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Re: Coronavirus
Event on May 4 in Ohio featuring RFK Jr and others
This event is in support of a bill in the Ohio legislature that would enable patients to access proven early treatment options for COVID... you know, the drugs the CDC and NIH tell doctors to avoid.
Steve Kirsch
May 1, 2022
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Sign up here to reserve your place at the event on May 4 in Columbus, Ohio. There aren’t many slots left.
The registration link is here and the form is at the very bottom of the page: “COVID-19 Alternative Therapies and the Right to Choose: Protecting the Vulnerable and Honoring the Fourth Estate Conference.” Your donation is tax deductible.
There are two options:
you can register for just the event on May 4 ($90), or
register for the dinner the night before (with the speakers) and the event ($250 for both). If you register for the dinner, they will let you know where it is (in Dublin, OH).
The event will take place on Wednesday, May 4th at the Ohio Statehouse in Columbus, OH, from 9:00 a.m. to 3:00 p.m. EDT.
Although attendees are required to register for this event, guests can sign in at the event venue registration table. The Statehouse Conference address is 1 Capitol Square, Columbus, Ohio 43215.
This will be a roundtable event similar to Senator Johnson’s “A second opinion panel” focused on testimony supporting the Ohio early treatment bill. There will be several small roundtables (not one giant one).
Here’s the bill HB 631.
Where is fluvoxamine?
Note, I’m not happy at all that fluvoxamine isn’t included in this bill as there is a peer-viewed systematic review and meta-analysis supporting fluvoxamine in treating COVID-19, which is the highest level of evidence based medicine. It is ridiculous that it isn’t included. Fluvoxamine reduces your chance of death by 12X. That’s from a widely praised Phase 3 trial. No other drug has better data than that. It should be included in the list of drugs in the bill.
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Re: Coronavirus
https://live.childrenshealthdefense....day-roundtable
https://ecp.yusercontent.com/mail?ur...Bqa04sx3lg--~D
Most Recent Episode - April 29, 2022
‘Friday Roundtable’ Episode 5: Crimes Against Humanity – A Cross Examination of the Global Pandemic With Judy Mikovits, Reiner Fuellmich + More
1:18:58 video runtime
https://live.childrenshealthdefense.org/shows/chd-friday-roundtable/FGvW0mLg5I
“Part of the playbook for the response was to prohibit free speech by medical professionals” argues Meryl Nass, M.D.
“In the very beginning of the pandemic, China immediately started clinical trials with the chloroquine drugs. China knew that they were likely to work against coronaviruses. How did China know that? Because research from Europe, the CDC, and at the NIH had shown in test tubes that Chloriquines could kill the MERS Virus and original SARS 1 virus.” In Fauci’s own division, research was done at the CDC in 2004 and 2014 including published papers. What did they do? They surpassed them.”
“What we have is the suppression of science to push a narrative...to censor those attempting to sort through the mess we’ve been given and figure out what is true.”
Segment from FRIDAY ROUNDTABLE Episode 5 on CHD.TV – New Episodes LIVE every Friday 11:30am PT // 2:30pm ET
Today‘s “Friday Roundtable” is a powerful testament to the efforts being made to expose corruption, produce true science, and put forth eye-opening evidence. In this episode, individuals from the Crimes Against Humanity Tour join for this discussion. These guests are Reiner Fuellmich, Patrick M. Wood, Dr. Richard M. Fleming, Nash Singh, Nisha D., and Judy A. Mikovits, Ph.D.
WATCH THE FULL EPISODE:
...https://live.childrenshealthdefense....day-roundtable...
video also on Rumble at
https://rumble.com/v136oab-supressio...1-a44baf6ca9cf
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Re: Coronavirus
New VAERS Data as of Apr.22, 2022 (posted Apr.29, 2022)
29,907 Deaths and 1,333,668 Adverse Events
27,532 Pfizer/Moderna and 2,375 J&J Deaths
Source: https://www.drtenpenny.com/newslette...#comp-l2o5oqmx
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Re: Coronavirus
https://twitter.com/drsimonegold/sta...34639704182784
Dr. Simone Gold
@drsimonegold
BREAKING: A new study from MIT has found a 25% increase in cardiovascular events in young people during the vaccine rollout.
