(Nov. 11, 2022) — The U.S. Food and Drug Administration and the Centers for Disease Control and Prevention jointly run and, allegedly, monitor the Vaccine Adverse Events Reporting System (VAERS) for safety signals.
Both agencies have been blatantly derelict in their duties in this regard, as the safety signals in VAERS have been screaming for attention since the first quarter of 2021. Yet both the FDA and CDC claim they’ve found nothing of concern. Nothing at all.
They’re so unconcerned they even added the COVID jabs to the childhood vaccination schedule, with the first jab series to be given to toddlers and babies as young as 6 months. Meanwhile, data from around the world, including data in VAERS,1 V-Safe and the Defense Medical Epidemiology Database (DMED), suggest these shots are the deadliest in the history of vaccines. No other product comes even close.
CDC Invents Facts to Drive a Narrative
In the video above, Megyn Kelly interviews Robert F. Kennedy Jr. about the difficulty in determining how many lives may have been saved by the COVID shots, versus how many lives have been lost because of them, and highlights some of the outright false statements issued by the CDC.
For example, the CDC has publicly warned that COVID is one of the Top 10 causes of death in children aged 5 to 11, yet when asked to produce the data, they admitted they never conducted an analysis for that age group.
So how did they conclude that COVID is a top cause of death in an age group they’ve never analyzed mortality data for? The rational conclusion is that they just made it up.
As noted by Kennedy, the CDC is also discouraging autopsies of people who die post-jab, and they’re engaging in a whole host of other obfuscation tactics that make good data hard to come by, and this has been going on since the very beginning of the pandemic.
FDA Is Withholding Crucial Study Findings
The FDA is also guilty of massive data obfuscation. In a recent BMJ article,2 investigative journalist Maryanne Demasi discusses the FDA’s failure to follow up on and release data showing an increase in serious adverse events in elderly individuals who received the Pfizer shot:
“In July 2021 the US Food and Drug Administration (FDA) quietly disclosed findings of a potential increase in four types of serious adverse events in elderly people who had had Pfizer’s COVID-19 vaccine: acute myocardial infarction, disseminated intravascular coagulation, immune thrombocytopenia, and pulmonary embolism.
Little detail was provided, such as the magnitude of the increased potential risk, and no press release or other alert was sent to doctors or the public. The FDA promised it would ‘share further updates and information with the public as they become available.’
Eighteen days later, the FDA published a study planning document (or protocol) outlining a follow-up epidemiological study intended to investigate the matter more thoroughly.
This recondite technical document disclosed the unadjusted relative risk ratio estimates originally found for the four serious adverse events, which ranged from 42% to 91% increased risk. (Neither absolute risk increases nor confidence intervals were provided.)
More than a year later, however, the status and results of the follow-up study are unknown. The agency has not published a press release, or notified doctors, or published the findings by preprint or the scientific literature or updated the vaccine’s product label.
The BMJ has also learnt that the FDA has not publicly warned of similar signals detected in a separate observational cohort study3 it conducted of the third dose (first booster dose) in the elderly …
[Nor] has the agency publicly acknowledged other published observational studies or clinical trial reanalyses reporting compatible results. Experts spoke to The BMJ about their concerns about the data and have called on the FDA to notify the public immediately.”
Serious Side Effects in Seniors Are Being Hidden
As explained by Demasi,4 the July 2021 findings came from a surveillance system called Rapid Cycle Analysis (RCA), which provides “near real-time” monitoring of 14 “adverse events of special interest.” Like VAERS and other surveillance tools, the RCA cannot establish causality, but unlike the others, its strength lies in detecting potential safety signals more rapidly.
The FDA’s protocol document for the planned follow-up study indicates that a manuscript of the original RCA study is being prepared, but more than a year later, neither the original RCA study nor the follow-up study have been published. Why?
The FDA is also hiding other studies. Buried inside yet another study protocol, the FDA discusses findings from “a cohort study of the third dose safety in the Medicare population where historical controls were used.” In that Medicare study, the FDA found:
“… a statistically significant risk for immune thrombocytopenia (incidence rate ratio 1.66, confidence interval 1.17 to 2.29) and acute myocardial infarction (IRR 1.15, CI 1.02 to 1.29) among people with prior COVID-19 diagnosis as well as an increased risk of Bell’s palsy (IRR 1.11, CI 1.03 to 1.19) and pulmonary embolism (IRR 1.05, CI 1.0001 to 1.100) in general.”
Why were those results buried in a study protocol and never published or announced to the public? As noted by Dr. Joseph Fraiman, an emergency medicine physician in New Orleans, “If the FDA is stating publicly that they’re collecting [data], then they should be publicly reporting it. They shouldn’t be burying the results in protocols as they’ve done.”5
Dutch epidemiologist and president of the International Society of Drug Bulletins, Dick Bijl, agrees, telling Demasi that any warning signals found in July 2021 “should have been analyzed and published within months.”
Reanalysis of Trial Data Confirms Safety Problems
Fraiman is particularly concerned as his team recently reanalyzed data from the Pfizer and Moderna Phase 3 trials, finding results that match those that the FDA are now hiding.
Their reanalysis,6 which focused on serious adverse events highlighted in a World Health Organization-endorsed ‘priority list7 of potential adverse events relevant to the COVID-19 shots, found Pfizer’s shot was associated with an increased risk of serious adverse events at a rate of 10.1 events per 10,000. The rate for Moderna’s jab was 15.1 events per 10,000.
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