Here’s what government and industry came up with to wiggle out of liability for monkeypox vaccine injuries
By Meryl Nass, MD | August 7, 2022
Although I don’t have the full story yet, I am warning you that the moneypox vaccine Jynneos is a huge scam, in every way, including the supposed shortage. I will disclose more about that soon.
But since it is actually licensed, the moneypox vaccine (like other licensed drugs and vaccines) has liability attached to it. You can currently sue government program planners, the doctor who recommended it, the manufacturer, etc. if anything goes wrong.
To forestall that, some crook came up with the idea of splitting the doses, under the guise of a fake shortage, which provides an excuse to make the lower dose an EUA–in other words, turning it into a product for which you cannot sue anyone if something goes wrong. Pretty clever, eh?
Licensed products are not supposed to receive EUAs unless they are used for something different than what they were licensed for. Splitting the dose does not change the fact it is licensed for monkeypox and being used for moneypox.
Here is another possible but diabolical reason to split (dilute) the dose: it potentially allows the federal government access to the vials–so the vials won’t go straight from the manufacturer to the wholesaler but instead go somewhere else to be diluted. And what is in the diluent?
From the NY Times :
… Federal officials have ordered nearly seven million doses of Jynneos, but the shots will not arrive for months. So far, the Biden administration has shipped about 600,000 doses to states. It said last week that 800,000 additional doses were being allocated to states, but the distribution could take weeks.
Faced with shortages, some cities, including Washington and New York, are restricting second doses to stretch their supplies. Officials at the Food and Drug Administration and the C.D.C. have disagreed with that strategy, noting that Jynneos is approved as a vaccine to be given in two doses spaced 28 days apart.
But as federal health officials declared a public health emergency on Thursday, Dr. Robert Califf, the commissioner of the F.D.A., said the agency was now considering authorizing shots that contain just one-fifth of the regular dose, delivered between layers of the skin instead of under it.
The F.D.A. would need to grant Jynneos an emergency use authorization in order for it to be administered this way.
The dose-sparing approach has been used when supplies of other vaccines are scarce. But giving intradermal shots requires more skill than is needed for more traditional immunizations.
One shot is probably enough to forestall severe symptoms in most people, and the dose-sparing strategy may work just as well. But it’s unclear whether a scaled-back regimen is enough to prevent infection, and if so, how long that immunity may last, federal health officials said…
U.S. Declares Monkeypox Health Emergency, FDA Offers Vaccine to Some Kids Despite No Clinical Trials
By Megan Redshaw | The Defender | August 5, 2022
The U.S. declared monkeypox a public health emergency to raise awareness and allow for additional funding to fight the disease’s spread, U.S. Department of Health and Human Services Secretary Xavier Becerra said on Thursday.
“We’re prepared to take our response to the next level in addressing this virus, and we urge every American to take monkeypox seriously and to take responsibility to help us tackle this virus,” Becerra said.
Becerra said he also is considering a second declaration that would allow federal officials to expedite medical countermeasures — such as potential treatments and vaccines — designed to ensure drugs are safe and effective.
President Biden said in a tweet he remained “committed to our monkeypox response: ramping-up vaccine distribution, expanding testing, and educating at-risk communities.”
“That’s why today’s public health emergency declaration on the virus is critical to confronting this outbreak with the urgency it warrants,” Biden said.
The last time the U.S. declared a public health emergency was in January 2020, for COVID-19.
According to the Centers for Disease Control and Prevention (CDC), more than 7,100 cases of monkeypox have been reported in the U.S., including five cases in children.
Symptoms of monkeypox infection are usually mild and include fever, rash and swollen lymph nodes, and occasionally intense headache, back pain, muscle aches, lack of energy and skin eruptions that can cause painful lesions, scabs or crusts.
The virus is rarely fatal and no deaths have been reported in the U.S.
Monkeypox primarily is spread through skin-to-skin contact during sex and affects mostly gay and bisexual men, public health officials say, although the virus can affect anyone.
According to the CDC, about 98% of monkeypox patients who provided demographic information to clinics identified as men who have sex with men.
Public health emergency paves way for vaccine for kids
Now that the Biden administration has declared the monkeypox outbreak a public health emergency, the U.S. Food and Drug Administration (FDA) can move to issue an Emergency Use Authorization for the JYNNEOS vaccine for children under 18.
There are two vaccines that may be used “for the prevention” of monkeypox virus infection: JYNNEOS — also known as Imvamune or Imvanex — and ACAM2000, which is licensed by the FDA for use against smallpox and “made available for use against monkeypox under an Expanded Access Investigational New Drug application.”
The FDA told ABC News on Thursday that while the current monkeypox vaccine, JYNNEOS, is approved only for adults ages 18 and older, it will be available for kids on a case-by-case basis.
The JYNNEOS vaccine, delivered in a two-dose series, was not tested through clinical trials in children.
However, the FDA confirmed to ABC News that “numerous” children have been granted access to the vaccine through a special permission process, but declined to state exactly how many children have received the vaccine to date through this process.
“If a doctor decides a person under 18 was exposed to monkeypox and the benefit of the vaccine is greater than any potential risk, they can submit a request to the FDA,” ABC News reported.
According to the CDC, the “immune response” takes “14 days after the second dose of JYNNEOS and 4 weeks after the ACAM2000 dose for maximal development.”
The CDC website also states: “No data are available yet on the effectiveness of these vaccines in the current outbreak.”
According to the latest data from the Vaccine Adverse Event Reporting System (VAERS), between June 14 and July 21, 2022, 31 adverse events were reported following vaccination with JYNNEOS — manufactured by Bavarian Nordic.
The World Health Organization (WHO) declared monkeypox a global health emergency after more than 26,000 cases were reported across 87 countries.
A global emergency is the WHO’s highest level of alert, but the designation does not necessarily mean a disease is particularly transmissible or lethal.
The U.S. makes up 25% of confirmed cases globally although the U.K. was the first to alert the world to the outbreak in May after confirming several cases.
A monkeypox fictional simulation was held in March 2021
As The Defender reported in May, the Nuclear Threat Initiative, in conjunction with the Munich Security Conference, in March 2021 held a “tabletop exercise on reducing high-consequence biological threats,” involving an “unusual strain of monkeypox virus that first emerged in the fictional nation of Brinia and spread globally over 18 months.”
This is similar to “Event 201,” a “high-level pandemic exercise” organized by the Johns Hopkins Center for Health Security, along with the World Economic Forum and the Bill & Melinda Gates Foundation — just weeks before the COVID-19 outbreak — that mirrored what later followed with COVID-19 pandemic.
According to the Nuclear Threat Initiative, the monkeypox exercise, which was “developed in consultation with technical and policy experts,” brought together “19 senior leaders and experts from across Africa, the Americas, Asia, and Europe with decades of combined experience in public health, biotechnology industry, international security, and philanthropy.”
The fictional start date of the monkeypox pandemic in this exercise was May 15, 2022. The first European case of monkeypox was identified on May 7, 2022.
Key participants in the simulation included Johnson & Johnson and Janssen, the Bill & Melinda Gates Foundation, the Chinese Centers for Disease Control and Prevention, the Nuclear Threat Initiative, GAVI — the Vaccine Alliance, Merck and the WHO.
Several of the participants listed above also “participated” in Event 201.
Megan Redshaw is a staff attorney for Children’s Health Defense and a reporter for The Defender.
© 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.
New Evidence: Fauci Imposed a Vaccine Delay that Cost Trump the Election
By Toby Rogers | July 31, 2022
I. Fauci fires Trump
Think back to July 2020. Trump and Fauci were at war with each other. Key leaders within the Trump administration, including Peter Navarro, wanted to fire Fauci. There were riots in the streets as people protested the murder of George Floyd. And new evidence shows that behind the scenes, Fauci was working to torpedo Trump’s chances for re-election.
We already knew that Fauci, the FDA, CDC, and the pharmaceutical industry went to great lengths to block safe and effective treatments including hydroxychloroquine and ivermectin in order to prolong the pandemic and create the market for Covid-19 vaccines. But a new book reveals that Fauci also forced Moderna to delay their clinical trial by three weeks — which pushed the release of their preliminary results until after the presidential election.
This key piece of information comes from The Messenger: Moderna, the Vaccine, and the Business Gamble That Changed the World published last week by Harvard Business Review Press. The author, Peter Loftus, is a reporter for the Wall Street Journal and they published his essay about the book in their Review section on Saturday. What’s astonishing is that Loftus does not even realize the enormity of the story he just stumbled upon. Cultural capture and too many shots apparently prevent one from connecting the dots, so I will do it for him.
Most people already know the broad brush strokes of the Moderna story — they had never successfully brought a product to market before Operation Warp Speed. They were grifters — they took $25 million from the Defense Advanced Research Projects Agency (DARPA) in 2013 to develop mRNA products that never worked and another $125 million from the Biomedical Advanced Research and Development Authority (BARDA) in 2015 for a vaccine for Zika that also failed. But Fauci really liked these grifters and so when the pandemic began in 2020, BARDA directed $483 million to Moderna for Covid-19 vaccine development — and Moderna cut NIH in on the patents. That gave NIH and especially Fauci control over what came next.
The key paragraphs from Loftus’ WSJ essay are here:
Dr. Zaks [Chief Medical Officer for Moderna] had wanted to use a private contract research organization to run the whole trial, but NIAID officials wanted their clinical-trial network involved. Eventually, Dr. Zaks backed off, and both entities participated. “I realized we were at an impasse, and I was the embodiment of the impasse,” Dr. Zaks said.
Next, when Moderna’s 30,000-person study began enrolling volunteers in July 2020, the subjects weren’t racially diverse enough. Moncef Slaoui, who led Warp Speed’s vaccine efforts, and Dr. Fauci began holding Saturday Zoom calls with Mr. Bancel and other Moderna leaders to “help coax and advise Moderna how to get the percentage of minorities up to a reasonable level,” Dr. Fauci recalled.
Drs. Fauci and Slaoui wanted Moderna to slow down overall enrollment, to give time to find more people of color. Moderna executives resisted at first. “That was very tense,” Dr. Slaoui said. “Voices went up, and emotions were very high.” Moderna ultimately agreed, and the effort worked, but it cost the trial about an extra three weeks. Later, Mr. Bancel called the decision to slow enrollment “one of the hardest decisions I made this year.”
The claim that Fauci cared about racial diversity in the clinical trial is a lie. How do we know this? Later “clinical trials” for Pfizer and Moderna in kids looked at antibodies in the blood, not actual health outcomes, in only about 300 study participants. The number of people of color enrolled in those undersized trials were in the single digits (literally two or three Black participants total) — so those results were not statistically significant. Yet this did not stop authorization. It appears that Fauci’s delay tactics were designed to accomplish a different goal.
Let’s do the math:
Moderna released their preliminary results — claiming 94.5% effectiveness — on November 16, 2020.
The presidential election was less than two weeks earlier — on November 3, 2020.
Trump lost by less than 1% of the vote in 4 key swing states.
Fauci’s demand to slow down enrollment in July 2020 cost Moderna 3 weeks.
If Moderna had released their results 3 weeks earlier — on October 25, 2020, Trump would have scored a major win in the final week of the campaign and won the election.
It does not matter how one feels about Trump or Biden. A massive political win in the week before the election would have convinced enough voters of Trump’s competence and thus pushed Trump’s vote total over the top.
What about Pfizer? They also could have published their preliminary results prior to the election which would have secured Trump’s re-election. According to Loftus, Pfizer “opted out of Operation Warp Speed for fear it would slow the company down.” Pfizer still took $2 billion off of the Trump administration for advance purchase orders. But Scott Gottlieb and Pfizer clearly preferred Biden and so they held their preliminary results until November 9, 2020 — just 6 days after the election. The Biden administration returned the favor by giving Pfizer a blank check and authorizing shots for additional age groups based on the worst “clinical trial” results anyone has ever seen.
The important thing to understand in all of this is that Fauci, the FDA, NIH, and CDC are political functionaries pretending to be scientists. Pandemics, vaccines, and public health are a way for the Democratic Party machine to direct billions of dollars to their base and reward large donors to the party. These companies and their bureaucratic enablers were happy to take money off of Trump. But they knew that they could get an even better deal from Biden.
As you know, the results of this criminal scheme are gruesome. The Covid-19 shots authorized right after the 2020 election have made no discernible impact on the course of the pandemic. Far more people have died of Covid-19 since the introduction of the shots under Biden than during the Trump administration when no Covid-19 shots existed. The Covid-19 shots have negative efficacy and even quadruple-dosed Biden and quadruple-dosed Fauci have contracted Covid-19, twice. These are the deadliest and most toxic shots in the history of the world.
So what started out as a grift turned into mass murder and a crime against humanity.
And now it’s happening again…
II. Pfizer and Moderna move up the release date for reformulated Covid-19 shots in the effort to help Democrats win the midterm elections
On Thursday of last week, the White House and the FDA told their favorite stenographers at the NY Times that Moderna and Pfizer are going to release their reformulated Covid-19 shots, that will completely skip clinical trials, in mid-September.
As readers of my Substack will recall, back on June 28, Pfizer said that the fastest the reformulated shots could be released was October; Moderna said “late October or November” — provided they could skip clinical trials (which of course the FDA granted because they work for Pharma). Did Pfizer and Moderna not understand their own production capabilities? How did Pfizer and Moderna suddenly speed up their production schedule by 6 weeks?
