The U.S. Food and Drug Administration (FDA) in White Oak, Md., on June 5, 2023. (Madalina Vasiliu/The Epoch Times)
Posted on 01/31/2024 9:44:24 PM PST by SeekAndFind
Updated COVID-19 vaccines may cause heart inflammation and severe allergic shock, according to a new study from the U.S. Food and Drug Administration (FDA).
The U.S. Food and Drug Administration (FDA) in White Oak, Md., on June 5, 2023. (Madalina Vasiliu/The Epoch Times)
Researchers with the FDA, the U.S. National Institutes of Health, and companies like CVS looked at health care databases to try to figure out if there were signs the Moderna and Pfizer bivalent COVID-19 vaccines might be linked to any health issues.
They found several safety signals. One signal was for myocarditis, a form of heart inflammation, and a related condition called pericarditis following Pfizer vaccination in adults aged 18 to 35. Another was for anaphylaxis, or severe allergic shock, following Moderna and Pfizer vaccination in people aged 18 to 64.
The signals were detected in a database from Carelon Research.
The incidence rate for anaphylaxis was 74.5 cases per 100,000 person-years following Pfizer vaccination and 109.4 cases per 100,000 person-years following Moderna vaccination.
Researchers arrived at an incidence rate of 131.4 cases of myocarditis/pericarditis per 100,000 person-years after a Pfizer shot.
No stratification was done by gender, despite myocarditis, according to many studies, disproportionately affecting males.
Person-years is a measure used in some studies. In this study, all time during post-vaccination periods of time known as risk intervals were included. The risk intervals were different depending on the health outcome. For anaphylaxis, the risk interval was 0 to 1 day; for myocarditis/pericarditis, it was 0 to 7 days or 0 to 21 days.
Additional issues were also identified in the four databases that were analyzed, but none rose to the level of a safety signal, a set criteria that is an indication of a vaccine causing an issue.
The study analyzed data from people aged 6 months and older from August 2022 to July 2023. The bivalent shots were replaced soon after by updated vaccines because their effects, which already started low, were shown to wane in observational studies.
Researchers only included people who were continuously enrolled in an insurance plan and did not suffer health issues during a “clean interval,” or if the health outcome in question did not occur during a certain interval.
“References for the clean interval could not be located in the literature and are based on clinician input,” the authors said in a footnote.
Pfizer and Moderna, which make COVID-19 shots that utilize modified messenger RNA (mRNA), did not return inquiries.
Patricia Lloyd, an FDA researcher, and her co-authors said the study “supports the safety of these vaccines” and “supports the conclusion that the benefits of vaccination outweigh the risks.”
Asked for evidence to support those conclusions, Ms. Lloyd referred a request for comment to the FDA.
“With over a billion doses of the mRNA vaccines administered, available scientific evidence supports the conclusion that the vaccines are safe and effective. The FDA stands behind its findings of quality, safety, and efficacy for the mRNA vaccines. Additionally, it is simply a fact that millions of lives have been saved because of the COVID-19 mRNA vaccines, which most Americans undergoing vaccination have received,” an FDA spokesperson claimed.
The agency provided a single citation from the Commonwealth Fund, a foundation that used modeling to estimate that through November 2022, the vaccines prevented millions of deaths.
The study was published ahead of peer review on the medRxiv server.
Dr. Peter McCullough, a cardiologist and president of the McCullough Foundation, told The Epoch Times in an email that results from the paper show “cardiovascular and neurological safety events are numerous and unacceptable on a population basis.”
Dr. McCullough, who was not involved with the paper, noted that the study did not analyze COVID-19 vaccine effectiveness.
“The FDA’s conclusion on risk benefit is not valid and reflects agency bias in attempting to promote the unsafe, ineffective products,” he said. “Our regulatory agencies should not be promoting or advertising the products they are charged with regulating.”
The FDA clears vaccines. The agency in 2022 authorized and approved the bivalent vaccines despite there being no clinical trial data available.
Limitations of the new paper included the lack of medical record review. Many authors reported their employment for health care companies as conflicts of interest.
