What Dr. Paul Alexander Was Told Privately About the VVV’s in 2020

What Dr. Paul Alexander Was Told Privately About the VVV’s in 2020


Warning: coming many Americans, many people will die because of these COVID injections, many healthy children WILL die due to these shots; FDA, CDC, NIH, Moderna, & Pfizer secretly told me this

I was told in discussions with FDA, CDC, NIH, Moderna, & Pfizer officials in Washington at HHS July/August 2020, their grave concerns, why they must be silent as in fear for safety and careers; Toby!!

I have been trying to warn. I have written on this here in stack.

I was told by these officials, in confidential secret discussions, that in about 6 to 6.5 years from roll-out, in those who take the injections, they feared mass auto-immune disease and deaths, they feared viral immune escape and very problematic variants, and they anticipated constant deaths from the injections but a major number of deaths to emerge. They said, based on all they knew, that the COVID injections could never work, especially the mRNA platform. It never worked in the animal model and was pathological. They told me that in about 6 to 6.5 years, there will be a surge in deaths in persons who take the injections. They advised me they nor their families will never take any of the COVID injections.

I am being open with you to inform you. I am sick and tired, years now, of the lies and fraud and disaster put out by the media, the alphabet health agencies, etc. You trusted your public health officials, you think ‘they care about you’. Well, they never cared about you, your family, or the truth. It is to them about the $CIENCE.

I think I shared prior that my office was on the 6th floor of the HHS building in DC, Operation Warp Speed and Moderna were stationed on the 7th floor. FDA, CDC, etc. have sub-satellite offices at HHS. At least, when I was there and Hahn, Redfield, etc. came there daily after Congress or White House to see their staff, various persons, persons in various offices.

These people I talked with came to me out of anger and fear, too. They knew who I was and wanted to tell me their stories and how worried they were for the population, and fearful for their lives and own careers as to the COVID injections (and other issues). If they spoke out openly so had to talk secretly.

They were very very dismayed and angered and worried as to why the agencies they worked for, e.g. FDA and NIH and CDC etc. and the pharmaceuticals were not properly regulating and conducting the proper safety studies, proper durations of follow-up. They felt the COVID injection program was a pure disaster and should be stopped back then. This is 6 months or so before roll-out (ER: summer 2020). They felt no healthy children should ever be given the very injections they were working on. They were that concerned.

I want to be clear again, based on all I know today, based on what I was told, many many children will die due to these injections. Healthy children will die, not ‘if’, but ‘will’ die. Healthy children, healthy people, normal people never needed and do not need these injections. I have told you before that (strong research and scholarship by Geert) we will be in a pandemic for 100 years if we continue these injections. It is the COVID injection itself that is driving the variants and these CDC, NIH, Moderna, and Pfizer officials are malfeasants IMO who are continuing this. There is no sound justification. These malfeasants know that they are vaccinating with the Wuhan strain (legacy strain) that has been gone many months now and omicron dominates. The vaccinal antibodies are to the original Wuhan strain and will not hit the omicron spike antigen (original antigenic sin (OAS)).

It is the COVID injection (and consequent non-neutralizing antibodies pressuring the spike antigen) that is causing the vaccinated to become infected, hospitalized, and die. The data is clear. Massive antibody-dependent enhancement, some refer to this as antibody mediated viral enhancement. Some pathogenic priming. All IMO the very same. The recall antibodies are to something that does not exist today. The key is to reduce viral pressure, infectious pressure on the population, so that the sub-optimal injections have less virus to put under pressure. We have effective chemoprophylaxis, we can do this. We have early treatment. This can worked effectively and this can thus help reduce viral transmission. At the same time, the best step is to stop these filed injections.

I want all of these people investigated in proper public and legal inquiries, and if it is shown they did wrong, in proper inquiries, I want them arrested. I want all who made policy decisions that costed lives, to be jailed! All their monies taken!

Dr. Toby Rogers looked at the FDA June 28th meeting and his takeaway is bang on and what we have been saying here for near a year now here:

‘‘Yesterday, the FDA’s Vaccines and Related Biological Products Advisory Committee approved a bivalent Covid-19 shot with the Wuhan strain and the Omicron variant.

The vote was:

19 yes.
2 no.

A few thoughts:

The Wuhan strain is no longer in circulation. So they are vaccinating against a strain that no longer exists.

The Omicron variant that they are going to put into this shot is Omicron BA.4/BA.5:

1. By the time it gets to market in the fall, Omicron BA.4/BA.5 will likely no longer be in circulation.

2. There is no efficacy data whatsoever on vaccines against Omicron BA.4/5.

3. There is no safety data whatsoever on vaccines against Omicron BA.4/5.

4. They do not intend to gather any efficacy or safety data between now and when these shots will be released in the fall:

At the meeting, the manufacturers (Moderna, Pfizer, and Novavax) were asked what their production timelines are… and they said out loud, “So long as we don’t have to provide any clinical data, we’ll have them ready by fall.”

Dr. Toby Rogers is a smart guy.

His work:

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Editor of the British Medical Journal, Peter Doshi’s latest paper shows COVID-19 vaccines associated with increased risk of serious adverse events.

Editor of the British Medical Journal, Peter Doshi’s latest paper shows COVID-19 vaccines associated with increased risk of serious adverse events.