It appears that once again, the public health gatekeepers are doing politics not science. If shots go into bodies in the last two weeks of September, Democrats will claim progress against Covid during October right before the midterm elections on November 8. It’s basically the political win that these same actors denied to Trump (it’s not a public health win, as I will show below).
What’s likely driving this is that Fauci, Pfizer, Moderna, the FDA, CDC, and NIH all want Democrats to retain the House and Senate in order to prevent hearings into their bungling of the Covid-19 response. Of course they also want to keep the Covid-19 vaccine gravy train going as long as possible.
But, you’re surely saying to yourself, we know that these 5th dose reformulated shots are likely to cause catastrophic harms. We’re already seeing a 5% to 15% increase in all-cause mortality across the most heavily vaccinated countries as a result of non-specific effects from these shots. There are 29,790 VAERS reports of death following these shots and this is likely an underestimate by a factor of 41 (so actual death toll = 1,221,390). These reformulated shots are going to use a form of mRNA never tried before and skip clinical trials altogether, so the harms could be even worse. There also seem to be cumulative harms from these shots — the more doses, the more messed up the immune system, the more vulnerable one is to Covid and all sorts of other diseases including cancer.
So how exactly do they plan to get away with this, especially right before an election?
The same way they always get away with it — they own the media. Pfizer and Moderna will rush out press releases claiming that these reformulated shots are a miracle. The CDC’s in-house newsletter, MMWR, will rush out articles and janky studies claiming that these reformulated shots are a miracle. The mainstream media will dutifully report that these reformulated shots are a miracle. Meanwhile, people you know and love — coworkers, friends, neighbors, and family — will be getting injured and killed by these shots. Yet all of the stories in the news will be hosannas about the genius of Tony Fauci, Peter Marks, and the FDA. Billions of dollars of dark money from Pharma will flow into Democratic Congressional campaign coffers. If Democrats can retain the House and Senate they will reward Pfizer and Moderna by blocking any inquiry into the failed Covid-19 response. Win, win, win for Pharma. Everyone else loses.
Which brings me to my last point….
III. Republicans, you have to step up and fight for us or you will lose
Republicans thought that they could take back the House and Senate simply by not being Democrats. Most Republicans did not really fight for us, they just sat back and let Dems destroy themselves. That plan was working until the Supreme Court overturned Roe. Now the Republican advantage in the generic Congressional ballot (‘which party do you prefer’) has evaporated. Pelosi has passed a range of popular bills. Manchin has fallen in line so Biden will likely get some late legislative wins. Gas prices have declined somewhat. And now it appears that Democrats, who were left for dead just weeks ago, will retain the Senate and may retain the House.
IF REPUBLICANS WANT TO WIN THE MIDTERM ELECTIONS THEY HAVE TO MAKE IT ABOUT DEMOCRATS’ FAILED RESPONSE TO COVID!
No more sitting back. No more making warrior mamas do all of the emotional labor for our country. If Republicans want to win they have to make it clear that they will fire, arrest, and prosecute Fauci (and all of his lieutenants) as soon at Republicans take power. Fauci funded the creation of the chimera virus, blocked access to safe and effective treatments, and inflicted deadly toxic vaccines on the entire population. Over 2 million Americans are dead as a direct result of Fauci’s corruption (1 million dead from/with Covid, over 1 million dead from the shots). If Republicans cannot be bothered to sink this two-foot putt then they don’t deserve to win. If Republicans want the votes of the 18 million single-issue medical freedom voters who decide every national election these days — that’s what they have to run on: #ArrestFauci!
Children Don’t Need COVID Vaccines, Canadian and Australian Groups Tell Public Health Officials
By Julie Comber, Ph.D. | The Defender | July 25, 2022
Groups in Canada and Australia are urging public health officials to reconsider rolling out COVID-19 vaccines for young children, following the authorization earlier this month in both countries of Moderna’s COVID-19 vaccine for children ages 6 months to 5 years.
The Australian Vaccine-risks Network (AVN) on July 19 sent an open letter to Dr. Brendan Murphy, secretary of Australia’s Department of Health and Aged Care, voting members of the Australian Technical Advisory Group on Immunisation and members of parliament threatening to “move forward with preparations for seeking the intervention of the Federal Court of Australia” if officials don’t respond.
The Canadian COVID Care Alliance (CCCA) on July 14 published an open letter to Canadian health officials stating their members would “be happy to meet you to discuss findings documented in this letter in greater detail.”
Both letters emphasized three arguments against authorizing the mRNA shots in young children and babies:
- Children don’t need COVID-19 vaccination because they are at extremely low risk of COVID-19.
- In any case, the mRNA shots don’t work well.
- The potential harm from the mRNA shots outweighs the benefits for young children.
Both letters also referenced the June 30 open letter to U.K. health officials from more than 70 physicians and scientists warning against vaccinating younger children against COVID-19.
The U.K. letter, written in response to the U.S. Food and Drug Administration’s (FDA) Emergency Use Authorization (EUA) in mid-June of the Moderna and the Pfizer-BioNTech COVID-19 shots for children as young as 6 months, urged U.K. health officials to not “make the same mistake” the FDA made.
All three letters referenced Søren Brostrøm, director of the Danish Health and Medicines Authority, who in June said, “We did not get much out of having children vaccinated against coronavirus last year.”
Australia’s Therapeutic Goods Administration on July 18 provisionally approved a pediatric dose of Moderna’s Spikevax COVID-19 shot for children ages 6 months to 5 years old. Rollout of the vaccines is contingent on input from the Australian Technical Advisory Group on Immunisation.
A few days earlier, on July 14, Health Canada authorized the use of Spikevax for children 6 months to 5 years of age. According to the statement, “As a result of this authorization, approximately 1.7 million children are now eligible for vaccination against COVID-19.”
Risks ‘far outweigh’ benefits for children
The 11-page CCCA letter contains 117 references and six pages of figures and graphs to support the group’s argument that “the data shows that, in the Omicron era, when population-based immunity is widespread, the risks associated with COVID-19 mRNA vaccines far outweigh the benefits in children.”
The authors of the CCCA letter criticized the FDA, stating, “no gold standard, placebo-controlled disease endpoint trials, large enough [with at least 800,000 participants] to categorically establish the clinical safety and long-term efficacy of the Pfizer COVID-19 mRNA vaccinations in children 12- to 15-years-old, 5- to 11-years-old, 2- to 4-years-old, and 6-months-old to 23-months-old have been undertaken.”
Instead, the EUA for Pfizer was “based on the preliminary results of four very small immuno-bridging trials, enrolling fewer than 3,000 participants each.”
The CCCA letter presented data from the Canadian province of Ontario, which “reported a negative dose-response effect for the COVID-19 vaccinations [original emphasis].”
The letter continued:
“In other words, the proportion of cases of COVID-19 were highest among those who had been ‘boosted,’ lower among the ‘fully inoculated’ and least among the ‘not fully inoculated’ (which includes the ‘uninoculated’).”
The authors presented graphs from the Public Health Ontario website, noting a similar pattern was observed in the 12- to 17-year-olds and the 5- to 11-year-old age groups.
“Additionally, a greater proportion of ‘boosted’ Ontarians have died, revealing that the vaccinations may be associated with serious secondary effects.”
The CCCA letter concludes:
“We trust that our research has provided you with evidence needed to adjust Canadian health policy to protect our children from undue harm. We would be happy to meet you to discuss findings documented in this letter in greater detail.”
‘Huge gap’ in Pfizer’s vaccine trial documentation
According to the authors of the AVN letter, the Pfizer documentation presented to the FDA had huge gaps in the evidence provided.
For example, the letter stated:
“The protocol was changed mid-trial. The original two-dose schedule exhibited poor immunogenicity with efficacy far below the required standard. A third dose was added by which time many of the original placebo recipients had been vaccinated.”
The AVN letter argued the Moderna shot for young children fails to meet Australia’s regulatory requirements to be granted “provisional determination” (similar to EUA in the U.S.) under regulation 10L(1)(a) of the Therapeutic Goods Regulations.
To receive provisional determination, there must be “an indication of the medicine is the treatment, prevention or diagnosis of a life-threatening or seriously debilitating condition,” the letter stated.
The authors said Australia’s health department and TGA did not “show any data or science to support a conclusion that COVID-19, and particularly the Omicron variant now widespread across Australia, is ‘life-threatening’ to infants aged 6 months up through 4 years, nor indeed that infants 6 months up through 4 years suffer ‘seriously debilitating’ symptoms when infected with COVID-19.”
The authors also addressed the issue of manipulative strategies used to promote COVID-19 vaccination of children, and said pushing unnecessary and novel mRNA-based vaccines onto young children risks undermining parental confidence in routine immunization programs.
Julie Comber is a freelance science reporter for The Defender.
© 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.
How Pfizer Profited From the Pandemic
By Dr. Joseph Mercola | July 18, 2022
According to Kaiser Health News (KHN),1 the COVID-19 pandemic has been a real boon to Pfizer. Not only has it yielded “outsize benefits” in terms of profits, but it has also “given the drugmaker unusual weight in determining U.S. health policy.”
“Based on internal research, the company’s executives have frequently announced the next stage in the fight against the pandemic before government officials have had time to study the issue, annoying many experts in the medical field and leaving some patients unsure whom to trust,” KHN reporter Arthur Allen writes, adding:2
“When last year Bourla suggested that a booster shot would soon be needed, U.S. public health officials later followed, giving the impression that Pfizer was calling the tune.
Some public health experts and scientists worry these decisions were hasty, noting, for example, that although boosters with the mRNA shots produced by Moderna and Pfizer-BioNTech improve antibody protection initially, it generally doesn’t last.
Since January, Bourla has been saying that U.S. adults will probably all need annual booster shots, and senior FDA officials have indicated since April that they agree … The company’s power worries some vaccinologists, who see its growing influence in a realm of medical decision-making traditionally led by independent experts …
When President Biden in September 2021 offered boosters to Americans — not long after [Pfizer CEO Albert] Bourla had recommended them — Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia … wondered, ‘Where’s the evidence you are at risk of serious disease when confronted with COVID if you are vaccinated and under 50?’
Policies on booster recommendations for different groups are complex and shifting, Offit said, but the CDC, rather than Bourla and Pfizer, should be making them. ‘We’re being pushed along,’ he said. ‘The pharmaceutical companies are acting like public health agencies.’”
The fact that a vaccine-pusher like Offit — infamous for claiming a baby can safely tolerate 10,000 vaccines at once3 — is questioning and pushing back against Pfizer’s influence over health policy reveals just how brazen, unethical and potentially dangerous that is.
Massive Profits Made From Useless Products
According to Allen, Pfizer’s revenue in 2021 was $81.3 billion4 — approximately double that of 2020 — and the COVID shot accounted for $36.78 billion5 of that. For comparison, Lipitor, Pfizer’s previous top selling statin, generates roughly $2 billion a year,6 while their strep vaccine, Prevnar 13 rakes in $6 billion a year.7
Its mRNA gene transfer injection against COVID now dominates 70% of the U.S. and European markets, and Paxlovid, Pfizer’s COVID drug, has become a standard treatment choice in hospitals. This, despite researchers finding Paxlovid (molnupiravir) causes severe rebound and supercharges mutations.
In a rational scenario, that finding would have put a stop to its use, but no. In an official health advisory8 to the public, issued May 24, 2022, the U.S. Centers for Disease Control and Prevention first warns that Paxlovid is associated with “recurrence of COVID-19 or ‘COVID-19 rebound,’” and then in the very next sentence stresses in bold print a narrative supporting its use and enriching Pfizer with instructions saying:
“Paxlovid continues to be recommended for early- stage treatment of mild to moderate COVID-19 among persons at high risk for progression to severe disease.”
Allen also notes that, during an investor call, a Pfizer official highlighted reports of Paxlovid’s failure, but spun it into “good news” for investors, as patients may require multiple courses!9 Obviously the objective has long ago shifted from helping humans to raping them for as much profit as possible.
Similarly, while Pfizer’s COVID jab clearly doesn’t prevent infection or spread, and Americans are rejecting the shots in growing numbers — 82.2 million doses had expired and were chucked in the trash as of mid-May 202210 — the U.S. government still went ahead and ordered another 105 million doses at the end of June 2022.
These are intended for a fall booster campaign, at a cost to taxpayers of $3.2 billion.11 The U.S. is actually paying about 50% more for each of these new jab boosters this time around — $30.47 per dose compared to $19.50 per dose paid for the first 100 million doses.
The U.S. government has also promised to purchase another 20 million courses of Paxlovid, at an eye-watering cost of $530 per five-day course. Basically, Pfizer is being financially rewarded for producing products that are useless at best and dangerous at worst, and we’re all paying for it. In case you’re curious, that is another $10.6 billion transferred from U.S. taxpayers to Pfizer.
Future Boosters Won’t Undergo Human Clinical Trials
After you likely thought it couldn’t ever get any worse, KHN also touches on, but doesn’t delve into, the fact that Pfizer suggested they skip human trials as they move forward with jabs that are reformulated for newer variants. If this strikes you as crazy, you’d be right. It’s sheer madness, but the U.S. Food and Drug Administration — a clearly captured agency — has already surreptitiously agreed to this egregious miscarriage of science.
