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Posts Tagged ‘EUA’

CDC to Withdraw Emergency Use Authorization for RT PCR Test Because It Cannot Distinguish Between SARS-CoV-2 and the Flu

Posted by M. C. on July 28, 2021

https://healthimpactnews.com/2021/cdc-to-withdraw-emergency-use-authorization-for-rt-pcr-test-because-it-cannot-distinguish-between-sars-cov-2-and-the-flu/

by Brian Shilhavy
Editor, Health Impact News

The CDC quietly announced last week that it was withdrawing its request to the FDA for Emergency Use Authorization (EUA) of the 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel, the assay first introduced in February 2020 for detection of SARS-CoV-2.

Most of the public is probably unaware that similar to the current COVID-19 injections that are not yet approved by the FDA, but only given Emergency Use Authorization, so too the hundreds of diagnostic tests that supposedly detect COVID-19 are also NOT approved by the FDA, but only authorized via an EUA.

What is the reason the CDC is withdrawing its EUA request for the Real-Time RT-PCR Diagnostic Panel?

In preparation for this change, CDC recommends clinical laboratories and testing sites that have been using the CDC 2019-nCoV RT-PCR assay select and begin their transition to another FDA-authorized COVID-19 test.

CDC encourages laboratories to consider adoption of a multiplexed method that can facilitate detection and differentiation of SARS-CoV-2 and influenza viruses. (Source.)

Caitlin McFall, writing for Fox News, is the only one in the corporate media I could find that even reported this, and the few reports I found in the Alternative media so far have been mostly inaccurate.

McFall reports:

The Centers for Disease Control and Prevention (CDC) urged labs this week to stock clinics with kits that can test for both the coronavirus and the flu as the “influenza season” draws near.

The CDC said Wednesday it will withdrawal its request for the “Emergency Use Authorization” of real-time diagnostic testing kits, which were used starting in February 2020 to detect signs of the coronavirus, by the end of the year.

“CDC is providing this advance notice for clinical laboratories to have adequate time to select and implement one of the many FDA-authorized alternatives,” the agency said.

The U.S. has reported more than 34.4 million cases of the coronavirus since the pandemic began in 2020 and more than 610,000 deaths.

But while cases of COVID-19 soared nationwide, hospitalizations and deaths caused by influenza dropped.

According to data released by the CDC earlier this month, influenza mortality rates were significantly lower throughout 2020 than previous years.

There were 646 deaths relating to the flu among adults reported in 2020, whereas in 2019 the CDC estimated that between 24,000 and 62,000 people died from influenza-related illnesses.

The CDC urged laboratories to “save both time and resources” by introducing kits that can determine and distinguish a positive test for the coronavirus and flu. (Source.)

So there you have it. The CDC just basically admitted that many of the COVID-19 cases this past year could not be distinguished from “flu cases.” No wonder flu cases decreased to zero in so many places. See:

Health Officials Admit that Only Those Vaccinated for the Flu are Getting the Flu This Year

The ending of the EUA for the Real-Time RT-PCR Diagnostic Panel will not happen until the end of the year, December 31, 2021, and the CDC recommends that laboratories start transitioning to other types of COVID-19 diagnostic tests that have been given an EUA by the FDA here.

At the time of publication of this article, the FDA has issued 251 EUAs for COVID-19 diagnostic tests since April 1, 2020. The vast majority of them are for the RT-PCR tests, including about 20 that were just issued EUAs since the beginning of this month, July, 2021.

The cash cow for these tests and the hundreds of companies that got rich selling them will now have to move on to the next phase to be able to cash in.

Diagnostic Testing Fraud: Controlling the Masses and Medical Kidnapping

We have been covering the corruption in the medical diagnostic testing field for the better part of a decade now, and we exposed it early on in the COVID-19 Plandemic last year as well.

Here are some of our previous articles from last year exposing the fraud of COVID-19 diagnostic testing.

Not a Single COVID-19 Test is FDA Approved – Do We Really Know Who has COVID-19 and Who Does Not?

