Category Archives: FDA

FDA ignored medical warning of vaccinating previously Covid infected and deaths follow, Bobby Bolin forced to get vaccine, Dr. Noorchashm “Letter of Warning To FDA And Pfizer” January 26, 2021

FDA ignored medical warning of vaccinating previously Covid infected and deaths follow, Bobby Bolin forced to get vaccine, Dr. Noorchashm “Letter of Warning To FDA And Pfizer” January 26, 2021

“The vaccine doesn’t do anything to help you. It doesn’t. We think it caused the Delta variant. The nurses, among ourselves, we all talk. It got worse after the vaccine. It was hardcore. It was bad. A lot of people died. And I’m talking – we were losing 20-year-olds. The first Covid wave took the lives of older people with a lot of illnesses. The delta wave was mostly obese people, I will say that, but we lost people in their 20s, 30s, 40s, 50s – you name it.”...Nurse Helen Smith

“I’m not afraid of blowing the whistle “because my faith lies in God and not man … You know, like what kind of person would I be if I knew all of this — this is evil at the highest level. You have the FDA [U.S. Food and Drug Administration], you have the [Centers for Disease Control and Prevention] CDC, that are both supposed to be protecting us, but they are under the government, and everything that we’ve done so far is unscientific.”..Jodi O’Malley registered nurse

“Because COVID vaccines use experimental technology that may pose serious side effects such as blood clots, Yeadon said, “we should absolutely not be offering them to young, healthy people who are not at risk from the virus.””..Dr. Mike Yeadon, former vice president of Pfizer

 

Dr. Hooman Noorchashm, in a letter and email dated January 26, 2021, warned the FDA and Pfizer of the dangers of vaccinating the naturally infected.

“Retired surgeon and former U-Penn Medicine professor Dr. Hooman Noorchashm warned that orchestrating a blanket coronavirus vaccination for every American regardless of prior immunity or presence of risk factors could be a “dangerous medical approach.”

Noorchashm told Fox Nation’s “Tucker Carlson Today” that patients shouldn’t fear asking legitimate questions about the vaccine, immunity status or the vaccine “passport” system already being deployed in places like New York.”

“”Now the question is, have we done enough to make sure it’s safe in everyone. Are there categories in subset of people in whom this vaccine may actually pose some sort of risk? — I think the answer to that is yes.”

“They delivered an effective vaccine. Now, the safety part of it is what they’re making a mistake with: It’s a mistake to be vaccinating people who have had recent or current infections.””

“”If someone is natural immune there’s no reason to go and re-vaccinate them, those persons would actually be an unnecessary medical procedure … This is a very unusual thing,” he said.

“We are a literally in the middle of an outbreak where millions of American are naturally infected, or naturally immune. Deploying a vaccine that essentially reactivates the immune responses. So the question is number one is that necessary medical treatment? Number two is that a dangerous medical approach?””

https://citizenwells.com/2021/04/07/mass-covid-vaccinations-dangerous-pro-vaccine-dr-noorchashm-warns-fda-and-public-immunological-danger-the-covid-19-vaccine-might-pose-to-those-persons-naturally-infected/

Dr. Noorchashm’s article and letter to the FDA and Pfizer has been removed from the internet.

A click on the link yields:

ERROR

410

User deactivated or deleted their account.

The article can now be found here:

https://citizenwells.substack.com/p/a-letter-of-warning-to-fda-and-pfizer

The FDA, Pfizer, government and media have failed to heed this warning and people are dying.

From The Defender November 29, 2021.

“Exclusive: 49-Year-Old Who Survived COVID Forced to Get Vaccine to Remain on Lung Transplant List, Dies After Second Moderna Shot

In an exclusive interview with The Defender, Amy Bolin said in order to be approved for a double-lung transplant, her husband had to be fully vaccinated for COVID even though he’d had the virus and recovered. After his second Moderna shot, he developed a pulmonary embolism and heart condition and died before he could get new lungs.

A 49-year-old Texas man who recovered from COVID — but was required to be fully vaccinated against the virus before being approved for a life-saving lung transplant — died when he developed a pulmonary embolism and heart issues after his second Moderna vaccine.

In an exclusive Interview with The Defender, the man’s wife, Amy Bolin, said there was no reason her husband, Bobby Bolin, should have been forced to get the vaccine.”

