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FDA Bypasses Advisory Panel, Ignores Data & Lowers Efficacy in Order to Authorize COVID Booster For Kids

https://www.medpagetoday.com/infectiousdisease/covid19vaccine

A third dose of Pfizer/BioNTech’s COVID-19 vaccine is authorized for kids ages 5 to 11 years, the FDA announced on Tuesday.

The third 10 μg dose may be administered to children at least 5 months after the initial primary series under the terms of the emergency use authorization (EUA), the agency said.

“While it has largely been the case that COVID-19 tends to be less severe in children than adults, the Omicron wave has seen more kids getting sick with the disease and being hospitalized, and children may also experience longer term effects, even following initially mild disease,” said FDA Commissioner Robert M. Califf, MD, in a statement.  (See link for article)

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**COMMENT**

The FDA didn’t even bother to meet prior to the EUA. This is almost laughable if the consequences weren’t so dire.

Please watch this brief 12 minute video to learn that Dr. Marks lowered the 50% efficacy threshold at blocking symptomatic infection, which means they dropped a former FDA guidance requirement for EUA designation.  The latest cumulative mortality data from 46 states show ZERO COVID child deaths. Weiler recommends we each send his article to our Congressional Reps TODAY.

And go here to listen to Dr. Prasad discuss dropping the 50% efficacy requirement for EUA.

• Dr. Weiler corrects Prasad’s false claim of 95% efficacy in the RCTs on adults (it was 75% if you include people who received a COVID-19 diagnosis before the second dose). He also neglects to point out that efficacy has dropped to less than zero in vaccination studies against recent variants, and that later studies only had to show antibody levels, which we know are short-term, unreliable measures of immunity.

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https://childrenshealthdefense.org/defender/fda-pfizer-booster-kids-third-dose

FDA Authorizes Pfizer Booster for Kids 5 to 11, Bypasses Advisory Panel

By Megan Redshaw

5/17/22

The U.S. Food and Drug Administration today granted Emergency Use Authorization for Pfizer’s COVID-19 booster for children ages 5 to 11, without convening its vaccine advisory panel and despite the latest data showing higher case rates in vaccinated children compared with those not vaccinated.  (See link for article)

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Important Points:

• Booster approval is based on a study of 67 children showing antibody levels, which is a short-term and unreliable measure of immunity.  Further, this subset is not large enough to detect potential adverse events like myocarditis. Participants were only followed for 28 days.
• There are NO studies testing the efficacy against the current COVID strains.
• Two new studies show that for the vaxxed that get Omicron, infection provides better protection against future infections than a second booster.
• FDA Director of the Center for Biologics Evaluation and Research, Dr. Peter Marks, admits data increasingly show protection provided by two shots wanes over time, but believes “benefits outweigh the risks.”
• Pfizer has not published its actual data, precluding experts from conducting analysis.
• FDA’s Peter Marks told Congress the shots for youngest kids don’t need to hit 50% efficacy threshold.
• A study in JAMA showed protection from Pfizer’s shot turns negative among kids five months after receiving a 2nd dose, with recipients were more likely to get COVID-19 five months after being “vaccinated”.  Protection against hospitalization also waned significantly over time.
• The Moderna shot also delivered more risk than benefit in trials for kids, and the study was also too small to assess known adverse events, yet the FDA also is fixated on authorizing it as well.
• And while the FDA limits the J&J shot over blood clotting, experts state Pfizer and Moderna shots pose similar risks.
• Most non-randomized studies attempting to determine vaccine efficacy had “common flaws,” giving them biases towards overestimating any clinical benefit. Flaws include:
  • no accounting for baseline prior COVID-19 infection
  • no reporting for those who received a booster within a six-month time window
  • no adjudication of hospitalization or death due to COVID-19 or other conditions

Dr. Weiler admonished us not to get distracted with the news cycle which is rigged to shock and distract us from what really matters.  Excerpt:

Don’t be distracted. Stay on focus: The move to approve COVID-19 vaccines for kids under 5 is necessary for the states to begin to mandate COVID-19 vaccines, and then all vaccines, for all children under the age of 5 – before parents begin comparing notes on vaccines for school entry.

FDA postponed the decision given insufficient (unconvincing) data. But there cannot be any convincing new data that shows individual benefit for kids under five from the COVID-19 vaccines… they do not stop transmission; under any reality-based analysis, vaccines do not stop COVID-19; kids do not get COVID-19 or die from COVID-19.

What type of evidence of individual benefit could Pfizer/Moderna/FDA cook up in two months’ time?

• Will they show that individual children have decreased risk of death from COVID-19?
  • No, the vaccines being studied are targeting an extinct virus.
• Will they show that Will they show that individual children have decreased risk of hospitalization from COVID-19?
  • No.
• Will they show decreased transmission in this population?
  • No, Dr. Fantini’s results show INCREASED transmission due to vaccination against Wuhan-1 since the emergence of Beta, Gamma, Delta and Omicron.