Patients experienced a reduction in blood flow to the heart.
Excess deaths are associated with vaccine rollouts all over the world.
4:06 PM · May 2, 2022·Hootsuite Inc.
5,575
Retweets
285
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11.9K
Likes
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Dr. Simone Gold
@drsimonegold
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3h
Replying to
@drsimonegold
Read the study yourself and see data from
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https://pbs.twimg.com/card_img/15197...g&name=900x900
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Re: Coronavirus
https://www.sott.net/image/s32/64511...njury_apri.jpg
https://childrenshealthdefense.org/d...shot-cdc-data/
04/29/22
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COVID › News
1.2 Million Reports of Injuries After COVID Vaccines, VAERS Data Show
VAERS data released Friday by the Centers for Disease Control and Prevention included a total of 1,247,131 reports of adverse events from all age groups following COVID-19 vaccines, including 27,532 deaths and 224,766 serious injuries between Dec. 14, 2020, and April 22, 2022.
The Centers for Disease Control and Prevention (CDC) today released new data showing a total of 1,247,131 reports of adverse events following COVID-19 vaccines were submitted between Dec. 14, 2020, and April 22, 2022, to the Vaccine Adverse Event Reporting System (VAERS). VAERS is the primary government-funded system for reporting adverse vaccine reactions in the U.S.
The data included a total of 27,532 reports of deaths — an increase of 183 over the previous week — and 224,766 serious injuries, including deaths, during the same time period — up 1,930 compared with the previous week.
Excluding “foreign reports” to VAERS, 810,171 adverse events, including 12,672 deaths and 80,743 serious injuries, were reported in the U.S. between Dec. 14, 2020, and April 22, 2022.
1 Million Copies Sold — ‘The Real Anthony Fauci’ — The book that launched a movement. BUY TODAY!
Foreign reports are reports foreign subsidiaries send to U.S. vaccine manufacturers. Under U.S. Food and Drug Administration (FDA) regulations, if a manufacturer is notified of a foreign case report that describes an event that is both serious and does not appear on the product’s labeling, the manufacturer is required to submit the report to VAERS.
Of the 12,672 U.S. deaths reported as of April 22, 16% occurred within 24 hours of vaccination, 20% occurred within 48 hours of vaccination and 59% occurred in people who experienced an onset of symptoms within 48 hours of being vaccinated.
In the U.S., 572 million COVID-19 vaccine doses had been administered as of April 23, including 338 million doses of Pfizer, 215 million doses of Moderna and 19 million doses of Johnson & Johnson (J&J).
Every Friday, VAERS publishes vaccine injury reports received as of a specified date. Reports submitted to VAERS require further investigation before a causal relationship can be confirmed.
Historically, VAERS has been shown to report only 1% of actual vaccine adverse events.
U.S. VAERS data from Dec. 14, 2020, to April 22, 2022, for 5- to 11-year-olds show:
10,348 adverse events, including 256 rated as serious and 5 reported deaths.
19 reports of myocarditis and pericarditis (heart inflammation).
The CDC uses a narrowed case definition of “myocarditis,” which excludes cases of cardiac arrest, ischemic strokes and deaths due to heart problems that occur before one has the chance to go to the emergency department.The Defender has noticed over previous weeks that several reports of myocarditis and pericarditis have been removed by the CDC from the VAERS system in this age group. No explanation was provided.
42 reports of blood clotting disorders.
U.S. VAERS data from Dec. 14, 2020, to April 22, 2022, for 12- to 17-year-olds show:
31,455 adverse events, including 1,803 rated as serious and 44 reported deaths.The most recent reported death involves a 14-year-old girl from Tennessee (VAERS I.D. 2238618) who died after receiving her second dose of Pfizer’s COVID-19 vaccine. According to the VAERS report, the girl had a previous history of cancer but was hospitalized 29 days after receiving her second dose of Pfizer with severe COVID-19 and COVID pneumonia. She became “critically ill,” developed respiratory failure and bradycardia and later died.