Read more:

https://childrenshealthdefense.org/defender/bobby-amy-bolin-lung-transplant-dies-moderna-covid-vaccine/

 

 
CovidDeaths

 

 

 

 

 

 

Spike protein problems from Covid19 vaccines, Dr. Byrum Bridle warned early and called “toxin” and “pathogenic protein”, NEJM now hints “could explain the high incidence of myocarditis”

Spike protein problems from Covid19 vaccines, Dr. Byrum Bridle warned early and called “toxin” and “pathogenic protein”, NEJM now hints “could explain the high incidence of myocarditis”

“The vaccine doesn’t do anything to help you. It doesn’t. We think it caused the Delta variant. The nurses, among ourselves, we all talk. It got worse after the vaccine. It was hardcore. It was bad. A lot of people died. And I’m talking – we were losing 20-year-olds. The first Covid wave took the lives of older people with a lot of illnesses. The delta wave was mostly obese people, I will say that, but we lost people in their 20s, 30s, 40s, 50s – you name it.”...Nurse Helen Smith

“I’m not afraid of blowing the whistle “because my faith lies in God and not man … You know, like what kind of person would I be if I knew all of this — this is evil at the highest level. You have the FDA [U.S. Food and Drug Administration], you have the [Centers for Disease Control and Prevention] CDC, that are both supposed to be protecting us, but they are under the government, and everything that we’ve done so far is unscientific.”..Jodi O’Malley registered nurse

“Because COVID vaccines use experimental technology that may pose serious side effects such as blood clots, Yeadon said, “we should absolutely not be offering them to young, healthy people who are not at risk from the virus.””..Dr. Mike Yeadon, former vice president of Pfizer

From Citizen Wells June 8, 2021.

“Dr. Byram Bridle was funded by the Canadian government.

“We made a big mistake. We didn’t realize it until now,” said Byram Bridle, a viral immunologist and associate professor at University of Guelph, Ontario. “We thought the spike protein was a great target antigen, we never knew the spike protein itself was a toxin and was a pathogenic protein. So by vaccinating people we are inadvertently inoculating them with a toxin.”

https://citizenwells.com/2021/06/04/covid-vaccine-spike-protein-can-cause-organ-damage-we-made-a-big-mistake-scientific-research-proves-pathogenic-protein-gets-into-blood-almost-entirely-responsible-for-the-damage-to-the-cardiov/#comment-504950

Dr. Bridle has also warned about giving the Covid vaccine to children

“Not enough data on kids and COVID vaccines, Canadian expert cautions

A Canadian vaccine expert is voicing his concerns about the current push to get children vaccinated against COVID-19, noting that there is currently not enough data to conclude that the benefits outweigh the risks in younger age cohorts.

“When you get down to the low end of the spectrum, the cost-benefit analysis changes completely,” says Dr. Byram Bridle, an Associate Professor of Viral Immunology at the University of Guelph.”

https://torontosun.com/news/national/not-enough-data-on-kids-and-covid-vaccines-canadian-expert-cautions

Dr. Byram Bridle’s page at MIRC was scrubbed sometime after June 4, 2021.

“404 – File or directory not found.

THE RESOURCE YOU ARE LOOKING FOR MIGHT HAVE BEEN REMOVED, HAD ITS NAME CHANGED, OR IS TEMPORARILY UNAVAILABLE.”

https://mirc.mcmaster.ca/education/meet-our-alumni/alumni/bryam-bridle

It can still be found at the Wayback archive.”

https://citizenwells.com/2021/06/08/vaers-website-unavailable-due-to-routine-maintenance-for-days-cdc-adverse-events-report-deaths-not-updated-rfk-defender-site-reports-5165-deaths-spike-protein-researcher-dr-bridle-mirc-page/

From Alex Berenson November 26, 2021.

“A frightening new potential explanation for vaccine-driven myocarditis and other problems

Researchers in the New England Journal of Medicine raise the possibility of an uncontrolled autoimmune response to the coronavirus spike protein that may last indefinitely

Downstream effects of the antibodies that people produce against the coronavirus spike protein may lead to myocarditis and even neurological concerns, two veteran medical researchers have written in the top medical journal in the United States.

Our immune systems produce these antibodies in response to both vaccination and natural infection with Covid. However – though the researchers do not say so explicitly, possibly because doing so would be politically untenable – spike protein antibody levels are MUCH higher following vaccination than infection. Thus the downstream response to vaccination may be more severe.

The NEJM published the short paper Wednesday in its Basic Implications of Clinical Observations series. One of the writers is an oncologist and professor at Harvard Medical School; the other is a cancer researcher who has his own lab at the University of California, Davis.”

“In other words, Ab2 antibodies may continue to damage our bodies long after we have cleared either Sars-Cov-2 itself or the spike proteins that the vaccines cause our cells to make.

To be clear, the researchers did not provide proof that these anti-idiotype antibodies are actually causing problems, or even that they exist. The paper merely presents a theory. But the writers believe it could explain the high incidence of myocarditis “after vaccine administration” and even “neurologic effects of SARS-COV-2 infection or vaccines.”

And what the researchers do not say, but what even the Centers for Disease Control acknowledges, is that vaccination produces much higher levels of anti-spike protein antibodies than natural infection.”