Doctor Crashes FDA Meeting and Shares the Whistleblower Story They Ignored - Tennessee Star

Peter Doshi, editor of the British Medical Journal (BMJ) is once again bravely sticking his neck out with his latest co-authored paper.

He and six other authors from the US, Spain and Australia decided to investigate serious adverse events of special interest following mRNA vaccination in randomized trials.

They used a World Health Organisation (WHO) endorsed priority list of adverse events of special interest (AESIs) to identify serious adverse events that occurred during phase III clinical trials on which emergency use authorisation (EUA) was based. The list comprised of adverse events based on the specific vaccine platform, adverse events associated with prior vaccines in general, theoretical associations based on animal models and COVID-19 specific immunopathogenesis.

The study looked at the Pfizer and Moderna trial data which was expected to follow participants for two years. However, after EUA, participants were unblinded and those in the placebo arm offered the vaccine. This meant post authorisation data was less reliable so, to preserve randomisation, the authors used interim datasets from approximately 4 months after the trials commenced.

A serious adverse event (SAE) was defined as an adverse event that results in any of the following conditions: death; life-threatening at the time of the event; inpatient hospitalisation or prolongation of existing hospitalisation; persistent or significant disability/incapacity; a congenital anomaly/birth defect; medically important event, based on medical judgement.

SAE tables were located for both the Pfizer and Moderna trials submitted for EUA in the US. For the Moderna trial, these SAEs were from dose 1 but for Pfizer they were from dose 1 to 1 month after dose 2.

The authors found that, in the Pfizer trial, there was a 36% higher risk of SAEs, unrelated to COVID-19 in vaccinated participants in comparison with the placebo group. The Moderna trial had a 5% higher risk of SAEs. Combined there was a 15% higher risk of SAEs in the vaccine recipient group.

52 AESIs were reported in the Pfizer vaccine group versus 33 in the placebo group. This meant there was a 57% increased risk of serious AESIs and an absolute risk increase of 10.1 serious AESI per 10,000 vaccinated participants.

In the Moderna trial, there were 87 serious AESIs in the vaccine group versus 64 in the placebo group, representing a 36% increased risk. In this trial, there was an absolute risk increase of 15.1 serious AESIs per 10,000 vaccinees.

Combined, there was a 43% increased risk of serious AESIs and an absolute risk increase of 12.5 serious AESIs per 10,000 vaccinated participants.

In both trials, the largest increase in absolute risk was in coagulation disorders. There were more cardiovascular AESIs in the vaccine group in the Pfizer trial but it was balanced in the Moderna trial.

Taking into consideration the harm-benefits, they compared AESIs with vaccine risk reduction for COVID-19 hospitalisation. With the Moderna vaccine, the risk of AESIs was 15.1 per 10,000 participants compared with a Covid hospitalisation risk reduction of 6.4 per 10,000. The Pfizer trial had a AESI risk of 10.1 per 10,000 compared with a hospitalisation risk reduction of 2.3 per 10,000 participants. Therefore, with both vaccines, the risk of AESIs surpassed the risk reduction for COVID-19 hospitalisation.

The paper looks at the FDA reviews of SAEs which concluded that, for Pfizer, were “balanced between treatment groups”. For Moderna, the FDA said that SAEs were “without meaningful imbalances between study arms”. This current study, however, found an increased risk of SAEs so they tried to understand how there could be two very different conclusions. They concluded that the main reason for the discrepancy may be because the FDA used a different, larger analysis population. This was because the FDA included all individuals who had received at least one dose, irrespective of the duration of post-injection follow up time. The authors, in this paper, used a study population with medial follow up >2 months after dose 2, of which 98.1% had received both doses. Therefore, the FDA’S analysis included thousands of additional participants with very little follow-up, of which the large majority had only received 1 dose.

The authors discuss the results which show an excess risk of serious AESIs greater than the reduction in COVID-19 hospitalisation. They say that these results are compatible with another analysis (Benn et al) which found no evidence of a reduction in overall mortality. They say that both papers point to the need for formal harm-benefit analyses especially in individuals at low risk of COVID-19 hospitalisation or death.

It is suggested that because the majority of SAEs are relatively common events (e.g. stroke), signal detection is complicated because clinical suspicion of adverse vaccine reactions will be lower than less common SAEs such as myocarditis. Therefore, there is likely to be over and under reporting. Public health messages assuring safety may lower clinical suspicions whereas messages about potential harms may stimulate reports.

Because this study only looked at SAEs occurring past 1 month after dose 2 there may have been undercounting of serious AESIs.

The authors conclude that a systematic review and meta-analysis using individual participant data should be undertaken to address questions of harm-benefit in various demographic subgroups. Full transparency of the COVID-19 vaccine clinical trial data is needed to properly evaluate these questions. Unfortunately, well over a year after widespread use of COVID-19 vaccines, participant level data remain inaccessible.

Source: nakedemperor.substack.com/p/editor-of-the-british-medical-journal-6d1?utm_source=email

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The Massacre of the Innocents

The FDA and CDC launch a reckless nationwide medical experiment on children

I. The government is coming for your kids

Last week was shrouded in darkness. We saw the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) and the CDC’s Advisory Committee on Immunization Practices (ACIP) assemble the pieces of their Final Solution.

The meetings were surreal as so-called “experts” displayed no critical thinking skills and instead wallowed in clichés supplied to them by the pharmaceutical industry.

Over the course of five meetings in five days we witnessed crimes against humanity, the end of the bourgeoisie, and the likely end of America.

