CHD Says Pfizer and FDA Dropped Data Bombshell on COVID Vaccine Consumers
Children’s Health Defense | March 03, 2022
Washington, DC, — In a 55,000-page set of documents released on Tuesday, the U.S. Food and Drug Administration’s (FDA’s) Center for Biologics Evaluation and Research (CBER) is for the first time allowing the public to access data Pfizer submitted to FDA from its clinical trials in support of a COVID-19 vaccine license. This follows U.S. District Judge Mark T. Pittman’s decision on January 6 to deny the request from the FDA to suppress the data for the next 75 years which the agency claimed was necessary, in part, because of its “limited resources.”
A 38-page report included in the documents features an Appendix, “LIST OF ADVERSE EVENTS OF SPECIAL INTEREST,” that lists 1,291 different adverse events following vaccination. The list includes acute kidney injury, acute flaccid myelitis, anti-sperm antibody positive, brain stem embolism, brain stem thrombosis, cardiac arrest, cardiac failure, cardiac ventricular thrombosis, cardiogenic shock, central nervous system vasculitis, death neonatal, deep vein thrombosis, encephalitis brain stem, encephalitis hemorrhagic, frontal lobe epilepsy, foaming at mouth, epileptic psychosis, facial paralysis, fetal distress syndrome, gastrointestinal amyloidosis, generalized tonic-clonic seizure, Hashimoto’s encephalopathy, hepatic vascular thrombosis, herpes zoster reactivation, immune-mediated hepatitis, interstitial lung disease, jugular vein embolism, juvenile myoclonic epilepsy, liver injury, low birth weight, multisystem inflammatory syndrome in children, myocarditis, neonatal seizure, pancreatitis, pneumonia, stillbirth, tachycardia, temporal lobe epilepsy, testicular autoimmunity, thrombotic cerebral infarction, Type 1 diabetes mellitus, venous thrombosis neonatal, and vertebral artery thrombosis among 1,246 other medical conditions following vaccination.
“This is a bombshell,” said Children’s Health Defense (CHD) president and general counsel Mary Holland. “At least now we know why the FDA and Pfizer wanted to keep this data under wraps for 75 years. These findings should put an immediate end to the Pfizer COVID vaccines. The potential for serious harm is very clear, and those injured by the vaccines are prohibited from suing Pfizer for damages.”
The U.S. government has already purchased 50 million doses of the Pfizer vaccine intended for children under five years of age to be delivered by April 30, 2022 although the FDA has yet to grant an Emergency Use Authorization (EUA) for this age group. The risk of serious injury or death from COVID to healthy children is practically nil and so far, the vaccine is not effective when used in young children.
According to The Guardian, “Pfizer made nearly $37bn (£27bn) in sales from its Covid-19 vaccine last year – making it one of the most lucrative products in history – and has forecast another bumper year in 2022, with a big boost coming from its Covid-19 pill Paxlovid.” President Biden advertised Paxlovid in his State of the Union address on Tuesday, the same day the Pfizer data was released to the public. “We’re launching the ‘Test to Treat’ initiative so people can get tested at a pharmacy, and if they’re positive, receive antiviral pills on the spot at no cost,” Biden said during his speech.
From mid-December, 2020 through February 18, 2022, the U.S. government’s database, the Vaccine Adverse Events Reporting System (VAERS), has received 1,134,984 reports of adverse events, including 24,402 deaths, following COVID vaccination. Additionally, there have been 4,021 cases of myocarditis and pericarditis in the U.S. with 2,475 cases associated with Pfizer, 1,364 cases with Moderna and 171 cases with J&J’s COVID vaccine. These include 643 reports of myocarditis and pericarditis in children aged 12 to 17.
“It would be criminal to expose infants and young children to this extremely risky product,” said Holland. “VAERS data show the catastrophic health impacts the vaccine is having on millions of people, yet Pfizer and other vaccine makers are raking in billions of dollars with no fear of being held accountable for injuries and deaths from their vaccines.”
The FDA’s attempt to suppress these data in support of the pharmaceutical industry’s bottom line isn’t a new phenomenon in this country’s public health system. For more information on pharmaceutical corruption and the tight relationship the industry has with government regulatory agencies, read The Real Anthony Fauci: Bill Gates, Big Pharma and the Global War on Democracy and Public Health by CHD Chair and lead counsel Robert F. Kennedy, Jr.
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Children’s Health Defense is a 501(c)(3) non-profit organization. Its mission is to end childhood health epidemics by working aggressively to eliminate harmful exposures, hold those responsible accountable, and establish safeguards to prevent future harm. For more information, visit ChildrensHealthDefense.org.
FDA Executive Officer: “Almost a Billion Dollars a Year Going into FDA’s Budget from the People we Regulate”
Health Impact News | February 17, 2022
Project Veritas published Part Two of its series on the FDA on Wednesday night which featured FDA Executive Officer, Christopher Cole, speaking about the inner workings of the agency including the FDA’s conflicts of interest, overspending, and why it’s hard for those within the agency to speak out on such abuses.
https://www.bitchute.com/video/WT4CuKhKW6N9/
In the footage, Cole talks about the impact that pharmaceutical companies have on the agency including the process for approving drugs.