Read more:

https://alexberenson.substack.com/p/a-frightening-new-potential-explanation

Myocarditis

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FDA lawsuit first report reveals 158893 adverse events in 2.5 months, 25957 “Nervous system disorders”, Attorney Aaron Siri, European Union database shows 87639 serious nervous system disorders

FDA lawsuit first report reveals 158893 adverse events in 2.5 months, 25957 “Nervous system disorders”, Attorney Aaron Siri, European Union database shows 87639 serious nervous system disorders

“Why are we vaccinating healthy adults when 81 percent of Covid-19 cases are mild and there is  a 99 percent survival rate. Why are we testing vaccines on children who are minimally impacted by the disease?”…Citizen Wells

“I’m not afraid of blowing the whistle “because my faith lies in God and not man … You know, like what kind of person would I be if I knew all of this — this is evil at the highest level. You have the FDA [U.S. Food and Drug Administration], you have the [Centers for Disease Control and Prevention] CDC, that are both supposed to be protecting us, but they are under the government, and everything that we’ve done so far is unscientific.”..Jodi O’Malley registered nurse

” if you let your healthy teen – much less your healthy child – get this vaccine, you are insane.”…Alex Berenson

From Attorney Aaron Siri.

FDA Produces the First 91+ pages of Documents from Pfizer’s COVID-19 Vaccine File

Two months and one day after it was sued, and close to 3 months since it licensed Pfizer’s Covid-19 vaccine, the FDA released the first round of documents it reviewed before licensing this product.  The production consisted of 91 pdf pages, one xpt file, and one txt file. You can download them here.

While it is for the scientists to properly analyze, let me share one observation.  One of the documents produced is a Cumulative Analysis of Post-Authorization Adverse Event Reports of [the Vaccine] Received Through 28-Feb-2021, which is a mere 2 ½ months after the vaccine received emergency use authorization (EUA).  This document reflects adverse events following vaccination that have completed Pfizer’s “workflow cycle,” both in and outside the U.S., up to February 28, 2021.

Pfizer explains, on page 6, that “Due to the large numbers of spontaneous adverse event reports received for the product, [Pfizer] has prioritised the processing of serious cases…” and that Pfizer “has also taken a [sic] multiple actions to help alleviate the large increase of adverse event reports” including “increasing the number of data entry and case processing colleagues” and “has onboarded approximately [REDACTED] additional fulltime employees (FTEs).”  Query why it is proprietary to share how many people Pfizer had to hire to track all of the adverse events being reported shortly after launching its product.

As for the volume of reports, in the 2 ½ months following EUA, Pfizer received a total of 42,086 reports containing 158,893 “events.”  Most of these reports were from the U.S. and disproportionately involved women (29,914 vs. 9,182 provided by men) and those between 31 and 50 years old (13,886 vs 21,325 for all other age groups combined, with another 6,876 whose ages were unknown).  Also, 25,957 of the events were classified as “Nervous system disorders”

Females between the ages of 30 and 51. Nervous system disorders. That sounds familiar.  As a matter of fact, that sounds similar to the concerns raised by some of the women testifying or described in the videos below.”

Read more:

https://aaronsiri.substack.com/p/fda-produces-the-first-91-pages-of

“The official European Union database of suspected drug reaction website is now reporting 30,551 fatalities and 1,163,356 from COVID vaccines Pfizer, Moderna, and Johnson & Johnson, and AztraZeneca through November 13, 2021 based on the data submitted to its system.”

It also revealed 87,639 serious nervous system disorders

https://citizenwells.com/2021/11/19/european-and-swedish-covid-vaccine-data-reveal-alarming-adverse-reactions-and-deaths-sweden-major-red-flag-about-covid-vaccines-and-death-europe-1-16-million-reactions-and-30k-fatalities/

EuropeData

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4 and 5 year old kids get Covid vaccine at Walgreens instead of flu shots, Pfizer trying to make it legal, Taken to pediatric cardiologist “both are showing signs of heart issues”

4 and 5 year old kids get Covid vaccine at Walgreens instead of flu shots, Pfizer trying to make it legal, Taken to pediatric cardiologist “both are showing signs of heart issues”

“Furthermore, when you get vaccinated you know that you are now subject to the risks of the vaccine,” he said. “If you don’t get vaccinated, you only have a chance of contracting Covid, and therefore a chance of assuming the risks of Covid—it’s not 100% certain you’ll get Covid just because you were not vaccinated.”…UCI Medical Ethics director

“it is my sincere hope that this public letter might stimulate FDA, Pfizer and Moderna leaders to think critically and quickly about the immunological danger the COVID-19 vaccine might pose to those persons naturally infected by SARS-CoV-2 — most especially to those infected who are recently convalescent, asymptomatic carriers, the elderly and frail or those with significant cardiovascular risk factors.”...Dr. Hooman Noorchashm“

“Why are we vaccinating healthy adults when 81 percent of Covid-19 cases are mild and there is  a 99 percent survival rate. Why are we testing vaccines on children who are minimally impacted by the disease?”…Citizen Wells

From News14 October 8, 2021.