How this wicked scheme, known as the “Future Framework,”12 was adopted by the FDA without formal vote is explained by Toby Rogers, Ph.D. — a political economist whose research focus is on regulatory capture and Big Pharma corruption13 — in the video above. He also explained it in a June 29, 2022, Substack article:14
“Yesterday [June 28], the FDA’s Vaccines and Related Biological Products Advisory Committee approved a bivalent COVID-19 shot with the Wuhan strain and the Omicron variant … Wait, hold up, I thought the FDA was voting on the Future Framework yesterday?
The policy question was whether reformulated COVID-19 shots would be treated as new molecular entities (which they are) in which case they should be subject to formal review or whether reformulated shots would be treated as ‘biologically similar’ to existing Covid-19 shots and be allowed to skip clinical trials altogether.
Apparently the FDA did not have the votes to just pass this as a policy question. If you ask anyone whether reformulated mRNA represents a new molecular entity, well of course it is, so that would require formal regulatory review.
What the FDA did instead was to smuggle the policy question in disguised as a vote about reformulated ‘boosters’ for the fall.
In essence, the FDA just started doing the Future Framework (picking variants willy nilly, skipping clinical trials) and essentially dared the committee members to turn down a booster dose — knowing that all of the VRBPAC members are hand-picked because they’ve never met a vaccine they did not like.
So of course only two people on the committee had the courage to turn down a booster dose — even though it was based on this preposterous process (that was never formally adopted) where there was literally no data at all … By stealth, the FDA replaced a system based on evidence with a system based entirely on belief.”
Countries Held to Ransom
In 2021, secret details of Pfizer’s contracts came to light, showing they are essentially holding countries hostage to nonnegotiable demands for payment in full AND freedom from liability.15
In late February 2021, The Bureau of Investigative Journalism reported16 that Pfizer was demanding countries put up sovereign assets as collateral for expected vaccine injury lawsuits resulting from its COVID-19 jab.
Several countries, including Brazil, Chile, Colombia, the Dominican Republic and Peru, agreed to this demand, putting up bank reserves, military bases and embassy buildings as collateral. In short, theses governments are guaranteeing Pfizer will be compensated for any expenses resulting from injury lawsuits against it, so the company won’t lose a dime if its COVID shot injures people.
Shockingly, these terms are binding even if those injuries are the result of negligent company practices, fraud or malice!
In October that same year, Public Citizen published the secret contracts17,18 between Pfizer and Albania, Brazil, Colombia, Chile, Dominican Republic, the European Commission, Peru, the U.S. and the U.K., further revealing the extent to which these countries handed power over to Pfizer. In almost all scenarios, Pfizer’s interests come first.
For example, government purchasers must acknowledge that the effectiveness and safety of the shots are completely unknown, all while indemnifying Pfizer against any and all financial liability. This is the ultimate corporate maleficence, using their leverage to force the kill shot down these countries’ throats and avoiding any personal responsibility for damages.
Even if Pfizer eventually is convicted of fraud in the U.S. and loses all its liability protection from the COVID jabs because of it, that judgment would not impact these foreign contracts. These countries sold their souls to Pfizer and have absolutely no recourse but to pay even if the shots kill everyone.
The contracts for at least four countries also secure Pfizer’s intellectual property rights even if the company is found to have stolen intellectual property rights of others. In such case, the government purchaser becomes the liable party. As explained by Public Citizen :19
“For example, if another vaccine maker sued Pfizer for patent infringement in Colombia, the contract requires the Colombian government to foot the bill. Pfizer also explicitly says that it does not guarantee that its product does not violate third-party IP, or that it needs additional licenses.
Pfizer takes no responsibility in these contracts for its potential infringement of intellectual property. In a sense, Pfizer has secured an IP waiver for itself. But internationally, Pfizer is fighting similar efforts to waive IP barriers for all manufacturers.”
Equally shocking is that countries are forced to follow through on their vaccine orders even if other drugs or treatments emerge that can prevent, treat or cure COVID-19.20 Is it any wonder, then, that governments around the world have suppressed the use of safe and effective outpatient drugs like hydroxychloroquine and ivermectin?
If these drugs were allowed to be used and could be proven to work, the COVID injections would be completely unnecessary and their emergency use authorization would disappear, yet governments are on the hook for hundreds of millions of doses.
Pfizer Has ‘Habitual Offender’ Track Record
The fact that Pfizer has behaved like a criminal who works out a cover story for a planned murder before committing it is not surprising, considering its history. Pfizer, has been sued in multiple venues over unethical behavior, including unethical drug testing and illegal marketing practices.21
In his 2010 paper,22 “Tough on Crime? Pfizer and the CIHR,” Robert G. Evans, Ph.D., Emeritus Professor at Vancouver School of Economics, described Pfizer as “a ‘habitual offender,’ persistently engaging in illegal and corrupt marketing practices, bribing physicians and suppressing adverse trial results.”
Between 2002 and 2010 alone, Pfizer and its subsidiaries were fined $3 billion in criminal convictions, civil penalties and jury awards. They are recurrent criminal felons. None of these convictions has deterred their nefarious behavior.
In 2011, Pfizer agreed to pay another $14.5 million to settle federal charges of illegal marketing,23 and in 2014 they settled federal charges relating to improper marketing of the kidney transplant drug Rapamune to the tune of $35 million,24 as well as $75 million to settle charges relating to its testing of a new broad spectrum antibiotic on critically ill Nigerian children.
As reported by the Independent 25 at the time, Pfizer sent a team of doctors into Nigeria in the midst of a meningitis epidemic. For two weeks, the team set up right next to a medical station run by Doctors Without Borders and began dispensing the experimental drug, Trovan. Of the 200 children picked, half got the experimental drug and the other half the already licensed antibiotic Rocephin.
Eleven of the children treated by the Pfizer team died, and many others suffered side effects such as brain damage and organ failure. Pfizer denied wrongdoing. According to the company, only five of the children given Trovan died, compared to six who received Rocephin, so their drug was not to blame.
The problem was they never told the parents that their children were being given an experimental drug. What’s more, while Pfizer produced a permission letter from a Nigerian ethics committee, the letter turned out to have been backdated. The ethics committee itself wasn’t set up until a year after the trial had already taken place. Pfizer’s rap sheet also includes bribery, environmental violations, labor and worker safety violations and more.26
Wolves in Sheep’s Clothing
Now, despite Pfizer being one of the least ethical drug companies, we’re told to trust them with our very lives, and the lives of our precious children. They’re going to put out booster shots this fall that have undergone absolutely no testing whatsoever, and we’re to simply throw caution to the wind because Pfizer — which has no liability whatsoever — says so.
In 2014, Pfizer faced a surge of lawsuits that accused it of hiding known side effects of its anticholesterol drug Lipitor.27 They got off scot-free that time, as a federal judge dismissed thousands of cases alleging the drug caused Type 2 diabetes.28,29 But at least they had liability and could be sued.
When it comes to the COVID jabs, injured patients and family members of those killed by it won’t even have the ability to sue for damages, as governments around the world have indemnified them completely, and it looks as though they might not even be liable even if they’re found guilty of fraud. But we will have to see what the courts rule on that one. Still, that any nation would agree to a contract like that is just mindboggling.
Meanwhile, mounting evidence shows the COVID shots destroy immune function over time, and Pfizer’s own trial data reveal deaths and serious adverse events numbering in the tens of thousands.
It’s hard to tell who’s more deserving of punishment — Pfizer or the equally captured federal agencies, the FDA and the CDC, that go along with them and do nothing to protect the lives of the youngest members of our society. Clearly, it’s up to us to protect ourselves and our loved ones, because wolves in sheep’s clothing are ruling the roost — they’re making all the decisions, and captured agencies are simply doing their bidding.
Sources and References
- 1, 2, 4, 9 KHN July 5, 2022
- 3 Science Daily January 10, 2002
- 5 Washington Examiner February 8, 2022
- 6 Axios October 30, 2019
- 7 True Cost of Health Care
- 8 CDC Advisory May 24, 2022
- 10 NBC News June 6, 2022
- 11 Businesswire June 29, 2022
- 12 FDA Briefing Document June 28, 2022
- 13 Brownstone Institute June 22, 2022, Author’s Bio
- 14 uTobian June 29, 2022
- 15 STAT News February 23, 2021
- 16 The Bureau of Investigative Journalism February 23, 2021
- 17, 19 Public Citizen October 19, 2021
- 18 Twitter Zain Rizvi October 19, 2021
- 20 COVID19up.org August 17, 2021 (archived)
- 21 SGT Report January 7, 2021
- 22 Healthcare Policy 2010 May;5(4):16-25
- 23 DOJ October 21, 2011
- 24 Reuters August 6, 2014
- 25 The Independent March 23, 2014
- 26 Corporate Research Project Pfizer
- 27 Reuters August 8, 2014
- 28 Drugwatch Lipitor Lawsuits
- 29 Reuters May 12, 2021
More Deaths, Injuries Revealed in Latest Pfizer Vaccine Trial Document Dump
By Michael Nevradakis, Ph.D. | The Defender | July 14, 2022
This month’s release of Pfizer-BioNTech COVID-19 vaccine documents by the U.S. Food and Drug Administration (FDA) reveals three more reports of deaths among vaccine trial participants and further instances of Pfizer downplaying serious adverse events sustained by participants and listing the injuries as “not related” to the vaccine.
Of the approximately 80,000 pages released this month, the most revelatory is a 3,611-page “confidential” document with no title — only the file name “fa_interim_narrative_sensitive.”
The document contains information about vaccine trial participants who died, who sustained adverse events during the trial or who contracted COVID-19 during the trial.
All participants listed in the document received the 30 μg dose of the BNT162b2 candidate vaccine, which the FDA in August 2021 granted Emergency Use Authorization.
The FDA on July 1 released the documents as part of a court-ordered disclosure schedule stemming from an expedited Freedom of Information Act (FOIA) request filed in August 2021.
Public Health and Medical Professionals for Transparency, a group of doctors and public health professionals, initially submitted the FOIA request.
Document details deaths of three trial participants
The “interim narrative” document contains reports of three clinical trial participants who died — and in all cases, the investigator ruled out the possibility the deaths were related to Pfizer’s vaccines.
One instance pertains to a 56-year-old white female in the U.S. (unique Subject ID C4591001 1007 10071101), who suffered cardiac arrest on Oct. 18, 2021, and died three days later. She was vaccinated on July 30, 2020, and Aug. 20, 2020.
The “narrative comments” accompanying the report on the woman’s death stated her death could not have been related to the vaccine, due to the amount of time that had elapsed following her second dose:
“In the opinion of the investigator, there was no reasonable possibility that the cardiac arrest was related to the study intervention or clinical trial procedures, as the death occurred 2 months after receiving Dose 2.”
The woman’s medical history did not indicate any cardiovascular problems, although ongoing obesity, gastroesophageal reflux disease and sleep apnea syndrome were listed.
The second report of a death was that of a 60-year-old white male in the U.S. (unique Subject ID C4591001 1162 11621327), who received one dose of the vaccine (on Sept. 10, 2020) and died sometime in the following three days of atherosclerotic disease.
According to the document:
“The study site received a police report indicating that the police visited the subject’s home to perform a welfare check on 13 Sep 2020 (Day 4) and found him dead.”
The participant’s medical history indicated ongoing autoimmune thyroiditis, obesity and depression, and a prior craniocerebral injury and prior hip arthroplasty.
According to the report:
“It was reported that the subject’s body was cold and had visible lividity. According to the medical examiner, the probable cause of death was progression of atherosclerotic disease. Relevant tests were unknown. Autopsy results were not available at the time of this report.
“In the opinion of the investigator, there was no reasonable possibility that the arteriosclerosis was related to the study intervention, concomitant medications, or clinical trial procedures, but rather it was related to suspected [emphasis added] underlying disease. Pfizer concurred with the investigator’s causality assessment.”
In other words, the participant’s death was attributed to a “suspected” cause, while the possibility that it was vaccine-related in any way, was dismissed.
The third death listed in the “fa_interim_narrative_sensitive” documents was listed under the section in the document listing reports from trial participants who withdrew, not those who died.
The report pertained to a 72-year-old Hispanic/Latino male in the U.S. (unique Subject ID: C4591001 1152 11521497) who received one dose of the vaccine, on Oct. 7, 2020.
The subject sustained vasovagal syncope (a fainting incident) on Oct. 26, 2020, and was admitted to the hospital, causing him to miss his scheduled follow-up vaccination appointment on Oct. 28, 2020.
According to the document:
“The subject was transferred to the intensive care unit. Family medical history relevant to the syncope was unknown.
“On an unspecified date, the syncope resolved and the subject was discharged from the hospital.”
He was withdrawn from the study on Nov. 6, 2020. However, according to the subject’s sister, he died of “unknown” causes on Nov. 11, 2020.
As stated by the document (dated Nov. 22, 2020):
“The cause of death was reported as unknown. It was not reported if an autopsy was performed. A death certificate might be available at a later date.”
Nevertheless, this lack of information did not prevent the study investigator or Pfizer from dismissing the possibility that the participant’s death was vaccine-related. The document states:
“In the opinion of the investigator, there was no reasonable possibility that the syncope was related to the study intervention, concomitant medications, or clinical trial procedures.
“Pfizer concurred with the investigator’s causality assessment. Per Pfizer, the syncope was most likely coincidental and associated with underlying clinical conditions.”
The document contained no reports of deaths among trial participants who received the placebo.
