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Re: Coronavirus
https://childrenshealthdefense.org/w...re-800x417.jpg
Comirnaty, Pfizer's COVID-19 vaccine: The name represents a combination of the terms COVID-19, mRNA, community and immunity.
Spikevax, Moderna's COVID-19 vaccine: The first part of the name refers to the “spike” glycoprotein on the coronavirus.
Vaxzevria, AstraZeneca's COVID-19 vaccine: Including the "evri" sound in the name is intended to communicate that the vaccine is for everyone.
Nuvaxovid, Novavax's COVID-19 vaccine: The vaccine's name was designed to share a similar cadence to the drugmaker's name without an explicit association.
Vidprevtyn, Sanofi and GlaxoSmithKline's COVID-19 vaccine: The first syllable of the name likely refers to COVID-19, and the second syllable is likely meant to represent disease prevention, according to the report.
https://childrenshealthdefense.org/d...covid-vaccine/
02/02/22
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COVID › Views
FDA Grants Full Approval of Moderna’s Spikevax COVID Vaccine — Another ‘Bait-and-Switch?’
The U.S. Food and Drug Administration on Monday granted full approval of Moderna’s Spikevax COVID vaccine for people 18 and older. Similar to the agency’s licensing last year of Pfizer’s Comirnaty vaccine, the approval raised a number of legal questions.
By
Michael Nevradakis, Ph.D.
The U.S. Food and Drug Administration (FDA) on Monday granted full approval of Moderna’s Spikevax COVID vaccine for people 18 and older.
Similar to the agency’s licensing last year of Pfizer’s Comirnaty vaccine, the approval raised a number of legal questions related to mandates and product availability.
Spikevax is a two-dose primary series, approved also for administration as part of a heterologous (“mix and match”) single booster dose for individuals who previously completed their original series of vaccinations with the Pfizer or Johnson & Johnson COVID vaccines.
According to the FDA, Spikevax “has the same formulation as the [Emergency Use Authorization (EUA)] Moderna COVID-19 Vaccine and … can be used interchangeably with the EUA Moderna COVID-19 Vaccine to provide the COVID-19 vaccination series.”
However, in its approval letter, the FDA said Spikevax is “legally distinct” from the Moderna EUA vaccine:
“The licensed vaccine has the same formulation as the EUA-authorized vaccine and the products can be used interchangeably to provide the vaccination series without presenting any safety or effectiveness concerns. The products are legally distinct with certain differences that do not impact safety or effectiveness.”
BUY TODAY: Robert F. Kennedy, Jr.'s New Book — 'The Real Anthony Fauci'
The FDA made the same distinction between the Pfizer-BioNTech EUA vaccine and the Pfizer Comirnaty vaccine, which the agency fully licensed in August, 2021, a move that raised questions about liability and the legality of vaccine mandates.
After Monday’s announcement, media outlets were quick to reassure the public the two Moderna vaccines are the same and that this was just a marketing ploy, where Moderna simply “rebranded” what is otherwise the same vaccine.
No ‘fully licensed’ COVID vaccine actually available
While Moderna’s Spikevax vaccine is now fully licensed, the original Moderna vaccine will remain under EUA. Indeed, the FDA on Jan. 7 reissued the EUA.
The FDA has also made it clear the Spikevax vaccine will not be available to the American public, announcing:
“Although SPIKEVAX (COVID-19 Vaccine, mRNA) and Comirnaty (COVID-19 Vaccine, mRNA) are approved to prevent COVID-19 in certain individuals within the scope of the Moderna COVID-19 Vaccine authorization, there is not sufficient approved vaccine available for distribution to this population in its entirety at the time of reissuance of this EUA.”
These claims parallel the chain of events that followed the FDA’s full approval of the Pfizer Comirnaty vaccine in August 2021.
At the time, Pfizer and the FDA claimed Comirnaty was not yet available, as there were sufficient stocks of the Pfizer-BioNTech EUA vaccine still available to be administered.
As of this writing, the FDA states, via its website, that Comirnaty products are “not orderable at this time.”
The FDA has not indicated when, or if, the Spikevax and Comirnaty vaccines will be available for distribution in the U.S.
Are EUA and fully licensed vaccines really interchangeable?
As reported by The Defender, there is a significant legal distinction between products authorized under EUA and those fully licensed by the FDA.
EUA products are experimental under U.S. law. Under the Nuremberg Code and federal regulations, no one can force a human being to participate in this experiment.
Specifically, under 21 U.S. Code Sec.360bbb-3(e)(1)(A)(ii)(III), “authorization for medical products for use in emergencies,” it is unlawful to deny someone a job or an education because they refuse to be an experimental subject. Instead, potential recipients have an absolute right to refuse EUA vaccines.
That’s an issue military members, unable to find any vaccination sites that offer the fully licensed Comirnaty vaccine, cited in various lawsuits challenging vaccine mandates.
Notably, on Nov. 12, 2021, a federal judge rejected an argument by the U.S. Department of Defense, in defending the military’s vaccine mandate, that the Pfizer Comirnaty and Pfizer-BioNTech vaccines are “interchangeable.”