“An Evansville family and their attorney says they were accidentally given full adult doses of the Pfizer coronavirus vaccine instead of flu shots.

Alexandra and Joshua Price says it happened October 4, at the Walgreens on St. Joseph Avenue.

Their family of four includes two adults and two children who are just five and four years old.

The Pfizer vaccine isn’t approved for children that young. They are seeking approval for children ages five to 11, but the dosage would be one third that of the adult dose. Pfizer has not asked permission to vaccinate children age four or younger.

The family’s attorney, Daniel Tuley, shared with us what he says are the vaccination cards given to the family by Walgreens.

They show children born in 2016 and 2017 were given a Pfizer coronavirus vaccine.

The family says they left the pharmacy thinking they had received their flu shots, but a Walgreens employee later called them and said they had made a mistake.

“Walgreens called me to say there was a mix up, we did not receive the flu shot,” said Alexandra. “And I’m like well what did we get? And he was like we got the Covid19 shot, And instantly I was like, well what does this mean for my kids…?”

The attorney tells us the vaccine cards were then issued since the coronavirus vaccine had been given.

Tuley says the children have been taken to a pediatric cardiologist, and the family was told both are showing signs of heart issues.”

Read more:

https://www.14news.com/2021/10/08/attorney-covid-19-vaccine-given-family-including-small-kids-instead-flu-shots/

CovidKidsVaccinated

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Physician Danice Hertz “horribly ill” and “incapacitated” after Pfizer COVID vaccination, Diagnosis of “mast cell disorder”, “They knew about these adverse reactions before the vaccines were released from the clinical trials” 

Physician Danice Hertz “horribly ill” and “incapacitated” after Pfizer COVID vaccination, Diagnosis of “mast cell disorder”, “They knew about these adverse reactions before the vaccines were released from the clinical trials”

“A preprint paper by the prestigious Oxford University Clinical Research Group, published Aug. 10 in The Lancet, found vaccinated individuals carry 251 times the load of COVID-19 viruses in their nostrils compared to the unvaccinated.”...The Defender

“While moderating the symptoms of infection, the jab allows vaccinated individuals to carry unusually high viral loads without becoming ill at first, potentially transforming them into presymptomatic superspreaders. ”…The Defender

“The US is averaging 70 deaths per day due to COVID19 Vaccine since July 24th — or 3,296 COVID total vaccine deaths.”...VAERS database

From The Defender September 23, 2021.

“Exclusive: Physician ‘Horribly Injured’ After Pfizer Vaccine Pleads With Top U.S. Public Health Officials for Help — and Gets None

In an exclusive interview with The Defender, Dr. Danice Hertz said people like her who have been seriously injured by COVID vaccines are being dismissed or ignored, and because health officials won’t research their injuries and potential treatments, they have nowhere to turn.

Danice Hertz, a 64-year-old physician who was “horribly ill” and “incapacitated” after getting Pfizer’s COVID vaccine, claims U.S. health agencies are ignoring thousands of adverse events.

In an exclusive interview with The Defender, Hertz said if she could go back in time, she would not have gotten vaccinated.

Hertz said she has been in contact with numerous health agencies, physicians and researchers — including the National Institutes of Health (NIH), U.S. Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), U.S. Surgeon General and doctors at Harvard and Stanford universities and Cedars-Sinai Medical Center in Los Angeles — in an effort to obtain help for the neurological injuries she suffered after getting the vaccine.

Hertz told The Defender there are thousands of people like her — who have been injured by COVID vaccines — who are suffering and need help, yet they’re ignored by mainstream media and U.S. health agencies. Meanwhile, COVID vaccine mandates are being rolled out for millions of Americans, with barely any discussion of the risks.

Hertz, a gastroenterologist who retired in October, got her first and only dose of Pfizer’s vaccine on Dec. 23, 2020. “There was an opportunity to get the vaccine because the hospital was giving it to every doctor,” Hertz said. “I didn’t know if I would need to go back into the workforce, so I ran to get it. Within 30 minutes, I started experiencing adverse effects.”

“I waited the 15 minutes you’re required to wait after you get it, and I went to the car and my face started burning,” Hertz said. “I drove home five minutes away, and by the time I walked through the door, I told my husband to call the paramedics.”

Hertz said within 24 hours she developed neurological symptoms, including severe paresthesias in her face, tongue, scalp, chest wall and limbs, as well as tremors, twitching, weakness, headaches, tinnitus and imbalance.

“My blood pressure was 186 over 127, which I’ve come to find is characteristic of these reactions,” Hertz said.

Hertz called her doctor, and took Benadryl and steroids in case she was having an allergic reaction. The next day her face turned completely numb.