Investigators attribute 4 serious adverse events to vaccine, Pfizer disagrees
According to the latest document release, investigators attributed the vaccine to serious adverse events in four cases, however, Pfizer disagreed with the investigators’ conclusions in three out of the four cases.
The incidents are:
• A 53-year-old white female in the U.S. (unique Subject ID: C4591001 1018 10181159), who developed “lower back pain and bilateral lower extremity pain with radicular paresthesia” on Oct. 20, 2020, which was ongoing as of the date of the document (Nov. 22, 2020).
She was vaccinated on Aug. 14 and Sept. 4, 2020.
The woman’s medical history did not indicate lower back or lower extremity pain, just ongoing migraines and a prior history including a right shoulder dislocation, fibrocystic breast disease and Vitamin D deficiency.
The study investigator and Pfizer disagreed on whether the serious adverse event she experienced was related to the vaccination. As stated in the document:
“In the opinion of the investigator, there was a reasonable possibility that the lower back pain and bilateral lower extremity pain with radicular paresthesia were related to the study intervention, but not related to concomitant medications or clinical trial procedures.
“Pfizer did not concur with the investigator’s causality assessment and considered that there is not enough evidence to establish a causal relationship with the study vaccine apart from a chronological association at this time of the report.
“Based on the information currently available, it was more likely that the lower back pain and bilateral lower extremity pain with radicular paresthesia was associated with the subject’s underlying known neurological condition.”
• A 71-year-old white female in the U.S. (unique Subject ID: C4591001 1142 11421247) sustained ventricular arrhythmias on Oct. 14, 2020 — the same day she received the second dose of the vaccine — and which continued until Oct. 21, 2020.
The woman received her first dose on Sept. 21, 2020. Her medical history indicated she was wearing a cardiac pacemaker and was experiencing ongoing atrioventricular block (complete), atrial fibrillation and supraventricular tachycardia.
Again, the study investigator and Pfizer could not agree as to whether this adverse event was related to the vaccination. The document states:
“In the opinion of the investigator, there was a reasonable possibility that the ventricular arrhythmia was related to the study intervention based on the temporal relationship since the arrhythmias began within 24 hours of Dose 2, but not related to concomitant medications or clinical trial procedures.
“Pfizer did not concur with the investigator’s causality assessment. Additionally, Pfizer commented that there was not enough evidence to establish a causal relationship with the study intervention apart from a chronological association at this time of the report.
“In absence of evidence for an inflammatory response to study intervention, it was more likely that the ventricular arrhythmia was associated with the subject’s underlying known cardiac conditions.”
Pfizer dismissed the possibility that the vaccine may have exacerbated the subject’s existing cardiac conditions.
• A 48-year-old white female in the U.S. (unique Subject ID: C4591001 1178 11781107), who received one dose of the vaccine on Sept. 4, 2020, and withdrew from the study on Sept. 25, 2020.
In the interim, the participant sustained right axilla lymphadenopathy, with “at least four enlarged lymph nodes” — a condition that was still ongoing as of the document date of Nov. 22, 2020.
Her medical history indicated ongoing positional vertigo, osteoarthritis, eczema, sinus headaches, seasonal allergies and a Pitocin allergy, as well as prior menorrhagia, uterine fibroids and a past hysterectomy. In addition, her body mass index (BMI) was listed as being 36.9.
Pfizer also in this case did not agree with the study investigator’s assessment:
“In the opinion of the investigator, there was a reasonable possibility that the lymphadenopathy was related to the study intervention. Pfizer did not concur with the investigator’s causality assessment.”
• A 30-year-old Asian female in the U.S. sustained a shoulder injury related to vaccine administration (SIRVA).
The documents did not list any severe adverse events occurring in anyone outside the U.S., even though the documents contain reports from trials in Argentina, Brazil and South Africa.
‘Unrelated’ adverse event reports habitually dismiss possibility injuries were vaccine-related
The documents reveal a large discrepancy between the number of adverse events deemed to be related to the vaccination (four) compared to those reported to be “not related” (113 non-placebo participants).
The reports associated with each incident reveal an ongoing tendency to dismiss any possibility injuries were vaccine-related — even in instances where no alternative cause was identified or where patients had no relevant prior medical history.
In still other instances, the cause of the adverse event was attributed to itself, while in several other cases, pre-existing conditions worsened following vaccination.
A significant number of accidents and falls — and subsequent injuries — also were reported.
Instances where severe adverse events were brushed over as being “not related” to the vaccination, despite no relevant medical history, include:
• A 75-year-old white male in the U.S. (unique Subject ID: C4591001 1013 10131176), who was vaccinated on Aug. 13 and Oct. 7, 2020, sustained 13 adverse events between Aug. 29 and Sept. 16, 2020, many of which were ongoing as of the document date of Nov. 22, 2020.
These adverse events included congestive heart failure, acute hypoxic respiratory failure, acute renal failure, aspiration pneumonia, anemia, hypokalemia, hyponatremia, leukopenia, sepsis, small bowel obstruction and mild concentric left ventricular hypertrophy.
The participant had ongoing gastroesophageal reflux disease, hiatus hernia, hypercholesterolemia, hypertension and constipation, in addition to prior small intestinal and knee surgery.
The report attributed the patient’s adverse events to his prior surgical history. The document stated:
“In the opinion of the investigator, there was no reasonable possibility that the abdominal adhesions, small intestinal obstruction, pneumonia aspiration, and acute respiratory failure were related to the study intervention, concomitant medications, or clinical trial procedures, but were rather likely related to subject’s previous surgery.
“Pfizer concurred with the investigator’s causality assessment.”
• A 73-year-old white female in the U.S. (unique Subject ID: C4591001 1079 10791246) sustained a “cerebrovascular accident” (stroke), as well as expressive aphasia, on Oct. 22, 2020. She was vaccinated on Sept. 4 and Sept. 25, 2020.
Her medical history listed osteoarthritis, seasonal allergies and being postmenopausal. Nevertheless, her stroke and aphasia were deemed to be “not related” to the vaccine, although no cause was listed. Instead, the document stated, “pending medical records” with regard to the cause of her adverse events.
• A 66-year-old white female in the U.S. (unique subject ID: C4591001 1021 10211190) suffered a stroke on Nov. 2, 2020, with ongoing symptoms as of the document date on Nov. 22, 2020. She was vaccinated on Sept. 10 and Oct. 1, 2020.
Her medical history indicated ongoing gastroesophageal reflux disease, seasonal allergies and postmenopause, as well as a BMI of 28.5.
Her stroke was dismissed as being “not related” to the vaccine, although no alternative cause was listed.
• A 68-year-old white male in the U.S. (unique Subject ID: C4591001 1092 10921015) sustained arrhythmia atrial fibrillation and elevated troponin on Aug. 26, 2020. He received his first dose on Aug. 19, 2020, and his second dose on Oct. 6, 2020, as it required “clearance from his cardiologist.”
His medical history did not specifically indicate heart conditions. Instead, it indicated ongoing basal cell carcinoma on his nose, as well as hypersensitivity, seasonal allergies, myopia, dyslipidemia, hypertension, actinic keratosis and gastroesophageal reflux disease.
Although the study investigator wrote, in reference to the cause of his injuries, that “medical records [are] being reviewed not able to answer at this time,” the report dismissed possibility that his adverse events were related to the vaccine.
• A 45-year-old Black male in the U.S. (unique Subject ID: C4591001 1156 11561006) with ongoing Type 1 diabetes sustained deep vein thrombosis and a pulmonary embolism on Aug. 31, 2020. He received one dose of the vaccine, on Aug. 20, 2020, and was discontinued from the study on Sept. 8, 2020, “because he no longer met the eligibility criteria.”
Both adverse events were deemed as being “not related” to his vaccination, and were instead indicated as being “related to medical history of Type 1 diabetes mellitus.”
• A 67-year-old white male in the U.S. (unique Subject ID: C4591001 1178 11781015) sustained several adverse events on Oct. 10-11, 2020, including ascending aorta ectasia, diastolic dysfunction of the left ventricle and transient global amnesia. These conditions were ongoing as of the document date of Dec. 4, 2020. He was vaccinated on Aug. 25 and Sept. 15, 2020.
The patient’s medical record indicated ongoing depression, attention deficit hyperactivity disorder, hypertension, insomnia and neck pain.
While the cause of his adverse events was deemed as being “not related” to the vaccination, the study did state a cause, listing it as “possibly” having been hypertension.
• A 58-year-old Hispanic/Latino female from Argentina (unique Subject ID: C4591001 1231 12313674) sustained adverse events including panlobular emphysema, pneumonitis, and left submaxillary sialadenitis beginning on Sept. 29, 2020. The first two conditions were indicated as continuing as of the document date of Dec. 4, 2020.
She was vaccinated on Aug. 24 and Sept. 13, 2020. Her medical record indicated ongoing Sjogren’s syndrome and insomnia.
The cause of these adverse events was deemed as being “not related” to the vaccines, although for the first two adverse events, the stated cause was listed as “unknown,” while for the third, the cause was listed as Sjogren’s syndrome.
• A 56-year-old Hispanic/Latino female from Argentina (unique Subject ID: C4591001 1231 12314001) was diagnosed with acute coronary syndrome on Nov. 8, 2020, which was still ongoing as of the document date of Dec. 4, 2020. She was vaccinated on Aug. 25 and Sept. 15, 2020.
Her medical history consisted of ongoing hypothyroidism, allergic rhinitis and asthma — but no coronary troubles.
Nevertheless, according to the study investigator, her condition was determined to be “not related” to the vaccination, although the cause was listed as “unknown.”
‘Cause unknown’ but no chance the vaccine was to blame
In other examples, adverse events were assigned no specific cause or only a “probable” cause, but investigators dismissed the possibility the vaccines may have caused the injuries.
For example:
• A 34-year-old Hispanic/Latino male from Brazil (unique subject ID: C4591001 1226 12261745) developed a Leydig cell tumor in his left testicle on Sept. 23, 2020. He received the first dose of the vaccine on Sept. 16, 2020, and second dose on Oct. 7, 2020.
His medical history listed only ongoing allergic rhinitis.
While the study investigator claimed that the adverse event was “not related” to the vaccination, the cause was listed as “unknown.”
• A 19-year-old Hispanic/Latino female from Brazil (unique Subject ID: C4591001 1231 12311281) with no indicated medical history was diagnosed with acute appendicitis and QT interval prolongation — a heart condition — on Sept. 18, 2020. She was vaccinated on Aug. 15 and Sept. 4, 2020.
These conditions were deemed to be “not related” to the vaccination, although the causes were indicated as “unknown.”
• A 41-year-old Hispanic/Latino female from Argentina (unique Subject ID: C4591001 1231 12311315) was diagnosed with anemia and malignant melanoma on Sept. 25, 2020, with symptoms continuing as of the document date of Dec. 4, 2020.
She was vaccinated on Aug. 15 and Sept. 3, 2020.
The adverse events were indicated as being “not related” to the vaccination, but instead due to a “probable relationship with [a] vaginal tumor under study.”
• A 44-year-old Hispanic/Latino male from Argentina (unique Subject ID: C4591001 1231 12312854) was diagnosed with supraventricular arrhythmia on Sept. 17, 2020. He received the two vaccine doses on Aug. 21 and Sept. 11, 2020.
His medical history listed only ongoing sleep apnea syndrome and a BMI of 50.4.
According to the study investigator, the arrhythmia was “not related” to the vaccines, but instead “probably” corresponded “to an accessory intraventricular line.”
• A 56-year-old mixed-race male from Brazil (unique subject ID: C4591001 1241 12411825) was diagnosed with acute pyelonephritis on Nov. 2, 2020, and hypochromic anemia two days later. Both conditions were still listed as ongoing as of the document date of Dec. 4, 2020.
The participant was vaccinated on Sept. 17 and Oct. 8, 2020. His medical history listed ongoing hypertension.
According to the study investigator, these adverse events were “not related” to the vaccination. Instead, his acute pyelonephritis was due to a “possible” bacterial urinary tract infection, while the hypochromic anemia cause was “to be clarified.”
Worsening of pre-existing conditions ‘not related’ to vaccine
In other instances, participants experienced a worsening of pre-existing conditions. However, in all instances, no relation to the COVID-19 vaccine was determined.
For instance:
• A 72-year-old white male in the U.S. (unique Subject ID: C4591001 1092 10921187) sustained congestive heart failure on Oct. 1, 2020. He received his first dose of the vaccine on Sept. 15, 2020, and his second dose on Oct. 6, 2020.
The participant’s medical history included ongoing coronary artery disease, atrial fibrillation, type 2 diabetes, asthma, obesity, dyslipidemia, hypertension, insomnia and seasonal allergies. Moreover, he had previously had a defibrillator installed.
The cause of his adverse event was simply indicated as “progression of cardiovascular disease” unrelated to the vaccine. The possibility that the vaccine may potentially have precipitated the worsening of his heart condition was not considered.
• A 73-year-old white female in the U.S. (unique Subject ID: C4591001 1111 11111095) was reported as having sustained an “undiagnosed mental disorder” on Sept. 25, 2020, which was still ongoing as of the document date of Dec. 4, 2020. She was vaccinated on Aug.11 and Sept. 1, 2020.
The participant’s medical history did not indicate any prior mental disorders or conditions. Nevertheless, the cause of the adverse event was indicated by the study indicator as being “not related” to the vaccination and instead simply due to “mental instability.”