U.S. law also requires the EUA designation be used only when “there is no adequate, approved and available alternative to the product for diagnosing, preventing or treating such disease or condition.”
This means that, in legal terms, all EUA products should be withdrawn once alternative products have received full approval.
Perhaps the most significant legal distinction, however, pertains to the legal protections afforded vaccine manufacturers, depending on how their product is classified.
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Dr. Meryl Nass M.D. is expert on the Comirnaty deception and FDA and US government appear to be carrying out a similar deception for their own nefarious purposes on the full FDA approval of a Moderna vaccine called Spikevax.
The ostensible motivation of the U S government and BigPharma entities is to hurry up and get everyone vaccinated under EUA vaccines that have no liability for the vacine manufacturer. Whitney Webb interview spoke about Moderna company insolvent and about to go bankrupt a coupe of times in the past and were always bailed out but maybe this mysterious ploy to have Moderna offering a fully available in the uSA fully FDA licensed and approved vaccine for which the Moderna company has no liability shield is a plan to sacrifice Moderna company and do some kind of bait and switch with names and products.
However, the real goal is far beyond protecting the health of people by protecting them from "Covid 19".
I suggest the goal is a One World Death and Slavery System for all of humankind.
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Here are two great interviews of Dr. Meryl Nass M.D., one by Whitney Webb
https://unlimitedhangout.com/
podcast
https://rokfin.com/post/61739
podcast runtime 1:26:43
https://img.production.rokfin.com/ey...Jjb3ZlciJ9fX0=
FDA Corruption and Mandate Madness with Meryl Nass, MD
Whitney is joined by Dr. Meryl Nass to discuss the FDA's role in the current COVID-19 vaccine Emergency Use Authorizations and the mandate situation as well as how the FDA's conflicts of interest with Big Pharma led to the creation of the EUA system and has resulted in unethical, illegal behavior from the agency during the COVID-19 crisis. Show notes: https://unlimitedhangout.com/2021/11...-meryl-nass-md
FDA Corruption and Mandate Madness with Meryl Nass, MD Unlimited Hangout with Whitney Webb
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o News
Whitney is joined by Dr. Meryl Nass to discuss the FDA’s role in the current COVID-19 vaccine Emergency Use Authorizations and the mandate situation as well as how the FDA’s conflicts of interest with Big Pharma led to the creation of the EUA system and has resulted in unethical, illegal behavior from the agency during the COVID-19 crisis.
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and one by Dr. Joseph Mercola.
FDA, Boosters, and the CDC- Interview with Dr. Meryl Nass
https://www.bitchute.com/video/jtMKzuKfAlR3/
https://www.bitchute.com/video/jtMKzuKfAlR3/
FDA, Boosters, and the CDC- Interview with Dr. Meryl Nass
First published at 17:53 UTC on November 3rd, 2021.
1:15:13
Mercola
Mercola
11744 subscribers
In this interview, Dr. Meryl Nass, an internist specializing in toxicology, vaccine-induced illnesses and Gulf War sickness, shares her insights into the dangers of the COVID jab, which October 26, 2021, received emergency use authorization for children as young as 5.
We also discuss the conflicts of interest within the U.S. Food and Drug Administration that seem to be behind this reckless decision, and how the agency pulled the wool over our eyes with its approval of Pfizer/BioNTech’s Comirnaty COVID injection.
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Re: Coronavirus
https://www.youtube.com/watch?v=leGdJNElygU
https://www.youtube.com/watch?v=leGdJNElygU
Dr Pierre Kory , President of FLCCC Alliance - Use of Ivermecticin for Covid19 patients
9,306 views
Dec 23, 2020
1:15:58 video runtime
Dr Pierre Kory , President of FLCCC Alliance - Use of Ivermecticin for Covid19 patients
9,306 views
Dec 23, 2020
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Re: Coronavirus
https://static-3.bitchute.com/live/c...83_320x180.jpg
https://www.bitchute.com/video/yFYkVDZhIj83/
"PEOPLE POWER" COPS OVERPOWERED OUTSIDE GOVERNOR GENERAL'S CANBERRA 07/02/22
3:59 video runtime
irst published at 10:07 UTC on February 7th, 2022.
#australia
channel image
THE CRAZZ FILES
THE CRAZZ FILES
572 subscribers
All Australians who care about this country and want to end the tyranny need to get to Canberra ASAP.
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Dachsie comment:
Here we have people doing the right thing at the right time in the right way. The people who cannot see that what these Australia citizens are doing is courageous, right and true are most probably fascists. communists, Marxists, and/or Leninists who call evil good.
Isaiah 5:20
Woe to those who call evil good and good evil, who turn darkness to light and light to darkness, who replace bitter with sweet and sweet with bitter.
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Re: Coronavirus
https://twitter.com/DowdEdward/statu...reater-numbers
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Ed ☯️Free Thinker & Oracle
@DowdEdward
Malone calling out bump in DOD data & Insurance company results for death & disability.