Hertz said:

“My entire face felt like it was burning — like acid had been poured on my face. I had sensations throughout my body like it was vibrating. I felt like I had a tight band around my waist, chest pain and shortness of breath, and I went to bed for seven days.”

Hertz followed up with an allergist who treated her with steroids in case she was experiencing an allergic reaction to the vaccine. After a few weeks of no improvement, Hertz met with the chief neurologist at Cedars-Sinai.

“I saw six neurologists, five allergists, three rheumatologists, and no one had a clue,” Hertz said. “They did blood work, skin biopsies, an MRI and more, and nothing really came up. Unfortunately, if a doctor doesn’t know what’s wrong with you they’re done with you, though that’s not how I practice.””

“Hertz’s case was accepted into the CISA Project and was presented at the CDC’s grand rounds on March 23. Following the meeting, a physician forwarded a letter to Hertz suggesting she had “mast cell disorder.”

The CISA Project never followed up with her.

Mast cell activation syndrome (or mast cell disorder) is a condition in which a patient experiences repeated episodes of the symptoms of anaphylaxis — allergic symptoms such as hives, swelling, low blood pressure, difficulty breathing and severe diarrhea.

Systemic mastocytosis can cause skin lesions, pain in inner organs, bone pain, diarrhea and vomiting, weight loss and cardiovascular symptoms.

Hertz contacted the NIH and was evaluated remotely by Dr. Avindra Nath, a physician-scientist who specializes in neuroimmunology and is intramural clinical director of the National Institute of Neurological Disorders and Stroke at the NIH.

Hertz said she sent the NIH her blood for a study, because they were seeing quite a few patients like her. She also sent her blood to doctors at Stanford and Harvard for evaluation.

The Harvard physician also thought Hertz had mast cell activation, and put her on medications, but they didn’t help. “I’m now on a lot of medications for mast cell activation, but I’m still quite ill,” Hertz said.

“I don’t think that’s [mast cell activation] the whole explanation of what’s happening to us,” Hertz said. “I’m still here nine months later. I still don’t know what’s wrong with me. I am not as sick as I was initially, but I still get attacks where I feel like I’m being electrocuted, and my husband can actually feel my legs and arms vibrating.””

You are strongly urged to read more:

https://childrenshealthdefense.org/defender/dr-danice-hertz-injured-pfizer-covid-vaccine/

Vaccine Risk/Benefit

Opinion piece illustration fot the Wall Street Journal by Ladapo and Risch

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Covid vaccine risks “Evil at the Highest Level” HHS whistleblowers, Project Veritas video, Jodi O’Malley registered nurse, Government not reporting adverse Covid vaccine side effects

Covid vaccine risks “Evil at the Highest Level” HHS whistleblowers, Project Veritas video, Jodi O’Malley registered nurse, Government not reporting adverse Covid vaccine side effects

“A preprint paper by the prestigious Oxford University Clinical Research Group, published Aug. 10 in The Lancet, found vaccinated individuals carry 251 times the load of COVID-19 viruses in their nostrils compared to the unvaccinated.”...The Defender

“While moderating the symptoms of infection, the jab allows vaccinated individuals to carry unusually high viral loads without becoming ill at first, potentially transforming them into presymptomatic superspreaders. ”…The Defender

“The US is averaging 70 deaths per day due to COVID19 Vaccine since July 24th — or 3,296 COVID total vaccine deaths.”...VAERS database

From The Defender September 21, 2021.

‘This Is Evil at the Highest Level,’ Says HHS Whistleblower

In a video released Monday by Project Veritas, U.S. Health and Human Services insider, Jodi O’Malley, a registered nurse, shares recorded conversations between her and colleagues about the government’s failure to acknowledge COVID vaccine risks and lack of efficacy.”

“Here are some of the highlights from the video:

  • Dr. Maria Gonzales, ER doctor, HHS: “All this is bullshit. Now, [a patient] probably [has] myocarditis due to the [COVID] vaccine. But now, they [government] are not going to blame the vaccine.”
  • Dr. Gonzales: “They [government] are not reporting [adverse COVID vaccine side effects] … They want to shove it under the mat.”
  • Deanna Paris, registered nurse, HHS: “It’s a shame they [government] are not treating people [with COVID] like they’re supposed to, like they should. I think they want people to die.”
  • Jodi O’Malley, HHS insider and registered nurse: The COVID vaccine is “not doing what its purpose was.”
  • O’Malley: “I’ve seen dozens of people come in with adverse reactions.”
  • O’Malley: “If we [government] are not gathering [COVID vaccine] data and reporting it, then how are we going to say that this is safe and approved for use?”
  • O’Malley: I’m not afraid of blowing the whistle “because my faith lies in God and not man … You know, like what kind of person would I be if I knew all of this — this is evil at the highest level. You have the FDA [U.S. Food and Drug Administration], you have the [Centers for Disease Control and Prevention] CDC, that are both supposed to be protecting us, but they are under the government, and everything that we’ve done so far is unscientific.”
  • O’Malley: “At the end of the day, it’s about your health, and you can never get that back — and about your freedom, and about living in a peaceful society, and I’m like, ‘no.’ No. This is the hill that I will die on.””