“A long time ago, Congress approved user fees for [the] FDA. Basically, we charge the industry millions of dollars in order to hire more drug reviewers and vaccine reviewers, which will speed up the approval process, so they make more money,” Cole says in the hidden camera footage.
He then reveals that the FDA tones down the impact that these user fees have on the agency’s operations because, “they’re dependent on the drug companies, and the vaccine companies and these other companies for their agency to operate.”
The incendiary footage, which features Cole talking about how the additional money the FDA brings in “gets banked” to be spent on “whatever you can, whether it’s right or wrong,’’ also features Cole discussing reasons why it’s difficult for anyone in government to speak out about practices he sees as “probably excessive.”
“I don’t think there’s enough people saying they’re, like, ‘Look, that’s fine, but that’s not right. So, we’re not going to charge that.’ You don’t want to be that person. You’re not going to have a long shelf life in the agency if you’re always that person,” Cole said.
“There’s not an incentive to speak out in government, surprisingly. You would think there would be, but there’s not. It’s better just to just not say anything and just ignore it. The whistleblower, well, it’s high-profile whistleblower statutes and everything, that’s kind of ridiculous,” Cole said before adding “it’s better to just stay quiet and accept.”
Cole’s LinkedIn page lists him as an Executive Officer within the agency’s Countermeasures Initiatives, which plays a critical role in ensuring that drugs, vaccines, and other measures to counter infectious diseases and viruses are safe. He made these revelations on a hidden camera to an undercover Project Veritas reporter.
A spokesperson for FDA issued a statement yesterday saying, “The person purportedly in the video does not work on vaccine matters and does not represent the views of the FDA.”
This statement appears to contradict a phone call released Wednesday afternoon by Project Veritas wherein Cole reiterated, during the conversation with Project Veritas Founder and CEO, James O’Keefe, that he is “a manager in the office that helps oversee the approval of the COVID vaccines for emergency approval.”
See also: Part One
3,573 Fetal Deaths in VAERS Following COVID-19 Vaccines
By Brian Shilhavy | Health Impact News | February 13, 2022
The U.S. Government’s Vaccine Adverse Events Reporting System (VAERS) database was updated this past Friday, February 11, 2022, and it is now reporting that there have been 1,103,893 cases of injuries and deaths following COVID-19 vaccine since December of 2020, when the FDA issued emergency use authorizations for the COVID-19 vaccines. (Source.)
By way of contrast, there were 918,856 cases of injuries and deaths following all FDA-approved vaccines for the previous 30+ years, from 1990 through November of 2020. (Source.)
So there have been more injuries and deaths recorded in VAERS during the past 14 months following COVID-19 vaccines, than there were for the previous 30+ years combined following all vaccines recorded in VAERS.
Fetal Deaths Increase by 1,867% Following COVID-19 Vaccines
This most recent update of VAERS shows that there have now been 3,573 fetal deaths following COVID-19 vaccines. (Source.)
To arrive at the number of fetal deaths recorded in VAERS I had to test several different searches on listed “symptoms” and then see if the search results documented fetal deaths, since there is no demographic for “fetal deaths.”
The following is the current list of “symptoms” in VAERS that reveals fetal deaths:
- Aborted pregnancy
- Abortion
- Abortion complete
- Abortion complicated
- Abortion early
- Abortion incomplete
- Abortion induced
- Abortion induced incomplete
- Abortion late
- Abortion missed
- Abortion of ectopic pregnancy
- Abortion spontaneous
- Abortion spontaneous complete
- Abortion spontaneous incomplete
- Ectopic pregnancy
- Ectopic pregnancy termination
- Ectopic pregnancy with contraceptive device
- Foetal cardiac arrest
- Foetal death
- Premature baby death
- Premature delivery
- Ruptured ectopic pregnancy
- Stillbirth
This list may not be exhaustive. But if we use the exact same search using these symptoms, we can compare “apples to apples” in examining fetal deaths following COVID-19 vaccines as compared to fetal deaths following all non-COVID vaccines.
Using this search for all FDA-approved vaccines for the previous 30+ years before the COVID-19 vaccines were given emergency use authorization in December of 2020, we find 2,519 fetal deaths, the vast majority of which followed vaccines produced by Merck, which would include the Gardasil vaccines. (Source.)
Here are the yearly averages:
- 82 fetal deaths per year following non-COVID vaccines
- 3063 fetal deaths per year following COVID-19 vaccines
I arrived at these averages by taking the total number of fetal deaths following non-COVID vaccines and divided by 31, and for the fetal deaths following COVID-19 vaccines I divided by 14 to get the monthly average, and then multiplied by 12.
To get a more accurate percentage of how many more fetal deaths are following the COVID-19 vaccines than all other FDA approved vaccines, we have to also factor in the number of doses administered.
The U.S. Government’s Health Resources and Services Administration (HRSA) complies data on the National Vaccine Injury Compensation Program, and a report that they published on 12/01/2021 shows that there were over 4 billion (4,092,757,049) doses of vaccines administered in the United States between 1/01/2006 through 12/31/2019, a year before the COVID-19 vaccines were given emergency use authorizations. (Source.)
Using that date range I repeated the exact same search for fetal deaths recorded in VAERS during that time, and VAERS reports 1,369 deaths from among those 4 billion+ doses administered between 1/01/2006 through 12/31/2019. (Source.)