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https://twitter.com/i/status/1489436153719627777
9:10 PM · Feb 3, 2022·Twitter for iPhone
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https://trib247.com/articles/data-as...ign=Newsletter
Data: As vax mandates hit, younger people began dying in greater numbers
by: WorldTribune.com 02/07/2022 Source: WorldTribune.com
https://structurecms-production-psyc...jpg?1644291058
by WorldTribune Staff, February 7, 2022
A new analysis of excess mortality rates compared to pre-pandemic levels shows that younger, working-age people began dying in greater numbers as vaccine mandates were put in place.
Ed Dowd, former fund manager at Blackrock, said the data coming out of the insurance and funeral services industries is painting a disturbing picture.
Dowd reported that his analysis found:
• Mortality worsened in 2021 vs. 2020 despite widespread vaccinations.
• A spike in mortality among younger, working-age individuals coincided with vaccine mandates.
• The spike in younger deaths peaked in Q3 2021 when Covid deaths were extremely low (but rising into the end of September).
"The implication to many was clear — that the Covid-19 vaccine is linked to the excess mortality, and months of vaccine injury reports were now spilling over to actuarial data," Zero Hedge noted, adding that younger people were dying at a greater rate amid "a disease which primarily kills older, non-working age individuals."
Dowd noted in a Feb. 1 tweet that financial insurance company Unum had reported its Life segment saw an increase of 9 percent in the ratio of payouts vs. premiums (benefit ratio), a 17.4 percent increase in 2021 vs. 2020 despite widespread vaccinations.
"In 2021 they saw a 17.4% increase vs 2020. This is higher than the 13.3% increase vs 2019. So the higher payouts in 21 are occurring with a miracle vaccine & less virulent strains," Dowd wrote.
"In 2019 the unit had $266 million profit, last year a profit of $82 million & this year a loss of $192 million. A swing of $458 million lower over 2 years. Important to remember these are employed working age folks," Dowd added.
Funeral home company Carriage Services reported a 28 percent increase in September 2021 vs. 2020, and a 13 percent increase in August vs. the same period. Funerals and cremations are up 12 percent and 13 percent respectively on the quarter.
After seeing an uptick in funeral homes business in Q3, Dowd said he will be closely monitoring Q4 reports which are expected around Feb. 15.
Dowd noted that Carriage Services, a public company, saw its stock rise 106 percent in 2021, tweeting: "Curious no? Guys this is shocking as 89% of Funeral homes are private in U.S. We are seeing the tip of iceberg."
Lincoln National reported its death claims are up 13.7 percent year-to-year and up 57 percent in Q4 vs. 2019. Reinsurance Group of America reported in their earnings call last week that Q4 was impacted by a meaningful level of Covid-19 mortality claims despite the fact that the Covid-19 vaccines have been around for more than a year.
Also noting a spike in younger deaths which peaked in Q3 2022 is Hartford Insurance Group, which reported that mortality is up 32 percent from 2019 pre-covid levels, and 20 percent from 2020 pre-vaccine levels.
"It’s clear as day what changed in second half of 2021," Dowd wrote. "Variants less virulent than original but we had mandates & boosters hitting. This is a total shit show to behold."
Dr. Robert Malone, mRNA inventor, noted the troubling data in a recent appearance on Steve Bannon's "War Room":
embedded video link also to tweet given above
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Re: Coronavirus
https://beckernews.com/pentagons-lea...hNotifications
Pentagon’s Leaked Data Show Explosion of Vaccine-Related Injuries Among Military Service-Members
February 8, 2022
by Kyle Becker
https://beckernews.com/wp-content/up...w2-810x486.jpg
As the Pentagon begins processing immediate discharges for those who object to the Covid-19 ‘vaccines’ to leave the U.S. military, there is new data to support extraordinary concern for the shots’ safety.
Disturbing new data from the Defense Medical Epidemiology Database shows a startling increase in numerous medical health conditions year-over-year for all age-cohorts — some of these conditions being chronic and life-threatening.
It was first brought to public light in a February 1, 2022 letter to Pentagon chief Lloyd Austin from the U.S. Senate. Senator Ron Johnson cited the “dramatic increases in medical diagnoses among military personnel,” as well as evidence “diagnoses of myocarditis had been removed from the database.”
https://twitter.com/akheriaty/status...hNotifications
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Aaron Kheriaty, MD
@akheriaty
Keep an eye on this story as it develops. I presented at the Senate panel where Renz presented this disturbing data.
https://pbs.twimg.com/media/FLF6BSTV...g&name=900x900
Below are summarized 2021 (with vaccines) numbers with percentage changes relative to 2020 (without vaccines), as recently noted by mRNA vaccine expert Dr. Robert Malone.
Total Number of Diseases & Injuries Reported By Year (Ambulatory) up 988% in “uncorrected” data, down 3% in “corrected” data(this is basically a control for the data set).
