FDA Waives Clinical Trials for Boosters Ensuring a Perpetual Pandemic. Policy of Shots First, Questions Later, Is Not Informed Consent
Yes, you read that right. No trials. I mean, why bother? Science is now simply done by press release.
**UPDATE July, 2022**
Now we learn that the WHO is helping the FDA through “Future Framework” skip further COVID shot clinical trials and that the Bill & Melinda Gates Foundation is the biggest voluntary contributor to the WHO, so Gates is likely directing the play.
Important points:
- Moderna, Pfizer and Novavax are developing reformulated COVID-19 shots to target the original Omicron strain (BA.1) which has been replaced by newer variants.
- They know that the FDA is not going to look at health outcomes so they are going to great lengths to jack up the antibody response.
- Pfizer tested a double-strength dose (60 mcg of mRNA instead of 30 mcg) even though they had previously ruled out a higher dose because of safety concerns. So the antibody levels are through the roof.
- VRBPAC admitted that there are no known correlates of protection (antibody levels do not tell you who will be immune) so antibody measures are medically meaningless.
- Turbo charging the immune response may also turbo charge adverse events. But the “Future Framework” allows pharmaceutical companies to skip clinical trials altogether.
- The FDA is not looking out for worst case scenarios.
https://childrenshealthdefense.org/defender/fda-future-framework-covid-vaccines
FDA Panel Votes to Waive Clinical Trials for New COVID Boosters
The U.S. Food and Drug Administration’s vaccine advisory panel voted 19 to 2 on Tuesday to add an Omicron component to COVID-19 boosters this fall, over objections by panel members and despite a lack of data.
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.
(See link for article)
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**Comment*
Even 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 broke from the panel to vote against the initiative.
You know it’s bad when Offit finally puts his food down. He’s as pro-vaccine as you can get.
Two other little flies in the ointment are that by the time a subsequent booster is approved, it will contain outdated strains, as well as the fact they admit there’s no established correlate of protection, and that while antibody data is important so are the T-cells, which they simply don’t understand yet and which are “difficult to study.”
But problems & unknowns be damned and full-steam ahead!
Dr. Nass brings up yet another sticky point: the fact they will likely keep the current version and add another — which might double the amount of mRNA. Nobody seems to know.
Dr. Brian Hooker states this FDA action 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. Dustin Bryce, with Interest of Justice, said the FDA, CDC WHO 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.” “Gene therapies are still being studied and are experimental at this time.”
Bryce went on to state that gene therapy, unlike a vaccine, is so inherently unsafe the FDA 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 states we require due process, forbid the FDA from authorizing the proposed changes and demand that EUA is promptly revoked due to unreasonable risks in gene therapy products as evidenced by the large numbers of adverse events reports. He also states 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.
Some other sticky points:
- The FDA receives approximately 75% of its budget from Big Pharma
- Pfizer has paid the world’s largest criminal fine
- Moderna, has never made a safe product before we did away with long-term safety testing
- Dr. Feintuch asked the FDA to prove the spike protein doesn’t go systemically into the body. He states:
“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.”
Another important quote:
“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.”
“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?” ~ Dr. David Wiseman, research scientist with a background in pharmacy, pharmacology and experimental pathology
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**Comment**
Well this way they won’t have to deny and/or ignore those who pick apart the science, because now there simply isn’t any to pick apart.
BTW: the mantra the ‘powers that be’ continue to regurgitate is that these injections keep you from a severe case of COVID. Now, a another study decimates this notion.
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https://popularrationalism.substack.com/p/a-perpetual-pandemic-is-on-the-way
A Perpetual Pandemic is On the Way Thanks to Planned New COVID-19 Vaccines and FDA’s Insanity
FDA will allow Moderna & Pfizer to update the variants targeted by their mRNA injections and require no new studies. What’s even more insane? Their “updates” will ensure a Perpetual Pandemic.
Did you know that in their insane new framework, US FDA will allow them to change variants w/no new science?
Also – the new vaccines will include mRNA encoding the original, extinct Wuhan-1 spike protein – ensuring a forever pandemic.
(See link for article)
For more:
- https://madisonarealymesupportgroup.com/2022/06/29/heroic-mom-exposes-junk-covid-shot-data/
- https://madisonarealymesupportgroup.com/2021/09/01/lies-damned-lies-vaccine-statistics/
- https://madisonarealymesupportgroup.com/2022/03/29/researcher-blows-whistle-on-data-integrity-issues-in-pfizers-covid-shot-trial/
- https://madisonarealymesupportgroup.com/2021/11/03/another-whistleblower-promptly-fired-for-showing-pfizer-falsified-data-got-science-are-you-sure/
- https://madisonarealymesupportgroup.com/2022/06/22/cdc-admits-it-never-monitored-vaers-for-covid-vaccine-safety-signals-pfizer-classified-nearly-all-adverse-reactions-as-not-related-to-shots/
- https://madisonarealymesupportgroup.com/2022/06/24/worse-than-the-disease-reviewing-some-possible-unintended-consequences-of-mrna-vaccines-against-covid-19-fda-cdc-lying-about-vax-deaths-injuries/
- https://madisonarealymesupportgroup.com/2022/06/27/more-misinformation-from-cdcs-walensky/
- https://madisonarealymesupportgroup.com/2020/12/21/warning-3150-injuries-in-1st-week-of-covid-vaccines-among-american-healthcare-workers-pregnant-women-included/ Latest VAERS data and mounting list of adverse reactions & death
https://standforhealthfreedom.com/federal/public-comment/
The FDA’s policy of shots first, questions later, does not allow for informed consent
On June 28, 2022, FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) met to vote on COVID strain replacement in the shots. Stand for Health Freedom was selected to make oral public comment at the meeting. We took this opportunity to remind the federal government of American’s fundamental right to informed consent in medical decisions. This right does not disappear when a pandemic is declared. Listen and read below for full text of the comment made, with references.