Let’s talk about what actually happened at the meetings, the short and long-term implications of the decisions that were made, and where we go from here.

II. The meetings themselves

The clinical trials of Moderna and Pfizer mRNA shots in kids all had the same flaws — enabled and encouraged by the permissive FDA. Moderna and Pfizer each:

1. Failed to demonstrate actual health benefits (so they relied on junk science “immunobridging” even though there are no valid correlates of protection);
2. Wiped out the control group, so there is no long term safety data; and
3. Caused catastrophic adverse events.

Contrary to their statutory obligations, the FDA/VRBPAC and CDC/ACIP do not act as regulators. Instead they see themselves as partners with Pharma. Indeed FDA and CDC officials often slip and say “we” when referring to the applicant — it’s all one big happy crime family.

At the meetings, the FDA and CDC went to great lengths to exaggerate the risks of Covid in children. As you know, there is no Covid-19 emergency in kids But Emergency Use Authorization requires a public health emergency so the FDA and CDC manufacture one.

Many presentations at the meetings last week cited the same British pre-print study that claims that Covid-19 was the 4th or 5th leading cause of death in children in the U.S. This is false.

Kelley Krohnert from Covid Georgia dismantles the pre-print.

The British academics who wrote the paper make two obvious errors. First they count deaths “with Covid” (tested after they got to the hospital for some other reason or underlying condition) as “from Covid.” If you remove the “with Covid” from the tally, the numbers shrink by about 35%.

The second major error in the pre-print is that the authors “compare the cumulative number of Covid deaths over 26 months to deaths from other causes over a one year period.” Whoops. So the FDA and CDC made their case by double-counting Covid-19 deaths in children.

Once these errors are corrected, Covid-19 drops down to the 8th or 9th leading cause of death. But as Ms. Krohnert explains:

Even given the corrected rankings above, there are also issues with the entire concept of showing the impact of Covid deaths in children using rankings. Rankings overstate the impact of Covid, because the top few causes of death far outweigh the causes further down the list. For example, in ages 1-4, accidents account for almost 25 times as many deaths as Covid-19 on an annualized basis. Furthermore, for each of the 4 age groups covered by the CDC slide, the very broad “accidents” is the leading cause of death. If we break that down further, causes of death like drownings, vehicle crashes, drug overdoses, would be individual causes of death greater than Covid in various age groups.

For those who want to argue, “if-it-even-prevents-one-death(TM)”: Covid-19 is NOT a vaccine-preventable-disease given that these shots do not stop infection, transmission, hospitalization, nor death. And given adverse events, Covid-19 shots will cause a net increase in deaths not a decrease.

If one really cares about the health of children, mandate fences around swimming pools, not experimental gene-modifying injections for the entire childhood population.

Ms. Krohnert contacted the authors of the paper to alert them to these errors and now they are revising the paper (a new draft is due next week). Of course, the FDA and CDC never admit that they were wrong because they don’t actually care about data.

At these meetings it is standard practice for FDA and CDC to lie about the benefits of these shots. Indeed the FDA went to great lengths to downplay the risk of vaccine-induced myocarditis in the briefing documents for Moderna and Pfizer. In preparing these documents the FDA relies on fixers — Matt Oster, Tom Shimabukuro, and John Su at CDC and Nicola Klein at Kaiser Permanente — to manipulate the data to fit the Pharma narrative.

However, one of the unusual things about the VRBPAC meeting on Tuesday is that Ruth Link-Gelles from CDC just straight up admitted that these shots have negative efficacy.

Then Tom Shimabukuro (citing his own slides and those from John Su and Nicola Klein) just straight up admitted that these shots cause myocarditis:

So I’m watching at home thinking… ‘no observed health benefits (that’s why they had to switch to immunobriding) and they are admitting that the shots have negative efficacy and cause myocarditis, therefore the risks outweigh the benefits. So how are they going to try to get out of this?’

And their argument is (supplied by Jacqueline Miller, Senior VP at Moderna) that the risk of myocarditis from Covid is greater than the risk of myocarditis from these shots. One of the obvious problems with that argument is that THESE SHOTS DO NOT PREVENT COVID. So the FDA is accepting a known risk from these shots in return for an imagined benefit that does not exist in the real world.

The VRBPAC and ACIP do not care about the facts at all. As George Lakoff famously observed, “facts bounce off of frames” and the frame that guides these public health zombies is, “vaccines are infallible.”

Adverse events. Others have done a better job of flagging adverse events in these clinical trials. Quant genius Jessica Rose wrote an excellent article about the harms in the Pfizer clinical trial and the Moderna clinical trial.

Look at pages 169 to 171 of the FDA briefing document for Moderna that showed 18 serious adverse events in the vaccine group as compared with only 1 in the placebo group in kids 6 through 23 months of age.

Furthermore, no one at the FDA/VRBPAC nor CDC/ACIP can explain why VAERS reports skyrocketed following the introduction of Covid-19 shots at the end of 2020 and why reports of vaccine injury in kids skyrocketed following the authorization of the Pfizer mRNA shot in kids last fall. Indeed FDA honcho Peter Marks had a meltdown at the end of the VRBPAC meeting on Wednesday because VAERS was trending on Twitter (apparently the public was not impressed with the VRBPAC’s self-serving nonsense).

Further observations:

At these meetings there is no critical thinking, no hard questions, and no debate.