The FDA will be able show data on antibodies. Period. Antibodies against an extinct variant, Wuhan-1.

• The participants in the study will likely not be screened for prior immunity to COVID-19 from either natural infection, or from prior infection to viruses that confer cross-protection.
• And the study will be adjusted for outcomes-related confounders, if necessary (p-hacking).

And we know that antibodies do not tell the full story.

The only good news is that parents are increasingly reluctant to give these clot shots to their kids.

And rightly so.

Take a gander at the latest VAERS data and the mounting list of adverse reactions and death.

MUST SEE Global COVID Summit Highlights

https://thehighwire.com/videos/highlights-global-covid-summit/  Video Here (Approx. 8 Min)

Highlights: Global COVID Summit

SUMMARY:

• Many are now questioning “vaccine” efficacy and safety
  • Further, a Pfizer whistleblower has warned of clinical trial fraud and data integrity issues.
  • A former BlackRock advisor has exposed that Pfizer and the FDA hid data showing the clinical trials failed.
  • Pfizer and the FDA tried to withhold the trial data for 75 years – also suggestive of fraud.
  • And now, an Argentinian trial site (1231), somehow managed to recruit 10% of the total participants in 3 weeks without a contract research organization also suggesting fraud.
  • Dr. Polack, lead investigator for trial site 1231 just happens to be a consultant for the FDA‘s Vaccines and Related Biological Products Advisory Committee (RBPAC), an investigator for Fundacion Infant, funded by the Gates Foundation, and the first author of Pfizer’s paper, “Safety and Efficacy of the BNT162b2 mRNA COVID-19 Vaccine” published in 12/21. Well, now it doesn’t get any cozier than that.  Steve Kirsch goes through it in this 16 min video.
• Many are questioning the rushed COVID injections, specifically Dr. Robert Malone, inventor of mRNA and DNA “vaccines” and who discovered the lipid mediated and naked RNA transfection technologies.
• Doctors recently held a press conference on May 11, 2022 for the Global COVID Summit (GBS) which started in Oct of last year and which has had three previous declarations.  This group has grown to over 17,000 doctors from around the world. Their main goal is to restore scientific integrity.
• Interestingly and ironically, after the GCS was held, the Biden administration put together their own Global COVID Summit with a 6 minute press conference where Biden said the word “vaccine” eight times, with an emphasis on how the “vaccine” is our only way out of the pandemic despite failing miserably, and despite the fact there are cheap, effective, safe treatments.
• The press conference begins at 3:45 where the group announced:
  • the mission of GBS is to ‘end this orchestrated crisis & to formally declare that the actions of this corrupt alliance constitutes nothing less than crimes against humanity.”
  • “We declare and the data confirm that the COVID-19 experimental genetic therapy injections must end.” These products do not prevent infection, replication, and transmission of Omicron. The vast majority of COVID infections are in the “vaccinated.”
  • “We declare doctors should not be blocked from providing life-saving medical treatment.” Had early treatment not been blocked, millions would be alive today.  The FDA can agree or disagree, it doesn’t matter – it doesn’t change the science.
  • Dr. Brian Tyson states, “Never have I seen a policy to say, ‘Let’s hedge on the side of doing nothing compared to something with safe and effective drugs.'”
  • “We declare the state of National Emergency, which facilitates corruption and extends the pandemic, should be immediately terminated.”  The emergency phase of the pandemic is over. Only doctors can declare this.
  • “We declare that medical privacy should never again be violated; all travel and social restrictions must cease.  All personal data must be expunged from non-HIPAA compliant data-bases.”
  • “We declare that masks are not and have never been effective protection against an airborne, respiratory virus in the community setting.”  The CDC nor OSHA recognizes these facial coverings as PPE, yet NY just issued an alert advising people to wear masks, and the ever corrupt and laughable CDC states 50% of all Michiganians should mask up inside.
  • “We declare that funding and research must be established for ‘vaccine’ damage, death, and suffering. Public health officials have ignored the early warnings of negative efficacy that were evident even over a year ago.”
  • “We declare that no opportunity should be denied, including education, military service or medical careers, including medical treatment, over unwillingness to take an injection. ‘Vaccination’ status has become a new form of discrimination and it needs to stop.”
  • “We declare that the 1st Amendment violations and medical censorship by government, technology, and media companies should cease and the Bill of Rights be restored.”
  • “We declare that Pfizer, Moderna, BioNTech, Janssen, AstraZeneca and their enablers withheld and willfully omitted safety and effectiveness information from patients and physicians and should be immediately indicted for fraud.
  • “We declare government and medical agencies must be held accountable.”
  • The group then asks us to demand change, accountability, integrity, and respect to rebuild our community.

Go here for the hour long GCS Declaration IV: Restoring Scientific Integrity.

