A New Low for the FDA

vaccinetruthhttps://trialsitenews.com/a-new-low-for-the-fda/August 23, 2021
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An Op-Ed By: VaccineTruth

Note that views expressed in this opinion article are the writer’s personal views and not necessarily those of TrialSite.

Today, August 23, 2021, the FDA approved the Pfizer COVID19 vaccine in spite of the following issues:

1. The vaccines are more likely to kill you than save you. The clinical trial (gold-standard medical research) evidence to date shows the vaccine kills more people than it saves (including Pfizer’s own 6 month randomized study which demonstrated a 7% higher overall death rate for those administered the vaccine. The vaccine reduced COVID deaths by 50%, however this came at the cost of increasing deaths from cardiac arrest and other causes, so that the net benefit is negative, i.e., the vaccine is more likely to kill you than save you. For example, Pfizer’s own study showed deaths from COVID were reduced by a factor of 2, but this saving was more than offset by deaths from cardiac arrest which went up by 4X. This is not a good tradeoff. The safety data in VAERS compared with the CDC data on mortality for different age cohorts also confirms that the vaccines are more likely to harm than help.
2. No autopsies have ever been done in the US on patients who die after getting the vaccine to determine if the vaccine contributed to the death. It is astonishing there are 13,068 death reports in VAERS without even a single autopsy being done in the US and nobody in academia, Congress, or the mainstream media has called for autopsies. Autopsies are a huge risk for them because if they are done, people will realize just how unsafe these vaccines really are. 
3. Pathology reports from one of the world’s top pathologists showed that at least 30% of the deaths within 2 weeks of vaccination were due to the vaccine. He was immediately criticized by people who never examined the bodies!?! Calls by the Federal Association of German Pathologists to require autopsies in vaccinated patients who have died have been ignored by the German authorities. They don’t want to find out the truth either because once people learn how deadly the vaccines are, nobody will want to be vaccinated.
4. No analysis has been done of the obviously elevated neurological and cardiovascular events in the VAERS system (see table below). How can a safe vaccine cause all of these events to skyrocket vs. previous years?
5. A broken formula for adverse-event signal detection keeps the CDC from detecting safety signals that would alert the CDC of a problem with the vaccines. The CDC will not meet with us to discuss this serious error. They have no interest in seeing safety signals, so maintaining an obviously broken system gives them all plausible deniability.
6. A callous disregard for the health of our children. There are 18 deaths in VAERS for kids between 12 and 17. Five of those deaths are from cardiac arrest and none are from cancer. Yet the CDC says deaths from cancer are twice as likely than deaths from heart disease for teenagers. So the vaccine is clearly killing our kids by elevating cardiac arrests way above normal. Ignoring this is tragic. This UK article points out that just 1 in every 1.7 million children have died with Covid-19 in 18 months, while 1 in every 9 children suffered a serious adverse reaction to the Pfizer vaccine in the small and short clinical trial which left them unable to perform daily activities. Mothers should be absolutely furious about this data being hidden from them.
7. Refusal to listen to scientifically qualified VAERS experts who had analyses showing the vaccines were extremely unsafe, including Dose 1 vs. Dose 2 causality analyses that clearly showed the vaccines were causing significant adverse events. Dose-dependency is a very clear sign of causality but the FDA and CDC refuse to look at the data.
8. Failure to investigate clinical trial fraud such as 12-year-old Maddie de Garay, paralyzed in the Pfizer clinical trial, despite assurances by the head of the FDA that this would be investigated. The Pfizer clinical trial reported Maddie’s adverse event as abdominal pain with no mention of her severe neurological issues. 
9. An American death toll estimate of 150,000 can be calculated 5 different ways (and the FDA and CDC wouldn’t look at any of them).
10. Lack of any safety data on original antigenic sin aka linked-epitope suppression and ADE. In short, these vaccines may make the disease worse, not better, and the FDA knows both of these are risks, but the FDA isn’t waiting for the data to find out. In addition, there was never a proper safety study that measured the amount, duration, and distribution of the cytotoxic spike protein in non-human primates. 
11. A safer, more effective alternative exists: early treatment. Early treatment protocols, such as the Fareed-Tyson protocol have more than a 99% relative risk reduction, work for all variants, and have negligible side effects making them safer and more effective than any vaccine. The NIH and FDA ignore these early treatments.
12. Too many open questions about the vaccine that still need to be answered. Peter Doshi’s excellent op-ed in the BMJ points out that the list of concerns is now even longer than before, and the fact that the FDA did not seek input from the advisory committee as they had promised to do, is extremely troubling for a drug that is now being mandated.
13. Use of censorship, rather than open public discussion, to help the public discover the truth about these vaccines. We have 16 experts covering all aspects of COVID. Nobody in the world from academia or any government agency will publicly engage with us on any topic related to vaccine safety. Instead, they censor us. What are they all afraid of?

