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Home Type Curated

C-19 Injections: Massive Regulatory and Manufacturing Fraud

by Tessa Lena
November 25, 2022
in Curated, Videos
Covid Vaccines
He reigns. We pour. Promised Grounds is the Christian coffee company that happens to also offer the best coffee available.

STORY AT-A-GLANCE

  • Alexandra Latypova is an ex-pharmaceutical industry and biotech executive with a lot of experience in the areas of drug safety and clinical trials
  • Early on, she discovered that, based on the number of reported deaths and adverse events per lot, there was unprecedented variability in the toxicity of the product
  • According to Alexandra, the mRNA shots do not conform to their label specifications, and “in practice, both ‘blank’ and ‘lethal’ vials and anything in between is produced”
  • Having analyzed massive amounts of publicly available data, as well as documents that became available as a result of FOIA requests and other sources, she has found strong evidence of manufacturing and regulatory fraud

I recently had the pleasure of interviewing Alexandra Latypova, an ex-pharmaceutical industry and biotech executive, who has been investigating and exposing manufacturing and regulatory fraud related to COVID injections.

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We talked about the industry standards that were not adhered to during the clinical trials and the manufacturing of those injections, about the vial content quality testing procedures that had not been put in place, about the “hot batches” and their geographical distribution, about signs of fraud at every stage of testing and manufacturing the product, and about the general condition of living in a world run by a mob.

The latter was the lightest part of our conversation — evoking a lot of dark Eastern European humor — since both of us are Soviet expats, and in 2020, neither of us required a whole lot of imagination to embrace the existential possibility of living in a world run by a mob. We had seen it in the past without a disguise — and when something looks like a duck, walks like a duck, and quacks like a duck, maybe it’s just a duck!

Alexandra Latypova’s Background

Alexandra grew up in Soviet Ukraine and immigrated to America in the late 1990s. She received her MBA from Dartmouth College and the spent about twenty five years in pharmaceutical industry and biotech (including in the areas of drug safety and clinical trials).

Alexandra has had a very gratifying entrepreneurial career. She has founded a number of successful startups, sold them — all before COVID — and retired, hoping to focus on enjoying her life and especially painting, which she does masterfully.

When 2020 knocked on the door with a whole bag of ugly and weird “new normal” treats, Sasha smelled the rat right away. Initially, she became alarmed by the abnormalities in “COVID response,” including the very conspicuous campaign to prevent effective treatment of COVID.

Compelled to understand what was going on, Alexandra got to work. She looked at VAERS and discovered huge discrepancies between the lots, where some batches had just a few reported severe adverse events, and some had over 1500 (she later learned from FOIA’ed documents that lot sizes were in a relatively similar range, and thus the discrepancies could not be explained by the lot size).

And when it comes to VAERS, let’s not forget the 2010 Harvard Pilgrim study showing that VAERS was severely underreported — NOT overreported — capturing less than 1% of adverse events.

“Hot Batches”

Early on, Alexandra discovered the existence of “hot batches.” She is one of team members behind the famous “How Bad Is My Batch” webpage where people can look up the number of severe adverse events reported to VAERS associated with a COVID injection lot number. Other fearless members of the team are Dr Mike Yeadon, ex-head of Pfizer Respiratory Research, Jessica Rose, statistician, Craig Paardekooper, researcher, and Walter Wagner, lawyer.

The slide below show the unprecedented variability of serious adverse events and deaths in the U.S. per batch. Note the comparison to the variability of the flu vaccine lots.

In the interview, Alexandra also mentioned the uneven distribution of deaths per a hundred thousand doses from batch to batch in the U.S. The coasts did much better than some of the Midwestern states that showed a very high numbers of reported deaths per a hundred thousand doses. The worst state is South Dakota (30+ reported deaths per 100,000 doses).

The areas that did even worse, according to Alexandra, were some of the U.S. territories with high percentage of indigenous population. (The latter data became available after the presentation was created, not reflected in the slide.)

“Garbage Soup”: Non-Compliance With Good Manufacturing Practices

In the interview, Alexandra calls the COVID injections products “garbage soup,” both due to the massive non-compliance of the vial content to the specifications (per multiple independently done tests) — as well as due to their non-compliance with Good Manufacturing Practices. Wait, are the manufacturers trolling us? Are telling us that they do not comply (but we must)?!

