID-19 booster for individuals under 65. Individuals 65 and older should discuss this information with their health care provider, including potential concerns outlined in this guidance.
Providers and patients should be aware of outstanding safety and efficacy concerns:
The FDA now is flummoxed and cannot figure something out, while governments around the world assert that public data is either privileged, or required to be "authorized" for release? The edifice is crumbling now.
The perpetrators of and profiteers from this hoax will do everything they can to prop up the lies, anomalies and exculpatory evidence that might further the real facts in this.
The BigPharma *gift* that keeps on *giving*...
Just look at all of the $$$$ they’re NOW making off of attempting to TREAT the adverse effects of these horrid $hots.
Same agency claims they can say an untested drug is “safe and effective”.
In before the Branch Covidians.
The East Coast appears to be the most dangerous region for medical patients, with six of the 10 states in the study having a shoreline along the Atlantic Ocean.’
‘With reports of understaffing and strikes for wage increases within the healthcare sector, it will be interesting to monitor incidents of medical malpractice within the coming years for possible spikes or drops.’
New York topped the list as the state with the highest rate of medical malpractice.
According to the report, there have been 64,594 medical malpractice payment reports recorded in the state since 1990.
With 64,594 practitioners, that averages out to 1.25 cases per doctor.
https://www.dailymail.co.uk/health/article-12842909/safest-states-medical-patients-revealed.html
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