Go here to listen to 3 Min. statement: https://odysee.com/FDA_SHF_comment:56ddc5ccee578dd3558613d87fcff614a5405207?src=embed
Written prepared statement:
Thank you for this opportunity to comment. My name is Valerie Borek, I am Policy Analyst for Stand for Health Freedom, a national grassroots organization of over a half million Americans who are advocates for informed consent and no medical mandates.
Americans have a Constitutional right to informed consent. I urge you to uphold your mission to ensure safety and efficacy of COVID shots before voting on strain replacement without FDA-reviewed clinical trials.
Informed consent requires disclosure of risks, benefits, and alternatives, in terms a patient or guardian can understand – they must be able to ask questions and get answers from providers who have the information they need to answer those questions.
The FDA claims Americans aren’t entitled to informed consent for EUA products, but this is not true. Health professionals have a duty to their patients, including informed consent. EUA products are not fully approved by the FDA and are therefore experimental, requiring informed consent under US law.
In one of the first US Supreme Court Cases addressing COVID policy the Court affirmed that, quote, “We don’t cut the Constitution loose in a pandemic.” Chief Justice Roberts wrote, “As more medical and scientific evidence becomes available…courts should expect policies that more carefully account for constitutional rights.”[i] End quote.
Over the last two years the FDA has lowered their standards. Using antibody response instead of effectiveness when you do “not have the clinical data that we’d all love to have,” to quote Dr. Rubin in the April VRBPAC meeting[ii], is not legally, medically, or scientifically sound. Regarding waning immunity and boosters, Dr. Weir admitted, quote, “there’s just an awful lot we don’t know.” Dr. Meissner asked why SARS-CoV-2 mutates more than other viruses, and was told the spike protein in the shots is “driving the rate of evolution,” in other words, the shots made the mutations–yet the FDA has not investigated this. In CDC’s ACIP meeting on June 23, members asked about the difference between the Pfizer and Moderna formulations for our babies and toddlers, but no one could answer. This is not informed consent.
The FDA has not explored known potential risks, which is required for an EUA, and therefore cannot legally authorize any shots. The FDA is ignoring massive safety signals from VAERS, and reports of injury or death from shots, made in advisory committee meetings, in congressional hearings, and in the federal register. The shots were rushed at “Warp Speed,” with expedited FDA review, and clinical trials are ongoing through 2024. There is no long-term safety data for this novel mRNA technology.
The FDA has not addressed data fraud allegations made by Dr. Peter Doshi[iii], or Pfizer employee Brook Jackson[iv], nor has it answered US lawmaker concerns about authorization of shots for babies and toddlers. Studies were unblinded, confusing data, and eliminating controls. VRBPAC and ACIP members continually say they need more information about natural immunity and safety. How can the FDA tell parents or doctors that benefits outweigh the risks when you do not know the risks?
Even less is known about strain replacements for COVID shots. Americans need this missing data to make informed medical decisions. The more trustworthy your data, the more confidence Americans can have in your advice.
It is illegal for the FDA to authorize COVID shots without adequate safety or efficacy data. The FDA’s policy of shots first, questions later, does not allow for informed consent. On behalf of Stand for Health Freedom, I thank you for your time.
The advisory panel voted 19-2 to update the COVID boosters with the omicron strain genetic sequence. Check out the this Toby Rogers interview on CHD’s “Good Morning CHD” for a detailed recap of the meeting.
Take Action
Step One: Tell your governor to protect your family’s constitutional rights by standing up to federal overreach through public health agencies. The people can overrule the FDA and CDC!
Step Two: We can stop medical tyranny by voting people into office who will stand for health freedom! To have good candidates on the ballot in November, we must vote now in the primaries. Check out where your candidates stand using our Vote for Health Freedom Guide for your state! Go to our Vote for Health Freedom page, or Text the letters VHF to 52886, to learn about candidates in your area!
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References & Sources
[i] Roman Catholic 591 US ___2020, Dissenting opinion.
[ii] https://www.fda.gov/media/158030/download
[iii] https://blogs.bmj.com/bmj/2021/01/04/peter-doshi-pfizer-and-modernas-95-effective-vaccines-we-need-more-details-and-the-raw-data/
Madison Area Lyme Support Group 