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There are many theories about what’s behind for such wild inconsistency between batches, from manufacturing defects to deliberate toxicity testing — and anything in-between. In her TrialSiteNews article, Alexandra tackles one important angle of the challenge that so many of us had to “explain” when talking to the friends of a more mainstream persuasion:

“Many of us are familiar with the following conundrum: on one hand, highly credentialed scientists and doctors have written numerous research papers explaining the dangerous mechanisms of action underlying mRNA/DNA “platform” technologies. The papers are meticulously researched and depict, correctly in my opinion, many terrifying consequences of the technology that breaches the innate protective mechanisms of human cells.”

“Furthermore, these theoretical papers are validated by the observed outcomes, such as for example, increases in all-cause mortality in high correlation with increases in rates of vaccination in a given territory, unprecedented increases in the adverse events and deaths recorded by various passive reporting systems, astonishingly high reports of the adverse events and deaths from the pharmas’ own pharmacovigilance systems, and autopsy findings in vaccinated post-mortem showing the mechanisms of mRNA technology damage in histopathologic evaluations.

On the other hand, many who have received the injections report no adverse effects and deem the points above a ‘crazy conspiracy.'”

“The question from the uninjured seems to be – why don’t we see MORE deaths if what you say about mRNA products is true? Setting aside ethical limitations of this question, here is a possible answer why: The mRNA shots do not conform to their label specifications. In practice both “blank” and “lethal” vials and anything in between is produced [emphasis mine].”

Like I wrote earlier on my Substack, “remarkably, some analyzed vials were reported to contain left over magnetic beads (magnetic beads are used in production of mRNA). Remember the “crazy” videos of some people developing magnetism in the place of injection? Now we have a new, ‘non-conspiratorial’ explanation for the ‘conspiratorial’ videos! Yay, following the science!”

According to Alexandra, vials of mRNA injections are not routinely tested by the manufacturers for conformity to the label. She notes that “the more they conform to the mRNA specification, the deadlier they seem.”

The only vial-level tests specified, for instance, by Pfizer, in leaked Chemistry Manufacturing and Controls documents, are the vial weight at filling, manual inspection for large visible particles, and some tests related to integrity such as vial capping.

The documents don’t describe no routing vial or dose tests verifying the ingredients. Each Pfizer dose is supposed to contain 30 mcg of mRNA, as stated on the label, but there is no information about any testing done to verify that.

“The ingredient conformity tests described in Pfizer CMC package are based on the bulk product batch testing – an upstream manufacturing process step.

It is a regulatory requirement to retain samples of each batch produced, and these samples of vials should exist and be available for examination. Per contracts with the US Government/DOD, the product is shipped to the DOD who retains the ownership of the vials until the product is injected into people.”

Alexandra notes that those contracts are very detailed and specify manufacturing data to be delivered to the DOD, however, she not find any descriptions of sampling of the vials for purposes of verification of their contents vs the label. “Furthermore, it is expressly forbidden by the international vaccine supply contracts to perform the vial tests for label conformity.”

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Evidence of Collusion

In the interview, as well as in this article, Alexandra talks about the evidence of collusion between the manufacturers, the global regulatory agencies, and the US Department of Defense.

Having analyzed various public data from CDC’s VAERS database as well as various documents that have been obtained through FOIA releases and other source, she concluded that such collusion “led to the commercial release of the Covid-19 countermeasures that do not comply with the current Good Manufacturing Practices (cGMP).”

Evidence that Alexandra talks about includes Moderna’s non-clinical study summaries, Pfizer’s Chemistry Manufacturing and Controls documentation, and contracts between pharma and the DOD for supply of the mRNA/DNA products. According to her, “it reveals disregard for established safety rules, regulations, and safety practices throughout the development, manufacture, and distribution of these products.”

Moderna Red Flags

As reported by Children’s Health Defense, Alexandra reviewed 700 pages of documents that Moderna submitted to the FDA as part of its application process and obtained via a Freedom of Information Act request.