65 reports of anaphylaxis among 12- to 17-year-olds where the reaction was life-threatening, required treatment or resulted in death — with 96% of cases attributed to Pfizer’s vaccine.
649 reports of myocarditis and pericarditis — two fewer than last week — with 637 cases attributed to Pfizer’s vaccine.
165 reports of blood clotting disorders — 1 fewer than last week — with all cases attributed to Pfizer.
U.S. VAERS data from Dec. 14, 2020, to April 22, 2022, for all age groups combined, show:
20% of deaths were related to cardiac disorders.
54% of those who died were male, 41% were female and the remaining death reports did not include the gender of the deceased.
The average age of death was 73.
As of April 22, 5,460 pregnant women reported adverse events related to COVID-19 vaccines, including 1,709 reports of miscarriage or premature birth.
Of the 3,630 cases of Bell’s Palsy reported — three fewer than last week — 51% were attributed to Pfizer vaccinations, 40% to Moderna and 8% to J&J.
870 reports of Guillain-Barré syndrome, with 42% of cases attributed to Pfizer, 30% to Moderna and 28% to J&J.
2,343 reports of anaphylaxis — 12 fewer reports than last week — where the reaction was life-threatening, required treatment or resulted in death.
1,678 reports of myocardial infarction.
13,826 reports of blood-clotting disorders in the U.S. Of those, 6,199 reports were attributed to Pfizer, 4,925 reports to Moderna and 2,661 reports to J&J.
4,152 cases of myocarditis and pericarditis with 2,544 cases attributed to Pfizer’s, 1,415 cases to Moderna’s and 181 cases to J&J’s COVID-19 vaccine.
FDA to meet in June on COVID-19 vaccines for babies, toddlers
The FDA will meet in June — either June 8, 21 or 22 — to discuss COVID-19 vaccines for children under age 6. The agency’s vaccine advisory committee during its June meeting will also discuss Novavax’s request for Emergency Use Authorization (EUA) of its COVID-19 vaccine for adults.
Moderna on Thursday asked the FDA to authorize its COVID-19 vaccine for emergency use for children ages 6 months to 6 years.
The company conducted separate trials for two versions of the vaccine, one for infants and toddlers 6 months to 2 years, and one for children 2 to 6 years old.
The company claimed data showed “a robust neutralizing antibody response” and “a favorable safety profile.” But experts say Moderna is not providing the data needed to calculate the risk-benefit of its COVID vaccine.
Moderna’s KidCOVE study cited in Thursday’s press release shows the Moderna shot failed to meet the FDA’s minimum efficacy requirements for EUA in the 2- to under-6 age group, and barely surpassed the agency’s 50% efficacy requirement in the 6-month to 2-year age group after the vaccine maker changed its analysis of the study to meet the threshold.
It's Time to Follow the Science. Join our Campaign!
In the younger age group, Moderna said the effectiveness of its vaccine was 51%. In the older age group, vaccine efficacy was only 37% — substantially lower than the FDA’s requirement. These are different efficacy numbers than those the company reported last month.
Pfizer is expected to file its application in May for a three-shot vaccination using smaller individual doses for children under 5.
Lawmakers push FDA on COVID-19 shots for youngest age groups
Moderna’s announcement followed just days after the House Select Subcommittee on Coronavirus Crisis asked the FDA for a status update on COVID-19 vaccines for children under 5 over concerns “millions of young children still remain unprotected because no vaccine has yet been authorized” for this age group.
A top FDA official on Tuesday told The New York Times the agency has not cleared a COVID-19 vaccine for the youngest age group because Pfizer and Moderna have not finished their applications for authorization.
The agency said last week it is considering holding off on reviewing Moderna’s request to authorize its COVID-19 vaccine for children under 5 until it has data from Pfizer and BioNTech on their vaccine for children, pushing the earliest possible authorization of a vaccine from May to June.
The FDA said it would be simpler and less confusing to simultaneously authorize and promote two vaccines to the public, rather than green-lighting one on a faster timetable and the other down the road.
Agency officials were worried about authorizing Moderna’s vaccine only to find out just a few weeks later that Pfizer’s offered better protection.