The CDC reported this past week that there have been 543 million doses of COVID-19 vaccines administered as of February 3, 2022. (Source.)
So from 2006 through 2019, there was 1 fetal death recorded in VAERS for every 2,989,596 doses of vaccines administered.
From December, 2020 through February 4, 2022, there has been 1 fetal death recorded in VAERS for ever 151,973 doses of COVID-19 vaccines administered.
That’s a 1,867% increase of fetal deaths recorded in VAERS following COVID-19 vaccines.
I’ve run out of superlatives to use in the English language to describe this. And this is just using the U.S. Government’s own reported statistics, without even trying to figure out what the unreported factor is.
Here are two recent stories from young mothers who lost their unborn babies just after receiving a second COVID-19 vaccine. Perhaps their words and their experiences, which obviously represent, at least, many thousands of others, can better communicate just how truly horrible this is.
This is on our Bitchute channel, and also on our Telegram channel.
CHD Informs the FDA that the Facts Certainly Fail to Support Vaccinations in the 6 month-60 month age group
By Meryl Nass, MD
February 9, 2022
VIA FEDERAL EXPRESS and EMAIL
Dear Dr. Janet Woodcock:
We write to you on behalf of Children’s Health Defense (CHD), a non-profit organization devoted to the health of people and the planet. We have actively followed your work to evaluate, authorize and approve vaccines for the American public, and particularly children.
We are aware that you are likely to grant Emergency Use Authorization (EUA) of Pfizer’s BioNTech SARS-CoV-2 vaccine for children aged six months up to five years old following your upcoming meeting on February 15, 2022. We are writing to put you on notice that should you recommend this pediatric EUA vaccine to children under five years old, CHD is poised to take legal action against you. CHD will seek to hold you accountable for recklessly endangering this population with a product that has little, no, or even negative net efficacy but which may put them, without warning, at risk of many adverse health consequences, including heart damage, stroke and other thrombotic events and reproductive harms.
We briefly outline why such a recommendation would be reckless for nearly 20 million children in the United States, and millions more around the world.
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There is no COVID emergency for children under five years old. Children have a 99.995% recovery rate and a body of medical literature indicates that almost zero healthy children under five years old have died from COVID.
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A large study conducted in Germany showed zero deaths for children under 5 and a case fatality rate of three out of a million in children without comorbidities.
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A Johns Hopkins study monitoring 48,000 children diagnosed with COVID showed a zero mortality rate in children under 18 without comorbidities.,
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A study in Nature demonstrated that children under 18 with no comorbidities have virtually no risk of death.
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Data from England and Wales, published by the UK Office of National Statistics on January 17, 2022 revealed that throughout 2020 and 2021, only one (1) child under the age of 5, without comorbidities, had died from COVID in the two countries, whose total population is 60 million.
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Another study in Nature from April, suggests children’s bodies clear the virus more easily than adults.
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This study published in December in Nature demonstrated how children efficiently mount effective, robust and sustained immune responses.
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Over one third of all children are estimated to have natural immunity to COVID, according to CDC’s own data. There is no ethical justification for superfluous vaccination that will put children at elevated risk of vaccine harm.
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The risks demonstrably outweigh the benefits of COVID vaccination in young children. A study out of Hong Kong, showed one out of every 2,700 12-17 year old boys being diagnosed with myocarditis following the 2nd dose of Comirnaty vaccine, or 37 per 100,000 vaccinated. A study from Kaiser found the same rate of myocarditis in 12-17 year old American boys, 1/2700.
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While the CDC is saying that myocarditis is a mild disease, cardiologists know otherwise. CDC’s own preliminary data, reported at the February 4 ACIP meeting, revealed that nearly half of the young people diagnosed with myocarditis still had symptoms 3 months later, and 39% had their activity restricted by their physician. We know this serious adverse event occurs frequently in teenagers. But no one knows how often it occurs in younger children. This is of major concern for babies and younger children.
5. The clinical trials for children 2 through 4 years old failed., You’re proposing to use a product and schedule that failed in its clinical trials, and you may potentially add a third dose later in the spring. This is an unprecedented proposal not backed by science. It does not meet the risk-benefit standard of 21 U.S. Code § 360bbb–3 “the known and potential benefits of the product, when used to diagnose, prevent, or treat such disease or condition, outweigh the known and potential risks of the product.”
6. Some children likely will die and others will be permanently injured from these vaccines based on reporting to the current VAERS database. The latest data shows a total of 1,088,560 reports of adverse events from all age groups following COVID vaccines, including 23,149 deaths and 183,311 serious injuries between Dec. 14, 2020, and Jan. 28, 2022.
7. The pediatric clinical trials for the COVID vaccines were too small to detect safety signals–especially for a population in the tens of millions.
8. There are a) no long-term safety data for COVID vaccination of young children, and b) the proposal is to vaccinate children under the Emergency Use Authorization. Both a) and b) establish that vaccinating small children for COVID will be an experiment, not a standard medical procedure.
9. Unethical coercive pressure will be applied to children and their parents, as has occurred with older children and adults. To grant authorization is to abet this unethical coercion that violates the Nuremberg Code’s first principle.
10. There is no available care for children injured by COVID shots. There is no way to remove the spike protein and other toxic byproducts of vaccination, which may be produced for a considerable period of time following inoculation of messenger RNA. The science and medicine have not yet developed, and most families will be unable to cover the costs of potential catastrophic injuries.