Read more;

https://childrenshealthdefense.org/defender/project-veritas-jodi-omalley-hhs-whistleblower-covid-vaccine/

JoesephGoebbels

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Covid booster shot for 16 to 65 year olds rejected by FDA panel, Insufficient data from incomplete clinical trials and the potential risk of heart inflammation, Study: 2 doses of Pfizer vaccine “greater risk for Covid-19 hospitalizations.”

Covid booster shot for 16 to 65 year olds rejected by FDA panel, Insufficient data from incomplete clinical trials and the potential risk of heart inflammation, Study: 2 doses of Pfizer vaccine “greater risk for Covid-19 hospitalizations.”

“A preprint paper by the prestigious Oxford University Clinical Research Group, published Aug. 10 in The Lancet, found vaccinated individuals carry 251 times the load of COVID-19 viruses in their nostrils compared to the unvaccinated.”...The Defender

“While moderating the symptoms of infection, the jab allows vaccinated individuals to carry unusually high viral loads without becoming ill at first, potentially transforming them into presymptomatic superspreaders. ”…The Defender

“The US is averaging 70 deaths per day due to COVID19 Vaccine since July 24th — or 3,296 COVID total vaccine deaths.”...VAERS database

From GateWay Pundit September 17, 2021.

“FDA Panel Rejects Pfizer Booster Shot for Ages 16-65 Over Increased Risk of Heart Inflammation”

“The panel voted 16-2 to reject extra doses of experimental vaccine, citing insufficient data from incomplete clinical trials and the potential risk of heart inflammation – especially among young men. 

The panel did, however, vote unanimously to endorse the booster for people aged 65 or older and “high-risk” individuals.”

“In fact, one study that was conducted on 800,000 individuals showed that people who have taken both doses of the Pfizer jab are 13 TIMES more likely to have a breakthrough infection, and are at a “greater risk for Covid-19 hospitalizations.””

“So much for the ‘pandemic of the unvaccinated’..

The US health regime and Big Pharma have cleverly used the poor vaccine results to push another round of experimental shots. They have begun to acknowledge the decline in protection against infection, but refuse to mention anything about natural immunity and downplay the adverse reactions that have been well documented.”

Read more:

https://www.thegatewaypundit.com/2021/09/just-fda-panel-rejects-pfizer-booster-shot-ages-16-65-increased-risk-heart-inflammation/

Myocarditis

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FDA Pfizer vaccine Comirnaty BLA approval letter August 23, 2021 shocking contents, Vaccine does not prevent Covid or spread, 16 and older, Pediatrics deferred to 2023-24, Required studies: myocarditis pericarditis pregnancy

FDA Pfizer vaccine Comirnaty BLA approval letter August 23, 2021 shocking contents, Vaccine does not prevent Covid or spread, 16 and older, Pediatrics deferred to 2023-24, Required studies: myocarditis pericarditis pregnancy

“two papers published May 19 in the journal of Hospital Pediatrics found pediatric hospitalizations for COVID were overcounted by at least 40%, carrying potential implications for nationwide figures used to justify vaccinating children.”...The Defender

“it is universally known that children virtually never die from COVID-19 and given that children have a very strong immune system, they are more likely than adults to have an over-reaction to the shot.”…Dr. Steven Roth

“There is not yet enough evidence on the use of vaccines against COVID-19 in children to make recommendations for children to be vaccinated against COVID-19. Children and adolescents tend to have milder disease compared to adults. However, children should continue to have the recommended childhood vaccines.”…WHO

Only an idiot or agent of evil would approve a vaccine that does not prevent Covid or its spread and include the requirements for case studies post marketing of the impact of myocarditis, pericarditis and pregnancy problems.

From the FDA Pfizer BLA Comirnaty approval letter August 23, 2021.

“Please refer to your Biologics License Application (BLA) submitted and received on
May 18, 2021, under section 351(a) of the Public Health Service Act (PHS Act) for
COVID-19 Vaccine, mRNA.

LICENSING

We are issuing Department of Health and Human Services U.S. License No. 2229 to
BioNTech Manufacturing GmbH, Mainz, Germany, under the provisions of section
351(a) of the PHS Act controlling the manufacture and sale of biological products. The
license authorizes you to introduce or deliver for introduction into interstate commerce,
those products for which your company has demonstrated compliance with
establishment and product standards.
Under this license, you are authorized to manufacture the product, COVID-19 Vaccine,
mRNA, which is indicated for active immunization to prevent coronavirus disease 2019
(COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
in individuals 16 years of age and older.”