Roche CEO: COVID19 Tests “Not Worth Anything – Two of us could do it Overnight in the Garage”

FAIL: The Exact Same COVID Test will Produce Different Results Depending on the Laboratory

When we started MedicalKidnap.com back in 2014, we learned that fraudulent diagnostic testing was a common way for doctors and hospitals to order children be removed from their homes.

Often they create false drug test positive results to remove children from their parents.

Alabama Lab Owner Arrested for Falsifying Results of Drug Tests Used to Medically Kidnap Children

The worst offender, by far, in medically kidnapping children by use of a medical diagnostic test, is within the field of radiology and finding “proof” of child abuse simply by looking at x-rays.

This whole field has developed a recent new class of pediatricians “certified” as “Child Abuse Pediatricians,” and the lucrative jobs of these doctors depend on them finding abused children and putting them into the lucrative child trafficking network known as “foster care.”

We have actually published an eBook on this topic, or you can look up individual cases on our MedicaKidnap.com website to learn how this evil system works.

When it comes to diagnosing “influenza,” we have exposed the fraud there as well, as pre-COVID-19 the CDC simply used estimates of cases of the flu, since they cannot verify actual numbers each year by diagnostic testing.

Annual Flu Deaths Scam Unwittingly Exposed and Replaced by the COVID Deaths Scam

So COVID-19 allowed them to just further exploit the fraud of diagnostic testing to create fear and panic, and achieve their goals of enslaving the public and rolling out their experimental mRNA injections.

With this latest announcement by the CDC that they are now going to retire the RT-PCR Diagnostic tests and replace them with other tests that can now test both COVID and influenza, it is pretty easy to see what their game plan is for later this year.

Just about everyone in the U.S. will be able to be tested “positive” for something by this Fall when the flu season starts.

This will be the “Hegelian principle” implementation for 2021. The government creates the problem, and then they create the solution, which we know now is more “vaccines” for everything in life that ails us, and try to punish those who don’t want to play their game.

I’m ready. Are you?

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The Covered-Up Crimes of Vaccine-Maker Pfizer – Just Another “Too-Big-To-Fail” American Corporation – LewRockwell

Posted by M. C. on July 26, 2021

https://www.lewrockwell.com/2021/07/gary-g-kohls/the-covered-up-crimes-of-vaccine-maker-pfizer-just-another-too-big-to-fail-american-corporation/

By Gary G. Kohls, MD

This column high-lights the unethical/criminal attempts (of both the Trump-orchestrated, Biden-endorsed and Big Pharma-implemented Operation Warp-Speed, the unethical plan to totally skip both short-and long-term animal safety and efficacy studies) in order to promote potentially dangerous Covid-19 vaccines for both human adults and children.

Here is a very telling Announcement from the the American Academy of Pediatrics (AAP) website (May 4, 2021). Be aware that the AAP membership relies on routine vaccinations for a large portion of the annual revenues)

“Children ages 2-11 could potentially be eligible for (the still-experimental) COVID-19 vaccine this fall. Pfizer Chairman and CEO Albert Bourla, DVM, PhD (Doctor of Veterinary Medicine!), said on a quarterly earnings call Tuesday. He expects to request (experimental) Emergency Use Authorization (EUA) from the Food and Drug Administration (FDA) in September. Under his plan, an EUA request for ages six months to 2 years would follow in the fourth quarter.

Pfizer and its (German) partner BioNTech currently are waiting for an FDA decision on an EUA for adolescents ages 12-15 years.”

The list below was collated by Gary G. Kohls, MD

To back-up the accusation of “criminality” of Big Pharma corporations like vaccine-maker Pfizer, I attach a list of 14 Pfizer drugs that were FDA-approved for marketing before long-term safety Studies were done (Note that the corporate-controlled 1986 US Congress passed a law – signed by President Ronald Reagan – that made it against the law to sue pharmaceutical corporations for deaths or injuries caused by their vaccines!)