Pfizer requests EUA for booster dose for 5- to 11-year-olds
Pfizer and BioNTech on Tuesday announced they applied for EUA of a COVID-19 booster dose for children ages 5 to 11. In a press release, Pfizer cited data from its Phase 2/3 trial that claimed a third dose produced a “strong immune response” in the younger age group when administered six months after the second dose.
The data was based on a small study involving only 140 children 5 through 11 years old who received a booster dose six months after the second dose of Pfizer-BioNTech’s COVID vaccine as part of the primary series.
Pfizer said 30 children who participated in the study revealed a 36-fold increase in virus-fighting antibodies — levels high enough to fight the Omicron variant, which is currently not the dominant variant in the U.S.
Experts told The Defender the “clinical trial used to support the notion of a COVID-19 booster for 5- to 11-year-olds is entirely inadequate to make any such recommendation.”
Denmark suspends COVID-19 vaccine campaign
Denmark on Tuesday became the first country to suspend its national COVID-19 vaccine campaign after health officials said the pandemic is under control there.
Bolette Soborg, director of the Danish Health Authority’s department of infectious diseases, said Denmark is “winding down” the mass vaccination program, and invitations for vaccinations would no longer be issued after May 15.
Public health authorities cited several factors contributing to the decision to end the national vaccination campaign. These include a decline in the number of newly reported infections, stabilized hospitalization rates and an overall high level of vaccination.
Denmark plans to reopen the vaccination program in the fall, which will be preceded by a thorough professional assessment of who and when to vaccinate, and with which vaccines.
The decision comes just a few months after Denmark eliminated all COVID-19-related restrictions, becoming the first European Union member state to do so.
Children’s Health Defense asks anyone who has experienced an adverse reaction, to any vaccine, to file a report following these three steps.
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Re: Coronavirus
https://www.youtube.com/watch?v=Lf2utwWfDc0
https://www.youtube.com/watch?v=Lf2utwWfDc0
New COVID Bill Fines Parents For Unvaxxed Kids And Doubles Income Taxes, Introduced in R.I.
Premiered 76 minutes ago
Facts Matter with Roman Balmakov
13:25
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https://www.nature.com/articles/s41598-022-10928-z#Tab1
Article
Open Access
Published: 28 April 2022
Increased emergency cardiovascular events among under-40 population in Israel during vaccine rollout and third COVID-19 wave
Abstract
Cardiovascular adverse conditions are caused by coronavirus disease 2019 (COVID-19) infections and reported as side-effects of the COVID-19 vaccines. Enriching current vaccine safety surveillance systems with additional data sources may improve the understanding of COVID-19 vaccine safety. Using a unique dataset from Israel National Emergency Medical Services (EMS) from 2019 to 2021, the study aims to evaluate the association between the volume of cardiac arrest and acute coronary syndrome EMS calls in the 16–39-year-old population with potential factors including COVID-19 infection and vaccination rates. An increase of over 25% was detected in both call types during January–May 2021, compared with the years 2019–2020. Using Negative Binomial regression models, the weekly emergency call counts were significantly associated with the rates of 1st and 2nd vaccine doses administered to this age group but were not with COVID-19 infection rates. While not establishing causal relationships, the findings raise concerns regarding vaccine-induced undetected severe cardiovascular side-effects and underscore the already established causal relationship between vaccines and myocarditis, a frequent cause of unexpected cardiac arrest in young individuals. Surveillance of potential vaccine side-effects and COVID-19 outcomes should incorporate EMS and other health data to identify public health trends (e.g., increased in EMS calls), and promptly investigate potential underlying causes.
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Re: Coronavirus
Dachsie comment:
There are several of these Level 4 labs in the USA and they all could be and probably are operating with this same relationship with Communist China and that means these labs, located right here in our neighborhoods, leaking or releasing pathogens, deliberately or accidentally.
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the Galveston National Laboratory a Level 4 Biological Laboratory, Galveston, Texas.
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https://www.theepochtimes.com/natali...rce=pushengage
Sure would like to be able to watch the full show but I do not like recurring charges on my credit card.