“You may label your product with the proprietary name, COMIRNATY, and market it in
2.0 mL glass vials, in packages of 25 and 195 vials.

We did not refer your application to the Vaccines and Related Biological Products
Advisory Committee because our review of information submitted in your BLA, including
the clinical study design and trial results, did not raise concerns or controversial issues
that would have benefited from an advisory committee discussion.”

“We are deferring submission of your pediatric studies for ages younger than 16 years
for this application because this product is ready for approval for use in individuals 16
years of age and older, and the pediatric studies for younger ages have not been
completed.

Your deferred pediatric studies required under section 505B(a) of the Federal Food,
Drug, and Cosmetic Act (FDCA) are required postmarketing studies. The status of
these postmarketing studies must be reported according to 21 CFR 601.28 and section
505B(a)(4)(C) of the FDCA. In addition, section 506B of the FDCA and 21 CFR 601.70
require you to report annually on the status of any postmarketing commitments or
required studies or clinical trials.
Label your annual report as an “Annual Status Report of Postmarketing Study
Requirement/Commitments” and submit it to the FDA each year within 60 calendar
days of the anniversary date of this letter until all Requirements and Commitments
subject to the reporting requirements under section 506B of the FDCA are released or
fulfilled. These required studies are listed below:
1. Deferred pediatric Study C4591001 to evaluate the safety and effectiveness of
COMIRNATY in children 12 years through 15 years of age.
Final Protocol Submission: October 7, 2020
Study Completion: May 31, 2023
Final Report Submission: October 31, 2023
2. Deferred pediatric Study C4591007 to evaluate the safety and effectiveness of
COMIRNATY in infants and children 6 months to <12 years of age.
Final Protocol Submission: February 8, 2021
Study Completion: November 30, 2023
Final Report Submission: May 31, 2024
3. Deferred pediatric Study C4591023 to evaluate the safety and effectiveness of
COMIRNATY in infants <6 months of age.
Final Protocol Submission: January 31, 2022
Study Completion: July 31, 2024
Final Report Submission: October 31, 2024”

“POSTMARKETING REQUIREMENTS UNDER SECTION 505(o)
Section 505(o) of the Federal Food, Drug, and Cosmetic Act (FDCA) authorizes FDA to
require holders of approved drug and biological product applications to conduct
postmarketing studies and clinical trials for certain purposes, if FDA makes certain
findings required by the statute (section 505(o)(3)(A), 21 U.S.C. 355(o)(3)(A)).
We have determined that an analysis of spontaneous postmarketing adverse events
reported under section 505(k)(1) of the FDCA will not be sufficient to assess known
serious risks of myocarditis and pericarditis and identify an unexpected serious risk of
subclinical myocarditis.
Furthermore, the pharmacovigilance system that FDA is required to maintain under
section 505(k)(3) of the FDCA is not sufficient to assess these serious risks.
Therefore, based on appropriate scientific data, we have determined that you are
required to conduct the following studies:
4. Study C4591009, entitled “A Non-Interventional Post-Approval Safety Study of
the Pfizer-BioNTech COVID-19 mRNA Vaccine in the United States,” to evaluate
the occurrence of myocarditis and pericarditis following administration of
COMIRNATY. ”

Read more:

https://www.fda.gov/media/151710/download

Baby-getting-shot

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“The Real Anthony Fauci” by RFK Jr.,50 year reign as America’s public health czar, “wield extraordinary influence over hospitals, universities, journals and thousands of influential doctors and scientists — whose careers and institutions he has the power to ruin, advance or reward”

“The Real Anthony Fauci” by RFK Jr.,50 year reign as America’s public health czar, “wield extraordinary influence over hospitals, universities, journals and thousands of influential doctors and scientists — whose careers and institutions he has the power to ruin, advance or reward”

“Fauci has survived half a century in his government post — he’s the J. Edgar Hoover of public health — by kowtowing to (and profiting from) pharmaceutical interests.”...RFK Jr.

“Fauci orchestrated fraudulent studies, and then pressured U.S. Food and Drug Administration (FDA) regulators into approving a deadly chemotherapy treatment he knew to be worthless against AIDS.”…RFK Jr.

“Fauci repeatedly violated federal laws to allow his Pharma partners to use impoverished and dark-skinned children as lab rats in deadly experiments with toxic AIDS and cancer chemotherapies.”…RFK Jr.

From The Defender August 18, 2021.

“My New Book — ‘The Real Anthony Fauci’ — Now Available for Pre-Order

In my latest book — “The Real Anthony Fauci: Bill Gates, Big Pharma, and the Global War on Democracy and Public Health” — I take an in-depth look at the disastrous consequences of Dr. Anthony Fauci’s 50-year reign as America’s public health czar. The book, which will be released Nov. 9, is available now for preorder.”

“As director of the National Institute of Allergy and Infectious Diseases (NIAID), Dr. Anthony Fauci dispenses $6.1 billion in annual taxpayer-provided funding for scientific research.