Pfizer is one of the largest multinational pharmaceutical (drugs and vaccines) companies on the planet – and one of the five largest vaccine manufacturers (the five are Pfizer, Sanofi, Merck, GlaxoSmithKline and Johnson & Johnson.  (AstraZeneca is # 10). Pfizer has faced hundreds of thousands of lawsuits – just in the US – for fraudulent marketing and medical injuries caused by its most profitable, drugs.

Pfizer holds the record for the largest fine paid for a health care fraud lawsuit filed by the U.S. Department of Justice. Pfizer paid $2.3 billion in fines, penalties, and settlement for illegal marketing claims.

Here is a partial list of 14 of Pfizer’s most dangerous, most litigated, most potentially lethal drugs. (NOTE:  If any reader had adverse effects to any of these Pfizer drugs, he/she might want to consult an attorney).

Celebrex, Bextra, Geodon, Zyvox, Lyrica, Neurontin, Protonix, Prempro, Chantix, Depo-Testosterone, Zoloft, Effexor, Lipitor, Xeljanz, etc

Celebrex and Bextra

Prizer promoted its two COX-2 pain relievers Celebrex and Bextra which generated 7000 lawsuits and a $894 million settlement. Both medications were me-too drugs similar to Merck’s infamous Vioxx, which caused 50,000 lawsuits because of cardiovascular deaths and injuries. Merck settled most of the cases with a $4.85 billion settlement.

Geodon, Zyvox, and Lyrica

Pfizer paid $1 billion to resolve allegations under the civil False Claims Act that the company illegally promoted four drugs – Bextra; Geodon, an anti-psychotic drug; Zyvox, an antibiotic; and Lyrica, an anti-epileptic drug – and caused false claims to be submitted to government health care programs for uses that were not medically accepted indications.

Neurontin

Pfizer paid out $142 million for committing racketeering fraud in the marketing of Neurontin.

Protonix

As part of a larger group of proton pump inhibitor lawsuits, Pfizer faced a number of Protonix lawsuits after it acquired drug company Wyeth who had been accused of marketing the drug for unapproved uses. In 2013, Pfizer agreed to pay $55 million to settle illegal marketing claims, but the company may still be facing lawsuits for permanent kidney damage caused by Protonix.

Prempro

Nearly 10,000 Prempro lawsuits were filed by women who had been diagnosed with breast cancer. The lawsuits were largely settled by 2012 for about $1 billion.

Chantix

Pfizer faced about 3,000 Chantix lawsuits filed by people who claimed they experienced suicidal thoughts and psychiatric disorders after using Chantix for smoking cessation. Pfizer set aside about $288 million and at least some of the cases were settled.

Depo-Testosterone

Thousands of cases of medical injury due to testosterone replacement therapy have been filed. Other drug companies have paid $ billions to settle their cases, however some Pfizer testosterone lawsuits were dismissed.

Zoloft

About 250 Zoloft lawsuits were filed, claiming Pfizer actively promoted the use of Zoloft to pregnant women despite knowledge of birth defect risks from their research.

Effexor

Effexor was a medication originally produced by Wyeth which has also been the cause of multiple lawsuits. People who filed Effexor lawsuits claimed that it caused birth defects, and separately, suicidal thoughts and behaviors. In September 2015, Effexor lawsuits were dismissed but may have been eligible to refile.

Lipitor

Pfizer’s drug that lowers cholesterol (but only minimally decreases heart attack and stroke risk) causes serious muscle necrosis (death), muscle weakness, diabetes and other unforeseen health defects has generated billions of dollars of lawsuits.

Xeljanz

Pfizer had failed to do long-term safety and efficacy studies on its new arthritis and ulcerative colitis drug prior to FDA-approval. Xeljanz was therefore only belatedly acknowledged by Pfizer to cause cancer, serious cardiovascular events and venous thromboembolism (such as pulmonary embolism or deep vein thrombosis). Many lawsuits are now in progress.

