By Calvin Freiburger
A recent study by researchers with the U.S. Food & Drug Administration (FDA) found that Pfizer’s mRNA-based COVID-19 vaccine “met the threshold for a statistical signal” of blood clotting in the lungs of recipients aged 65 and older, as well as weaker thresholds for other complications, but the agency still claims the benefits outweigh the risks.
The study, published December 1 in Vaccine, reviewed data pertaining to fourteen “outcomes of interest” after vaccination from more than 30 million elderly Americans spanning December 11, 2020 through January 15, 2022, and compared the rates to the pre-vaccine historical rates for the ailments.
It found that outcomes of pulmonary embolism, acute myocardial infarction, disseminated intravascular coagulation, and immune thrombocytopenia initially “met the threshold for a statistical signal,” and that following additional evaluation, pulmonary embolism “still met the statistical threshold for a signal.”
While acknowledging that the findings warrant “more robust epidemiologic studies with adjustment for confounding, including age and nursing home residency” (which they claimed are underway), the authors took pains to downplay their significance.
“The statistical signals of four serious outcomes are not necessarily causal and may be due to factors potentially unrelated to vaccination,” such as variables not fully accounted for such as the different comorbidity baselines of elderly Medicare patients and other elderly groups and a “substantial fraction [having] pre-existing outcome-specific comorbidities and risk factors” that mean “some outcomes may be due to follow-up care to an existing condition preceding the vaccination.”
“FDA strongly believes the potential benefits of COVID-19 vaccination outweigh the potential risks of COVID-19 infection,” the authors concluded. “Per FDA communication of these findings, FDA is currently not taking any regulatory actions based on these signal detection activities because these signals are still under investigation and require more robust study.”
The new study “corroborates the concerns of doctors that the large uptick in blood clots, progression of atherosclerotic heart disease, and blood disorders is independently associated with COVID-19 vaccination,” cardiologist, epidemiologist, and prominent COVID-establishment critic Dr. Peter McCullough told The Epoch Times.
“A shortcoming of the CMS surveillance system is that it did not capture prior and subsequent SARS-CoV-2 infection which accentuate the cumulative risk of COVID-19 vaccination,” he added. “Given the large number of individuals who have been vaccinated, the population attributable fraction of medical problems ascribed to the vaccines is enormous. I have concerns over the future burden to the healthcare system as a consequence of mass indiscriminate COVID-19 vaccination.”
The study joins a body of evidence indicating the potential harms of the COVID shots, which were developed and tested in a fraction of the time vaccines usually take under former President Donald Trump’s Operation Warp Speed initiative.
The federal government’s Vaccine Adverse Event Reporting System (VAERS) reports 32,621 deaths, 185,412 hospitalizations, and 35,718 myocarditis and pericarditis cases as of December 2. An April study out of Israel indicates that COVID infection alone cannot account for such myocarditis cases, despite claims to the contrary. Reports submitted to VAERS about possible side effects are unconfirmed, as anyone can submit a report, but U.S. Centers for Diseasee Control & Prevention (CDC) researchers recognize a “high verification rate of reports of myocarditis to VAERS after mRNA-based COVID-19 vaccination,” leading to the conclusion that “under-reporting is more likely” than over-reporting.
Further, VAERS is not the only data source containing red flags. Data from the Pentagon’s Defense Medical Epidemiology Database (DMED) has been similarly alarming, showing that 2021 saw drastic spikes in a variety of diagnoses for serious medical issues over the previous five-year average, including hypertension (2,181%), neurological disorders (1,048%), multiple sclerosis (680%), Guillain-Barre syndrome (551%), breast cancer, (487%), female infertility (472%), pulmonary embolism (468%), migraines (452%), ovarian dysfunction (437%), testicular cancer (369%), and tachycardia (302%).
In September, the Japanese Society for Vaccinology published a peer-reviewed study conducted by researchers from Stanford, UCLA, and the University of Maryland, which found that the “Pfizer trial exhibited a 36% higher risk of serious adverse events in the vaccine group” while the “Moderna trial exhibited a 6% higher risk of serious adverse events in the vaccine group,” for a combined “16% higher risk of serious adverse events in mRNA vaccine recipients.”
Early this month, U.S. Sen. Ron Johnson (R-WI) hosted a roundtable discussion during which civil rights attorney Aaron Siri detailed data from the CDC’s V-Safe reporting system revealing that 800,000 of the system’s 10 million participants, or approximately 7.7 percent, reported needing medical care after COVID injection. “25 percent of those people needed emergency care or were hospitalized, and another 48 percent sought urgent care,” Siri added. “Also, another 25 percent on top of the 7.7 percent reported being unable to work or go to school.”
Another study by a team of American, British, and Canadian researchers, published December 5 by the in the Journal of Medical Ethics, found that COVID booster mandates for university students – a relatively healthy group at relatively low risk from the virus – do far more harm than good: “per COVID-19 hospitalisation prevented, we anticipate at least 18.5 serious adverse events from mRNA vaccines, including 1.5–4.6 booster-associated myopericarditis cases in males (typically requiring hospitalisation).”