• A 58-year-old white male from the U.S. (unique Subject ID: C4591001 1109 11091387), who sustained worsening osteoarthritis of the right knee on Oct. 14, 2020, and later also experienced deep vein thrombosis on Oct. 20, 2020, which was still ongoing as of the document date of Dec. 4, 2020.
The participant’s medical history indicated ongoing osteoarthritis, ongoing hypercholesterolemia, hypothyroidism, sleep apnea syndrome, rosacea and an enlarged prostate. A prior knee surgery was also listed.
Both adverse events were deemed to be “not related” to the vaccination and instead attributed to the patient’s prior knee surgery and “previous medical history.”
• A 70-year-old white female from the U.S. (unique subject ID: C4591001 1127 11271023) experienced a worsening of her asthma on Oct.1, 2020. She later also developed malignant invasive ductal carcinoma in her left breast, on Nov. 5, 2020. Both cases were still ongoing as of the document date of Dec. 4, 2020.
She received her two doses of the vaccine on July 30 and Aug. 18, 2020. Her medical history, aside from ongoing asthma, also indicated a recurrent urinary tract infection and ongoing bronchitis, seasonal allergies, myopia, migraines, hypothyroidism, hypertension, insomnia, hyperlipidemia, osteoarthritis, bilateral deafness and postmenopause.
According to the document, both adverse events were “not related” to the vaccination, and instead were attributed to an “allergy” and to a “malignancy,” respectively.
Reports of multiple adverse events ignored
Other examples include cases where patients sustained multiple adverse events, many of which were entirely ignored by the study investigators’ assessments.
These include:
• A 61-year-old white male from the U.S. (unique Subject ID: C4591001 1114 1114108), who sustained 10 vaccine injuries beginning on Sept. 12, 2020, after he received the first dose of the vaccine on Aug. 24, 2020, and his second dose on Sept. 30, 2020.
The adverse events he experienced included acute kidney injury, atrial fibrillation, chest pain, left ventricular hypertrophy, mitral valve regurgitation, bilateral hand pain, pulmonary hypertension, skin avulsion on his left finger, a Staphylococcal infection and tricuspid regurgitation. Several of these conditions were still ongoing as of the document date of Dec. 4, 2020.
The patient’s medical history indicated ongoing peripheral neuropathy, type 2 diabetes, anxiety, depression, asthma, Staphylococcal infection, hypertension, hyperlipidemia and a prior leg amputation.
According to the study investigator, “the staphylococcal infection” was “not related” to the vaccine, but instead was connected to the patient’s hypertension, musculoskeletal causes and an “infection.” No mention was made in this assessment as to the probable causes of the other adverse events.
Some adverse events ‘caused’ by … the adverse event
In still other cases, the “cause” of participants’ adverse events was indicated as being the same as the adverse event itself.
Examples include:
• A 68-year-old white male from the U.S. (unique Subject ID: C4591001 1095 10951204), who was diagnosed with bladder cancer on Nov. 2, 2020. He was vaccinated on Sept. 2 and Sept. 21, 2020.
According to the document, the participant’s ongoing medical history included hypertension, benign prostatic hyperplasia, hypercholesterolemia, angina pectoris, coronary arterial stent insertion, coronary artery disease, erectile dysfunction and osteoarthritis.
However, the cause of his bladder cancer was attributed as “cancer” and deemed to be “not related” to the vaccination and “most likely coincidental and associated with the underlying clinical conditions.”
• A 48-year-old white male from the U.S. (unique Subject ID: C4591001 1124 11241106) sustained an acute myocardial infarction on Sept. 27, 2020. He previously received two doses of the vaccine, on Aug. 26 and Sept. 16, 2020.
His medical history indicated ongoing high cholesterol, gastroesophageal reflux disease and back pain.
According to the study investigator, the adverse event sustained by the participant was “not related” to the vaccination, but instead “related to cardiovascular risk,” with no further elaboration provided.
• A 73-year-old white female in the U.S. (unique Subject ID: C4591001 1223 12231159) was found to have a pancreatic mass on Nov. 5, 2020. She was vaccinated on Sept. 10 and Oct. 1, 2020.
Her medical records indicated ongoing osteoarthritis, menopause, gastroesophageal reflux disease, hypertension, dyslipidemia, hypothyroidism, Eustachian tube dysfunction, prophylaxis, irritable bowel syndrome, osteoporosis and benign monoclonal hypergammaglobulinemia.
The cause of her adverse event, which was indicated to be “not related” to the vaccination, was listed as “new development of pancreatic mass” without any elaboration as to the factors that may have caused it to appear.
‘Cause unknown’ but no chance the vaccine was to blame
In other examples, adverse events were assigned no specific cause or only a “probable” cause, even as the possibility that they were related to the vaccination was dismissed.
For example:
• A 34-year-old Hispanic/Latino male from Brazil (unique Subject ID: C4591001 1226 12261745) developed a Leydig cell tumor in his left testicle on Sept. 23, 2020. He received the first dose of the vaccine on Sept. 16, 2020, and second dose on Oct. 7, 2020.
His medical history listed only ongoing allergic rhinitis.
While the study investigator claimed that the adverse event was “not related” to the vaccination, the cause was listed as “unknown.”
• A 19-year-old Hispanic/Latino female from Brazil (unique Subject ID: C4591001 1231 12311281) with no indicated medical history was diagnosed with acute appendicitis and QT interval prolongation — a heart condition — on Sept. 18, 2020. She was vaccinated on Aug. 15 and Sept. 4, 2020.
These conditions were deemed to be “not related” to the vaccination, although the causes were indicated as “unknown.”
• A 41-year-old Hispanic/Latino female from Argentina (unique Subject ID: C4591001 1231 12311315) was diagnosed with anemia and malignant melanoma on Sept. 25, 2020, with symptoms continuing as of the document date of Dec. 4, 2020.
She was vaccinated on Aug. 15 and Sept. 3, 2020.
The adverse events were indicated as being “not related” to the vaccination, but instead due to a “probable relationship with [a] vaginal tumor under study.”
• A 44-year-old Hispanic/Latino male from Argentina (unique Subject ID: C4591001 1231 12312854) was diagnosed with supraventricular arrhythmia on Sept. 17, 2020. He received the two vaccine doses on Aug. 21 and Sept. 11, 2020.
His medical history listed only ongoing sleep apnea syndrome and a BMI of 50.4.
According to the study investigator, the arrhythmia was “not related” to the vaccines, but instead “probably” corresponded “to an accessory intraventricular line.”
• A 56-year-old mixed-race male from Brazil (unique Subject ID: C4591001 1241 12411825) was diagnosed with acute pyelonephritis on Nov. 2, 2020, and hypochromic anemia two days later. Both conditions were still listed as ongoing as of the document date of Dec. 4, 2020.
The participant was vaccinated on Sept. 17 and Oct. 8, 2020. His medical history listed ongoing hypertension.
According to the study investigator, these adverse events were “not related” to the vaccination. Instead, his acute pyelonephritis was due to a “possible” bacterial urinary tract infection, while the hypochromic anemia cause was “to be clarified.”
Other explanations for participants’ vaccine injuries include:
• A 78-year-old white male from the U.S. (unique Subject ID: C4591001 1097 10971011), who suffered from pneumonia between Sept. 20 and Oct. 5, 2020. He had previously received two doses of the vaccine, on Aug. 20 and Sept. 9, 2020.
According to the document, the cause of his pneumonia was “not related” to the vaccines. Instead, the listed cause was “pt [patient] contracted pneumonia from somewhere.”
• An 84-year-old white male from the U.S. (unique Subject ID: C4591001 1097 10971084) contracted pneumonia on Oct. 7, 2020, symptoms of which were still ongoing as of the document date of Dec. 4, 2020. He had previously been vaccinated on Sept. 1 and Sept. 23, 2020.
Similar to the patient above, the cause of the participant’s pneumonia was indicated as being “not related” to the vaccination. The narrative comment instead stated that “Pt [patient] contracted pneumonia from unknown source.”
Very few severe adverse events — and no deaths — were reported in other countries, although Argentina, for instance, was home to the largest of the Pfizer vaccine trials in 2020.
The next 80,000-page cache of FDA documents pertaining to the FDA’s authorization of the vaccine is set to be released on Aug. 1.
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.
‘Why the Rush for Toddler Vaccines?’ Asks Wall Street Journal Editorial Board Member
By Susan C. Olmstead | The Defender | July 5, 2022
A Wall Street Journal (WSJ) editorial board member Monday called into question the motives behind the U.S. Food and Drug Administration’s (FDA) decision to extend Emergency Use Authorization of Pfizer and Moderna’s COVID-19 vaccines to toddlers and infants as young as 6 months old, writing that the decision was motivated by politics and pressure rather than science.
In her WSJ opinion piece — “Why the Rush for Toddler Vaccines?” — Allysia Finley wrote:
“The FDA standard for approving vaccines in otherwise healthy people, especially children, is supposed to be higher than for drugs that treat the sick.
“But the FDA conspicuously lowered its standards to approve COVID vaccines for toddlers. Why?”
Finley started her piece with a quote from President Biden, which praised the FDA’s recommendation: “This is a very historic milestone. The United States is now the first country in the world to offer safe and effective COVID-19 vaccines for children as young as six months old.”
She responded, writing, “In fact, we don’t know if the vaccines are safe and effective.”
She continued:
“The rushed FDA action was based on extremely weak evidence. It’s one thing to show regulatory flexibility during an emergency. But for children, Covid isn’t an emergency.
“The FDA bent its standards to an unusual degree and brushed aside troubling evidence that warrants more investigation.”
“Mr. Biden’s hypocrisy is hard to stomach,” she wrote, listing many reasons for caution in vaccinating young children against COVID-19, including:
- Children are at low risk of dying from COVID-19: Only 209 kids between 6 months and 4 years old have died from COVID-19 — about 0.02% of all virus deaths in the U.S. About half as many toddlers were hospitalized with COVID-19 between October 2020 and September 2021 as were hospitalized with the flu during the previous winter.
- The two children in Pfizer’s trial who got sickest with COVID-19 also tested positive for other viruses. It’s possible that many hospitalizations attributed to COVID-19 this winter were instigated or exacerbated by other viruses.
- The FDA authorized vaccines for toddlers based on a comparison of the antibodies they generated to the original Wuhan variant with those in young adults who had received two doses. But two doses offer little if any protection against Omicron infection in adults, and even protection against hospitalization is only around 40% to 60%.
- Vaccinated toddlers in Pfizer’s trial were more likely to get severely ill with COVID-19 than those who received a placebo. Most children who developed multiple infections during the trial were vaccinated.
“FDA granted the Pfizer and Moderna vaccines for toddlers an emergency-use authorization allowing the agency to expedite access for products that ‘prevent serious or life-threatening diseases or conditions,’” wrote Finley.
“While adult COVID vaccines clearly met this standard in late 2020, the toddler vaccines don’t.”
As to why the FDA “rushed” and “bent its standards,” Finley suggested, “perhaps [the FDA] felt pressure from the White House as well as anxious parents.”
White House COVID-19 response coordinator Ashish Jha repeatedly told parents that he expected vaccines for toddlers would be available in June, she wrote.
© 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.
Will Pfizer Be Charged for Mislabeling Vaccine Side Effects?
By Dr. Joseph Mercola | July 5, 2022
As the U.S. Food and Drug Administration continues to release Pfizer’s clinical trial documentation,1 we’re finding more and more evidence that very little has been done on the up-and-up, and the COVID jab trials may be among the most fraudulent in medical history.
Can All Serious Adverse Effects Be Written Off?
Importantly, Pfizer classified almost all severe adverse events that occurred during its Phase 3 trials as unrelated to the injection. As reported by The Defender, June 21, 2022:2
“The latest release by the U.S. Food and Drug Administration (FDA) of Pfizer-BioNTech COVID-19 vaccine documents reveals numerous instances of participants who sustained severe adverse events during Phase 3 trials. Some of these participants withdrew from the trials, some were dropped and some died.
The 80,000-page document cache includes an extensive set of Case Report Forms (CRFs) from Pfizer Phase 3 trials conducted at various locations in the U.S., in addition to other documentation pertaining to participants in Pfizer-BioNTech vaccine trials in the U.S. and worldwide …
The CRFs included in this month’s documents contain often vague explanations of the specific symptoms experienced by the trial participants. They also reveal a trend of classifying almost all adverse events — and in particular severe adverse events (SAEs) — as being ‘not related’ to the vaccine.”
The Defender article includes 11 examples3 of trial participants who experienced severe adverse effects that were classified as “unrelated” to the experimental gene transfer technology they’d received just days or weeks earlier.
A 2,566-page document4 catalogues the serious adverse events and six deaths that occurred during the trial. These events were all classified as “toxicity level 4,” which is the most serious, yet none of them were deemed related to the injection.
This simply isn’t believable. It’s completely unrealistic, especially when serious events occur in multiple participants. A handful of examples of Level 4 adverse events listed in this document — all of which were written off as “not related” to the mRNA injection — include:5
- Acute respiratory failure
- Cardiac arrest
- Brain abscess
- Adrenal carcinoma (adrenal cancer)
- Chronic myeloid leukemia (blood and bone marrow cancer)
The six deaths reported were listed as being caused by arteriosclerosis, cardiac arrest, hemorrhagic stroke and myocardial infarction.6 Many participants also dropped out or were excluded from the trial due to serious side effects involving the heart, cardiovascular system, cancer, stroke, hemorrhage and neurological impacts.