Total Number of Diseases & Injuries Reported By Year (Hospitalization) up 37%
Total Number of Diseases of the Nervous System By Year up 968%
Total Number of Malignant Neuroendocrine Tumor Reports By Year up 276%
Total Number of Acute Myocardial Infarct Reports By Year up 343%
Total Number of Acute Myocarditis Reports By Year up 184%
Total Number of Acute Pericarditis Reports By Year up 70%
Total Number of Pulmonary Embolism Reports By Year up 260%
Total Number of Congenital Malformations Reports By Year up 87%
Total Number of Nontraumatic Subarachnoid Hemorrage Reports By Year up 227%
Total Number of Anxiety Reports By Year up 2,361%
Total Number of Suicide Reports By Year up 227%
Total Number of Neoplasms for All Cancers By Year up 218%
Total Number of Malignant Neoplasms for Digestive Organs By Year up 477%
Total Number of Neoplasms for Breast Cancer By Year up 469%
Total Number of Neoplasms for Testicular Cancer By Year up 298%
Total Number of Female Infertility Reports By Year up 419%
Total Number of Dysmenorrhea Reports By Year up 221.5%
Total Number of Ovarian Dysfunction Reports By Year up 299%
Total Number of Spontaneous Abortion Reports By Year DOWN by 10%
Total Number of Male Infertility Reports By Year up 320%
Total Number of Guillian-Bare Syndrome Reports By Year up 520%
Total Number of Acute Transverse Myelitis Reports By Year up 494%
Total Number of Seizure Reports By Year up 298%
Total Number of Narcolepsy & Cataplexy Reports By Year up 352%
Total Number of Rhabdomyolysis By Year up 672%
Total Number of Multiple Sclerosis Reports By Year up 614%
Total Number of Migraine Reports By Year up 352%
Total Number of Blood Disorder Reports By Year up 204%
Total Number of Hypertension (High Blood Pressure) Reports By Year up 2,130%
Total Number of Cerebral Infarct Reports By Year up 294%
Instead of responding to Senator Ron Johnson, the DoD contacted discredited, partisan “fact checker” Politifact:
“But Peter Graves, spokesperson for the Defense Health Agency’s Armed Forces Surveillance Division, told PolitiFact by email that “in response to concerns mentioned in news reports” the division reviewed data in the DMED “and found that the data was incorrect for the years 2016-2020.”
Officials compared numbers in the DMED with source data in the DMSS and found that the total number of medical diagnoses from those years “represented only a small fraction of actual medical diagnoses.” The 2021 numbers, however, were up-to-date, giving the “appearance of significant increased occurrence of all medical diagnoses in 2021 because of the underreported data for 2016-2020,” Graves said.
The DMED system has been taken offline to “identify and correct the root-cause of the data corruption,” Graves said.
Thus, similarly to VAERS, when the data do not support authoritarian measures, the data ‘can’t be trusted.’ When they do support government coercion, the data is as infallible as “the science.”
Thomas Renz’s website Renz Law, however, shows that the Department of Defense appears to be fiddling with the data to allay concerns about vaccines and its misguided mandate.
https://beckernews.com/wp-content/up...-PM-scaled.jpg
Dr. Robert Malone had some pointed questions about the DOD’s purported explanation for the huge spike in cases”
So, what do the original data show (prior to Defense Health Agency’s Armed Forces Surveillance Division correction of the “data corruption”).
In reviewing these data, what we see are baseline data from 2016 to 2019 (pre SARS-CoV-2/COVID-19), 2020 (the first year of SARS-CoV-2/COVID-19 when no vaccines were available), and 2021 (the year that vaccines were available and mandated for the US Military).
As noted above, there are many potential confounding variables, but whatever the cause, if these data are not due to longstanding and previously undiscovered “data corruption”, then we have a major issue with the overall health of our armed services.
And if they are due to previously undiscovered “data corruption”, why wasn’t someone running around with their pants on fire trying to figure out what is going on here long before the whistleblowers brought this to national attention?
A U.S. federal district court judge in early February halted the Department of Defense’s rejection of soldiers’ exemption requests on religious objection grounds, and went even further by stating that the objectors’ case is likely to prevail upon appeal.
“Finally, the military is most likely unable to establish, and certainly has not established, that permitting the relatively small number of RFRA objectors, even if every request for exemption (much less the two at issue in this motion) were sincere and successful, to serve without adverse consequences to their standing and the terms and conditions of their service will adversely affect the public’s interest in the maintenance and readiness of the nation’s military forces,” Judge Steven D. Merryday ruled. “In fact, the public undoubtedly has some considerable interest in maintaining the services of skilled, experienced, highly trained, patriotic, courageous, and esteemed service members, such as the two moving service members, in whom the public has an immense financial investment and who are not, to say the least, readily replaceable.”
Every U.S. service-member deserves such respect, particularly as the vaccines have failed to slow the spread of the disease, and according to an initial reading of the Department of Defense’s own data, is leading to an explosion of adverse effects cases.
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Re: Coronavirus
The U S Military has just been caught in the most horrendous murderous lie and coverup in our nation's history.
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Re: Coronavirus
According this Telegram post a criminal case has been opened in the Sonoma County Sheriff's Office for charges of murder and crimes against humanity
https://t.me/drchristianenorthrup/4080
This just in.
From Michelle Ford
I have a HUGE DEVELOPMENT I get to report.