We are basically using people of the world as guinea pigs in the largest scientific clinical trial ever, a trial with no “stopping condition” due to the number of deaths caused by the vaccines. No IRB would allow any clinical trial to exist without a death-stopping condition. What’s even more amazing is that not a single member of the medical establishment has a problem with the lack of a death-stopping condition on the vaccine. We remember that back in 1976, the H1N1 vaccine was stopped after just 35 deaths. Today in 2021, 150,000 deaths caused by these vaccines is not even large enough to notice.

However, the FDA doesn’t deserve all the credit. A number of other groups contributed to this remarkable “accomplishment”:

1. The CDC ACIP members, charged with safety monitoring, refused to listen to any evidence that there might be a safety problem with the vaccines or a problem with their safety signal monitoring algorithm.
2. Medical academia who refused to demand autopsies on people who died within 2 weeks after vaccination, refused to demand a death-stopping condition for the EUA, refused to look at the VAERS data, and refused to openly debate anyone with divergent views (such as our team). The Stanford team who did listen to our concerns said they could not dispute what we said but that it didn’t matter because the decision on mandating vaccination for students was made at a higher level.
3. Medical journals who refused to publish papers that went against the narrative even after peer review and galley proofs were accepted.
4. Mainstream media that ignored vaccine victims, including Maddie de Garay, even though this was clear clinical trial fraud. They refused to give any voice to qualified people such as Robert Malone and Peter McCullough.
5. Social networks including YouTube, Facebook, and Twitter who did a marvelous job censoring anyone who has views that are different from the narrative espoused by the CDC, WHO, and US government. For example, when people in the Facebook vaccine side effects group started pointing out that the drug companies made it difficult-to-impossible to report adverse events in the Phase 3 clinical trials, Facebook removed the groups so that all evidence of clinical trial fraud would be covered up and so that vaccine victims would never discover that hundreds of thousands of other people had been disabled by the vaccines.
6. Members of Congress and their staff for refusing to seriously listen to any constituent who brought up legitimate safety concerns with the vaccines that were backed with primary data. Rather than explain how the evidence presented could possibly be consistent with a safe vaccine, the Members and their staff simply told their constituents that they were wrong and refused to read the evidence presented to them.

Today, all of these groups are proud of what they have accomplished: a coordinated effort to suppress legitimate scientific evidence and dissent through censorship and intimidation and approve a vaccine that has caused enormous death and disability in America that has no scientific evidence whatsoever of an all-cause mortality benefit.

It’s a sad day in America

We salute scientists and doctors who are not afraid to speak out like Dr. Robert Malone, Dr. Peter McCullough, Dr. Geert Vanden Bossche, Dr. Sucharit Bhakdi, Dr. Bret Weinstein, Dr. Byram Bridle, Dr. Chris Martenson, Dr. Ryan Cole, Dr. Charles Hoffe, Dr. Francis Christian, Dr. Sin Hang Lee, Dr. Jessica Rose, Dr. Tess Lawrie, as well as courageous journalists including Del Bigtree, Joe Rogan, and former NY Times reporter Alex Berenson, and others who are the real truth tellers here. 

America should be listening to and embracing all of these people, not ignoring them.

Finally, here is a table of elevated adverse events that was extracted from the VAERS system. Anyone can replicate this table. The methodology is described starting on page 41 of this document. This is not a complete list. What this table shows is that this is the most deadly vaccine ever produced in modern times. Every cardio and neurological symptom we looked at was elevated. These events are consistent with the mechanism of action of the vaccines (causing a cytotoxic spike protein to be produced inside all organs). No vaccine in recent times has a breadth of impact as wide as these vaccines. 

Thanks to the FDA and others, we’ll now be mandating these very deadly vaccines for all our kids.

In this chart, the numbers in the right hand column indicate the factor over “normal” that the symptom is elevated, so 473 means 473 times higher than the average annual reporting rate in VAERS over the past 5 years (from 2015-2019 for ages 20 to 60), The spelling matches the VAERS symptom spelling and the searches were done on the SYMPTOM field which is coded by HHS and not the reporter.
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Symptom	Incidence rate elevation over normal (X factor)
Pulmonary embolism	473
Stroke	326
Deep vein thrombosis	264.3
Thrombosis	250.5
Fibrin D dimer increased	220.8
Appendicitis	145.5
Tinnitus	97.3
Cardiac arrest	75
Death	58.1
Parkinson’s disease	55
Slow speech	54.3
Aphasia (inability to talk)	52.3
Fatigue	50.9
Pericardial effusion	50.5
Headache	46.4
Chills	45.6
Pericarditis	44.9
Deafness	44.7
Myocarditis	43.2
Haemorrhage intracranial	42.5
Abortion Spontaneous	41.3
Cough	38.5
Bell’s Palsy	36.6
Paraesthesia	29.5
Blindness	29.1
Dyspnea (difficulty breathing)	28.4
Myalgia	28.4
Dysstasia (difficulty standing)	27.8
Seizure	27
Anaphylactic Reaction	21
Suicide	18.3
Speech disorder	17.2
Convulsion	16.3
Thrombotic thrombocytopenic purpura (TTP)	16.3
Paralysis	16
Swelling	14.3
Diarrhoea	11.9
Neuropathy	11.2
Multiple organ dysfunction syndrome	11.1
Depression	8.9

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