There’s no science at all at these meetings, just a theatrical performance of science-y sounding things.

Quite literally, these so-called experts apologized to Moderna for asking them questions.

No one asks about adverse events.

There’s no discussion of antibody dependent enhancement, prion disease, or any of the other nightmare possibilities that seem to be emerging.

No VRBPAC member ever uses the phrase “negative efficacy” — even though the Pfizer application in kids showed negative efficacy between dose 1 and dose 2 and negative efficacy against the Omicron variant.

Antibodies are accepted as a valid measure even though everyone knows that there are no correlates of protection.

No one questioned the fact that FDA and CDC spent a year minimizing the risks of myocarditis and still could not get the safety signal to go away entirely.

No one questioned the fact that the international scientific consensus is that mRNA shots cause myocarditis in young people and that the U.S. is the only country in the world to push these shots on little kids.

The VRBPAC and ACIP members live in an alternative universe where sacrificing children is always acceptable to serve “The Greater Good(TM).”

VRBPAC and ACIP meetings are a horror movie come to life.

While these shots showed no benefit and catastrophic harms… the VRBPAC members wanted MORE, MORE, MORE!

Paul Offit led the charge on Tuesday by arguing that Moderna’s toxic shot should be a THREE dose series instead of the two doses that Moderna was applying for. Because VRBPAC members are selected for ideological conformity and groupthink, several other members piled on and echoed Offit’s call for MORE Moderna doses in kids.

On Wednesday, Offit again led the charge by arguing that Pfizer was “underdosed” (his word) at 3 mcg of mRNA in little kids and that they should have put MORE mRNA in there to produce a larger antibody response — adverse events in children be damned.

At this point, the bloodlust of these committees is unquenchable.

In the end, there was no need to even hold the meetings because the decisions were already made before they started.

On Tuesday, VRBPAC voted 21 to 1 to authorize the Moderna EUA application to inject mRNA into kids 6 to 17 years old. (There was 1 abstention — from the new guy, Bruce Gellin.)

On Wednesday, VRBPAC voted 21 to 0 to authorize the EUA applications to inject Moderna into kids 6 months to 5 years old and Pfizer into little kids 6 months to 4 years old.

On Saturday the CDC let it slip that Covid-19 shots in kids will be 10-dose vials. 10-dose vials are terrible because administration errors go up and because it’s impossible to guarantee consistency across doses (unless perfectly shaken before each dose, the ingredients may not be evenly distributed across the 10 doses). The federal government has paid billions of dollars to these companies up front for these shots. The fact that they did not require single dose vials shows that they do not know what they are doing and they have absolutely no concern for your health.

At the end of the meeting Saturday ACIP voted 12 to 0 to authorize the applications to inject Moderna and Pfizer into little kids.

Rochelle Walensky signed off on the Final Solution on Saturday night.

The federal government’s massacre of the innocents began Monday June 20, 2022.

III. The short and long-term implications of these decisions

The VRBPAC and ACIP believe that they achieved some sort of great victory. They got nostalgic at the end of the meeting as they looked back over the Final Solution that they had constructed over the last year. One can imagine Reinhard Heydrich and the other participants in the Wannsee Conference in 1942 felt the same way.

The reality is quite different. The FDA and CDC have guaranteed their own collapse.

Here’s how the next few years are likely to play out:

About one-third to half of the Democratic Party (including the overwhelming majority of the public health establishment) are afflicted with hypochondria, Stockholm Syndrome, and/or Munchausen Syndrome by Proxy. They are going to take their kids to be injected right away at any nearby CVS, Walgreens, or out of the back of a windowless van down by the river. They don’t care — “needles into arms (and legs)” is the only thing that Democrats believe in now. They’re junkies who get high from deadly virtue signaling.

Those poor kids are going to develop a wide range of adverse events — myocarditis, heart attacks, strokes, autoimmune disorders, cancer, endocrine disorders, infertility, and sudden “unexplained” death, to name a few. The over-boosted adults will suffer a similar fate. The bourgeoisie will lose their health, their dignity, and then all of their wealth to the Pharma cartel.

Over time, about half of injured families will come over to our side and become single issue medical freedom voters. That will give us the numbers we need to take power and prosecute the evil doers. All of the demographic advantages that Democrats thought would carry them to permanent majorities will evaporate.

Republicans, who understand vaccine injury better than Democrats at this point, will win the November midterm elections, the 2024 Presidential election, and the majority of local, state, and federal elections for the foreseeable future. Republicans will control all of the appropriations committees and oversight committees that have purview over HHS, FDA, CDC, and NIH. Fauci, Walensky, Califf, and Marks will all quickly retire to avoid being called to testify.

The meritocratic bourgeoisie system that has guided the U.S. for two centuries has already collapsed. It turns out that meritocracy was always a lie. Many of the most esteemed bourgeois institutions in the country were represented at the meetings last week — Stanford, Harvard, NEJM, and the Rockefeller Foundation — and they have no credibility now. When the fate of our nation was on the line they revealed themselves to be fascist clowns whose ideology renders them less smart than the average homeschooled fifth grader. The trust that was the lifeblood of our system is no more.

By failing to listen to the majority of the country that is deeply skeptical of these shots, the FDA and CDC deepened the polarization and made reconciliation nearly impossible.