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May 3, 2022
May 3, 2022 American Thought Leaders
Natalie Winters: Texas Lab Agreed to Destroy Records If Asked by Wuhan Institute of Virology
American Thought Leaders
JAN JEKIELEK
“I had never seen a clause like this, and it basically stipulated that the Wuhan Institute of Virology could demand that the Galveston National Laboratory—again, a taxpayer-funded U.S.-based lab—would have to delete files, pathogens, materials.”
National Pulse investigative reporter Natalie Winters recently broke the story of the Galveston National Laboratory’s memorandum of understanding with the Wuhan Institute of Virology.
We discuss her extensive research into Chinese Communist Party influence in America, from TikTok to compromised “fact-checkers” to serious conflicts of interest among the individuals that shaped America’s COVID-19 policy.
“Even since COVID-19, millions of dollars have continued to pour out of this country, taxpayer funds, to Chinese Communist Party-run labs and to fund research in China—when we know there’s no transparency.”
Subscribe to the American Thought Leaders newsletter so you never miss an episode.
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Re: Coronavirus
FDA's bait-and-switch strategy explained.
Fraud vitiates every transaction and all contracts. Indeed, the principle is often stated, in broad and sweeping language, that fraud destroys the validity of everything into which it enters”–37 Am Jur 2d, Section 8
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See original article posting for hyperlinks.
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https://childrenshealthdefense.org/d...3-ec304b98b1ae
https://ecp.yusercontent.com/mail?ur...YHUt7cJvYg--~D
Military’s COVID Vaccine Mandate Violates the Law — Here’s Why
The COVID-19 vaccines granted Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) are voluntary products that cannot be administered to military personnel and civilians without informed consent.
In the military, this voluntary consent requirement for investigational drugs was upheld in the anthrax vaccine case, Doe v Rumsfeld (2003), which determined that in the absence of a presidential waiver, the U.S. Department of Defense (DOD) can legally mandate vaccines only if they are FDA-approved.
The voluntary consent requirement for COVID-19 EUA vaccines remains in place, despite false reports that the currently available EUA Pfizer-BioNTech and Moderna products have a Biologics License Application (BLA) and are FDA-approved.
Comirnaty had an expired marketing date on the FDA-approved BLA when the DOD mandated it, and Pfizer is not distributing Comirnaty in the U.S.
As a result, military personnel and civilians are within their legal rights to refuse the vaccine, per Title 21 U.S. Code §360bbb-3(e)(1)(a)(ii) and related regulations.
This article will detail how the courts clarified DOD was implementing an illegal vaccine mandate in November 2021, and how despite that, the DOD continues to coerce vaccine uptake and punish for noncompliance — similar to what occurred during the years following the illegal experimental anthrax vaccine mandate.
Congress should investigate DOD’s illegal enforcement EUA drug mandate
On Aug. 23, 2021, behind closed doors and without public discussion, the FDA approved a BLA (BLA125742) for the Comirnaty SARS-CoV-2 vaccine. The BLA expired the same day it was issued.
On Aug. 24, 2021, the DOD issued a vaccine mandate for a drug that did not exist and did not have an active BLA.
For the majority of vaccinations that occurred under the DOD mandate from August to December 2021, there was no license for the drug.
On Dec. 22, 2021, the FDA reissued the BLA (BLA125742) for Comirnaty, without a marketing end date, and with new National Drug Codes.
Congress has probable cause to investigate the DOD for two reasons.
First, the DOD knew the drug’s license was expired prior to the military mandate. Second, the DOD knew and understood that an EUA-labeled drug cannot be substituted for an FDA-approved drug, as clearly indicated in Doe v Rumsfeld.
In a future Congressional oversight investigation, the DOD must prove that it did not willfully enact an illegal mandate of the SARS-CoV2 vaccine.
The secretary of defense must also admit he knows the FDA-approved Comirnaty vaccine is not available to service members, and also that he knows the Comirnaty vaccine would have a BLA label with distinct National Drug Codes.
On Sept. 13, 2021, the National Institutes of Health published an announcement stating:
“At present, Pfizer does not plan to produce any product with these new NDCs and labels over the next few months while EUA authorized product is still available and being made available for U.S. distribution.