Examples of Level 3 Adverse Events
Most Level 3 adverse events were also dismissed as unrelated to the shot. As reported by The Defender, only a “small number” were listed as being related to the injection. Examples of Level 3 side effects include:7
- Deafness/hearing loss
- Tachycardia (disruption of the normal electrical impulses that control your heart rate — the very problem that underlies most cases of “sudden adult death syndrome” or SADS)
- Ventricular arrhythmia (abnormal heart rhythm that makes the lower chambers twitch rather than pump — another underlying cause of SADS)
- Neutropenia (low neutrophil level in your blood; neutrophils are a type of white blood cell made by your bone marrow that fight infections by destroying viruses and bacteria)
- Vertigo
45% Experienced One or More Adverse Events
Another document8 that raises suspicions of bias is one admitting that “40% to 45% of participants who received BNT162b1 and BNT162b2 across age groups and across dose levels reported one or more AEs [adverse events] from Dose 1 through 28 days (i.e., 1 month) after Dose 2.”
BNT162b2 was the candidate injection that went on to receive Emergency Use Authorization (EUA) from the FDA. Among those who got the highest dose (30 micrograms) of BNT162b2, 50% of younger participants 25% in the older age group reported one or more adverse events.
The most common adverse events were nervous system disorders, followed by musculoskeletal and connective tissue disorders. Yet despite high rates of side effects across dose levels, this document also insists that “most AEs were considered by the investigator as not related to study intervention.”
During the open-label period of the study, 12,006 participants were followed for a minimum of six months, and among those, 28.8% reported at least one adverse event at some point during that follow-up, and 2.1% reported one or more severe adverse events.
Incidence Rate in Treatment Group FAR Higher Than Placebo
As reported by The Defender :9
“The review provides data for participants from dose 3 … to the data cutoff date. The severe adverse event incidence rate (IR) was 6.0 per 100 PY (patient-years), with specific conditions reported including pulmonary embolisms, thrombosis, urticaria, a cerebrovascular accident and COVID-19 pneumonia.
Here, the review adds that the IR for original placebo participants who had at least 1 life-threatening AE from Dose 3 to the data cutoff date was 0.5 per 100 PY.
Only one such life-threatening event, an instance of anaphylactoid reaction, was considered to be related to the vaccination. Other life-threatening, serious adverse events included cardio-respiratory arrest, gastrointestinal necrosis, deep vein thrombosis and pulmonary embolism …
Notably, according to the review, ‘all … events of facial paralysis were considered by the investigator as related to study intervention.” [Editor’s note: these specifically refer to events that occurred during the open-label follow-up period when BNT162b2 Dose 3 or Dose 4 was offered to both placebo and initial treatment groups.]
Young Children Have Extremely Low Risk of Death From COVID
In the end, we all know what happened. Despite all the evidence to the contrary, Pfizer concluded the shot was safe and effective for everyone and the FDA went along with it. The vaccine manufacturers and the FDA have decided it isn’t even worth invoking the precautionary principle for the very youngest of children, which is nothing short of reprehensible, criminal maleficence.
In mid-June 2022, against strong objections from physicians, scientists and researchers, the FDA’s vaccine advisory panel — the Vaccines and Related Biological Products Advisory Committee (VRBPAC) — unanimously agreed to grant EUA to both Pfizer’s and Moderna’s COVID shots for infants and young children.10,11
Pfizer’s EUA is for a three-dose regimen (3-microgram shots) for children 6 months to 5 years old, while Moderna’s EUA is for a two-dose regimen (25-microgram shots) for children 6 months to 6 years.
According to the U.S. Centers for Disease Control and Prevention,12 an estimated 75% of American children ages birth to 11 already have some level of immunity, having been exposed to one of the several variants that have come into circulation over the past two-plus years.
This immunity level alone makes EUA for COVID shots questionable. CDC data also prove young children have a very low risk of hospitalization and death from COVID, which makes the EUAs even more questionable.
Data13 published in mid-March 2022 suggest babies and young children under the age of 4 have had a peak hospitalization rate for COVID of 14.5 per 100,000. That peak occurred after Omicron became predominant. The hospitalization rate for the Delta variant in this age group was 2.9 per 100,000.
In all, since March 2020, a total of 2,562 infants and young children (6 months to 4 years) have been hospitalized WITH COVID. Of those, 2,068 had COVID listed as the primary reason for admission (84.7% of the total), and only 624 required ICU admission.
The median length of hospital stay was 1.5 days (range: one to three days). Of the 2,562 children with suspected COVID infection, 16 of them (0.6%) died in the hospital. Death certificate data push that number a bit higher. The Vaccine Reaction notes,14 “According to death certificate data,15 202 deaths have been attributed to COVID-19 among children 6 months to 4 years of age through May 11, 2022.”
While any death is tragic, it’s worth noting that 923 (35.8%) of the children hospitalized with suspected COVID also had one or more underlying medical conditions.16 We don’t know for sure, but it’s quite possible that those who died with a COVID diagnosis actually died from whatever underlying condition was present or had brought them to the hospital in the first place.
What I’m trying to say is that 16 to 202 deaths over two-plus years aren’t cause for panic, and that’s true even if COVID was the primary cause of those deaths. The likelihood of your child getting injured by the mRNA shot is undoubtedly significantly greater than their risk of dying from COVID.
Jab More Likely to Put You in the Hospital Than Keep You Out
The same is true for adults, by the way. A June 2022 analysis17,18 of Pfizer and Moderna trial data found the shots are more likely to put you in the hospital than keep you out of it. As reported by The Daily Sceptic :19
“A new paper20 by BMJ Editor Dr. Peter Doshi and colleagues has analyzed data from the Pfizer and Moderna COVID vaccine trials and found that the vaccines are more likely to put you in hospital with a serious adverse event than keep you out by protecting you from COVID.
The pre-print (not yet peer-reviewed) focuses on serious adverse events highlighted in a WHO-endorsed ‘priority list21 of potential adverse events relevant to COVID-19 vaccines.’ The authors evaluated these serious adverse events of special interest as observed in ‘phase III randomized trials of mRNA COVID-19 vaccines’ …
Dr. Doshi and colleagues found that the Pfizer and Moderna mRNA COVID-19 vaccines were associated with an increased risk of serious adverse events of special interest of 10.1 events per 10,000 vaccinated for Pfizer and 15.1 events per 10,000 vaccinated for Moderna …
When combined, the mRNA vaccines were associated with a risk increase of serious adverse events of special interest of 12.5 per 10,000 vaccinated … The authors note that this level of increased risk post-vaccine is greater than the risk reduction for COVID-19 hospitalization in both Pfizer and Moderna trials, which was 2.3 per 10,000 participants for Pfizer and 6.4 per 10,000 for Moderna.
This means that on this measure, the Pfizer vaccine results in a net increase in serious adverse events of 7.8 per 10,000 vaccinated and the Moderna vaccine of 8.7 per 10,000 vaccinated.”
Doshi’s team wasn’t the first to reanalyze Pfizer’s trial data. The Canadian COVID Care Alliance has also published a clear and easy-to-read summary22 of the Pfizer trial results, and the many questions raised by it. As noted by Dr. Robert Malone:23
“The bottom line is that the Pfizer Phase 3 trial which was used by NIAID [the National Institutes of Allergy and Infectious Diseases], FDA and CDC to justify the emergency use authorization is pretty much a junk clinical trial which was inappropriately halted long before it even got close to meeting the intended follow up period, did not provide a sufficiently long follow up analysis of vaccination-associated adverse events, and in which the control group was intentionally eliminated.
This resulted in basically erasing any opportunity to ever get to the bottom of what the major true risks of the Pfizer mRNA inoculations were. In terms of more minor risks, the study was not powered (not big enough) to evaluate those.”
FDA and CDC Have Neglected Important Duties
Doshi and his coauthors also note the FDA also watered down results by including “thousands of additional participants with very little follow-up, of which the large majority had only received one dose.”
They then further diluted the appearance of risk by counting only the number of people affected rather than counting the total number of individual adverse events. This makes a big difference, as twice as many people in the treatment group reported multiple serious adverse events, as compared to the placebo group.
The FDA and CDC have both also failed to produce promised follow-up investigations. In July 2021, now a full year ago, the FDA said it would investigate four “potential adverse events of interest following Pfizer vaccination,” namely pulmonary embolism, acute myocardial infarction, immune thrombocytopenia and disseminated intravascular coagulation, but to date, no update has been issued.
Similarly, in early 2021, the CDC published a protocol on how to use proportional reporting ratios to detect signals in the U.S. Vaccine Adverse Event Reporting System (VAERS), but no study or report showing what that protocol might have found has ever been published.
As it turns out, the CDC hasn’t been looking for safety signals in VAERS — not with the proportional ratios protocol or any other. So, while they’ve publicly claimed they haven’t seen any signals of concern, the reason they haven’t seen any signals is very simple: They never looked at the data!24
That’s how ridiculous things are now. When a drug company or health agency claims they haven’t found a problem, you actually have to ask them, “where, when, how and how often did you look?” But of course, virtually no one would ever ask such questions because they would assume these agencies are competent, which of course is a false assumption.
Their Fraudulent Behavior Could Be Their Undoing
As you probably know, the makers of the COVID shots are indemnified against legal liability for any injuries and all deaths stemming from their products. No one is able to sue them for damages.
The only way to hold them responsible is to prove they’ve committed fraud. This would remove their liability immunity. As detailed at the beginning of the article, their consciously choosing to miscategorize adverse events during the initial trials and concealing the harms should be a slam dunk to convict them of fraud.
But there is also another fact they concealed: There’s evidence showing they knew the mRNA doesn’t stay in the injection site but, rather, distributes throughout the body,25 and this too could be a smoking gun that proves fraud. If convicted of fraud, Pfizer, Moderna and Janssen would likely face liabilities in the trillions of dollars in damages.
When I exposed Merck’s Vioxx scandal in 1999 in this newsletter, before they even released their drug on the market, I thought that was huge. Their drug killed more than 60,000 people, and they could have been liable for $25 billion in damages, but their clever lawyers reduced it to $5 billion.
Well, that catastrophe is a drop in the bucket compared to the COVID scam, which has likely killed between 600,000 and 750,000 Americans, disabled as many as 5 million, and injured an estimated 30 million Americans in one way or another.26,27 That’s just the estimated toll in the U.S., so you can imagine what the global numbers might be. It’s a catastrophe of unprecedented proportions. A June 2022 survey by Steve Kirsch also found:28
- 6.6% of COVID jabbed respondents suffered heart injury (about 10 million Americans, based on the national vaccination rate)
- 6.3% had to be hospitalized for their side effects (another 10 million Americans)
- 9.2% of those who took the jab had to seek medical help for their injury, which translated over the whole country would be about 18 million doctor’s visits
- People who got the shot were more likely to die from COVID than the unvaccinated
- 2.63% of the responders had lost someone in their household to COVID infection, and 2.03% had lost someone in their household to the COVID jab
Expect Depopulation
Whether intentional or not, mounting evidence now indicates the COVID-19 injections will result in depopulation through premature death and adverse effects on fertility in women and men alike. I’ve previously discussed the risk of pregnancy loss and infertility in women who get the shot, as the mRNA has an affinity for accumulating in the ovaries29 (as well as the adrenals, liver and bone marrow).
Research30,31 from Israel now also reveals the shot deteriorates sperm count and sperm motility in men for about three months. Considering the multidose mRNA shots are recommended at three-month intervals, you can see how this can really decimate a man’s prospects of fathering a child.
Fertility has been on a steady decline for decades in most parts of the world,32 but the worldwide COVID jab campaign may massively speed that up. Germany recently released data showing a 10% decline in birth rate during the first quarter of 2022.33
Other countries are also seeing a drop in birth rate, nine months after the start of the mass vaccination campaign against COVID. Between January and April 2022, Switzerland’s birth rate was 15% lower than expected, the U.K.’s was down by 10% and Taiwan’s was down 20%.34
What punishment could possibly be appropriate for company heads and health agency leaders responsible for causing massive depopulation worldwide through products that were based on fraudulent science and fictional claims? I doubt if there’s enough money in the world to set that right.
Future Trials To Be Skipped Altogether
As if matters weren’t already beyond horrible, the FDA is considering allowing manufacturers to reformulate their COVID injections in perpetuity without conducting any additional clinical trials!35 In other words, they’d allow drug companies to change the mRNA and/or other ingredients without any safety or efficacy testing whatsoever. As reported by Toby Rogers, Ph.D., in a June 27, 2022, article in The Defender :36
“FDA released a briefing document37 in connection with this scheme to end science as we know it in connection with future COVID-19 shots … The briefing document is 18 pages of text, 1.5 line spacing, with just 19 references — 9 of which are pre-prints or from the CDC’s in-house newsletter Morbidity and Mortality Weekly Report (MMWR) which means they are not peer-reviewed.
Any true believer in The Narrative(TM) could have written this in a few hours. To base the entire future of COVID-19 shots on this glorified undergrad term paper is madness …
The core argument of the briefing document is hilarious (or rather, it would be hilarious if it was not a plan to permanently institutionalize genocide and hide the evidence). In several places the FDA argues (colloquialisms mine):
1. These COVID-19 shots work great … Boosters too, total home run, the Israelis even have 10-weeks of data showing that they might help old people. What more evidence could you want?