____________________________________________________________________________________________________________________________

Environmental Pollution Lawsuits Against Pfizer

See the rest here

Dr. Kohls [send him mail] is a retired physician from Duluth, MN, USA. In the decade prior to his retirement, he practiced what could best be described as “holistic (non-drug) and preventive mental health care”. Since his retirement, he has written a weekly column for the Duluth Reader, an alternative newsweekly magazine. His columns mostly deal with the dangers of American imperialism, friendly fascism, corporatism, militarism, racism, and the dangers of Big Pharma, psychiatric drugging, the over-vaccinating of children and other movements that threaten American democracy, civility, health and longevity and the future of the planet. Many of his columns are archived at Duluthreader.com, Globalresearch.ca or at Transcend.org.

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Physicians Group Files Motion to Halt Use of COVID Vaccines in Children • Children’s Health Defense

Posted by M. C. on July 22, 2021

She went on to say: “Children were not included in the trials, and the adult trials do not have any long-term safety data currently available.”

https://childrenshealthdefense.org/defender/americas-frontline-doctors-files-motion-halt-covid-vaccines-children/

By  America’s Frontline Doctors

The Defender is experiencing censorship on many social channels. Be sure to stay in touch with the news that matters by subscribing to our top news of the day. It’s free.

America’s Frontline Doctors (AFLDS) Wednesday filed a motion in the U.S. District Court for the Northern District of Alabama requesting a temporary restraining order against the Emergency Use Authorization (EUA) permitting using the COVID-19 vaccines in children under the age of 16, and that no further expansion of the EUAs to children under the age of 16 be granted prior to the resolution of these issues at trial.

The case will challenge the EUAs for the injections on several counts, based on the law and scientific evidence that the EUAs should never have been granted, the EUAs should be revoked immediately, the injections are dangerous biological agents that have the potential to cause substantially greater harm than the COVID-19 disease itself, and that numerous laws have been broken in the process of granting these EUAs and foisting these injections on the American people.

AFLDS Founder Dr. Simone Gold spoke about the reasons for filing the motion: “We doctors are pro-vaccine, but this is not a vaccine,” she said. “This is an experimental biological agent whose harms are well-documented (although suppressed and censored) and growing rapidly, and we will not support using America’s children as guinea pigs.”

She continued:

“We insist that the EUA not be relinquished prematurely; certainly not before trials are complete — Oct. 31, 2022 for Moderna and April 27, 2023 for Pfizer. We are shocked at the mere discussion of this, and will not be silent while Americans are used as guinea pigs for a virus with survivability of 99.8% globally and 99.97% under age 70.

“Under age 20 it is 99.997% — ‘statistical zero.’

“There are 104 children age 0-17 who died from COVID-19 and 287 from COVID + Influenza – out of ~72 million. This equals zero risk. And we doctors won’t stand for children being offered something they do not need and of whom some unknown percentage will suffer.”

AFLDS Pediatric Director Dr. Angie Farella explained: “My greatest concern with the vaccination of children under the age of 18 is the fact that there is no prior study of these individuals before Dec. of 2020.”

She went on to say: “Children were not included in the trials, and the adult trials do not have any long-term safety data currently available.”

AFLDS Legal Director Ali Shultz commented on AFLDS’ filing:

“Not many people could have taken this on. Dr. Simone Gold is a doctor, and a lawyer and a fierce warrior who will stop at nothing to protect humanity.

“She has a certain finesse in developing the right team to see this medical/legal mission through.”

Read the motion and all supporting documents.

Originally published by America’s Frontline Doctors.

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The FDA Botched Covid Testing in 2020. Nothing Has Changed Since Then. | Mises Wire

Posted by M. C. on January 28, 2021

The purpose of the EUA process, and FDA oversight, is clear enough—to weed out poorly performing test providers. But there are big problems here: First, this assumes that FDA employees are experts at everything they are regulating, which cannot be the case. Second, if the oversight is faulty or results in unnecessary delays (as was the case with covid-19 testing), nothing happens. The FDA still has the same authority now that it had in 2019. Third, oversight with lab testing is largely meaningless without having regulators (assuming they understand the scientific basis for what’s being done) observing what’s happening in the lab.

https://mises.org/wire/fda-botched-covid-testing-2020-nothing-has-changed-then

Dave Albin

Ah, the covid-19 test results—much maligned by some and worshipped by others! As part of the ongoing covid-19 pandemic, the results of covid-19 tests are repeatedly blasted at us from many places, often with analysis. It is easy to understand why this is the case. News media and information outlets of all types can present the absolute numbers of positive tests and data trends, which are easy to find, and many viewers can seemingly grasp what’s happening and where. And people are concerned about the spread of a novel virus and what it might do to them, their families, and their communities. In short, this is information that people demand. As such, they will get it.