A previous study analyzing the health claims databases detected signals for seizures/convulsions among children aged 2 to 4 after Pfizer vaccination and children aged 2 to 5 following Moderna vaccination. That study analyzed the version of the vaccines that preceded the bivalent shots.
In another new study, co-authored by Dr. McCullough, researchers reported finding a spike in reports of myocarditis in the federally-run Vaccine Adverse Event Reporting System in 2021.
“We found the number of myocarditis reports in VAERS after COVID-19 vaccination in 2021 was 223 times higher than the average of all vaccines combined for the past 30 years,” the researchers said.
Applying causality principles, the researchers said that COVID-19 vaccination was “strongly associated with a serious adverse safety signal of myocarditis, particularly in children and young adults resulting in hospitalization and death.”
Federal officials have said that the COVID-19 vaccines cause myocarditis, pericarditis, and anaphylaxis, but that the vaccines also provide protection against infection and severe illness, tilting the risk-benefit balance in their favor. They have increasingly cited, in lieu of clinical trials, observational studies from the FDA and U.S. Centers for Disease Control and Prevention (CDC), some of which lack peer review.
Current U.S. recommendations are for essentially all Americans aged 6 months and older to get one of the newest COVID-19 vaccines, introduced in 2023. That contrasts with a number of other countries, such as the United Kingdom, which have stopped offering or no longer recommend COVID-19 vaccination for wide swaths of their populations.
Ping for your interest
So, just like the old vax.
The China virus may make you sick but big Pharma’s China virus jab is likely to kill you. Yeah, that makes me want to run out and get another mRNA jab. /s
So the good old FDA, with pharmaceutical company execs on the board of directors, found the vaccines effective?
The CEO of Pfizer caught covid.
My dear friend had every shot and booster. And she had covid three times after that. I’ve been buying groceries for her as she can’t go out.
My daughter’s best friend, a total liberal, had every shot and booster and caught covid recently. Prior to that she was truly shocked when I told her my MD didn’t think I needed a vax. SHOCKED.
Does anyone know what happened to the guy in Europe who was caught getting vaxxed for others for a fee?
They should wait for the VAERS data to ignore.
“Does anyone know what happened to the guy in Europe who was caught getting vaxxed for others for a fee?”
I heard he turns into the superhero they all call ‘The SpikeMann’
He itches himself, grabs the shedding spikes and hurles them at his antagonists
To die suddenly and unexpectedly from cardiac arrest is not uncommon for 73 years old men, but my first thought and I can’t help but wonder if his was a vaxx related died suddenly.
May God rest his soul and comfort his family and friends.
The expression "Safety Signal" is a classic Orwellian twisting of language.
Perhaps a more-honest headline would have read:
FDA Finds Updated COVID-19 Shots Can Kill You
Small Consolation: At Least Updated Shots Are Somewhat Less Lethal than Original COVID-19 Shots
Regards,
Of course they are going to say that.
They have to or they've destroyed any credibility they may have left and they might as well be disbanded as proving themselves to be useless and untrustworthy.
The government is a master at Orwellian speak.
And in other news, FDA pulled their heads out of their collective asses and still REFUSES to see the daylight.
Yep that’s a trustworthy, honest , respectable bunch of politically and financially motivated stooges. /Spit
The honest FDA. The same FDA that lied and told people not to take Ivermectin since it is for horses.
Very impressive! It took them only 4 years to discover what was known here in 2020.
FDA-Frikken Death AdminisTraitors
Ping
Per McCullough.
Yet FDA says "tilted" toward "safe & effective" because the jabs,
...also provide protection against infection and severe illness...
Criminal. We will have to present piles of corpses before they relent on this utter BS.
Ping
Why should that surprise you? Financially compromised people, and people so enamoured of their genius and degrees love the MutatedRNA heart destroying shots. Here at FR we knew this from the beginning but compromised people love the financial gains and the fruits of their compromised genius more than truth. The moral boys and girls are that there are very intelligent people willing to delude themselves for profit or self delusion of their arrogant greatness.
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