These decisions will make no difference on the pandemic. If anything these authorizations of more shots for kids mean that the pandemic will continue for years — because the shots do not work and they fuel the evolution of variants that evade vaccines.

One might think that these decisions will lead to civil war or partition of the country into separate independent red and blue countries. At this point there is no need for red states like Texas and Florida to split off to form their own countries because Republicans are about to control EVERYTHING — Congress, the Presidency, and the Courts.

IV. Where do we go from here?

We’re all traumatized right now but we need to keep our head in the game. We need to become the leaders who will take over as things begin to fall apart.

The Advisory Committee on Immunization Practices is still going to vote on Thursday June 23, on Moderna’s EUA application to inject mRNA into kids 6 to 17. You can still register a formal comment — look for the blue comment button in the upper left hand corner or upload your own file.

Then, eight days from now the FDA is going to vote on the “Future Framework”. It’s a proposal to exempt Covid-19 vaccine manufacturers from clinical trials for reformulated shots. It’s literally the worst idea in the history of public health.

Long term we need to shift our strategy from lobbying others to taking power ourselves. Right now it seems the Republican Party is the best vehicle for accomplishing this goal. But honestly at this point, how many national Republican leaders (10? 20?) actually understand the enormity of the catastrophe that has been inflicted upon us over these past two years?

We need to make the point every chance that we get that the November midterm election is not about inflation, guns, abortion, drag shows, nor Ukraine. The 2022 midterm election is about stopping the Pharma genocide. Vote for politicians who publicly speak out against all of the following ongoing atrocities:

• Tony Fauci funded the creation of a gain-of-function virus that got loose and killed 6 million+ people.

• The medical establishment blocks access to safe and effective treatments in order to create the market for vaccines.

• Hospitals used and continue to use the wrong protocols because all of their financial incentives are not aligned with health.

• Poorly tested genetic experiments were injected into BILLIONS of people worldwide causing an increase in all-cause mortality and a wide range of horrific adverse events that are going to wreck human health and the economy for DECADES.

• Social media companies censor life saving information to protect the cartel while enriching themselves; the entire mainstream media is complicit in covering up the genocide.

• Schools and universities are incapable of conducting even basic risk benefit assessments and instead sacrifice the students in their care to the predatory pharmaceutical industry.

• The FDA and CDC sold the American people to the pharmaceutical industry.

THAT’S what needs to be addressed, unraveled, and prosecuted. Everything else is secondary.

Source

BOMBSHELL: Dr. Clare Craig Exposes How Pfizer Twisted Their Clinical Trial Data for Young Children

BOMBSHELL: Dr. Clare Craig Exposes How Pfizer Twisted Their Clinical Trial Data for Young Children

Must watch!

Source: https://rumble.com/v18s66i-bombshell-dr.-clare-craig-exposes-how-pfizer-twisted-their-clinical-trial-d.html

Source

DR. DAVID MARTIN CONDEMNS VAX-PUSHING CORPORATE CEOS: THEY ARE COMMITTING “TERRORISM”

Puretrauma357 – May 20th, 2022

Dr. David Martin Condemns Vax-Pushing Corporate CEOs

SourceSouth Australian Gov Criminal Organisation

Here’s Why The Military’s ‘Mandate’ Violates The Law

Here’s Why The Military’s ‘Mandate’ Violates The Law


Military’s COVID Vaccine Mandate Violates the Law — Here’s Why

The U.S. Department of Defense by law cannot mandate a medical product unless it’s fully licensed, and there are no fully licensed COVID-19 vaccines available in the U.S. That’s just one of the reasons there are 23 lawsuits challenging the military’s mandate.

The COVID-19 vaccines granted Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) are voluntary products that cannot be administered to military personnel and civilians without informed consent.

In the military, this voluntary consent requirement for investigational drugs was upheld in the anthrax vaccine case, Doe v Rumsfeld (2003), which determined that in the absence of a presidential waiver, the U.S. Department of Defense (DOD) can legally mandate vaccines only if they are FDA-approved.

The voluntary consent requirement for COVID-19 EUA vaccines remains in place, despite false reports that the currently available EUA Pfizer-BioNTech and Moderna products have a Biologics License Application (BLA) and are FDA-approved.

Comirnaty had an expired marketing date on the FDA-approved BLA when the DOD mandated it, and Pfizer is not distributing Comirnaty in the U.S.

As a result, military personnel and civilians are within their legal rights to refuse the vaccine, per Title 21 U.S. Code §360bbb-3(e)(1)(a)(ii) and related regulations.

This article will detail how the courts clarified DOD was implementing an illegal vaccine mandate in November 2021, and how despite that, the DOD continues to coerce vaccine uptake and punish for noncompliance — similar to what occurred during the years following the illegal experimental anthrax vaccine mandate.

Congress should investigate DOD’s illegal enforcement EUA drug mandate

On Aug. 23, 2021, behind closed doors and without public discussion, the FDA approved a BLA (BLA125742) for the Comirnaty SARS-CoV-2 vaccine. The BLA expired the same day it was issued.

On Aug. 24, 2021, the DOD issued a vaccine mandate for a drug that did not exist and did not have an active BLA.

For the majority of vaccinations that occurred under the DOD mandate from August to December 2021, there was no license for the drug.

On Dec. 22, 2021, the FDA reissued the BLA (BLA125742) for Comirnaty, without a marketing end date, and with new National Drug Codes.

Congress has probable cause to investigate the DOD for two reasons.