“As such, the CDC, AMA, and drug compendia may not publish these new codes until Pfizer has determined when the product will be produced with the BLA labels.”
On Sept. 14, 2021, the acting assistant secretary of defense published a memorandum stating the Pfizer-BioNTech and Comirnaty vaccines can be used “interchangeably.”
This resulted in an increase in vaccination uptake across the branches of the military.
However, there are very strict FDA requirements for “Biosimilar and Interchangeable Products” and these requirements would make it an unprecedented for an EUA drug to be approved as biosimilar to an FDA-approved drug, with additional testing required for biosimilar approval and comparison to the, in this case, not-yet-produced Comirnaty.
Moreover, the FDA does not list Comirnaty as biosimilar to BioNTech in the Purple Book database of biosimilar drugs. As stated in the Cominarty Highlights of Prescribing Information:
“There are no data available on the interchangeability of COMIRNATY with COVID-19 vaccines from other manufacturers to complete the vaccination series. Individuals who have received 1 dose of COMIRNATY should receive a second dose of COMIRNATY to complete the vaccination series.”
FDA-approved drugs have marketing requirements, packaging and labeling requirements, package insert and informed consent fact sheet requirements, designated facility and product manufacturing requirements, and distribution and administration requirements that are different from those for EUA drugs.
The DOD communicated the concept of “interchangeably” in violation of the FDA requirements for biosimilar substitutions and in violation of the law, under the Doe v Rumsfeld ruling.
FDA, Pfizer and Congress colluded to deceive public
The FDA colluded in misleading and confusing the public by violating its own requirement that an EUA drug, for which pharma companies can’t be held liable if the product causes injury, cannot coexist in the market with its FDA-approved counterpart — which does not come with the same liablity protection.
As previously reported by The Defender, the FDA informed product recipients in a fact sheet that both BioNTech and Comirnaty are actually under EUA liability shield protections:
“This EUA for the Pfizer-BioNTech COVID-19 Vaccine and COMIRNATY will end when the Secretary of HHS determines that the circumstances justifying the EUA no longer exist or when there is a change in the approval status of the product such that an EUA is no longer needed.”
The FDA approved Comirnaty yet continued to allow Pfizer to sell stockpiles of the EUA Pfizer-BioNTech vaccine, stating:
“In the August 23, 2021 revision, FDA clarified that, subsequent to the FDA approval of COMIRNATY (COVID-19 Vaccine, mRNA) for the prevention of COVID-19 for individuals 16 years of age and older, this EUA would remain in place for the Pfizer-BioNTech COVID-19 Vaccine for the previously-authorized indication and uses.”
On Aug. 23, 2021, Pfizer published a letter for healthcare professionals in which the company falsely claimed some lots of EUA Pfizer-BioNTech vaccine are considered “BLA-approved,” despite having a legally distinct EUA label:
“Many lots of Pfizer-BioNTech COVID-19 Vaccine are in circulation that were authorized for emergency use, and are labelled in accordance with the EUA. Some of these lots comply with the recently approved BLA for COMIRNATY and are therefore considered “BLA-approved” lots for administration to individuals 16 years of age and older.”
Attorneys and health policy analysts in September 2021 outlined for Congress via a Congressional Research Service report how the Comirnaty and Pfizer-BioNTech are legally distinct.
Here’s an excerpt from the report:
“Why did FDA refer to Comirnaty and the Pfizer-BioNTech vaccine as ‘legally distinct’?
“In the EUA, FDA states that the Comirnaty and Pfizer-BioNTech vaccines ‘are legally distinct with certain differences that do not impact safety or effectiveness.’ While the Comirnaty and Pfizer-BioNTech vaccines have the same formulation, they are legally allowed to be marketed and used pursuant to different legal authorities.
“Specifically, Comirnaty is licensed pursuant to a BLA issued under the Public Health Service (PHS) Act (42 U.S.C. §262). The Pfizer-BioNTech vaccine is authorized for emergency use pursuant to the Federal Food, Drug, and Cosmetic (FD&C) Act (21 U.S.C. §360bbb-3).