2. Okay, well, it depends on what you mean by ‘work.’ These shots do not stop infection, transmission, hospitalization, or death, even though that’s why we licensed them. Any protection wears off fairly quickly, but It’s Not Our Fault(TM) because This Wily Virus(TM) mutates too fast and no one told us that it would ever mutate.
3. So these shots must be reformulated but we cannot possibly ask Lord Pharma to do proper clinical trials ever again because we already know that these shots work great (see point #1)!”
In short, the FDA argues that since there are time constraints, evaluation of effectiveness must rely on “measures other than actual health outcomes.” In other words, whether the shots actually lower your risk of severe illness, hospitalization and death will have no bearing.
The only measure they’ll take into account is whether or not the jab triggers a rise in antibody levels, which has never been proven to be beneficial. If anything, the increase in COVID antibodies actually increases your risk of infection. This also means that as long as antibody levels are through the roof, the death rate could be just about anything, because it’s not part of the safety equation.
Faith in Magic Has Officially Replaced Science
As noted by Rogers,38 “The ‘Future Framework’ is a plan to base the entire COVID-19 vaccine program on magical thinking rather than science.” Indeed, Dr. Deborah Birx recently confirmed that the whole vaccine push has been based in faith in magic.39
June 23, 2022, Birx answered questions from the House Select Subcommittee on the Coronavirus Crisis. Rep. Jim Jordan, R-Ohio, asked whether the government was lying or guessing when they stated that vaccinated individuals couldn’t catch or spread COVID. At first, she claimed she didn’t know, but when pressed, she replied, “I think it was hope that the vaccine would work in that way.”40
So, the government issued mandates and made unequivocal, absolute statements that were not allowed to be questioned because they HOPED the shots would work a certain way — all while insisting they were the ones following and trusting the science and anyone who questioned their logic was a dangerous nut job. Let that sink in. Hope is literally the diametrical opposite of science.
It’s an Insiders’ Plot
As explained by Rogers, the same old players are behind this brazen attempt to eliminate the need for clinical trials: CDC staffers, academics who are in the pockets of Bill Gates and the NIAID, the drug companies themselves and the World Health Organization. Rogers writes:41
“I did not understand until just yesterday (as I started to write this article) that this entire ‘Future Framework’ is actually coming from the WHO. The Bill & Melinda Gates Foundation is the biggest voluntary contributor to the WHO. So Gates is likely directing the play.
Gates requires that WHO use the McKinsey consulting firm so this is probably a McKinsey operation (and McKinsey also works for Pharma so this is a huge conflict of interest). As Naomi Wolf points out, the involvement of the WHO also raises troubling questions about the influence of the Chinese Communist Party over this process.
As far back as January, the WHO/Gates/McKinsey junta realized that these shots were terrible and so they decided to use that as an opportunity to seize even more power and control.
The WHO set up a Technical Advisory Group on COVID-19 Vaccine Composition (TAG-CO-VAC) to implement these Orwellian ‘Future Frameworks’ across the developed world to lower manufacturing costs for Pharma and avoid bothersome health data that might hurt profits. All the messaging we have seen from the FDA and leaked to the press was initially developed and released by TAG-CO-VAC.”
No doubt, we live in unprecedented, precarious times. Logic, reason, science and sanity itself has been tossed aside by those who claim the right to make decisions for all mankind. If the FDA goes forward with this “Future Framework” scheme, the only safe assumption is that COVID shots will become more and more dangerous.
Worse, we can expect other vaccines and drugs to be allowed on the market without clinical trials as well. It truly could change the science of medicine as we know it.
Of course the WHO also wants to seize control over health care worldwide, which would eliminate medical rights everywhere. It’s a nightmare scenario with no end in sight as of yet. All we can do is continue to push back, to inform ourselves, to speak out, share facts and data, and refuse to comply with unscientific recommendations based on little more than hope in fabricated conclusions.
Sources and References
- 1 PHMPT.org Pfizer Documents Released by FDA
- 2, 3, 5, 6, 7, 9 The Defender June 21, 2022
- 4 PHMPT.org 16.2.7.1 Adverse Events Legend
- 8 PHMPT.org 2.5 Clinical Overview for BNT162b2
- 10 The Defender June 15, 2022
- 11, 14 The Vaccine Reaction June 21, 2022
- 12 CDC MMWR April 29, 2022; 71(17): 606-608
- 13, 16 CDC MMWR March 18, 2022; 71(11): 429-436
- 15 FDA. Briefing Document on EUA amendment request for Pfizer-BioNTech COVID-19 vaccine for use in children 6 months […]. VRBPAC Meeting June 15, 2022
- 17, 20 SSRN June 23, 2022
- 18, 23 Robert Malone Substack June 22, 2022
- 19 The Daily Sceptic June 22, 2022
- 21 SPEAC October 26, 2021
- 22 Canadian COVID Care Alliance, More Harm Than Good
- 24 Jackanapes Substack June 16, 2022
- 25, 29 Paul Alexander Substack June 27, 2022
- 26 the New American June 27, 2022
- 27, 28 Steve Kirsch Substack June 25, 2022
- 30 Andrology June 17, 2022 DOI: 10.111/andr.13209
- 31 Expose June 26, 2022
- 32 Bloomberg June 21, 2022
- 33 Twitter Jikkyleaks June 26, 2022
- 34 SWPRS June 2022
- 35, 36, 38, 41 The Defender June 27, 2022
- 37 FDA Briefing Document June 28, 2022
- 39, 40 Daily Caller June 23, 2022
U.S. Orders 2.5 Million More Monkeypox Vaccine Doses, as CDC Looks to Expand Vaccine for Kids
By Suzanne Burdick, Ph.D. | The Defender | July 1, 2022
The Biden administration today said it ordered 2.5 million more doses of Bavarian Nordic’s Jynneos monkeypox vaccine, bringing the total vaccine doses to be delivered in 2022 and 2023 to more than 4 million.
The news followed Tuesday’s announcement of the first phase of the U.S. government’s “national monkey vaccine strategy,” which will expand testing capabilities and make Bavarian Nordic’s Jynneos vaccines readily available to anyone exposed to the virus.
The U.S. Department of Health and Human Services (HHS) said the government’s “enhanced” nationwide strategy “will vaccinate and protect those at-risk of monkeypox,” as well as provide guidance to communities on how to respond to outbreaks.
“We are focused on making sure the public and healthcare providers are aware of the risks posed by monkeypox and that there are steps they can take — through seeking testing, vaccines and treatments — to stay healthy and stop the spread,” said Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention (CDC).
As part of the strategy, the CDC and HHS began shipping tests to five major laboratory companies across the country: Aegis Science, Labcorp, Mayo Clinic Laboratories, Quest Diagnostics and Sonic Healthcare.
The government, which for months has been buying more Jynneos doses to add to the national stockpile, is now distributing the vaccine. It’s currently making available 296,000 doses and expects to roll out 750,000 doses over the summer, with an additional 500,000 doses produced and released in the fall — for a total of 1.6 million doses this year.
The Jynneos vaccine is licensed for use in adults and is considered safer than Emergent BioSolutions Inc.’s ACAM2000 smallpox vaccine, which also can be used against monkeypox, the HHS said.
The vaccine will be made available to individuals “with confirmed and presumed monkeypox exposures,” said the HHS.
“This includes those who had close physical contact with someone diagnosed with monkeypox, those who know their sexual partner was diagnosed with monkeypox, and men who have sex with men who have recently had multiple sex partners in a venue where there was known to be monkeypox or in an area where monkeypox is spreading.”
Health officials seeking to expand use of monkeypox vaccine for kids, despite lack of safety data
U.S. health officials also are seeking to expand use of the monkeypox vaccine for children, Bloomberg reported.
The CDC is developing a protocol aimed at allowing use of the Jynneos vaccine in children “should cases in children occur,” Kristen Nordlund, a CDC spokesperson, said in an email to Bloomberg.
“I’m concerned about sustained transmission because it would suggest that the virus is establishing itself, and it could move into high-risk groups, including children, the immunocompromised, and pregnant women,” Tedros Adhanom Ghebreyesus, director-general of the World Health Organization (WHO) said in a Wednesday press briefing.
“We’re starting to see this with several children already infected,” he added.
There have been 350 cases so far of monkeypox in the U.S. — all adults — according to the CDC. The agency confirmed 5,115 cases worldwide.
The WHO confirmed two cases in children in the U.K. and said Wednesday it is following up on reports of cases in children in Spain and France.
No safety trials have been done in children for the Jynneos vaccine as of yet, partly because clinical research involving participants under the age of 18 must pose no more than “minimal risk” to children, which can be difficult for vaccine manufacturers to argue.
Commenting on the CDC’s actions, Dr. Meryl Nass, a member of the Children’s Health Defense scientific advisory committee, told The Defender, “It’s kind of extraordinary that they want to vaccinate everyone in the country before knowing what the safety issues are.”
Nass, an internist and biological warfare epidemiologist, said, “We don’t actually know” if the Jynneos vaccine prevents monkeypox in humans because it was developed as a smallpox vaccine, and prevention studies have been conducted using only animals.
“It is hard to believe that the [U.S. Food and Drug Administration (FDA)] gave this vaccine a license when you read the FDA reviewers’ comments in their own report,” Nass wrote in her June 23 substack newsletter.
“They could not test the vaccine for efficacy against smallpox because there is no smallpox, nor against monkeypox, because the disease is so rare,” Nass wrote. “So the FDA relied on neutralizing antibody titers.”
At the same time, the FDA admitted there is no established correlate of protection, Nass said.
“This means that there is no evidence that the titers represent actual immunity to infection,” Nass wrote. “So FDA relied on animal studies to simply guess the vaccine might be effective in humans.”
According to the FDA, the effectiveness of Jynneos for the prevention of monkeypox is “inferred from the antibody responses in the smallpox clinical study participants and from studies in non-human primates that showed protection of animals vaccinated with Jynneos who were exposed to the monkeypox virus.”
Jynneos, a replication-deficient live Vaccinia virus vaccine, was licensed in the U.S. in 2019, by the FDA for use in individuals 18 and over considered to be at high risk for smallpox or monkeypox.
In 2021, the CDC’s Advisory Committee on Immunization Practices (ACIP) voted to recommend Jynneos as a safer alternative to the ACAM2000 vaccine because of ACAM2000’s propensity to cause serious adverse effects, including myocarditis and pericarditis — i.e., inflammation of the heart.
However, Nass noted, Jynneos also was linked to heart inflammation, according to the FDA licensure review of the Jynneos smallpox-monkeypox vaccine which reported:
“Up to 18.4% of subjects in 2 studies developed post-vaccination elevation of troponin [a cardiac muscle enzyme signifying cardiac damage]. However, all of these troponin elevations were asymptomatic and without a clinically associated event or other sign of myopericarditis.”
These higher levels of troponin were not studied further, and the reviewers admitted they did not know if the Jynneos vaccine caused myocarditis, Nass said.
The Jynneos manufacturers said they would conduct an “observational, post-marketing study” in which they would “collect data on cardiac events that occur and are assessed as a routine part of medical care.”
But myocarditis — particularly asymptomatic forms of myocarditis that lack outer signs of the condition — could fly under the radar of the “routine part of medical care,” noted Nass.
The manufacturers would need to test for heightened troponin levels — something that is not typically done in “routine” check-ups.
The authors of a 2015 study reported evidence of heart injury following vaccination in a sample of 1,445 individuals who received a smallpox or trivalent influenza vaccine.
They found that chest pain, shortness of breath and/or palpitations occurred in 10.6% of those who received the smallpox vaccine SPX-vaccinees and 2.6% of those who received the trivalent influenza vaccine within 30 days of immunization.
Additionally, the study authors reported levels more than double the upper limit of troponin — a protein that flags cardiac injury — in 31 of the individuals who received the smallpox vaccine.
“Passive surveillance significantly underestimates the true incidence of myocarditis/pericarditis after smallpox immunization,” they concluded.
The authors added:
“Evidence of subclinical transient cardiac muscle injury post-vaccine immunization is a finding that requires further study to include long-term outcomes surveillance. Active safety surveillance is needed to identify adverse events that are not well understood or previously recognized.”
Suzanne Burdick, Ph.D., is an independent journalist and researcher based in Fairfield, Iowa.
© 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.
FDA Panel Votes to Waive Clinical Trials for New COVID Boosters
By Megan Redshaw | The Defender | June 29, 2022
The U.S. Food and Drug Administration’s (FDA) vaccine advisory panel on Tuesday voted 19 to 2 to recommend new COVID-19 booster shots that include the Omicron variant this fall.
The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) did not issue guidance on whether additional data would be needed to recommend an updated composition of the primary-series vaccines authorized for emergency use in the U.S., or whether it would be appropriate to continue to use a primary-series vaccine as a booster.
It is the first time VRBPAC has suggested vaccine makers modify their vaccines to target a different variant, according to CNBC, which also reported the FDA will likely accept the committee’s recommendation.
If so, the FDA would be authorizing a vaccine change without requiring additional data showing a bivalent vaccine — containing both the original 2019 Wuhan variant and one of the Omicron variants — is safe and effective for those age groups that are already authorized to receive a booster dose.
The FDA plans to decide by early July whether vaccines will target the now-dominant BA.4 and BA.5 Omicron subvariants or the BA.1 Omicron variant that led to a surge in infections last winter, Reuters reported.