First, the DOD knew the drug’s license was expired prior to the military mandate. Second, the DOD knew and understood that an EUA-labeled drug cannot be substituted for an FDA-approved drug, as clearly indicated in Doe v Rumsfeld.

In a future Congressional oversight investigation, the DOD must prove that it did not willfully enact an illegal mandate of the SARS-CoV2 vaccine.

The secretary of defense must also admit he knows the FDA-approved Comirnaty vaccine is not available to service members, and also that he knows the Comirnaty vaccine would have a BLA label with distinct National Drug Codes.

On Sept. 13, 2021, the National Institutes of Health published an announcement stating:

At present, Pfizer does not plan to produce any product with these new NDCs and labels over the next few months while EUA authorized product is still available and being made available for U.S. distribution.

As such, the CDC, AMA, and drug compendia may not publish these new codes until Pfizer has determined when the product will be produced with the BLA labels.”

On Sept. 14, 2021, the acting assistant secretary of defense published a memorandum stating the Pfizer-BioNTech and Comirnaty vaccines can be used “interchangeably.”

This resulted in an increase in vaccination uptake across the branches of the military.

However, there are very strict FDA requirements for “Biosimilar and Interchangeable Products” and these requirements would make it an unprecedented for an EUA drug to be approved as biosimilar to an FDA-approved drug, with additional testing required for biosimilar approval and comparison to the, in this case, not-yet-produced Comirnaty.

Moreover, the FDA does not list Comirnaty as biosimilar to BioNTech in the Purple Book database of biosimilar drugs. As stated in the Cominarty Highlights of Prescribing Information:

There are no data available on the interchangeability of COMIRNATY with COVID-19 vaccines from other manufacturers to complete the vaccination series. Individuals who have received 1 dose of COMIRNATY should receive a second dose of COMIRNATY to complete the vaccination series.”

FDA-approved drugs have marketing requirements, packaging and labeling requirements, package insert and informed consent fact sheet requirements, designated facility and product manufacturing requirements, and distribution and administration requirements that are different from those for EUA drugs.

The DOD communicated the concept of “interchangeably” in violation of the FDA requirements for biosimilar substitutions and in violation of the law, under the Doe v Rumsfeld ruling.

FDA, Pfizer and Congress colluded to deceive public

The FDA colluded in misleading and confusing the public by violating its own requirement that an EUA drug, for which pharma companies can’t be held liable if the product causes injury, cannot coexist in the market with its FDA-approved counterpart — which does not come with the same liablity protection.

As previously reported by The Defender, the FDA informed product recipients in a fact sheet that both BioNTech and Comirnaty are actually under EUA liability shield protections:

This EUA for the Pfizer-BioNTech COVID-19 Vaccine and COMIRNATY will end when the Secretary of HHS determines that the circumstances justifying the EUA no longer exist or when there is a change in the approval status of the product such that an EUA is no longer needed.”

The FDA approved Comirnaty yet continued to allow Pfizer to sell stockpiles of the EUA Pfizer-BioNTech vaccine, stating:

In the August 23, 2021 revision, FDA clarified that, subsequent to the FDA approval of COMIRNATY (COVID-19 Vaccine, mRNA) for the prevention of COVID-19 for individuals 16 years of age and older, this EUA would remain in place for the Pfizer-BioNTech COVID-19 Vaccine for the previously-authorized indication and uses.”

On Aug. 23, 2021, Pfizer published a letter for healthcare professionals in which the company falsely claimed some lots of EUA Pfizer-BioNTech vaccine are considered “BLA-approved,” despite having a legally distinct EUA label:

Many lots of Pfizer-BioNTech COVID-19 Vaccine are in circulation that were authorized for emergency use, and are labelled in accordance with the EUA. Some of these lots comply with the recently approved BLA for COMIRNATY and are therefore considered “BLA-approved” lots for administration to individuals 16 years of age and older.”

Attorneys and health policy analysts in September 2021 outlined for Congress via a Congressional Research Service report how the Comirnaty and Pfizer-BioNTech are legally distinct.

Here’s an excerpt from the report:

Why did FDA refer to Comirnaty and the Pfizer-BioNTech vaccine as ‘legally distinct’?

In the EUA, FDA states that the Comirnaty and Pfizer-BioNTech vaccines ‘are legally distinct with certain differences that do not impact safety or effectiveness.’ While the Comirnaty and Pfizer-BioNTech vaccines have the same formulation, they are legally allowed to be marketed and used pursuant to different legal authorities.

Specifically, Comirnaty is licensed pursuant to a BLA issued under the Public Health Service (PHS) Act (42 U.S.C. §262). The Pfizer-BioNTech vaccine is authorized for emergency use pursuant to the Federal Food, Drug, and Cosmetic (FD&C) Act (21 U.S.C. §360bbb-3).

Each product must be manufactured, labeled, marketed, distributed, and administered in accordance with the requirements of the legal regime under which it was approved or authorized. These requirements may differ in a number of ways.

For example, under the EUA, the Pfizer-BioNTech vaccine must be accompanied by fact sheets for the vaccine administrator and recipient informing them, among other things, of the product’s emergency authorization, known and anticipated risks and benefits, and the right to decline the vaccine [emphasis added]. Comirnaty need not be accompanied by this information if it is being administered pursuant to the BLA rather than the EUA; instead, the PHS Act and other FDA regulatory labeling requirements apply.