11. First, do no harm. You are a physician who owes a duty to patients and medical ethics. If you recommend these shots to this age group, given all you know, will you be upholding your oath? If not, is it possible that your acts could later be seen as reason to remove your medical licenses?
12. The liability-free nature of your deliberations may not stand the test of time. In the fullness of time, your decisions may not have the liability protection that they currently enjoy. Under the PREP Act of 2005, all actors advancing an EUA agenda for medical countermeasures enjoy liability protection, absent willful misconduct., Nonetheless, if at a later point these shots are deemed non-therapeutic gene products that you knowingly and recklessly recommended, and which were then distributed to children as a direct result of your decision, it is possible that liability could later attach.
13. There are safer drugs that could be used prophylactically and therapeutically for COVID in children. There is extensive and compelling medical evidence for this assertion; and the choice to eschew use of these drugs in favor of a demonstrably dangerous vaccine is arbitrary and capricious.
14. The vaccines do not prevent transmission. They do not prevent infection. There is no statistically valid evidence that they prevent severe disease or deaths in children. Which begs the question: what are you actually trying to accomplish by vaccinating small children? What is your goal?
15. On August 23, 2021, FDA’s letter to BioNTech explained that neither the VAERS nor the VSD surveillance systems were adequate for FDA to determine the risk of myocarditis resulting from the Pfizer vaccine. Therefore, Pfizer and BioNTech were instructed by FDA to carry out a series of studies of myocarditis to ascertain the risk in different groups, including children. These studies were scheduled to produce final reports to FDA over the next five years. If the FDA is willing to wait until 2027 to learn the actual risks of myocarditis from the vaccine for children, shouldn’t it be required to wait until 2027 before inoculating millions of small children with a vaccine anticipated to provide them no benefit and possibly substantial risks?
16. An important Cell article in press, written by scientists from Stanford, has shown that, based on lymph node sampling after mRNA vaccination, spike protein and its mRNA remain present in the germinal centers of draining lymph nodes for up to 60 days, which is when sampling ceased. This was not supposed to happen. The demonstration of vastly prolonged spike protein production has revealed that the dose of spike protein produced in vivo by mRNA vaccines is unpredictable. FDA, however, requires uniformity of dosing. This fact alone should disqualify all authorizations and approvals of mRNA COVID vaccines.
We ask that you carefully consider all the information above before making any recommendation for Pfizer’s vaccine in the 6 months to under 5 year age group at your meeting on February 15, 2022.
_____________________________________
Robert F. Kennedy, Jr. Meryl Nass, M.D.
Unfortunately, the footnotes are missing from this version. They can be found at:
https://childrenshealthdefense.org/wp-content/uploads/CHD-Letter-to-FDA__EUA-Under-5_2-9-2022-1.pdf
The Pfizer clinical trial in kids under age 5 has now failed TWICE
By Toby Rogers | February 12, 2022
On December 17, 2021, Pfizer announced that the clinical trial of its mRNA shot in kids under age 5 had failed. Rather than withdraw this product, Pfizer “amended” its clinical trial to add a third dose. So Pfizer kept the original trial going and subjected these little kids to yet another shot of genetically modified mRNA.
The drug dealers at the FDA said, ‘sounds great, let’s proceed with authorization even in the absence of data.’ That created a huge public backlash as parents rightly protested that the FDA should not approve a drug for kids that failed in a clinical trial.
Yesterday (Feb. 11, 2022), the FDA was forced to admit defeat and Pfizer pulled its Emergency Use Authorization (EUA) application to inject kids under age 5.
Pfizer and the FDA claimed that they were “waiting for more data” that would be available in early April. We now know that this was a lie.
Buried deep in an article on page A13 of the NY Times this morning we learned the real reason why Pfizer withdrew its EUA — the clinical trial had failed, again.
Remember, Pfizer kept the clinical trial going after December 17. So between then and yesterday’s announcement, there was now roughly 55 more days worth of data. And it was truly terrible.
From the NY Times :
Then, late on Thursday [Feb. 10], Pfizer alerted the F.D.A. that it had more recent data, from mid-January on, showing a more discouraging picture as the Omicron variant bore down. The new data revealed that two doses were not sufficiently effective in preventing symptomatic infection.
Read that again. They have the data. And the data show that this shot does not work.
But even here, I think there is reason to believe that they are still lying. We already knew that “two doses were not sufficiently effective” — Pfizer announced that in December. The “more recent data, from mid-January on” is not the two dose regimen anymore, that phase of the trial is finished.
I think there is every reason to believe that this is now the three dose trial that they are describing. If the three dose trial was on track and showing promising results, they would have proceeded with authorization. So now we likely have the first evidence that the three dose trial has failed as well.
(Here’s my math: Pfizer likely injected the third dose into these kids between Dec. 17 and mid-January. So “from mid-January on” (to Feb. 10) is looking at the data in the 25 days after the third injection. In the comments, please let me know if you interpret this differently.)
So it is definitely NOT the case that this is just an incomplete trial that they are waiting to finish up in early April. All of the existing data is bad. Pfizer is now scrambling to find ways to save this product even though the clinical trial has now failed twice. And what’s Pfizer’s plan going forward — to just hope that the data in the next 60 days (from now through early April) magically turns the corner!? Talk about wishful thinking!