It’s important to understand the basics of the two main types of tests being used to detect the virus. First, a PCR test is used to amplify and detect the presence of a DNA segment that is highly specific to covid-19. Second, an antibody test is used to detect the presence of an antigen (often a specific protein) that is present on the outside of a pathogen like covid-19. Both of these tests take biological processes and manipulate them to detect the presence of something specific—in these cases, markers of covid-19. There’s nothing magical or sacred about what’s happening. Anyone with the supplies and proper training can run these tests and report findings. And, like with any analytical procedure, there are restrictions on what can be detected. False positives and false negatives are possible, detection levels have limits, and sampling technique affects the results. All of these can be examined to better define the accuracy of the results.

And, yet, as concerns about covid-19 were rapidly increasing, many people were without this vital information that they wanted. Why was this? In the US, the Food and Drug Administration has authority over all medical testing, and in times of emergency, what is known as emergency authorized use, or EUA, can be granted so that labs around the country can begin testing. However, due to bureaucracy and red tape, the FDA took weeks, rather than days, to grant EUAs (another way of saying that it was slow to give up a little authority) so that testing could begin. It was even reported that the FDA and state authorities instructed one lab to halt their plans of repurposing existing tests for covid-19 testing. (By the way, history is already being rewritten, so it seems.) Some labs reported being ready to give results, with validated testing protocols in hand, but being forced to wait due to the FDA’s slow response time. Thus, critical time was lost; people were flying blind for weeks as fear increased.

The purpose of the EUA process, and FDA oversight, is clear enough—to weed out poorly performing test providers. But there are big problems here: First, this assumes that FDA employees are experts at everything they are regulating, which cannot be the case. Second, if the oversight is faulty or results in unnecessary delays (as was the case with covid-19 testing), nothing happens. The FDA still has the same authority now that it had in 2019. Third, oversight with lab testing is largely meaningless without having regulators (assuming they understand the scientific basis for what’s being done) observing what’s happening in the lab. Reviewing documents or protocols is largely ceremonial if the “experts” don’t have a clear understanding of the procedures and, more importantly, if they are not in the labs with the technicians performing the tests. Who knows if the tests are being administered properly, or if, following employee turnover, a new staff member is poorly trained and improperly gives the tests? This last scenario cannot ever be tracked and controlled by regulators.

These regulatory challenges would have been much better addressed with private sector testing facilities competing for customers. In order for a testing lab to be chosen by eager customers, its results have to be meaningful—those that do not provide this will not be in business for long. 

In addition, a private testing system would have allowed quicker data sharing sooner (and the use of various platforms) and for testing to be conducted in a way that pleases customers. In some areas, the reporting would have been different, but ultimately it would have had to satisfy customers. And with something like a global pandemic, broader sharing of information would likely have been welcomed at first and might have changed later—the market could have decided over time. Competing evidence would even have served as an important quality control.

It’s a good bet that an approach like the one outlined here would have mediated the effects of the covid-19 pandemic. There’s no question (with the benefit of hindsight) that covid-19, and the response to it, was going to cause difficulty and suffering for many people. Lives have been lost, businesses and services derailed, and trust eroded. But, with the right information in hand, decision-making would have been improved. Trouble areas and practices could have been avoided. Personal risk could have been assessed more accurately. We could have understood what was happening sooner and worked to get through the covid-19 pandemic more quickly. Instead, we’re left with the same stagnant, bloated system that’s slow to respond—troubling because other pathogens are sure to arise in the future. We can’t afford to stumble in the darkness again. Author:

Contact Dave Albin

Dave Albin conducts process development research and provides technical support for a food equipment manufacturer in Iowa.

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