As another example, the Pfizer-BioNTech vaccine may be manufactured only at facilities identified and agreed upon in Pfizer’s EUA request, must be distributed directly by Pfizer or through authorized distributors to emergency response stakeholders (as defined in the EUA) as directed by the U.S. government, and must be administered by vaccination providers (as defined in the EUA) only to individuals 12 years of age and older.

These limitations do not apply to Comirnaty vaccines manufactured and distributed pursuant to the BLA; instead, the PHS Act and FD&C Act requirements apply. Comirnaty may be manufactured only at facilities identified and approved in the BLA.”

Court verdict questioned legality of DOD’s mandate enforcement

On Nov. 12, 2021, District Judge Allen Winsor stated in his ruling on Doe v Austin, (Case No. 3:21-cv-1211-AW-HTC), “The DOD’s interpretation of § 1107a is unconvincing.”

Judge Winsor wrote:

On August 23, 2021 — roughly eight months after the EUA first became effective — the FDA approved a Biologics License Application (“BLA”) and issued a full FDA license to produce and distribute the vaccine and label it with its proprietary name, ‘Comirnaty.’ ECF No. 1-4 at 2-3.

The BLA approval requires that Pfizer produce Comirnaty only at approved locations, subject to specific manufacturing, packaging, and labeling requirements. Id. at 2 (Doe v Austin, page 5).

Notably, though, the plaintiffs have shown that the DOD is requiring injections from vials not labeled ‘Comirnaty.’ Indeed, defense counsel could not even say whether vaccines labeled ‘Comirnaty’ exist at all. ECF No. 45 at 48:5-7. (Although the DOD’s response said it had an adequate Comirnaty supply, it later clarified that it was mandating vaccines from EUA-labeled vials. See id. at 46:22-47:3.)

In the DOD’s view, this is fine because the contents of EUA-labeled vials are chemically identical to the contents of vials labeled ‘Comirnaty’ (if there are any such vials). According to the DOD’s argument, this means servicemembers are not required to accept ‘a product authorized for emergency use.’ 10 U.S.C. § 1107a(a)(1).

Rather, the DOD argues that once the FDA licensed Comirnaty, all EUA-labeled vials essentially became Comirnaty, even if not so labeled. ECF No. 45 at 60:1-3. Thus, the DOD argues, the ‘product’ injected is a chemical formulation that has received full FDA licensure — not merely an EUA — so § 1107a does not apply. Id. at 65:1-6.8.

The DOD’s interpretation of § 1107a is unconvincing. For starters, FDA licensure does not retroactively apply to vials shipped before BLA approval. See 21 U.S.C. § 355(a) (‘No person shall introduce . . . into interstate commerce any new drug, unless an approval of an application [for FDA licensure] is effective with respect to such drug’ [emphasis added]).

Thus, as a legal matter, vaccines sent before August 23 — and vaccines produced after August 23 in unapproved facilities — remain ‘product[s] authorized for emergency use under section 564 of the Federal Food, Drug, and Cosmetic Act.’ § 1107a(a)(1).

Section 1107a’s explicit cross-reference to the EUA provisions suggests a concern that drugs mandated for military personnel be actually BLA-approved, not merely chemically similar to a BLA-approved drug. And the distinction is more than mere labeling: to be BLA compliant, the drug must be produced at approved facilities, see ECF No. 1-4 at 2; 21 C.F.R. §§ 600.11, 600.20-.21, and there is no indication that all EUA-labeled vials are from BLA-approved facilities.

Moreover, the DOD concedes that some of its current vials are not BLA-compliant, and that there is no policy to ensure that servicemembers get only BLA-compliant vaccines. See ECF No. 45 at 61:10-12. It is difficult to see how vials that the DOD admits are not BLA-compliant — and thus could only be EUA products — could fall outside § 1107a’s prohibition on mandatory administration.”

One detail Judge Winsor did not take notice of was the same-day expiration of the Comirnaty BLA on Aug. 23, 2021. (See page 23 of the original version of Comirnaty’s “Highlights of Prescribing Information.”)

If Judge Winsor were to revise his verdict summation, documenting the subsequent re-issuance of the BLA in December 2021 with different National Drug Codes and without a marketing expiration date, this would result in a more comprehensive record of the facts to benefit other pending lawsuits.

Despite this court verdict, the DOD refused to change course on the SARS-CoV-2 vaccine military mandate.

Similarly, with the anthrax vaccine, the DOD spent a decade in the judicial process defending what was ultimately decided as an illegal mandate of an experimental drug that eventually did acquire FDA approval years later.

During this time, service members faced court-martial, confinement, and loss of rank, pay and retirement benefits. Years of experience were lost in separated service members, specifically pilots. The personnel losses were not counterbalanced in the pursuit to protect the health of the force.

Again today, the DOD is struggling to meet recruiting goals, yet still remains steadfastly on course while negatively affecting the lives of thousands of service members and their families.

It is apparent that only Congress can provide the necessary oversight to prevent this mandate from exacerbating critical personnel shortages in the U.S. Armed Forces and to safeguard our national security.

Pharmaceutical contracts in the DOD are lucrative with 1.4 million active-duty personnel (with additional DOD civilians, National Guard, and Reserve units). These contracts with mandated populations remain profitable even with years of attorney fees.

In 2020, the DOD’s initial contract with Moderna cost $1.97 billion, and the initial contract with Pfizer cost $1.95 billion.