Just when I think the cartel and its enablers in the mainstream media could not possibly get any more cynical they sink to new lows.
Janet Woodcock and Peter Marks at the FDA must be fired and prosecuted for reckless endangerment of children. Pfizer must stop this grotesque clinical trial immediately and permanently suspend any plans to inject genetically modified mRNA into children under 5. Anything less is savagery and barbarism.
Pfizer, FDA Lose Bid to Further Delay Release of COVID Vaccine Safety Data
By Michael Nevradakis, Ph.D. | The Defender | February 7, 2022
A federal judge Wednesday rejected a bid by the U.S. Food and Drug Administration (FDA), with the support of Pfizer, to delay the court-ordered release of nearly 400,000 pages of documents pertaining to the approval of Pfizer’s COVID vaccine.
Federal judge Mark Pittman of the U.S. District Court for the Northern District of Texas, in an order issued Feb. 2, said the FDA must release redacted versions of the documents in question according to the following disclosure schedule:
- 10,000 pages apiece, due on or before March 1 and April 1, 2022.
- 80,000 pages apiece, to be produced on or before May 2, June 1 and July 1, 2022.
- 70,000 pages to be produced on or before Aug. 1, 2022.
- 55,000 pages per month, on or before the first business day of each month thereafter, until the release of the documents has been completed.
The order grants the FDA the ability to “bank” excess pages as part of this release schedule — meaning that if the agency exceeds its monthly quota in any given month it can apply those extra pages to a subsequent month.
Last week’s ruling is the most recent development in an ongoing court case that began with a Freedom of Information Act (FOIA) request filed in August 2021 by Public Health and Medical Professionals for Transparency (PHMPT), a group of doctors and public health professionals.
PHMPT, a group of more than 30 medical and public health professionals and scientists from institutions such as Harvard, Yale, and UCLA, in September 2021 filed a lawsuit against the FDA after the agency denied its original FOIA request.
In that request, PHMPT asked the FDA to release “all data and information for the Pfizer vaccine,” including safety and effectiveness data, adverse reaction reports, and a list of active and inactive ingredients.
The FDA argued it didn’t have enough staff to process the redaction and release of hundreds of thousands of pages of documents, claiming it could process only 500 pages per month.
This would have meant the cache of documents would not be fully released for approximately 75 years.
In his Jan. 6 order, Pittmann rejected the FDA’s claim and instead required the agency to release 12,000 pages of documents by Jan. 31 and an additional 55,000 pages per month thereafter.
Pfizer responded, to the Jan. 6 order by filing a memorandum with the court on Jan. 21, requesting to intervene in the case for the “limited purpose of ensuring that information exempt from disclosure under FOIA is adequately protected as FDA complies with this Court’s order.”
Pfizer claimed to support the disclosure of the documents, but asked to intervene in the case to ensure that information legally exempt from disclosure will not be “disclosed inappropriately.”
As reported by The Defender, this request, if granted, would have also meant further delay for the release of the next tranche of documents, until May 1.
Lawyers for PHMPT, in a brief submitted Jan. 25, asked Pittman to reject Pfizer’s motion, prompting Pittman’s Feb. 2 order.
The first batch of documents produced in Nov. 2021, which totaled a mere 500 pages, revealed there were more than 1,200 vaccine-related deaths within the first 90 days following the release of the Pfizer-BioNTech COVID vaccine.
Michael Nevradakis, Ph.D., is an independent journalist and researcher based in Athens, Greece.
© [Article Date] Children’s Health Defense, Inc. This work is reproduced and distributed with the permission of Children’s Health Defense, Inc. Want to learn more from Children’s Health Defense? Sign up for free news and updates from Robert F. Kennedy, Jr. and the Children’s Health Defense. Your donation will help to support us in our efforts.
Pfizer, FDA Ask Court to Further Delay Release of COVID Vaccine Safety Data
By Michael Nevradakis, Ph.D. | The Defender | January 31, 2022
Days prior to today’s scheduled release of a tranche of documents related to the Pfizer COVID vaccine, the pharmaceutical company asked a federal court to let it intervene before any information is released.
It’s the latest development in an ongoing court case that began with a Freedom of Information Act (FOIA) request filed in August 2021 by Public Health and Medical Professionals for Transparency (PHMPT).
PHMPT asked the U.S. Food and Drug Administration (FDA) to release all documents related to its Emergency Use Authorization (EUA) of the Pfizer-BioNTech COVID vaccine and full approval of the Pfizer-Comirnaty COVID vaccine.
Judge Mark Pittman of the U.S. District Court for the Northern District of Texas on Jan. 6 issued an order requiring the FDA to release 12,000 pages of documents by Jan. 31 and an additional 55,000 pages per month thereafter, until the release of the nearly 400,000 pages of documents is complete.
Pfizer claims to support the disclosure of the documents, but asked to intervene in the case to ensure that information exempt from disclosure will not be “disclosed inappropriately.”
In a memorandum it submitted to the court, Pfizer said it:
“[S]eeks leave to intervene in this action for the limited purpose of ensuring that information exempt from disclosure under FOIA is adequately protected as FDA complies with this Court’s order.”
