A few months before the first COVID-19 vaccines received Emergency Use Authorization<\/a> (EUA) in late 2020, a global vaccine safety expert cautioned<\/a> the rushed circumstances made it essential to \u201cget [safety monitoring] right\u201d by \u201cintensively\u201d and \u201crobustly\u201d scrutinizing adverse events following the experimental rollout.<\/p>\n As this expert <\/a>stated, \u201cDeploying any new vaccine based on data from expedited clinical trials into a population without a functioning safety monitoring system in place is reckless and irresponsible given the tools that are available.\u201d<\/p>\n Moreover, she added, any investments needed to beef up safety monitoring would be \u201cinexpensive in comparison\u201d to the massive funding allocated to COVID-19<\/a> vaccine development and scale-up.<\/p>\n In theory, the U.S. has had a national vaccine safety monitoring system in place since 1990 \u2014 the Vaccine Adverse Event Reporting System<\/a> (VAERS) \u2014 intended to function as an \u201cearly warning system<\/a>.\u201d<\/p>\n VAERS and its U.S. Food and Drug Administration (FDA) counterpart FAERS<\/a> (FDA Adverse Event Reporting System) constitute the principal data sources<\/a> that regulators rely on when pulling drugs or vaccines from the market for safety reasons.<\/p>\n Not only has VAERS never lived up to its promise<\/a>, but there can be little doubt its glaring failures<\/a> are largely, and malignantly, by design.<\/p>\n For example, when a government-commissioned study highlighted VAERS inadequacies in 2010 \u2014 estimating more than 99% of vaccine adverse reactions were going unreported and that one of every 39 doses<\/a> of vaccine administered was linked to adverse events corroborated in vaccine package inserts<\/a> \u2014 the Centers for Disease Control and Prevention (CDC) simply shut the project down.<\/p>\n Now, in less than a year, more than half a million reports of injuries<\/a> have flooded into VAERS following experimental COVID jabs, including thousands of deaths. Yet a deafening regulatory silence has greeted this record-setting volume of adverse reactions, which accounts for nearly a third<\/a> of all reports accumulated by VAERS over its entire three-decade lifespan.<\/p>\n How is the absence of \u201cearly warning system\u201d alarm bells possible? In a recent commentary<\/a>, \u201cDefining Away Vaccine Safety Signals,\u201d an experienced statistician suggested not only have safety experts\u2019 admonitions to get COVID vaccine safety monitoring \u201cright\u201d not been heeded, but CDC and other public health agencies have taken steps to intentionally hide safety signals.<\/p>\n It\u2019s all in the algorithm<\/strong><\/p>\n Statistician Mathew Crawford\u2019s various articles have a humble aim<\/a>: to \u201clay out the tools for how to think about difficult problems\u201d that he suspects \u201cmany people are highly confused about.\u201d<\/p>\n In the matter of COVID vaccine safety signals<\/a>, Crawford performs a valuable service by competently scrutinizing the VAERS \u201cStandard Operating Procedures for COVID-19,\u201d which, he notes, CDC published<\/a> \u201cwithout much fanfare\u201d on Jan. 29.<\/p>\n Specifically, Crawford dissects a key data-mining tool outlined by CDC in the Jan. 29 document. The tool, called a \u201cproportional reporting ratio\u201d (PRR), assesses one vaccine against another \u2014 comparing<\/a> \u201cthe proportion of a specific AE [adverse event] following a specific vaccine versus the proportion of the same AE following receipt of another vaccine.\u201d<\/p>\n So far, so good \u2014 except rather than doing the job it is professed to do, the PRR instead appears to be shockingly impervious to safety signals.<\/p>\n Even for those with no statistical background, Crawford\u2019s bottom-line conclusion could not be plainer:<\/p>\n \u201c[O]ne vaccine that kills and cripples 20 or 50 or 1,000 times as much as a very safe vaccine will show the same PRR \u2026 and no safety signal will be identified by the CDC. By design<\/strong> \u2026 [E]ven if I take a cell \u2026 and plug in some enormous number like 1500, there is still no safety signal as per CDC definitions.