There are currently 23 lawsuits by service members against the DOD SARS-CoV-2 vaccine mandate, and thousands of service members awaiting religious accommodation request approvals.

Other service members face involuntary separation for refusing a voluntary EUA drug. As of late April 2022, there is at least one marine at Quantico who was retained in an administration separation board after agreement with the defense lawyer that there was no possible way for the service member to comply with the vaccine order because FDA-approved Comirnaty and Spikevax are not available.

The FDA approved Spikevax using a similar bait-and-switch strategy as Comirnaty, adding to the evidence that the FDA acted unethically and the DOD should have reasonably known to verify the licensure and availability of these two products.

••••

The above article (Military’s COVID Vaccine Mandate Violates the Law — Here’s Why) was published on The Defender and is re-published here by ‘contribution’ with attribution to the authors, Pam Long & Rose M. Freeman and website The Defender.

About this articles Authors:

Pam Long is graduate of USMA at West Point and is an Army Veteran of the Medical Service Corps.

Rose M. Freeman is a graduate of MIT and a Navy Veteran.

Image Credit: Photo in Featured Image (top) – by David Mark from Pixabay

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Hundreds of CDC Employees Never Got Their CVV-19 Jabs

Hundreds of CDC Employees Never Got Their CVV-19 Jabs


Hundreds of CDC Employees Never Got Their COVID-19 Jabs

Hypocrisy of Our Overlords

NEWS WIRE

This is only the tip of a much bigger iceberg. You’ll find this is the case right across government. While the federal government was threatening and blackmailing American workers with mandatory vaccines, the main agency tasked with creating the crisis narrative has been exposed for double standards.

This is hardly surprising to anyone who has been paying attention. Remember, it was the CDC, a valuable tool of Big Pharma, who were constantly producing the misleading COVID and vaccine claims and statistics, while diligently hiding any evidence which might have confounded the government’s dubious official narratives about an ‘out-of-control, deadly pandemic’ and ‘safe and effective’ experimental mRNA COVID gene therapy vaccines. 

Here they are, in all of their glory.

Zachary Stieber from Epoch Times reports…

Nearly 400 employees at the U.S. Centers for Disease Control and Prevention (CDC) haven’t received a COVID-19 vaccine, according to data obtained exclusively by The Epoch Times.

A total of 382 workers at the CDC are unvaccinated, Roger Andoh, a Freedom of Information Act (FOIA) officer at the agency, told The Epoch Times.

Another nine employees have just had one dose of the Pfizer or Moderna vaccines, meaning they also don’t qualify as ‘fully vaccinated’ per the CDC’s guidelines.

Collectively, the number is 3.2 percent of the CDC’s workforce.

Andoh initially pointed to a statement from the government that contained data as of December 2021 and declined to fully answer The Epoch Times’ FOIA request, which asked for more detailed figures that were current as of March 15.

“Please note that this is the most recent and most complete data available and some data elements that you requested are not available,” Andoh said initially.

When asked to clarify, another CDC officer repeated Andoh’s statement.

After The Epoch Times filed an appeal to the Department of Health and Human Services (HHS), the CDC’s parent agency, the office changed its stance without explaining why.

“After an additional search, we are providing you with the following information,” Andoh said in the new response.

“The response I got to your appeal from CDC gave me the impression they didn’t mean to withhold any information in the first place,” Jonathan Nelson, a FOIA analyst with HHS, told The Epoch Times in an email. “Based on that, my (personal) belief is that this was just an accidental omission on their part.”

Continue this story at Epoch Times

*********

(TLB) published this article from 21WIRE

READ MORE VACCINE NEWS AT: 21st Century Wire Vaccine Files

YOU CAN HELP SUPPORT 21WIRE’S INDEPENDENT MEDIA PLATFORM HERE

Header featured image (edited) credit: CDC head Rochelle Walensky currently under fire for numerous scandals and corruption allegations/Original article from 21WIRE

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The Liberty Beacon Project is now expanding at a near exponential rate, and for this we are grateful and excited! But we must also be practical. For 7 years we have not asked for any donations, and have built this project with our own funds as we grew. We are now experiencing ever increasing growing pains due to the large number of websites and projects we represent. So we have just installed donation buttons on our websites and ask that you consider this when you visit them. Nothing is too small. We thank you for all your support and your considerations … (TLB)

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Disclaimer: TLB websites contain copyrighted material the use of which has not always been specifically authorized by the copyright owner. We are making such material available to our readers under the provisions of “fair use” in an effort to advance a better understanding of political, health, economic and social issues. The material on this site is distributed without profit to those who have expressed a prior interest in receiving it for research and educational purposes. If you wish to use copyrighted material for purposes other than “fair use” you must request permission from the copyright owner.

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報道されない新型コロナウイルスとワクチンの真実

報道されない新型コロナウイルスとワクチンの真実

闇ッツチャンネル – April 23rd, 2022

闇ッツチャンネル
http://hellomitz3.net/?p=3922

【パンダにエサをやる】
https://www.amazon.co.jp/hz/wishlist/ls/2EAYMUF1JPNJX?ref_=wl_share

Editors Note: A big thanks to 闇ッツチャンネル for posting this on Bitchute. I am not Japanese, but if this just helps one Japanese person, then it was worth re-posting here. Please share.

SourceSouth Australian Gov Criminal Organisation

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