And according to her, “out of nearly 700 pages, about 400 pages are irrelevant studies that Moderna repeated multiple times. Moderna also submitted three versions of a single module, she said. And one module contained only narrative summaries of Moderna’s studies, but no actual study results.” Alexandra’s conclusion is that we are missing a large number of results, such as full reports that would support their narrative.

“The FDA ‘obviously did not object’ to any of this, she said. ‘That’s evidence of collusion to me with the manufacturer.'”

Other “abnormalities” that Alexandra highlighted both in the interview and in the Children’s Health Defense article, were Moderna’s clinical trials timeline and the fact that their product has two — not one — Investigational New Drug (IND) number.

Normally, there is one IND application for one product. “In this case, however, there are two IND applications — one belonging to Moderna, and one belonging to the National Institutes of Health, which partnered with Moderna on its COVID-19 vaccine.”

“The Investigational New Drug (IND) application meeting is supposed to occur with the FDA when the company initiates human clinical trials. Moderna and the FDA had a pre-IND meeting on Feb. 19, 2020, and the IND application was formally opened the next day. The global pandemic was declared on March 11, 2020.”

In the words of Alexandra, “Somehow these visionaries could predict the future with such certainty that they opened a clinical trial for the vaccine, for which a pandemic was announced a month later.”

Pfizer Red Flags

As Alexandra notes in her article titled, “Did Pfizer Perform Adequate Safety Testing for its Covid-19 mRNA Vaccine in Preclinical Studies? Evidence of Scientific and Regulatory Fraud,” “both the manufacturer and the regulators behaved in a highly dishonest manner and conspired to push an entirely novel technology and product on millions of people without carrying out a single well designed safety assessment.”

For example, she points out that a review of clinical studies released by FOIA uncovered that at least 4 different variants of active ingredient were included in the single Investigational New Drug application by Pfizer IND#19736:

  • BNT162a1 — Unmodified mRNA (uRNA; variant RBL063.3)
  • BNT162b1 — Methylpseudouridine-modified mRNA (modRNA; variant RBP020.3)
  • BNT162b2 — Methylpseudouridine-modified RNA (modRNA; variant RBP020.2)
  • BNT162c2 — Self-amplifying unmodified mRNA (saRNA; variant RBS004.2)

Alexandra writes that while the use of multiple versions of a product in the early stages of development is often inevitable, each chemical or biological entity is nevertheless deemed legally distinct for the purpose of product approval.



“Therefore, studies conducted with versions of the product that don’t conform to the exact specification of the final version may serve only as supporting information for the approval of the latter, but they should never be deemed definitive and sufficient tests for claims of safety or efficacy pertaining to the final product.”

She further mentions that in September 2021, the FDA issued a draft guidance entitled “Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial,” which states that each version of product requires a separate IND application.

However, stunningly, “a footnote in this guideline exempts ‘vaccines intended to prevent infectious diseases’ from this requirement. No explanation is given as to why this exemption is made, and no conceivable scientific or legal basis exists for this exemption, other than that the FDA had already arbitrarily allowed this unprecedented deviation from the regulatory standard and later needed to cover their tracks.

In fact, arguably this regulatory ‘exception’ does not even apply to Pfizer’s COVID-19 ‘vaccine,’ since the product does not prevent infection or transmission of the disease. Is intent to prevent illness alone a sufficient condition? After all, every new drug is intended to do something like preventing an illness, but only few successfully do so.”

Alexandra’s article is very detailed, and I highly recommend reading it in full. You can also find Alexandra on TrialSiteNews and on her Bitchute channel. To summarize her take on Pfizer, she make the following points:

  • Pfizer’s program did not include a comprehensive end-to-end test of all components of the final approved product (the mRNA COVID-19 vaccine). Instead, the studies included in the document package submitted to the FDA employed several variants and analogues of the product, whose comparability to the actual COVID-19 vaccine was not demonstrated or evaluated. Thus, no comprehensive assessment of product safety can be made on the basis of these studies.
  • A key determinant of a drug’s toxicity is its distribution within the body. However, with the mRNA active ingredient of Pfizer’s COVID-19 vaccine, this crucial aspect was never studied!
  • Pfizer claimed absence of potential for “vaccine-elicited disease enhancement” based on studies of an animal species that does not get sick from SARS-CoV-2.
  • The CDC, the FDA and Pfizer all lied about “vaccine staying at the injection site;” they knew all along that distribution of the vaccine throughout the body had to be expected.
  • Pfizer skipped major categories of safety testing altogether.
  • Pfizer used dishonest and self-serving interpretation of regulatory guidelines to justify the shortcuts it took in routine safety testing.
  • Both FDA and Pfizer knew about major toxicities associated with gene-therapy medicines in general, and they therefore cannot claim lack of anticipatory knowledge of these risks with the particular gene therapy medicine that is Pfizer’s COVID-19 vaccine. This points to intentional fraud and collusion between Pfizer and the regulators, who conspired to push this untested dangerous product on the market.

Yes, They Are Trolling Us — But We Are Not Helpless

Even though it is rather disheartening to know we live in a world that run by a mob, the challenge is centuries old, and remembering it can bring us much needed perspective and balance. The novel and “sudden” part of the challenge is that is happening to us, here and now, in broad daylight. That’s shocking! But throughout history, many of our ancestors had to deal with tyrants, and today, it is our turn to be brave. May our brave ancestors be our inspiration.

AMAZING coffee from a Christian company: Promised Grounds tastes incredible, is ethically sourced, and proceeds go to missionary work. Drink faithfully!

I would like to end this story with a short quote from my earlier article titled, “Is Our World Run Like a Mafia? So What Do We Do?:”

“Good news: As the mafia bosses do their predatory thing, something mysterious is happening the hearts of those of us who insist on love. Under pressure, we are forced to remember that we are not theirs.” We are not theirs. It is true.

About the Author

To find more of Tessa Lena’s work, be sure to check out her bio, Tessa Fights Robots.

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Two Storms, One Harvest

Empty Shelves

Every food crisis in living memory has been a one-shock event. The 2008 price spike was a commodity bubble. The 2020 shortages were a logistics failure. The 2022 grain scare was a war on one exporter’s ports. Each time, the system bent, adjusted, and recovered, and each time the experts assured us afterward that global markets are simply too big and too diversified to fail.

What nobody in Washington seems eager to discuss is that 2026 is shaping up to be something the modern food system has never actually faced. Two independent shocks, one climatic and one geopolitical, are converging on the same harvest cycle at the same time. Not sequentially. Simultaneously.

Start with the weather. The Pacific Ocean is currently building toward what forecasters now openly call a record event. NOAA’s Climate Prediction Center puts the odds of at least a strong El Niño near 88 percent, with roughly two in three odds it reaches “very strong” status, the tier reserved for perhaps three or four events in the entire satellite era. Every major global model now projects a median peak in Super El Niño territory, and most of them project it exceeding the 2015-16 event, which until now held the modern record. Sea surface anomalies were already brushing the super threshold in mid-July, months before these events normally peak. The atmosphere has already shifted into El Niño mode, and the event is forecast to crest in late fall and early winter.

This is not about “climate change.” It’s about the standard cycles of weather, and the cycle we’re currently in is one that has likely devastated societies in the past. We’re better prepared as a society today, but not all Americans are equally prepared.

Serious households have started doing the quiet math on their own. Grocery bills tell part of the story, and the forecast maps tell the rest, which is why long-term food storage has moved from fringe hobby to mainstream line item in the family budget, with established suppliers like Heaven’s Harvest seeing demand from people who five years ago would have rolled their eyes at the idea. That instinct is not paranoia. It is pattern recognition, and the pattern is worth walking through carefully.

Editor’s Note: Heaven’s Harvest IS a sponsor, but the warnings of this article are real and would be written even if we didn’t have a survival food sponsor. With that said, those who take advantage of what they offer can use promo code “Patriot” for 15% off.

The Fertilizer Clock Is Already Running

While the Pacific warms, the second shock has been unfolding in the Strait of Hormuz. The conflict with Iran turned the world’s most important energy chokepoint into a contested waterway, and the consequences reach far beyond the gas pump. Roughly a third of global fertilizer trade moves through Hormuz, and the disruption sent urea prices up 86 percent year over year by March, with a 53 percent jump in a single month.