At the beginning of the meeting, Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, suggested a newly designed shot could begin in October, adding that it takes manufacturers around three months to choose a vaccine design and begin producing doses.
Dr. Paul Offit, director of the Vaccine Education Center and professor of pediatrics in the Division of Infectious Diseases at Children’s Hospital of Philadelphia, and Dr. Hank Bernstein, professor of pediatrics at Zucker School of Medicine, were the only two members who broke from the panel to vote against the initiative.
Offit acknowledged there’s a benefit to providing a booster in the fall to some age groups, but questioned whether Omicron was the right strain. He said the move to new-variant vaccines was happening too fast, with too little data.
“I think as a new product it should be handled as a new product,” Offit said. “I think we need a higher standard than what we’ve been given. …“I’m not comfortable enough to support the risk of a new product.”
Bernstein expressed concern over the lack of data used to justify changing the strain, and the potential that by the time a subsequent booster is approved, it will contain outdated strains.
“So, in sum, I think including an Omicron strain in the vaccine seems to have some potential, but data especially for BA.4 and BA.5 are limited at this time, and that’s why I’m struggling to even make a strain change at this time,” Bernstein said.
Bernstein also said he didn’t see a need to change the strain as the current vaccine being used is shown to be effective against severe disease — a claim made just two weeks earlier at a prior VRBPAC meeting.
Bernstein said the strain change would need to be supported by data showing improved vaccine effectiveness and he “didn’t think we really have the data to be able to say that” even though the panel looked at the immune response.
Dr. Ofer Levy, VRBPAC member and an infectious disease physician at Boston Children’s Hospital, voted “yes” to change the computation of COVID-19 boosters, despite Pfizer’s admission there is “no established correlate of protection,” referring to the level of antibodies needed to confer protection.
“You have a lot of data now,” Levy told Pfizer. “What is your relative protection?”
“I would say there is no established correlate of protection,” Kena Swanson, Ph.D., vice president of viral vaccines at Pfizer, told Levy.
Levy circled back during the meeting:
“I would like to hear from FDA what their overall approach will be around improving our understanding of correlate protection. We spend a good amount of time reviewing antibody data. We have no doubt antibody data is important. We don’t have a level of antibody that anybody is comfortable stating is correlated [with] protection.
“So yes, the antibodies are important but so are the T cells. We heard from Dr. Weir, yes, T-cell assays are trickier and they’re more diverse, but it’s not going to happen without federal leadership to have a standardization of the T-cell assay and encourage or in fact require the sponsors to gather that information.”
“So what is the effort to standardize the pre-clinical assays?” Levy asked. “This is an effort that’s critical not just now but for future cycles of vaccine revision. If we aren’t able to define a standard for correlate protection we are fighting with one arm behind our back.”
Marks acknowledged the importance of Levy’s question, but said T-cell-mediated immunity was “difficult to study” initially.
“We have been having conversations with our colleagues at the NIH [National Institutes of Health] and throughout government about how we might move forward here,” Marks said. “It is something that we don’t have an answer to yet.”
Marks said as vaccines are developed in the future, it will “become even more important” to define a standard of correlate protection because “we won’t be able to have a large naive population to vaccinate with newer vaccines.”
“We will need to understand the T-cell response better,” Marks said. “I take your point, it’s just that we haven’t solved the problem yet.“
Dr. Meryl Nass, a member of the Children’s Health Defense scientific advisory committee, told The Defender that in her opinion, Tuesday’s meeting was a “vote to essentially approve a future framework — the future framework being a dearth of evidence required to change the booster, without clinical evidence and without a correlation of protection.”
Nass added:
“They voted on using an Omicron variant in the next booster iteration — which could contain any Omicron variant and could be either mono- or bi-valent.
“But most likely they will keep the current version and add another — which might double the amount of mRNA, or not.”
The new formulation might be for adults alone or adults and children, or only older adults and the immunocompromised, Nass said.
Brian Hooker, Ph.D., Children’s Health Defense chief scientific officer and professor of biology at Simpson University, told The Defender :
“The proposed move by VRBPAC will increase the harm to the U.S. public to unprecedented levels, as this action will further circumvent necessary clinical trials even beyond the slapdash testing of COVID-19 vaccines under Emergency Use Authorization.
“This adds to a foundation of lies used to authorize the original COVID-19 vaccines without anywhere near proper testing.”
Dr. Cody Meissner, VRBPAC panel member and professor of pediatrics at Tufts University, expressed concern about the financial risk pharmaceutical companies “are taking by making these vaccines.”
“If there’s a low likelihood the vaccines will be recommended, then they could incur significant loss,” he said.
Marks responded:
“I guess I would say that I would make recommendations here knowing the vaccine manufacturers will be kept whole by the United States government at least for some vaccines. I could be wrong but I think that’s a reasonable assumption.”
During the meeting, Moderna told the panel it would be ready with a “couple of hundred million” bivalent, or double-targeted, vaccines designed to combat BA.1 by September, but it would be late October or early November if the company needs to design a new vaccine targeting subvariants.
Pfizer said it and partner BioNTech have a significant amount of vaccine doses designed for the BA.1 variant ready and are already preparing to produce a large number of doses targeting BA.4 and BA.5 Omicron subvariants.
Pfizer said either could be ready for an early October rollout.
Multiple concerns raised during the public comment session
During the public comment session of the meeting, experts raised concerns that were largely ignored by the advisory panel.
Dr. Dustin Bryce, with Interest of Justice, said the FDA, Centers for Disease Control and Prevention (CDC) and the World Health Organization are “usurping Congress’ definition of a vaccine — which is any substance designed for the prevention of one or more disease.”
“FDA actually classifies mRNA as gene therapy, which they say is to treat or cure an existing disease by modifying your genes,” Bryce said. “Gene therapies are still being studied and are experimental at this time.”
Citing FDA documents, Bryce said gene therapy, unlike a vaccine, is so inherently unsafe the FDA says it requires 15 years of research to follow up on safety due to known risks of antibody-dependent enhancement, alteration of DNA and delayed adverse effects, such as cancer.
Bryce said:
“FDA says that gene therapy use in the mass population represents an unreasonable risk and they should limit the number of subjects who might be exposed to risk. We require due process and forbid the FDA from authorizing the proposed changes.
“We are demanding that EUA [Emergency Use Authorization] is promptly revoked because unreasonable risks are inherent in gene therapy products, as evidenced by large numbers of reports of adverse serious events linked to or suspected of being caused by an EUA product, product failure and product ineffectiveness.”
Bryce said COVID-19 vaccines fail to meet the requirements of EUA because not a single mRNA vaccine has been found to be effective for the prevention or treatment of an existing disease.
Michael Briskin pointed out in his public comment that the FDA receives approximately 75% of its budget from pharmaceutical companies, which he believes represents a conflict of interest.
Briskin challenged the use of the phrase “safe and effective” to describe COVID-19 vaccines, given the FDA has done no long-term testing to determine whether these products are safe.
Briskin presented data showing a significant rise in reported deaths among working-age Americans following COVID-19 vaccine mandates.
He said:
“In the short-term, 2021 was a very interesting year. We saw a stark increase [in death] among working-age adults from 18 to 64 and specifically in Q3 and into Q4, so something new for the working-age demographic partly through 2021 would be the clear correlation.
“With comparable trends in BLS [Bureau of Labor Statistics] data, children’s health insurance data, Israeli ambulance data, and of course we have the [Vaccine Adverse Event Reporting System (VAERS)] data — which the CDC tried to minimize but a recent FOIA [Freedom of Information Act] request forced them to reveal that they never once did the PRR calcification that was supposed to be their tool for spotting safety signals, according to their posted documents.”
“And what do we do when people get injured from these vaccines?” Briskin asked the panel. “We leave them in the mud.”
Briskin chastised the panel for authorizing boosters for infants two weeks earlier when data showed two doses weren’t effective and only 10 cases were used to assess efficacy.
“Three-quarters of the severe COVID in the trial was in the vaccine arm, as was the only hospitalization case which was accompanied by a seizure,” Briskin said. “And Moderna is so dangerous in young people Nordic countries won’t allow it to be used in anyone under the age of 30.”
Briskin said:
“In fact, the director of health of Denmark just admitted that vaccinating children was a mistake, whereas our officials only ever doubled down. And now we’re about to double down so hard we are about to lose the pretense of holding these pharmaceutical companies to any statistically meaningful regulatory standards for formula modification.
“For people following at home, what this agency is proposing is not just modifying the genetic code in the vaccine and the structure of the proteins produced to chase variants, but even things like doubling the microgram count for Pfizer — all without doing any statistically powered safety studies.”
“And to be clear,” Briskin added, “the companies we’re giving carte blanche to include Pfizer, the world’s largest criminal organization having paid the world’s largest criminal fine, and Moderna, which never made a safe product before we did away with long-term safety testing.”
Dr. Eric Feintuch, a chiropractor, asked the FDA if the agency knows how long mRNA from COVID-19 vaccines and the spike protein stay in the body, whether they know what the rate of protein production is and whether the FDA is aware of the consequences of the methylpseudouridine substitutions at the codon optimization step.
“For anyone on this panel who says it doesn’t go anywhere, tell me what proof you have of that,” Feintuch said, referring to the spike protein.
Feintuch said COVID-19 vaccines are associated with prion disease, noting 26 people have reported experiencing sudden onset of a severe and fatal brain disorder within one month of the second mRNA vaccine dose.
“This information needs to be researched and seen,” Feintuch said.
“A thousand peer-reviewed studies question the safety of COVID-19 vaccines. Doesn’t anyone see the safety signals? Is there anyone here who will stand up?” he asked. “Some of you know this, you need to stand up and you need to help us.”
Dr. David Wiseman, a research scientist with a background in pharmacy, pharmacology and experimental pathology, said VRBPAC is once again being asked to opine on inadequate information.
Wiseman said the FDA recently waived efficacy requirements for COVID-19 vaccines and has ignored its experts, notably Levy, who “has called for federal efforts to validate and standardize a correlate of protection.”
“Recent vaccine decisions were based on irrelevant Wuhan immunobridging,” Wiseman said. “Omicron assays are unvalidated and unverified by FDA.”
Wiseman said safety questions surrounding COVID-19 vaccines remain unanswered:
“We have shown correlations between vaccination and all-cause mortality. FDA says VAERS is under- and misreported. A FOIA disclosure reveals that CDC has not conducted safety signal analyses, which we have provided to FDA. Neurologic adverse events are finally being acknowledged [but there are] still no cancer studies.”
Wiseman further pointed out that FOIA requests show vital studies involving the spike protein have not been done:
“A Stanford study in [the journal] Cell showed vaccine message and antigen persisting for at least eight weeks. Does spike accumulate? Is this why myocarditis rates after boosting match or best primary series rates for some ages?
“Does spike persistence contribute to immune suppression, imprinting and negative efficacy? What is the toxicity of multiple doses? How will sameness of the manufacturing process be defined? Are the guidelines talking about monovalents or bivalents?”
Pfizer has dismissed concerns about the spike protein as “academic,” Wiseman said, “but it is certainly not.”
Booster formulation should be changed to combat waning efficacy, committee said
During the meeting, which occurred two weeks after the panel signed off on the primary COVID-19 vaccine series for the nation’s youngest children, a change in booster composition was deemed necessary due to waning effectiveness.
Dr. Mahesh Shenai, neurosurgeon and data analyst, said in a tweet:
“After many months of extolling benefits of vax and booster, now they are criticizing its efficacy and durability. . . to set the stage for a new updated booster!?”
In a briefing document published ahead of Tuesday’s meeting, FDA officials predicted a major COVID-19 outbreak will occur in the fall “due to the combination of waning immunity, further evolution of variants and increased indoor activity.”
A similar committee that advises the WHO recently suggested COVID-19 vaccines be reformulated to include both the original SARS-CoV-2 Wuhan variant and the first version of Omicron, BA.1 — although this variant has since been replaced by other strains of BA.4 and BA.5.
Moderna and Pfizer studied Omicron-specific vaccines in preparation for fall boosters, but efforts have been complicated by new subvariants.
If the government decides it wants a booster shot that targets BA.4 and BA.5 — two strains derived from the Omicron variant that are becoming dominant — vaccine manufacturers will have to race to produce the doses by fall, The New York Times reported.
Vaccines produced by Pfizer, Moderna, Novavax and Johnson & Johnson were developed against the original Wuhan COVID strain that emerged in 2019, but as the virus has rapidly evolved, these vaccines have become less effective.
COVID-19 vaccines target the spike protein the SARS-CoV-2 virus uses to invade human cells, but as the virus mutates away from the original strain, it has trouble “recognizing and attacking the spike,” CNBC reported. The Omicron variant has more than 30 mutations.
Marks said during the meeting he hopes changing the booster will “convince people to go get that booster,” adding the FDA plans to begin a booster campaign in October.
Megan Redshaw is a staff attorney for Children’s Health Defense and a reporter for The Defender.
© 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.
FDA ATTEMPTS TO “FLU SHOT” FUTURE COVID VACCINES
The Highwire with Del Bigtree | June 24, 2022
Public comment is needed NOW to stop the FDA from considering bypassing their already fractured process of Covid vaccine safety and efficacy testing to ‘Flu shot’ future Covid vaccines and boosters.
Make your comment before the hearing, June 27th, to stop the agency allowing plug and play updates to these mRNA shots lacking proper clinical trials.
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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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