“When you risk life and limb to help test a drug, are you helping science—or Big Pharma?”–Carl Elliot, Mother Jones, 2010
They were rushed and not tested well.
The vaccines went even faster than the bottom chart. The first COVID case hit the United States January 21, 2020. We had no idea it would be a pandemic, nor had such a statement been declared. March 13, 2020, is when President Trump declared a national emergency. Three days later, Moderna was injecting their experimental vaccine in humans. The virus wasn’t even identified in China until January 1, 2020, yet somehow, pre-clinical trials happened on the Moderna vaccine by March 16?! They usually take approximately 556 days!
- Anybody can read the CDC’s usual protocol for approving vaccines and notice how very different these vaccines have been treated.
- Also useful: The Journey of Your Child’s Vaccine
The FDA stated that they would have the VRBPAC advisory committee look over the vaccine for safety, and then bypassed that committee in the end.
“FDA is also committed to ensuring that data from COVID-19 vaccine trials is reviewed in a transparent, deliberative manner. To this end, the agency intends to convene its Vaccines and Related Biological Products Advisory Committee (VRBPAC) when data from trials becomes available. VRBPAC is one of the many advisory committees at FDA, and is composed of independent experts in the fields of vaccine safety and infectious disease. By convening VRBPAC, FDA will ensure public transparency around discussions of vaccine safety and effectiveness to provide a window into its decision-making process and help address potential concerns from vaccine-hesitant populations.”-August 2020 (Source)
This is from Pfizer’s site about the VRBAC:
“The VRBPAC meeting is a standard part of the vaccine development process. This committee is made up of independent scientific experts that the FDA selects to review and evaluate evidence regarding whether a vaccine or other biological product is safe and effective for its intended use. This meeting is an important milestone in the FDA’s scientific review process to ensure that any investigational COVID-19 vaccine it authorizes for use has been adequately evaluated for safety, efficacy and quality.”OUR COVID-19 VACCINE STUDY – WHAT’S NEXT?
- Article: Two FDA officials stepped down after their advisory committee was bypassed.
- Article: C.D.C. Chief Overrules Agency Panel and Recommends Pfizer-BioNTech Boosters for Workers at Risk
Reported in the British Medical Journal the day before FDA “approval.” “But here we are, with FDA reportedly on the verge of granting a marketing license 13 months into the still ongoing, two year pivotal trial, with no reported data past 13 March 2021, unclear efficacy after six months due to unblinding, evidence of waning protection irrespective of the Delta variant, and limited reporting of safety data.”–Does the FDA think these data justify the first full approval of a covid-19 vaccine?
The FDA has not had any meetings to talk about Pfizer since Dec 10, 2020. They approved it today without a meeting and without any between Dec 10 and now. They’re not discussing the adverse events or deaths at all. You can’t find what you’re not looking for, but that doesn’t mean it’s innocent. August 23, 2021
The trials for the vaccines should have included several safety standards. They should have done blood work before and after, but didn’t. They should have done PCR tests throughout, but didn’t. They should have had trial participants see a physician for someone to look them over–but didn’t. The only “safety” that was reported was when a trial participant logged an issue on an app. And–mysteriously, hundreds of trial participants’ data wasn’t even submitted in multiple final reports. Were those people kept safe? Did they have severe reactions? Did they die? We don’t know.
Senator Ron Johnson was concerned about the lack of safety meeting and wrote a letter to Francis Collins and Rochelle Walensky:
The FDA says that Phase I trials focus on safety. Pfizer’s phase one trial is NOWHERE to be found. There is zero documentation for it. They started on Phase II/III trials on 43,000+ humans in April 2020. It appears as though they completely skipped Phase I.
- Article: CDC DIRECTOR OF VACCINE SAFETY ADMITS TO MAKING “AGENCY POLICIES OR DECISIONS” WITH VACCINE MAKERS
- Video: Dr. Ron Brown Discusses Outcome Reporting Bias in COVID-19 mRNA Clinical Trials
- Article: Waterloo University Dr. Ron Brown, report of Bias in COVID-19 mRNA vaccine
- Article: I was vaccinated in a clinical trial. But officially, my COVID-19 vaccine doesn’t “count”
- Article: FDA REFUSES TO ENFORCE ITS OWN RULES AGAINST MISINFORMATION RELATED TO COVID-19 VACCINES
- Article: Why we petitioned the FDA to refrain from fully approving any covid-19 vaccine this year
- Article: A Citizen Petition with FDA: Immediate Revocation of the Emergency Use Authorizations (EUAs) for COVID Vaccines and Restraint for Licensing Them
- Podcast: Absence of Due Process in COVID-19 Vaccine Approval – Propaganda in Open View, Ang Peng, MD
- Video: DR. BRET WEINSTEIN: ‘PERVERSE INCENTIVES’ IN THE VACCINE ROLLOUT AND THE CENSORSHIP OF SCIENCE
- Video: U.S. Health Officials Jumping Ship
- Video: PFIZER VAX APPROVED BEHIND CLOSED DOORS
- Video: Vaccines and Related Biological Products Advisory Committee – 12/10/2020 You can see excerpts of this meeting here: Hearing Without Listening
“Pfizer vaccine: lack of safety studies
It was felt unnecessary to see how the Pfizer injection affects the brain, kidneys, lungs or heart of people who get it.