The research I conducted for my new book exposes how Fauci’s gargantuan yearly disbursements allow him to dictate the subject, content and outcome of scientific health research across the globe.

These annual disbursements also allow Fauci to exercise dictatorial control over the army of “knowledge-and-innovation” leaders who populate the “independent” federal panels that approve and mandate drugs and vaccines — including the committees that allowed the Emergency Use Authorization of COVID-19 vaccines.

Fauci uses the financial clout at his disposal to wield extraordinary influence over hospitals, universities, journals and thousands of influential doctors and scientists — whose careers and institutions he has the power to ruin, advance or reward.

These are the same doctors who appear on network news shows, publish on the op-ed pages of influential media, and craft and defend the pharmaceutical cartel’s official narratives.”

“Instead of addressing the rise in chronic diseases, Fauci transformed NIAID from a world-class regulator into a product incubator for Big Pharma by developing new drugs and vaccines for which he, his agency and his employees often share patents and royalties.

For example, Fauci and four of his hand-selected deputies will partake with Moderna in millions of dollars in royalties from sales of Moderna’s COVID vaccine — which was co-developed by Moderna and NIAID.

Fauci has made himself the leading proponent of “agency capture” — the subversion of democracy and public health by the pharmaceutical industry.

As “The Real Anthony Fauci” reveals, Fauci has steadily failed upward. His legacy is a nation that uses increasingly more pharmaceuticals, pays nearly three times more for prescription drugs than people in dozens of other countries, and has worse health outcomes and a sicker population than other wealthy nations.

Today, prescription drugs — many developed by the National Institutes of Health (NIH) during Fauci’s tenure at the NIH’s NIAID — are America’s third leading cause of death.

My book also reveals how Fauci and his cohorts in Pharma profit handsomely from sickness — but not so much from good health.”

Read more:

https://childrenshealthdefense.org/defender/robert-f-kennedy-jr-book-the-real-anthony-fauci/

Mengele

Cone Health nurses protesters on mandated Covid19 vaccinations: “I’m a nurse. We’ve done the research we don’t feel safe about it”, Greensboro Moses Cone Hospital protest, Over half employees vaccinated

Cone Health nurses protesters on mandated Covid19 vaccinations: “I’m a nurse. We’ve done the research we don’t feel safe about it”, Greensboro Moses Cone Hospital protest, Over half employees vaccinated

“two papers published May 19 in the journal of Hospital Pediatrics found pediatric hospitalizations for COVID were overcounted by at least 40%, carrying potential implications for nationwide figures used to justify vaccinating children.”...The Defender

“it is universally known that children virtually never die from COVID-19 and given that children have a very strong immune system, they are more likely than adults to have an over-reaction to the shot.”…Dr. Steven Roth

“There is not yet enough evidence on the use of vaccines against COVID-19 in children to make recommendations for children to be vaccinated against COVID-19. Children and adolescents tend to have milder disease compared to adults. However, children should continue to have the recommended childhood vaccines.”…WHO

Over half of the Cone Health employees have been vaccinated.

Obviously if the vaccines were proven to be safe and effective, more of the employees would have been vaccinated.

From News 2 Greensboro, NC July 29, 2021.

“Healthcare workers protested in front of Moses Cone Hospital about the vaccination requirement.

Protesters started gathering Thursday morning around 10 a.m. along North Church Street in Greensboro.

Cone Health announced the requirement last week, which takes effect starting July 30. Employees will have until October 1 to become fully vaccinated with a deadline of October 8 to submit the proof of vaccination.

Cone Health said employees can apply for medical and religious exemptions.

In a statement released Thursday, Cone Health said, “We value our team members’ rights to voice their concerns. At the same time, we remain steadfast in our decision to require the COVID-19 vaccine because keeping our patients and communities safe at all times is at the core of our values and our commitments.”

Protesters had signs, music and even megaphones to have their voices heard.

“We don’t feel safe about that. We’ve done our own research as nurses. I’m a nurse. We’ve done the research we don’t feel safe about it ourselves. we love what we do we want to keep doing what we do, and we want to have a choice. if we get it great if we don’t want to get it that’s great too,” said one nurse, who didn’t want to be identified in fear she’d lose her job.

Another healthcare worker said she isn’t ready to get the shot just yet.

“I’m just not ready to get the shot yet. I might get it later, but I’m just not ready to get it by September and I don’t want to lose my job just because I’m not ready to do something yet,” she said.”

Read more:

https://www.wfmynews2.com/article/news/local/greensboro-healthcare-workers-protesting-the-covid-19-vaccine-cone-health/83-1c066367-59eb-44dd-9471-a3366f09893d?ref=exit-recirc

Vaccine Risk/Benefit

Opinion piece illustration fot the Wall Street Journal by Ladapo and Risch

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