Attorneys for Pfizer also claimed while it was not asking the court to reconsider the Jan. 6 order, it would consider challenging the order at an unspecified later date, telling the court:
“Pfizer does not presently intend to move the Court to reconsider its January 6, 2022 order, but Pfizer is not in a position at this time to waive its ability to do so if circumstances change such that there is good cause at a later time to do so.”
Pfizer did not clarify what such a change of circumstances might entail.
Lawyers for PHMPT, in a brief submitted Jan. 25 to the court, asked Pittman to reject Pfizer’s motion and requested the judge ask Pfizer to clarify how, exactly, its intervention would help expedite the release of the documents, arguing that Pfizer:
“… provides no reason why it needs to intervene in this matter to render that purported assistance. Nor can Plaintiff discern why Pfizer needs to intervene in this matter to assist the FDA with expediting release of the requested documents—it can render this assistance without intervening.”
PHMPT, a group of more than 30 medical and public health professionals and scientists from institutions such as Harvard, Yale, and UCLA, in September 2021 filed a lawsuit against the FDA when the agency denied its original FOIA request.
In that request, PHMPT asked the FDA to release “all data and information for the Pfizer vaccine,” including safety and effectiveness data, adverse reaction reports, and a list of active and inactive ingredients.
The first batch of documents released in November 2021, which totaled a mere 500 pages, revealed there were more than 1,200 vaccine-related deaths within the first 90 days following the release of the Pfizer-BioNTech COVID vaccine.
Arguments regarding Pfizer’s motion are scheduled to be heard in court on Jan. 28, though as of this writing, no further updates regarding the case or this scheduled hearing have been publicly disclosed.
Pfizer represented by world’s third-largest law firm
Pfizer on Jan. 21 submitted two filings to the court: a motion to intervene in the case “for a limited purpose,” and an accompanying “memorandum of points and authorities” supporting the motion.
It remains unclear how Pfizer defines “inappropriately” or “for a limited purpose,” or why it waited two weeks after Judge Pittman’s order, and only days before the Jan. 31 scheduled release of 12,000 pages to file its motion.
Pfizer claims it was unaware of the case until executives read news reports about it in December 2021, despite the fact that the case garnered coverage from major news outlets, including Reuters, in November of that year.
Still, the company hired DLA Piper LLP, one of the world’s most high-powered law firms, to represent it. DLA Piper is headquartered in London and maintains offices in 40 countries.
In 2014, the firm had revenues totaling $2.48 billion, making it the third-largest law firm in the U.S. by revenue.
DLA Piper was the 12th largest donor to President Obama’s 2012 re-election campaign and the 9th largest donor to Hillary Clinton between 1999 and 2018.
Douglas Emhoff, spouse of U.S. Vice President Kamala Harris, was employed at the firm until 2020, earning $1.2 million in partnership income that year.
FDA supports Pfizer’s motion, requests extension
In a response to Pfizer’s motion, the FDA said it welcomed Pfizer’s “help,” claiming that this is “due to the unprecedented speed with which the Court has ordered [the] FDA to process the records at issue.”
In addition to supporting Pfizer’s motion, the FDA also requested an extension from the court that would further delay the scheduled release of the documents.
Aaron Siri of the Siri & Glimstad law firm, who is representing PHMPT in its lawsuit against the FDA, explained:
“The FDA now insists it must delay its first 55,000-page production until May 1, 2022 – four months after the Court entered its order.
“However, the FDA’s own papers seeking this delay make plain it can produce at a rate of 55,000 pages per month in February and March.”
The FDA claimed Pfizer is entitled to intervene in the case and the process of redacting the documents in question, due to the “Trade Secrets Act,” signed into law by President Obama in 2016, stating:
“FDA anticipates that coordination with Pfizer to obtain the company’s views as to which portions of the records are subject to Exemption 4, the Trade Secrets Act, 18 U.S.C. § 1905, or other statutory protections will be a necessary component of the agency’s endeavors to meet the extraordinary exigencies of this case.”
However, according to The Gateway Pundit, the Trade Secrets Act is being misinterpreted by the FDA and Pfizer:
“[T]he protections provided under that law allow for an owner of a trade secret to sue in federal court when its trade secrets have been misappropriated and does not even imply that a company could intervene in a public records request through the FOIA.”
PHMPT, in its Jan. 25 brief, also rejected the FDA’s continued claim that it cannot adhere to the disclosure schedule Pittman ordered on Jan. 6, arguing “the FDA has more than sufficient resources to expeditiously produce the requested documents.”
Siri, on his blog, also questioned this aspect of FDA’s argument, writing:
“The FDA … attests that over the coming weeks, it will have 28.5 full-time people reviewing the documents. Working 7.5 hours per day for 20 business days per month, 28.5 people reviewing 50 pages per hour can review a total of approximately 213,750 pages per month.
“The FDA affirms it has already ‘allocated the equivalent of nearly 11 full-time staff to this project’ and that ‘a review speed of 50 documents per hour was within the normal range for document review in a complex matter’ in private practice; and here the 50 document per hour rate would be faster since there is only a need to review for personally identifying information (‘PII’) for most pages. Hence, if the FDA’s 11 full-time reviewers work only 7.5 hours per day and review 50 pages (not documents) per hour, the FDA could review over 88,000 pages per month in February and March. That is more than sufficient to produce the 55,000 pages per month currently ordered for these two months.”