The Sonoma County Sheriff has officially opened a criminal investigation into the charges of MURDER and CRIMES AGAINST HUMANITY regarding the Covid injections after I petitioned them to stand up for the PEOPLE and enforce the law.
We have a case number!!!!
So similar to the UK we can now place ads in papers in local Nextdoor listings - essentially EVERYWHERE and ask anyone who has experienced adverse effects to the injections that they can now report it as evidence OF A CRIME.
I need help creating an action team ASAP to help get this information OUT TO THE PEOPLE OF CALIFORNIA in short order
I think we need to notify all our connections and truther groups across the state
I’m thinking Childrens Defense Fund, ICAN, who else?!?
THIS IS HUGE.
We need to be very specific about what people are contacting the Sheriff’s office about - for
Specifically ANY ADVERSE EFFECTS or DEATHS OR FOR FAMILY OR FRIENDS THAT HAVE BEEN ADVERSELY EFFECTED
KINDA LIKE THAT AD IN UK PAPERS!!!
Omg. This is big, big.
The case # is 220125009
Do not contact them for any other reason than to report adverse effects - as I suspect their office will soon to be INUNDATED.
Sonoma County Sheriff’s office.
Marcia and Andy! Let’s connect!!!
This is a direct action that will implicate ANYONE PUSHING THE INJECTIONS
I HAVE PUT BOTH THE SONOMA COUNTY AND MARIN COUNTY HEALTH BOARDS ON NOTICE. And sent the directors the criminal case number.
Please get this out to any CA groups who can help us get the word out!!
If the Sheriff’s find enough compelling evidence , I demanded that they SEIZE ALL THE VIALS AS EVIDENCE. A chain of custody seizure from every hospital, doctors office or pop up clinic. The proof is in the vials. Anywhere issuing the ‘injection’. IMMEDIATELY.
This is helpful to have a case number because we as individuals can now call up our doctors offices or anywhere and let them know they may be held personally liable for conducting crimes against humanity to the FULL EXTENT OF THE LAW by issuing or even RECOMMENDING these injections TO ANYONE MOVING FORWARD!!
This is huge, huge!! Bigly huge.
Congratulations. Now let’s get to work!!
Share this everywhere.
More information:
https://jdfor2024.com/2022/02/update...accine-injury/
UPDATED February 7, 2022:
**Note: This news story is still unfolding.
The case # 220125009, has been verified
.
However, please be aware that Sonoma County Sheriff’s Office stated that they are not conducting an investigation into vaccine side effects or mandates and the case number is informational only to document a number of emails submitted on this topic.
Keep checking back for updates and please let us know if you have more information. Thanks.
California: Criminal investigation opened in Sonoma on vaccine injury
February 6, 2022 | by Steve Kirsch |
“I just got this today and haven’t had a chance to find out if this will go anywhere, but it is an interesting development that if successful can be repeated everywhere in the US.
This is breaking news. I will have more on this later, but wanted to get this out now.
This post is in two parts: a message from Michelle Ford and then a supplementary statement from an unknown source which may not be credible, but certainly worthy of discussion.
What is odd to me is that I’m just hearing this now (Feb 6), yet the case was opened on January 25, 2022 which was almost 2 weeks ago.
I am (currently) skeptical that this will go anywhere
For someone to be convicted of a crime, there must be criminal intent. The people who are giving the vaccine and mandating its use have been brainwashed into believing the vaccine is safe and effective. Same is true of judges who happily get their booster shots. There is a provision in the law about “reasonable minds can differ” which means in this case that if a lot of people think the vaccines are perfectly safe and effective, anyone giving them can’t be convicted of a crime. When you have judges who willingly took the vaccine, it’s going to be a tough case to prosecute.
So take everything below with a huge grain of salt and consider this “news” as for discussion purposes only at this point.
Note that the case number is legitimate and a friend of mine validated it with the Sheriff’s department in Sonoma.
With that intro, here’s the scoop.
https://i0.wp.com/cdn.substack.com/i...00%2C750&ssl=1
A message from Michelle Ford
Michelle Ford, is a nurse and founder of VIAL – Vaccine Injury Awareness League sent out the following message:
I have a HUGE DEVELOPMENT I get to report.
The Sonoma County Sheriff has officially opened a criminal investigation into the charges of MURDER and CRIMES AGAINST HUMANITY regarding the Covid injections after I petitioned them to stand up for the PEOPLE and enforce the law.
We have a case number!!!!
So similar to the UK we can now place ads in papers in local Nextdoor listings – essentially EVERYWHERE and ask anyone who has experienced adverse effects to the injections that they can now report it as evidence OF A CRIME.
I need help creating an action team ASAP to help get this information OUT TO THE PEOPLE OF CALIFORNIA in short order I think we need to notify all our connections and truther groups across the state I’m thinking Childrens Defense Fund, ICAN, who else?!?
THIS IS HUGE.
We need to be very specific about what people are contacting the Sheriff’s office about – for Specifically ANY ADVERSE EFFECTS or DEATHS OR FOR FAMILY OR FRIENDS THAT HAVE BEEN ADVERSELY EFFECTED
KINDA LIKE THAT AD IN UK PAPERS!!!