To see a longer discussion on why these doctors aligned to form the Global COVID Summit, and their tireless mission to spread truth and restore scientific integrity, please see the following May 13 video:  https://thehighwire.com/videos/malone-cole-urso-a-doctors-roundtable/

New Study & Confidential Pfizer Docs Prove COVID ‘Vaccine’ Shedding Has Been and Still is Occurring With Dangerous Consequences

https://expose-news.com/2022/05/10/study-confidential-covid-vaccine-shedding/

New Study & Confidential Pfizer Docs. prove COVID “Vaccine Shedding” has been and still is occurring with dangerous consequences

A new study conducted by scientists at the University of Colorado confirms the vast majority of humanity have had absolutely no choice in the matter of whether they wish to get the Covid-19 injection or not because the vaccinated have been transmitting antibodies generated by the injections through aerosols.

The findings should however come as no surprise, because a confidential Pfizer document had already confirmed exposure to the mRNA injections was perfectly possible by skin-to-skin contact and breathing the same air as someone who had been given the Covid-19 jab.

Important excerpts:

This also adds weight to the claims made by Dr Phillipe van Welbergen, who demonstrated that graphene, an alleged undisclosed ingredient of the Covid-19 injections, is being transmitted from the vaccinated to the unvaccinated and destroying red blood cells, & causing dangerous blood clots.

This means Covd-19 vaccine shedding is perfectly possible when we take into account a study performed on behalf of Pfizer in Japan.  The study observed the distribution of the Covid-19 injection in the bodies of Wister Rats over a period of 48 hours. One of the most concerning findings from the study is the fact that the Pfizer injection accumulates in the ovaries over time. The highest concentration was noted in the liver. But it also accumulates in the salivary glands on the skin.

Pfizer admitted as much in their ‘A PHASE 1/2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, IMMUNOGENICITY, AND EFFICACY OF SARS-COV-2 RNA VACCINE CANDIDATES AGAINST COVID-19 IN HEALTHY INDIVIDUALS’ document.

The document contains a whole section covering the possibility of ‘mRNA vaccine shedding’ in which it is possible for those who have been in close proximity of someone who has had the Pfizer mRNA jab to suffer an adverse reaction. (See link for article)

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SUMMARY:

• Dr. van Welbergen released images of blood samples of vaxxed patients after they started complaining about chronic fatigue, dizziness, memory issues, even sometimes paralysis and late onset of heavy menstruation (women in their 60s upwards).  News report shows thousands of women reporting severe menstrual side-effects.
  
• Their blood had unusual tube-like structures and particles which lit up, as well as many damaged cells, with few healthy cells visible. Until three months earlier, he had never seen these formations in blood.
• In Feb. 2022, he presented images showing his unvaccinated patients had been “infected” with “vaccine” toxins through shedding, including what is allegedly graphene.  A full review of his slides can be viewed here. Go here for a short clip.
• Graphene is organizing and growing into larger structures, gaining magnetic properties or an electrical charge.
• “Shards” of graphene are being transmitted from “vaccinated” to the unvaccinated destroying their red blood cells and causing blood clots.

Meanwhile, corrupt public health authorities are blaming COVID.

WHO & Global Predators Plot Global “Health” Tyranny

The first major deadline to stop the WHO power grab is May 22, 2022 before their meeting in Geneva.

The first and most urgent assault on liberty and self-government involves a series of 13 controversial amendments being proposed by the Biden administration to the WHO’s so-called International Health Regulations (IHR). The details of the amendments were only released publicly — and very quietly — about a month ago.

https://thenewamerican.com/who-global-predators-plot-global-health-tyranny

WHO & Global Predators Plot Global “Health” Tyranny

Dr. Breggin and his wife wrote the book “COVID-19 and the Global Predators: We Are the Pray”

In fact, COVID tests are being regularly recalled due to contamination, lack of data, and inaccuracies.

Yet, the drum beats on.  Truth, data, and ethics don’t matter.

But, it doesn’t stop there.

“issues directives that were totally not commensurate to the situation.”

“They are so sneaky,” she said. “They are going to take the instrument that will be adopted the quickest, and the instrument likely to be adopted the quickest is the International Health Regulations.”

“We have to be liberated from the United Nations,” said Stuckelberger before urging everyone to contact their elected officials, attorneys, and others in a bid to derail the WHO power grab. ~ Dr. Astrid Stuckelberger

Sign this Petition support H.R. 419 to defund the WHO and its power grab which violates the U.S. Constitution and our freedoms.

• https://madisonarealymesupportgroup.com/2022/04/04/the-chilling-reason-they-wont-declare-the-pandemic-over-creation-of-the-pandemic-treaty/
• https://madisonarealymesupportgroup.com/2022/04/15/who-pandemic-treaty-supersedes-constitution/
• https://madisonarealymesupportgroup.com/2022/05/10/the-global-pandemic-treaty-what-you-need-to-know/
• https://madisonarealymesupportgroup.com/2022/04/26/the-who-is-an-absolutely-corrupt-organization-that-needs-to-go-away/
• https://madisonarealymesupportgroup.com/2021/07/29/corruption-in-public-health-and-beyond-is-rampant-warns-fed-turned-whistleblower-how-they-pull-in-millions-from-licensing-deals-including-covid-related-technologies/