Instead of complying with this court’s “reasoned order,” Siri Wrote, the FDA claims these 11 reviewers can only review a total of 10,000 pages per month.
What the FDA does not say, and what basic math shows, according to Siri, is that a rate of 10,000 pages a month for 11 full-time reviewers amounts to only 5 pages per hour.
Siri also questioned the FDA’s commitment to transparency and hinted at a cover-up, stating:
“The Court is, other than Congress, the only check on the FDA. In a free country, transparency is paramount, and the FDA has chosen to thwart transparency and the requirements of FOIA by anemically understaffing the office it maintains to respond to FOIA requests.
“It is also incredible for the FDA to claim that compliance here would harm its health policy objectives. Even if the FDA really does need to spend $4 to $5 million which … is an absurd overestimate, that is an inconsequential amount of its overall $3.41 billion discretionary budget.
“It is understandable that the FDA does not want independent scientists to review the documents it relied upon to license Pfizer’s vaccine given that it is not as effective as the FDA originally claimed, does not prevent transmission, does not prevent against certain emerging variants, can cause serious heart inflammation in younger individuals, and has numerous other undisputed safety issues.”
Siri said the FDA’s “potential embarrassment” over its decision to license the Pfizer vaccine must take a back seat to the transparency demanded by FOIA and “the urgent need and interests of the American people to review that licensure data.”
Michael Nevradakis, Ph.D., is an independent journalist and researcher based in Athens, Greece.
© 2022 Children’s Health Defense, Inc. This work is reproduced and distributed with the permission of Children’s Health Defense, Inc. Want to learn more from Children’s Health Defense? Sign up for free news and updates from Robert F. Kennedy, Jr. and the Children’s Health Defense. Your donation will help to support us in our efforts.
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New wave of Stasi censorship likely reveals the next phase of Pharma’s playbook
Pfizer and Moderna set to ask the FDA & CDC to grandfather in their reformulated coronavirus vaccines with almost no data
By Toby Rogers | January 27, 2022
I just got another 30-day suspension from Facebook. It’s always interesting to see which posts set off the Stasi. The purpose of censorship is to delete any facts that contradict the Pharma narrative. So every time they censor one of my posts it tells me that this content was directly over the target.
Many of my previous suspensions were in the weeks leading up to key FDA and CDC decisions on mRNA vaccine applications. I was highly visible on social media sharing information about why the risks of these shots outweigh the benefits. It seems that Pfizer and Moderna just put out the word that they want to get the approval across the line and the Stasi get to work banning anyone with data or analysis that might hurt their application. They ban me about three weeks before the FDA/CDC decision, get the approval they seek, and then my suspension expires.
And that seems to be the case again here.
In this instance, Facebook suspended me for a post from two months ago. They never explain their decision and never point out any factual errors in my post. But ask yourself, why did this particular post trigger the Thought Police?
November 28, 2021
Guys and gals listen up. The battle ahead is this: both Pfizer and Moderna have announced plans to develop new multivalent mRNA shots within 100 days to address new variants. They will argue to the FDA and CDC that these new shots (now the fourth dose of a failed product) should be grandfathered in without further clinical trials because they are similar to the existing (deadly toxic junk) product. If that happens, then all future doses of this product, whatever the formulation, will never go through clinical trials of any kind.
I am hard-pressed to imagine a more apocalyptic scenario — injections, for most everyone in the developed world, every six months, forever, with no clinical trials, and no idea of what is in the vial. It’s a eugenicists’ dream.
We must begin pushing now to tell every elected official and every regulator that there must be new clinical trials or they will be prosecuted at Nuremberg 2.0.
Republicans hoping to take back the Congress in 2022 must be on record as demanding new clinical trials.
Existing trials are terrible but they give us a chance to see how these companies rig the data and they give us a point of comparison (to show that they lied) when real world data comes in. We have very little data on new variants but Pfizer and Moderna’s plans to proceed without clinical trials are a possible extinction-level event for humanity.
Updated to add: the message to elected officials has to be simple — Any new formulation needs a proper new clinical trial (50,000 participants, at least 2 years follow up, conducted by an independent 3rd party).
My assertions in this post are based on years of studying the Pharma playbook. Is there any evidence that anything I said in this post is incorrect? Pharma is going to try to get these reformulated coronavirus vaccines grandfathered in without further regulatory scrutiny.
To the extent that there are any clinical trials — they will be these sham trials like the recent third dose Emergency Use Authorization applications. As you will recall, the Moderna third dose “trial” had 149 participants in the treatment group and the Pfizer “trial” had 200 participants total. I wrote about that (here). These “trials” were so bad that the top two vaccine safety regulators at the FDA quit rather than approve this worthless toxic junk under political pressure from the Biden administration. Indeed these “trials” were so bad that the hand picked Yes-men (and women) on the Vaccines and Related Biological Products Advisory Committee rejected the applications (16 to 2) — so Janet Woodcock just pushed the applications through under her signature, against their advice.
The fact that FB censored this two-month old post out of the blue suggests that this is exactly what Pfizer and Moderna are about to do — they are going to bum-rush these reformulated coronavirus vaccines through the rotten FDA and CDC and start injecting them into billions of people with no data on safety or effectiveness.