Omg. This is big, big.
The case # is 220125009 (i.e., the 9th case opened on Jan 25)
Do not contact them for any other reason than to report adverse effects – as I suspect their office will soon to be INUNDATED.
Sonoma County Sheriff’s office.
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Re: Coronavirus
Munchausen by proxy is a felony. The victims are minors and seniors. The perps are 'caregivers'.
Adults are not under the control of caregivers and hence MUNCHAUSEN'S is not a felony when an adult is the victim.
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Re: Coronavirus
Dachsie comment:
I wrote the author to ask why "the government" is attempting the same deception it pulled with Comirnaty. SpkeVax is also a product that is not now available in the USA. We the people do not know all we need to know about these FDA machinations.
(See original site for full hyperlinks in article.)
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https://childrenshealthdefense.org/d...c-f0221a80e575
02/08/22
•
COVID › Views
Please Don’t Call This ‘Science’: How FDA, CDC Justified Approval of Moderna’s Spikevax
The U.S. Food and Drug Administration’s approval last week of Moderna’s Spikevax COVID vaccine — backed by the Centers for Disease Control and Prevention — made a mockery of science and the regulatory process.
By
Josh Mitteldorf, Ph.D.
https://childrenshealthdefense.org/w...re-800x417.jpg
The U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) did it again.
The FDA last week granted its seal of approval for a ghost vaccine that is unavailable in the United States — and it did so using a preordained process that made a mockery of “science” and of “regulation.”
Days later, the CDC backed the FDA’s decision, using similarly flawed data and reasoning.
The approval of Moderna’s Spikevax COVID-19 vaccine was an even greater travesty than the FDA’s approval last August of Pfizer’s Comirnaty shot.
That’s because Moderna has been even more secretive than Pfizer about its trial data, and because Moderna’s shot is linked to an even higher rate of heart disease than Pfizer’s.
The FDA’s approval of the Pfizer Comirnaty vaccine led people to believe they would get a fully licensed, FDA-approved vaccine — when in fact they were still getting the Pfizer-BioNTech vaccine distributed under Emergency Use Authorization (EUA).
People can ask for the Comirnaty vaccine as often as they like — but it is not being distributed in the U.S. The Comirnaty vaccine is supposed to be the same formulation as the old Pfizer-BioNTech vaccine, but the vials labeled “Comirnaty” are in a legal class of their own.
BUY TODAY: Robert F. Kennedy, Jr.'s New Book — 'The Real Anthony Fauci'
Why this Kabuki theater?
Because any adult who is harmed or killed as a side effect of an “FDA-approved” vaccine can sue the manufacturer. But if you are harmed in exactly the same way by an EUA vaccine, you are out of luck — the manufacturer and everyone in the chain of delivery has full immunity from lawsuits. The law depends on the label.
Now Moderna has the same legal advantage as Pfizer. Its “Spikevax” is the same formula as the old Moderna vaccine, but only if you are dosed with a vial bearing the “Spikevax” label can you sue for bodily harm. So, of course, the Moderna vaccine continues to be distributed, but Spikevax is not available in the U.S.
The approval of Spikevax is not just a legal sham. It’s also a scientific sham. FDA approval is supposed to include long-term safety testing, but there is no long-term data available for a product that has been in existence less than a year.
The FDA hearings on the licensing of Spikevax were one-sided and dominated by self-congratulatory rhetoric. They also raised more questions than answers.
Questions for the FDA
Besides offering publicity to the manufacturer and sowing confusion in the public mind, why would the manufacturers want FDA approval for a vaccine that is not available in the U.S.?
Neither Pfizer nor Moderna explicitly specified the content of their placebos, but a published review claims they were simple saline. If this is the case, why is the rate of medical problems following injection with a “placebo” so much higher with Moderna’s placebo compared to Pfizer’s placebo?
For example, 18 people out of 15,000 in the Moderna placebo group died before the start of the trial (2 weeks from the second vaccination), while only 4 people out of 22,000 who received Pfizer’s placebo dose died in a comparable period. There were 31 “severe adverse events” in the placebo group of the Moderna trial, and zero in the (larger) Pfizer placebo group. What was in that “placebo” that killed 18 people and sent 31 to the hospital?
The FDA relies on the Vaccines and Related Biological Products Advisory Committee (VRBPAC) to help assess the safety of vaccines before approval. There was an animated debate at the VRBPAC meeting for the Pfizer vaccine. Why was VRBPAC not invited to convene for the Moderna vaccine? The answer is given in this letter of approval from the FDA to Moderna (January 31, 2022):
“We did not refer your application to the Vaccines and Related Biological Products Advisory Committee because our review of information submitted in your BLA [Biologics License Application], including the clinical study design and trial results, did not raise concerns or controversial issues that would have benefited from an advisory committee discussion.”
The FDA plainly states that it limited the scope of its analysis to the trial data alone. Why isn’t the FDA interested in the enormous amount of data that has become available in the last year?
Safety: Did FDA cook the books?