“Each product must be manufactured, labeled, marketed, distributed, and administered in accordance with the requirements of the legal regime under which it was approved or authorized. These requirements may differ in a number of ways.
“For example, under the EUA, the Pfizer-BioNTech vaccine must be accompanied by fact sheets for the vaccine administrator and recipient informing them, among other things, of the product’s emergency authorization, known and anticipated risks and benefits, and the right to decline the vaccine [emphasis added]. Comirnaty need not be accompanied by this information if it is being administered pursuant to the BLA rather than the EUA; instead, the PHS Act and other FDA regulatory labeling requirements apply.
“As another example, the Pfizer-BioNTech vaccine may be manufactured only at facilities identified and agreed upon in Pfizer’s EUA request, must be distributed directly by Pfizer or through authorized distributors to emergency response stakeholders (as defined in the EUA) as directed by the U.S. government, and must be administered by vaccination providers (as defined in the EUA) only to individuals 12 years of age and older.
“These limitations do not apply to Comirnaty vaccines manufactured and distributed pursuant to the BLA; instead, the PHS Act and FD&C Act requirements apply. Comirnaty may be manufactured only at facilities identified and approved in the BLA.”
Court verdict questioned legality of DOD’s mandate enforcement
On Nov. 12, 2021, District Judge Allen Winsor stated in his ruling on Doe v Austin, (Case No. 3:21-cv-1211-AW-HTC), “The DOD’s interpretation of § 1107a is unconvincing.”
Judge Winsor wrote:
“On August 23, 2021 — roughly eight months after the EUA first became effective — the FDA approved a Biologics License Application (“BLA”) and issued a full FDA license to produce and distribute the vaccine and label it with its proprietary name, ‘Comirnaty.’ ECF No. 1-4 at 2-3.
“The BLA approval requires that Pfizer produce Comirnaty only at approved locations, subject to specific manufacturing, packaging, and labeling requirements. Id. at 2 (Doe v Austin, page 5).
“Notably, though, the plaintiffs have shown that the DOD is requiring injections from vials not labeled ‘Comirnaty.’ Indeed, defense counsel could not even say whether vaccines labeled ‘Comirnaty’ exist at all. ECF No. 45 at 48:5-7. (Although the DOD’s response said it had an adequate Comirnaty supply, it later clarified that it was mandating vaccines from EUA-labeled vials. See id. at 46:22-47:3.)
“In the DOD’s view, this is fine because the contents of EUA-labeled vials are chemically identical to the contents of vials labeled ‘Comirnaty’ (if there are any such vials). According to the DOD’s argument, this means servicemembers are not required to accept ‘a product authorized for emergency use.’ 10 U.S.C. § 1107a(a)(1).
“Rather, the DOD argues that once the FDA licensed Comirnaty, all EUA-labeled vials essentially became Comirnaty, even if not so labeled. ECF No. 45 at 60:1-3. Thus, the DOD argues, the ‘product’ injected is a chemical formulation that has received full FDA licensure — not merely an EUA — so § 1107a does not apply. Id. at 65:1-6.8.
“The DOD’s interpretation of § 1107a is unconvincing. For starters, FDA licensure does not retroactively apply to vials shipped before BLA approval. See 21 U.S.C. § 355(a) (‘No person shall introduce . . . into interstate commerce any new drug, unless an approval of an application [for FDA licensure] is effective with respect to such drug’ [emphasis added]).
“Thus, as a legal matter, vaccines sent before August 23 — and vaccines produced after August 23 in unapproved facilities — remain ‘product[s] authorized for emergency use under section 564 of the Federal Food, Drug, and Cosmetic Act.’ § 1107a(a)(1).
“Section 1107a’s explicit cross-reference to the EUA provisions suggests a concern that drugs mandated for military personnel be actually BLA-approved, not merely chemically similar to a BLA-approved drug. And the distinction is more than mere labeling: to be BLA compliant, the drug must be produced at approved facilities, see ECF No. 1-4 at 2; 21 C.F.R. §§ 600.11, 600.20-.21, and there is no indication that all EUA-labeled vials are from BLA-approved facilities.