These reformulated vaccines are ostensibly to address the Omicron variant — although a new variant will have already taken its place by the time these reformulated vaccines are available. So once again these vaccines are likely to have zero or negative efficacy against the virus and produce unknown levels of harm including iatrogenic injury and antibody dependent enhancement. The introduction of reformulated vaccines is also likely to accelerate the evolution of new variants.
This is why we need a revolution. This is why we must overthrow the existing regime. Common carriers and most bourgeois institutions in the U.S. work for the Cartel. And the Cartel is engaged in democide throughout the developed world because democide is very profitable and this is now their business model.
“How Bad is my Batch” The story of my vaccine injury – Robert W Malone MD, MS
By Robert W Malone MD, MS | January 13, 2022
In fact, I do have a personal life. My wife of of 42 years and I are actually pretty private. Sharing personal history is not something I do everyday. However, as many of you know – I was vaccinated with Moderna twice and had a pretty significant vaccine injury. This was pretty early in the roll-out of the vaccines. It was long before the FOIA Japanese pre-clinical trial data that had so many red-flags and irregularities, long before we learned of all the issues with the clinical trials, and long before the VAERs and adverse events began to be known.
To write it, I have never been an “anti-vax” person. I have spent my career working with vaccines. I also know that some vaccines are “hot,” and are less safe. Usually these types of vaccines are reserved for extremely dangerous viruses like Ebola or Yellow fever. Where the goal is to make the vaccine 100% effective. Other vaccines, that are distributed widely, like the flu vaccines need to be very safe. The trade-off being that they are less effective. There is a whole science and art to crafting vaccines to appropriately respond to the “threat.” So, I know to read the literature, do my own due- diligence, etc before taking an experimental product or any vaccine. That is what I thought I did. The government assured us that these vaccines were very safe. I could never imagine that clinical data would be corrupted and even falsified – as we now know it was.
Anyway, back to my story. I knew in the beginning of April, 2021, that I had to travel overseas and the word on the street was that the European Union was going to require full vaccination before entering any EU country by summer (that actually never happened BTW). I knew that a full vaccination protocol was a process of weeks – and that i had better get started! Furthermore, there was a lot of buzz around the idea that vaccination would help with “long-COVID.” I had already had COVID, and just couldn’t shake a number of chronic issues that I had developed after getting the disease. Frankly, I should have done more homework on that one- because this idea really didn’t hold up to scrutiny.
Be that as it may, in April, 2021, I got vaccinated. It was early enough in the cycle, that I had no choice but to take the Moderna vaccine, as that was available in my area The vaccine was distributed at a local college, with the Army Reserves administering the program.
The first shot was fine. No issues.
The second shot almost did me in. As in I almost died.
After the injection, I had the usual fatigue, muscle-ache and then the palpitations started, as well as shortness of breath. Within a couple days, it got worse – I am not someone who goes to the doctor easily, but luckily for me, I happened to have a routine appointment with my physician. She cuffed me and my systolic blood pressure was through the roof. As she is also a cardiologist, she had more tests run, started me on high blood pressure meds and we got it under control. I kind of feel like I owe her my life. A call out to the fantastic Dr. C. Bove.
Fast forward to today.
One of the people who comments on my Substack articles, pointed me to this website:
This site matches up vaccine batch codes with information from the VAERS system, which is the event reporting system run by the CDC. This site matches the vaccine batches to adverse drug reactions, death, disability and life threatening illnesses from the VAERS system
According to the website above, the data reported in VAERS, reproduced on the site, show that adverse events triggered by Moderna batches have varied widely.
- 5% of the batches appear to have produced 90% of the adverse reactions
- Some Moderna batches are associated with 50 x the number of deaths and disabilities compared to other batches.
With that knowledge, I entered my batch code in the search box. The first injection had almost no significant adverse events associated with it. The second jab, frankly shocked me
Here are the results:
Now, I don’t know how many doses are in each batch. But I do know my batch was most definitely in the top 5%. So, not really a surprise in retrospect that I had such a serious adverse event profile.
I always felt I was lucky that I happened to be going to my physician that day, who is also a cardiologist (she is my internist – so I wasn’t seeing her for that specialty).
But just think- our government had this data way back when in the VAERs system -even last summer. This data is so compelling and yet… crickets. How many people could they have helped by releasing this data? People like me, who if I wasn’t a physician and hadn’t gone to my physician could have easily dropped dead.
What is wrong with our government that a site like this is not available from the CDC or the FDA?
If anyone has any doubts about adverse events from these vaccines, take a look at some of the peer reviewed research or look at the VAERS data for deaths in young adults and children.
People have the right to be given informed consent of risks and benefits of a medical procedure. Informed consent is not given, if the risks are hidden.
WHERE THERE IS RISK, THERE MUST BE CHOICE
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From the Archives
A short history of British torture
ICC | December 2005
When the House of Commons was debating how much to increase the time limit for detention without trial the question of torture came up. Officially this was limited to the nice considerations of whether it was all right to send people to places where torture is used and whether Britain can use information collected by the use of torture in other countries. This discussion gave an impression of democratic Britain as the home of civilised behaviour where the very idea of torture is repugnant to our legislators – unlike, say, the US with its secret CIA jails… In reality, the British state has a long history of using and developing a whole range of torture techniques. … continue
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