Deaths and disabilities associated with the mRNA “vaccines” have occurred with shocking frequency, 90 times as many as the worst vaccine in the past. There have been more than 1 million COVID vaccine reactions reported to the Vaccine Adverse Event Reporting System (VAERS), compared to 11,000 for the worst vaccine in 2020 (Shingrix).
There were more than twice as many deaths related to the COVID vaccines this year as the sum total of all vaccine deaths in the 30-year history of VAERS.
To rig the approval process in favor of such a product, the FDA needed to rewrite the rule book. The agency did this with a new statistical criterion, masking murder with mathematics. I am grateful to Matthew Crawford for having decoded the algebra and sounded the alarm.
The safety criterion chosen by the FDA is an obscure computation called PRR, which stands for Proportional Reporting Ratio. As the name implies, it is based on RATIOS of different event types and is utterly blind to the ABSOLUTE RATE of such events.
PRR measures the distribution of different kinds of adverse events, e.g. blood clots, heart attacks and deaths. If those ratios are severely out of line with the great variety of vaccine reactions in the past, PRR would detect that.
For example, if the new vaccines caused an extraordinary risk of myocarditis, but everything else was low, then PRR would flag that. But if myocarditis was just one risk among many that have been reported from past vaccines, then PRR would not pick that up.
The real scandal is that PRR is blind to the absolute risk numbers. PRR is defined in such a way as to look for unusual PATTERNS of adverse events, but it is completely insensitive to unusual RATES of adverse events.
Of course, it is the rates and not the patterns that are of primary concern, and the PRR is designed NOT to reflect that.
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For example, suppose we have two vaccines:
Vaccine A has 1 reported death per million vaccinations, 3 reported heart attacks per million, and 20 reported headaches per million.
Vaccine B has 1 reported death per hundred vaccinations, 3 reported heart attacks per hundred, and 20 reported headaches per hundred.
Vaccine A is quite safe, and vaccine B is extremely dangerous. And yet the formula for PRR will produce the same result for vaccine A and B!
Clearly, PRR is not an appropriate criterion for evaluating the safety of any particular vaccine. Did the FDA use PRR in order to cook the books?
In Moderna’s own trials, 1.3% of vaccine recipients had a reaction to the vaccine that was severe enough to require medical attention. The following possible side effects were listed in information given to doctors:
“Anaphylaxis and other severe allergic reactions, myocarditis, pericarditis, and syncope have been reported following administration of the Moderna COVID-19 Vaccine during mass vaccination outside of clinical trials.”
Off with his head! — the CDC’s ACIP hearings
In Alice’s Wonderland, the Red Queen’s justice began with the execution, then there was a verdict — and finally a trial.
The FDA hearing was followed by a meeting of the Advisory Committee on Immunization Practices (ACIP), which reports to the CDC.
The committee on Feb. 4 voted to recommend the Moderna Spikevax. Only after that action step had been secured did the committee hear testimony from the Public Health Agency of Canada that Moderna’s vaccine was associated with a myocarditis risk five times higher than Pfizer’s.
Questions for the CDC
All-cause mortality was equal in both placebo and vaccine groups (16 deaths in each). In the midst of a pandemic, Moderna’s vaccine demonstrated no survival benefit. This should have been enough to end any further consideration of approval.
We have detailed data on myocarditis from decades of past history. One-fourth of myocarditis patients are dead within 5 years, but the same study reports that if the myocarditis is caused by human immunodeficiency virus, then three-fourths die in the same 5 years.
We have no long-term data on vaccine-induced myocarditis, but we do have some 6-month data, which show 39% of cases still had their activity restricted by their doctors, 20% were still on heart medication, 32% still reported chest pain, 22% still had shortness of breath, 22% had palpitations and 25% still reported fatigue. Thirteen vaccine recipients died. (All these numbers were presented at the ACIP hearing on Feb. 4.)
Why should we have confidence that the course of vaccine-induced myocarditis will be much less severe than other forms of the disease?
The Moderna trial, like the Pfizer trial, was limited to healthy people, mostly young, with no pre-existing problems. Pregnant women were explicitly excluded. Why is the vaccine being approved as safe for everyone, including diabetics and immune-compromised, elderly and pregnant women?
When mRNA vaccines were approved on an emergency basis, the FDA promised to track all safety concerns with a new cell phone app called V-Safe. Why are the results of V-Safe being withheld from the public?
The FDA was considering approval of Moderna’s vaccine in January 2022. There was a full year’s experience with side effects reported from nearly 200 million doses of the Moderna vaccine in the U.S. alone. But the FDA limited its consideration to the 15,000 subjects who were in the Moderna trial, ending March 26, 2021. Why was this huge trove of data on vaccine safety not reviewed by the FDA?
Yes, we understand that the vaccine doesn’t become fully effective until 2 weeks after the second shot. But is that a reason to exclude from consideration the damage that is inflicted by enhanced vulnerability to disease during those two weeks, or, for that matter, the four weeks between shots? These have been counted as diseases of the “unvaccinated,” but in fact, people in this stage of treatment are much more vulnerable than the truly unvaccinated.