“Moreover, the DOD concedes that some of its current vials are not BLA-compliant, and that there is no policy to ensure that servicemembers get only BLA-compliant vaccines. See ECF No. 45 at 61:10-12. It is difficult to see how vials that the DOD admits are not BLA-compliant — and thus could only be EUA products — could fall outside § 1107a’s prohibition on mandatory administration.”
One detail Judge Winsor did not take notice of was the same-day expiration of the Comirnaty BLA on Aug. 23, 2021. (See page 23 of the original version of Comirnaty’s “Highlights of Prescribing Information.”)
If Judge Winsor were to revise his verdict summation, documenting the subsequent re-issuance of the BLA in December 2021 with different National Drug Codes and without a marketing expiration date, this would result in a more comprehensive record of the facts to benefit other pending lawsuits.
Despite this court verdict, the DOD refused to change course on the SARS-CoV-2 vaccine military mandate.
It's Time to Follow the Science. Join our Campaign!
Similarly, with the anthrax vaccine, the DOD spent a decade in the judicial process defending what was ultimately decided as an illegal mandate of an experimental drug that eventually did acquire FDA approval years later.
During this time, service members faced court-martial, confinement, and loss of rank, pay and retirement benefits. Years of experience were lost in separated service members, specifically pilots. The personnel losses were not counterbalanced in the pursuit to protect the health of the force.
Again today, the DOD is struggling to meet recruiting goals, yet still remains steadfastly on course while negatively affecting the lives of thousands of service members and their families.
It is apparent that only Congress can provide the necessary oversight to prevent this mandate from exacerbating critical personnel shortages in the U.S. Armed Forces and to safeguard our national security.
Pharmaceutical contracts in the DOD are lucrative with 1.4 million active-duty personnel (with additional DOD civilians, National Guard, and Reserve units). These contracts with mandated populations remain profitable even with years of attorney fees.
In 2020, the DOD’s initial contract with Moderna cost $1.97 billion, and the initial contract with Pfizer cost $1.95 billion.
There are currently 23 lawsuits by service members against the DOD SARS-CoV-2 vaccine mandate, and thousands of service members awaiting religious accommodation request approvals.
Other service members face involuntary separation for refusing a voluntary EUA drug. As of late April 2022, there is at least one marine at Quantico who was retained in an administration separation board after agreement with the defense lawyer that there was no possible way for the service member to comply with the vaccine order because FDA-approved Comirnaty and Spikevax are not available.
The FDA approved Spikevax using a similar bait-and-switch strategy as Comirnaty, adding to the evidence that the FDA acted unethically and the DOD should have reasonably known to verify the licensure and availability of these two products.
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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Pam Long's avatar
Pam Long
Pam Long is graduate of USMA at West Point and is an Army Veteran of the Medical Service Corps.
Rose M. Freeman's avatar
Rose M. Freeman
Rose is a graduate of MIT and a Navy Veteran.
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Re: Coronavirus
Stephen Harris
@joehonda7
Pfizer data released today. 80,000 pages. Pfizer knew vaccine harmed the fetus in pregnant women, and that the vaccine was not 95% effective, Pfizer data shows it having a 12% efficacy rate.
Stay informed
7:04 PM · May 2, 2022
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Re: Coronavirus
The Covid "vaccines" are bioweapons made in labs in China and in the USA.
https://www.bitchute.com/video/fTHHE6ai2V9G/
https://static-3.bitchute.com/live/c...9G_320x180.jpg
China’s Secret Death Sentence: Organ Harvesting
5:31 video runtime
First published at 23:43 UTC on May 4th, 2022.
https://www.bitchute.com/channel/jim-crenshaw/
China doesn't kill prisoners the way other countries do. The Chinese Communist Party makes sure that even in death, the Chinese people are still contributing to the glory of the motherland. By removing their hearts, livers, eyes, skin and other vital body parts, China's secret death sentence ensures that prisoners are disposed of with maximum profit and efficiency. In this episode of China Uncensored, we look at the Chinese Communist Party's practice of forced organ harvesting, who is being targeted by it, and how it's affecting other countries.
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