“[I]f data from other studies suggest that the vaccine may affect physiological functions (central nervous system, renal, respiratory or cardiovascular system functions), safety pharmacology studies should be incorporated into the toxicity assessment. This does not apply for COVID-19 mRNA Vaccine BNT162b2.”
No studies were done to see how the Pfizer injection reacts with other drugs that we may be taking.
“No PK drug interaction studies have been conducted with COVID-19 mRNA Vaccine BNT162b2.”
No toxicity studies were done on a single dose.
“No single dose toxicity studies have been performed.”
No toxicokinetics studies were done. These are studies that see what happens to a substance when it gets into our body.
“No toxicokinetic studies have been performed with the vaccine.”
No genotoxicity studies were done. These are studies that see if chemicals damage our DNA.
“No genotoxicity studies are planned for BNT162b2.”
No carcinogenicity studies were done. These are studies that determine if a substance causes cancer.
“Carcinogenicity studies with BNT162b2 have not been conducted.”
No studies were done on how the experimental injection affects prenatal and postnatal development in moms or newborns.
“Prenatal and postnatal development, including maternal function. No such studies have been done.”
No studies were done to find out what happens when parents get the injection and their children, born after, also get it.
“Studies in which the offspring (juvenile animals) are dosed and/or further evaluated. No such studies have been done.”
They have no idea whether the experimental injection is safe for pregnant women.
“[S]afe use of the vaccine in pregnant women cannot be provided at the present time.”
No studies were conducted to see how the Pfizer ingredients in the experimental injection are eliminated from our bodies.
“No excretion studies have been conducted with COVID-19 mRNA Vaccine BNT162b2.”British Medicines & Healthcare products Regulatory Agency Decision Summary of the Public Assessment Report for Pfizer/BioNTech COVID-19 vaccine Updated 31 December 2020”
How was Pfizer able to do Phase II/III testing in April 2020, when all other companies were on Phase I/II testing?
The majority of the world was still untouched by COVID-19 and we are still calling it Coronavirus. How were they already at Phase II/III? And, while we are at it, where was their Phase I trial? I can’t find that documentation, please tell me if you can! They had to have started it when barely anyone knew about the virus and it certainly hadn’t had a large death toll yet. It almost feels like an insider trading situation, where they knew what was coming…Help me research this and tell me what you find.
Why Did Vaccine Trials Start When So Few People in the World Had Been Affected By COVID? And, Did the Trials Cause the Spikes?
I find it SO odd that the world had seen very few deaths or even cases when arms were being injected with these experiments. Why did so many thousands of people sign up, when most of us had only just heard of the virus? See these graphics I made:
And when, exactly, were they doing Phase I trials and animal testing before that, etc., if they were injecting arms by March 16, 2020?). Someone said today “Well, they saw what was happening in Wuhan and prepared.” Wuhan is on these graphs. I got them from Worldometer and these are worldwide SARSCoV2 cases and deaths. Wuhan was a tiny blip! They were at an average of 13 deaths per day when the first person was injected. Why inject anyone for a disease that had barely done any damage?!
A big question is–how early were they preparing these vaccines (before March 2020) and how did they know this was coming?
The FDA Skipped the Advisory Committee and Public Comment Usually Required for Licensure
The advisory committee is a big deal, and skipping this provides evidence that this “FDA approval” is smoke and mirrors and meaningless.
FDA approval of a Pfizer product (though not the same one we have stocked in the United States) leads people to the conclusion that the vaccine is totally safe and effective. A CVS spokesman said:
the FDA approval underscores the vaccine’s safety and effectiveness
But this isn’t necessarily the case. Typically, a new medication must go through the FDA’s Vaccines and Related Biological Products Advisory Committee. This committee, which includes 15 voting members and a Chair, does the following:
The Committee reviews and evaluates data concerning the safety, effectiveness, and appropriate use of vaccines and related biological products which are intended for use in the prevention, treatment, or diagnosis of human diseases, and, as required, any other products for which the Food and Drug Administration has regulatory responsibility.
This seems like a pretty important role! It is alarming that the FDA chose to skip this crucial step in the approval of Pfizer’s Comirnaty vaccine.
According to Dr. Robert Malone:
The FDA bypassed/disregarded the normal advisory committee and public comment process for this license. See p2 “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.”FDA Pfizer authorization (Comirnaty): Key points to consider and discuss
The FDA didn’t meet to approve the Pfizer Comirnaty product. In fact, the FDA has not had a meeting since their December 10, 2020 meeting when they gave Pfizer their Emergency Use Authorization. It seems as though the approval of an investigational medication, given to more than 2 million Americans thus far, should have been worth a meeting. In fact, I believe that the FDA should have been meeting regularly since the EUA in order to discuss the safety.