France and Germany do not recommend Moderna’s vaccination for young people, presumably because the Moderna vaccine is associated with a higher rate of myocarditis than the Pfizer vaccine. How did our FDA come to a different conclusion?
Anaphylaxis following vaccination is an immediate, life-threatening and an undeniable consequence of the vaccine. The CDC claimed the rate of anaphylaxis is 6 per 1 million.
However, in March of 2021, an examination of anaphylaxis following mRNA vaccines revealed a much higher incidence of this adverse event. In fact, 9 of 38,971 Moderna vaccine recipients suffered documented anaphylaxis. This equates to 230 per million, or 38 times higher than the CDC estimate.
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Efficacy — but at what cost?
The proper measure of the efficacy of any medication is how it affects all aspects of a patient’s health. But in evaluating the Moderna vaccine, the FDA looked only at its effect on COVID.
There are early but disturbing indications that vaccination worldwide has had dramatic effects on other aspects of health, unrelated to COVID. Insurance company trade journals report that they are paying life insurance claims for adults 18-64 years of age at a rate 40% higher than during any normal year.
This number from OneAmerica (Indianapolis) has been echoed by other studies in Europe. A leaked spreadsheet from the Defense Medical Epidemiological Database showed that incidences of many medical problems in the U.S. military surged in this year of vaccination. For example, heart attacks were up 343%, cancers up 218%, among many other disorders.
Could it be that the vaccines have had a small benefit for COVID severity and disastrous impact on other aspects of human health?
We now have some real-world experience with the efficacy of vaccines. For example, we know the virus mutated to a more contagious, less lethal form. Omicron is now the dominant form of the virus in the U.S. and most other parts of the world today.
The Omicron mutations are concentrated in the spike protein — the only part of the virus to which the vaccinated population has immunity. This suggests the virus is mutating in response to the vaccine, and mutations are an important factor affecting efficacy in the long run
Nevertheless, the FDA considered efficacy data predominantly from the first five months of data (through March 26, 2021) in making its decision to fully license Spikevax, with an absolute cutoff in November, before Omicron became dominant.
More questions
Almost all subjects in the original Moderna trial who received placebo initially were subsequently given the vaccine. How will we ever know the long-term effects of the vaccine if we have no controls with which to compare?
Why do CDC studies of death rates based on vaccination status differ so markedly from the same question asked by independent groups in other countries?
Here, for example, is a report from Public Health Scotland stating that vaccination increases vulnerability to Omicron. Here is a similar report from England. This study shows countries with higher vaccination rates tend to have higher rates of COVID, and this one confirms the same result for U.S. states.
We are now in an era dominated by the Omicron variant, against which all the vaccines seem much less effective. But even “follow-up data” was analyzed only through March 26, 2021, nine months before Omicron took over. Why did the FDA base its decision on data only from older variants?
The secondary efficacy endpoint was the prevention of severe COVID-19. Now that it is accepted that there is little, if any, protective effect of mRNA vaccines from infection, the prevention of severe disease should be the primary focus of approval determination.
Moderna claims its vaccine efficacy is an astonishing 98.2% in preventing severe COVID-19 (Table 8). Pfizer’s was 96.7% (Table S6).
The reason for the calculated difference in efficacy between these two products was not from a lower incidence of severe disease in the vaccine arm of Moderna’s trial (it was lower in Pfizer’s trial). It was because the incidence of severe disease in Moderna’s placebo group was much higher than in Pfizer’s.
Severe COVID-19 in Pfizer’s placebo group occurred in 30 participants out of 23,0379. In Moderna’s, severe disease occurred in 106 participants out of 14,164 that received a placebo. Why was the incidence of severe COVID-19 nearly six times higher in Moderna’s placebo group than Pfizer’s?
Postscript: Failure was never an option
In America, why are clinical trials for new drugs run by the same companies that own the drugs, and will profit from them if the trial is successful?
It’s a glaring conflict of interest, but necessary within a capitalist system. Since the trials cost, typically, hundreds of millions of dollars, only the company that will profit from the drug is motivated to invest such huge sums in testing.
In the case of the COVID vaccines, however, the development and the trials were both publicly funded. There was no excuse for contracting the same organization both to develop and test their own product.
Moderna’s development cost was funded through Operation Warp Speed in the U.S. and Pfizer through the German government. Now, the companies are reaping windfall profits, though they risked no money of their own.
This leaves us wondering, did our government ever want a fair and unbiased evaluation of the COVID vaccines? Or — after a full year of telling the public that vaccines were the only path out of the COVID crisis — did NIH feel they could not risk the possibility that the trials might fail?
There were no animal tests. There was no time to experimentally optimize dosage and delivery. They had to guess right the first time.
Maybe they thought this is what the exigency of a pandemic required — but please don’t call it “science.”
The views and opinions expressed in this article are those of the authors and do not necessarily reflect the views of Children's Health Defense.
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Josh Mitteldorf, Ph.D.'s avatar
Josh Mitteldorf, Ph.D.
Josh Mitteldorf, Ph.D., has a background in theoretical physics. Since the 1990s, he is best known for his contributions to the biology of aging, including many articles and two books.
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