\u201d [Emphasis in original]<\/p>\n As Crawford points out, these undeniable mathematical patterns cannot help but raise suspicions that the PRR function is designed to \u201cestablish an illusion of safety\u201d and provide \u201ca reason to ignore the true signs of danger.\u201d<\/p>\n Initially, Crawford was willing to entertain the possibility that incompetence, rather than malevolence, might explain his findings \u2014 but he quickly rejected this explanation, in large part because the mathematical defect is so brazenly obvious that even a \u201cmiddling programmer without the fundamental mathematical training\u201d would notice it.<\/p>\n In Crawford\u2019s words, \u201cThere is a pride among geeks in identifying subtle mathematical or logical flaws in a system, and this is not subtle at all.\u201d<\/p>\n According to Crawford, this leads to some stark implications:<\/p>\n \u201cAt some point, when the potential for conflicts of interest are high and the point of failure is fundamental to the task of those doing the job, incompetence should no longer be differentiated from criminal intent.\u201d<\/p>\n The imploding safety narrative<\/strong><\/p>\n Statistical tricks<\/a> (and conflicts of interest<\/a>) are not new to the vaccine or pharmaceutical<\/a> industries, which have used them for decades to successfully mask the \u201cchasm<\/a> between vaccine rhetoric and reality.\u201d<\/p>\n Even when drug warning systems seem to \u201cwork,\u201d the lag time between reports of harm and regulatory action is, on average, 20 years<\/a>.<\/p>\n In that light \u2014 with FDA speeding toward full approval<\/a> of the Pfizer<\/a> injection, Moderna<\/a> gaining fast-track designation<\/a> to test other experimental mRNA vaccines<\/a> in children and adults and CDC benignly maintaining<\/a> that the results of COVID vaccine safety monitoring are \u201creassuring\u201d \u2014 it is not hard to be discouraged about the agencies\u2019 continued ability to get away with misusing<\/a> and abusing safety data from VAERS and other sources.<\/p>\n However, the safety narrative started imploding in a big way in late 2019, when the world\u2019s top vaccine experts gathered at the World Health Organization and admitted<\/a>, almost to a person, that vaccines are sometimes fatal and that safety monitoring is failing to capture the dangers.<\/p>\n COVID may have provided these worried experts with a temporary and convenient reprieve, but more and more people recognize that the premise that vaccine adverse events are \u201cone in a million<\/a>\u201d is an utter fiction.<\/p>\n With injuries from COVID vaccines occurring on an unprecedented scale \u2014 and credible doctors and scientists<\/a> issuing urgent warnings about short-term and longer-term<\/a> damage \u2014 it may become increasingly difficult for the vaccine establishment to shove its problems under the statistical carpet.<\/p>\n In 1976, public health authorities were forced to halt their rollout of a rapidly mobilized swine flu vaccine, after a spate of negative publicity<\/a> and some 4,000 serious adverse events \u2014 including Guillain-Barr\u00e9 syndrome<\/a> and death \u2014 became impossible to ignore. This \u201cmedical debacle<\/a>,\u201d now widely acknowledged as such, became the focus of a 1979 episode<\/a> of 60 Minutes.<\/p>\n With more than half a million COVID vaccine injuries now reported to VAERS alone, and many more<\/a> reported around the world, current events dwarf the 1976 \u201cdebacle.\u201d<\/p>\n Unfortunately, with 60 Minutes and its media ilk having abdicated their investigatory role, it is now more difficult to generate the kind of widespread attention to harm that typically mobilizes the public.<\/p>\n Last September, the global vaccine expert quoted above, Helen Petousis-Harris, Ph.D., wrote that failure to assess COVID vaccines for safety \u201cto our full ability\u201d would be fundamentally \u201cwrong<\/a>.\u201d<\/p>\n Without corporate media support, many individuals and organizations are therefore holding unethical government officials\u2019 and profiteering corporate executives\u2019 feet to the fire.<\/p>\n They recognize, as the nonprofit Stand for Health Freedom recently noted, that the matter of data is not inconsequential: \u201cThe COVID pandemic is built on data<\/a>,\u201d and data are driving policies that are \u201cchanging the structure of our society.\u201d<\/p>\n
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