The World Bank projects energy prices rising about 24 percent in 2026 and fertilizer about 31 percent. By its own accounting, fertilizer prices ran 35 percent higher in the first five months of this year than the same period last year.

Here is the mechanism the nightly news will not explain. Fertilizer is not a grocery item. It is a time-delayed input. The nitrogen a farmer in Iowa or Punjab could not afford to apply this spring does not show up as a problem this spring. It shows up as a thinner harvest six to twelve months later.

The World Bank’s own food security brief concedes that the effects of reduced applications earlier this season “are likely to become visible only later in harvest outcomes.” Translate that from institutional language into plain English and it means this. The damage is already done, it is already in the ground, and we are simply waiting for it to arrive on the shelf.

Now check the calendar. Six to twelve months from the spring planting season lands us squarely in late 2026 and early 2027. Which is precisely when the strongest El Niño in the instrumental record is forecast to peak, bringing its signature droughts to Southeast Asia, Australia, southern Africa, northern Brazil, and South Asia, the very regions that grow the world’s rice, sugar, and oilseeds.

The World Bank warns openly that a strong El Niño “could disrupt multiple crop belts simultaneously” on top of the conflict-driven input costs. Their baseline projection assumes the Middle East disruptions ease by autumn. What in the last two years of Middle East history suggests that assumption is safe?

The System Has No Slack Left

The comfortable answer is that global markets always adjust. But adjustment requires slack, and the slack is gone. Global cereal production is expected to decline from last year’s records even before El Niño does its work. The UN World Food Programme, hardly a den of right-wing preppers, is calling this the most significant disruption to its supply chains since Covid and the invasion of Ukraine, and its supply chain director put the stakes bluntly.

Today’s supply chain challenges are tomorrow’s hunger crisis.

There is also a political dimension that markets cannot price. When food gets scarce, governments do not behave like economists. They behave like politicians. Export bans, hoarding mandates, and panic buying at the national level turned the modest rice shortfall of 2008 into a global crisis, and analysts are already warning that import-dependent nations are the first dominoes.

The 2015-16 Super El Niño, a far weaker event than what is now forecast, threw tens of millions into food stress across Africa and Asia. This one is projected to be stronger, and it arrives with fertilizer already rationed by price and shipping lanes already contested by missiles.

What Joseph Knew

Scripture does not treat preparation for lean years as faithlessness. It treats it as wisdom delivered in advance to those willing to act on it.

Behold, there come seven years of great plenty throughout all the land of Egypt: And there shall arise after them seven years of famine; and all the plenty shall be forgotten in the land of Egypt.

Joseph did not respond to that warning with a hashtag or a committee. He stored grain during the years of abundance, and when the famine came, Egypt stood while its neighbors begged. The lesson is not that famine is certain. It is that the time to prepare is precisely when preparation still looks optional.

Nobody who filled a pantry in a year of plenty has ever regretted it, and nobody standing in an empty aisle has ever been glad he waited for certainty.

None of this calls for panic, and panic is the enemy of sound judgment anyway. It calls for the same unglamorous prudence our grandparents considered ordinary. Keep some cash margin, know your local growers, and put real food in deep storage while it is cheap and available, because the entire arc of this story is that cheap and available is a closing window.

Families looking for a straightforward place to start can visit Heaven’s Harvest and use promo code Patriot for 15 percent off long-term storable food. The forecasts may yet soften, the strait may yet reopen, and we should pray they do. But hope is a fine thing to hold and a foolish thing to eat.

Tags: Big PharmaCoronavirusCovid-19LedeModernaPfizerTop StoryVaccines
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Comments 1

  1. SSGT_USA1(AUDIT ALL STATES) says:
    4 years ago

    We have way too many SHEEP in our society, people with no spine..well they deserve what they get…
    This is a very observable proving of Darwinian Evolution: Survival of the fittest…the jabbed are not fit……..
    It also looks like my UNTAINTED blood will soon become a lucrative liquid asset as more and more people demand they get their blood from unjabbed people…..

    Reply

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