Recently TrialSite raised more awareness about a group called the Public Health and Medical Professionals for Transparency (PHMPT) and their FOIA lawsuit against the U.S. Food and Drug Administration (FDA) to compel them to disclose the documents in the Pfizer COVID-19 Biologics License Application (BLA). Represented by the law firm of Siri Glimstad the U.S. District Court Northern District of Texas sided with Pfizer not allowing full disclosure until 2076! In an absurd ruling the court proposed they share with the public 500 pages per month until all has been shared—and of course that’s 55 years. Aaron Siri, partner of Siri Glimstad reported in his blog that the first batch of documents were produced—precisely, 91 pdf pages, one xpt file, and one txt file which can be downloaded. In this first batch was a significant hint as to what could be in store for all in the years to come.
Acknowledging that only the appropriately trained scientists and experts could analyze nonetheless common sense never is far from relevant. One of the fist documents perhaps was released as a hint as for what is in store. One of the released artifacts, a document titled “Cumulative Analysis of Post-Authorization Adverse Event Reports of [the Vaccine] Received Through 28-Feb-2021 was actually originated 2.5 months after the vaccine received the emergency use authorization (EUA) grant. Siri shared “This document reflects adverse events following vaccination that have completed Pfizer’s workflow cycle” both in and outside the U.S. up to February 28, 2021.”
‘Large #s Spontaneous Adverse Events’
On page 6 Mr. Siri points us to a quote in the report “Due to the large numbers of spontaneous adverse event reports received for the product, [Pfizer] has prioritized the processing of serious cases…” and that Pfizer has also taken a [sic] multiple actions to help alleviate the large increase of adverse event reports” including “increasing the number of data entry and case processing colleagues” and “has onboarded approximately [REDACTED] additional full time employees (FTEs).
In the 2.5 months beyond the EUA the disclosed report captured 42,086 reports inclusive of 158,893 events. Siri shares that the U.S. is the origin of most of the reports and that they involved women far more than men (29,914 vs. 9,182). 25,987 of these events were tagged as “Nervous system disorders.”
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Just Business As Usual
Pfizer points out that “The findings of these signal detection analyses are consistent with the known safety profile of the vaccine.” And this message aligns with a recent October 21 press release titled Pfizer and BioNTech Announce Phase 3 Trial Data Showing High Efficacy of a Booster Dose of their COVID-19 Vaccine” which emphasized first that the clinical trial generated positive efficacy data (95.6%); that with over 10,000 participants 16 years of age and up that the booster “was found to have a favorable safety profile” and finally that Pfizer planned to submit the data to appropriate regulatory bodies such as the FDA to support licensure in America and beyond.
In the press release Pfizer declared “The adverse event profile was generally consistent with other clinical safety data for the vaccine, with no safety concerns identified.”
Yet, Aaron Siri points out that if the adverse event reports were expected, why would they declare “large numbers of spontaneous adverse event report” while also needing to hire more personnel to deal with the deluge of reports? Wouldn’t their business planning have taken that into account?
Clearly the numbers of adverse events caught Pfizer by surprise or at least caught them off guard—needing adjustments to handle.
One Interpretation of Reality
COVID-19 has been a grave geopolitical health catastrophe, hitting developed societies in many cases worse than most low-and-middle-income countries (LMICs).
For example, more Americans have died (approaching 800,000) than any other nation. When reviewing COVID-19 by total numbers of reported deaths the impact on what has been the most powerful nation on the planet since the end of World War 2 is striking. America is joined by what would traditionally be considered developing (or emerging) nations in the globe’s pecking order of economic power. America is followed by Brazil, India, Mexico and Russia as the places most devastated by COVID-19.
The number of new orphans, or loss of a caregiver to a child created by the disease is just one indicator of the severity of this situation. A recent study in the journal Pediatrics in the U.S. alone one child loses a parent or caregiver for every four COVID-19 associated deaths. On this point the CDC points out that the findings “illustrate orphanhood as but one hidden and ongoing secondary tragedy caused by the COVID-19 pandemic.”
With 48.5 million cases in America conservatively around 10% to 20% will experience ongoing Long COVID while the subset of total cases that involve critical illness leads to a significant probability of death and/or new material symptoms. And the list of problems mounts.
In normal times the number of “spontaneous adverse events” associated with all of these vaccines would have probably triggered wide-spread pauses in the public health programs now underway. In that more normal scenario, the vaccine companies would have had to go back to the labs to figure out how to stabilize their investigational products.
However, we have gone down the path of no return. Put another way, due to the confluence of forces worldwide in response to this severe contagion the current rapid mass vaccination program is the only means of beating this pandemic according to top decision makers.
Undoubtedly this profound decision results from a collective set of parallel activities over time. Driven by a top-down set of elite directives, what emerges is an unfolding movement for a globally integrated, digitally centric, unified public health-driven set of actionable directives. This movement didn’t just arrive with the pandemic. Rather it resulted from the last couple of decades as new or modified paradigms for better public health and welfare—supportive of economic growth–influenced by change agents such as Bill Gates and other influential players’ foundations, industry, and importantly global finance. With money, prestige, and power comes a new kind of public health, heavily intertwined with life science-based investment and private equity financial logic ultimately leading to robust demands for financial returns.
TrialSite’s founder Daniel O’Connor shared “One cannot underestimate the societal impacts of decisions made by prominent and influential, well-placed change-agents a decade ago on today’s reality…and the ultimate capital calls…that will follow” O’Connor commented that this is the reason why so many people feel like the response to COVID-19 is some kind of “conspiracy” or “planned agenda.” But rather it’s just a logical set of unfolding outcomes based on decisions and actions already done.
But in all actuality the current unfolding of events represent the evolution (or devolution) of ideas combined with actions led by a top-down cadre of scientist, public health bureaucrat, financier and industry executive driven point of view: all directed by companies and capital-infused nonprofits as well as private equity bankers more than governments in shaping the visions and associated strategies that ultimately led to pragmatic goals and objectives that now drive our collective behavior.
So, this is all to say that the current adverse events (those known, as well as those suppressed) are frankly the cost of doing pandemic-fighting business for those in the driver’s seat. What is the acceptable threshold for those in power? Clearly that point isn’t anywhere near close, at least not yet.