1. Registering for the Forum

    We require a human profile pic upon registration on this forum.

    After registration is submitted, you will receive a confirmation email, which should contain a link to confirm your intent to register for the forum. At this point, you will not yet be registered on the forum.

    Our Support staff will manually approve your account within 24 hours, and you will get a notification. This is to prevent the many spam account signups which we receive on a daily basis.

    If you have any problems completing this registration, please email support@jackkruse.com and we will assist you.

the-fake-news-that-fda-approved-the-vaccines-is-made-clear-in-the-letter/?

Discussion in 'The Cave' started by Penny, Aug 24, 2021.

  1. Penny

    Penny New Member

  2. Dan2

    Dan2 New Member

    Post other places you find information about this in this thread, please?

    edit: PDF compilation explaining it in post #12
     
    Last edited: Oct 24, 2021 at 9:01 AM
  3. Dan2

    Dan2 New Member

    ( @John Schumacher )


    edit: After reading what Meryl Nass and others have said, what Robert Malone said in the second paragraph of this, that I now emphasized, seems, compared to Meryl Nass, RFK Jr., and Ron Johnson, to be misleading. BioNTech isn't licensed; it's EUA. And I don't know why Malone said "it" (referring to BioNTech, I'm assuming) is called COMIRNATY.

    https://raypeatforum.com/community/...n-monday-august-23rd.42096/page-3#post-688171

    In that post is a Twitter video posted by TanyaRo58329998, an excerpt of an interview with Dr. Robert Malone by Steve Bannon.

    Steve Bannon:
    "When you look at these two letters [FDA letters attached to this post? not sure which he's referring to], the way you've broken them apart -- and I want to go back to what you've said about the data; there's really no data -- [the FDA] has authorized the use of a vaccine. Does that vaccine currently exist? If I go to a doctor today, can I get this one that has this sketchy shady FDA approval? Is that available right now to the best of your knowledge, sir?"

    Robert Malone:
    "It's absolutely not available. The little trick that they've done here is that they've issued two separate letters for two separate vaccines. The Pfizer vaccine, which is what is currently available, is still under emergency use authorization, and it still has the liability shield. Once again, the mainstream media has lied to you -- I'm sorry to say that, I know it's a shock. But the product that's licensed is the BioNTech product, which is substantially similar but not necessarily identical. It's called COMIRNATY... and it's not yet available; they haven't started manufacturing it or labeling it. And that's the one that liability waiver will no longer apply to. So the one that's actually licensed is not yet available, and when it does become available it will no longer have the liability shield. In the interim, the one that does have the liability shield is the Pfizer product, and that's what's currently available and it's still under emergency use authorization, so that's no change. The press has just not done their work and figured out what's actually going on here."

    Steve Bannon:
    "The Emergency Use Authorization by the FDA for the Pfizer product, as it currently stands, does not allow its use for children under 16. Is that correct?"

    Robert Malone:
    "Correct."
     

    Attached Files:

    Last edited: Oct 24, 2021 at 3:35 AM
    Richard Watson likes this.
  4. Dan2

    Dan2 New Member

    Blog posts by Meryl Nass MD
    (I think these are a better explanation than my previous post.)


    https://anthraxvaccine.blogspot.com/2021/08/i-explain-my-theory-of-comirnaty.html

    August 23, 2021

    I explain my theory of the COMIRNATY "license" scam by referring to passages in the FDA approval letter

    [full post copied]
    "Read the FDA approval letter please [https://www.fda.gov/media/150386/download]. This is how they scam you, by making it nearly impenetrable. Below, I identify the two most relevant passages. The rest of the letter is repetitive blather to keep your head spinning.

    page 2 last line, footnote: here FDA quietly admits that the licened Pfizer vaccine and the authorized Pfizer vaccine are identical w.r.t. safety and efficacy, but they are "legally distinct." That's code for one has manufacturer liability, while the other doesn't. It is also code for "we don't want to impose a mandate on the EUA product 'cause it is illegal, but we can probably get away with a mandate on the licensed product."

    page 12 AA. This tells you that yes, we licensed the vaccine, but...there is a lot of the old vaccine out there, actually "a significant amount" and this amount will be considered an EUA vaccine and will continue to be used. Maybe for a very long time.

    Now, why would they do that? Why specify that identical versions of the product will be legally different? Because they need the license to impose the mandates. But they need the EUA to evade liability.

    Along with the license comes liability for the manufacturer. (But all EUA products were given a liability shield.)

    Unfortunately, our federal overlords would prefer us to be without recourse if we are injured, rather than have Pfizer risk defending its product in court.

    So, my inference is that the feds want the public to THINK the vaccine they are receiving is licensed, which will make people submit because they believe it can now be mandated, but instead the public is almost certain to receive the EUA vials instead, to save Pfizer's behind.

    * You will be able to tell the difference when you see the vaccine vial. The letter explains that the COMIRNATY-labelled vials will be the licensed ones, and the others (under EUA) will say something like Pfizer BioNTech Covid-19 Vaccine without the brand name COMIRNATY.

    Yes, a stingy CICP injury program exists, which I have previously written about, but it has not paid out for a single Covid vaccine injury, last time I checked.

    How did I figure this out? Because I have read other FDA approval letters, and this one had significant weasel wording. And I have seen other FDA tricks. So it just took me awhile to identify what was being hidden. I could be wrong. But then we would need another explanation for the language in the approval letter. I'm happy to entertain other interpretations.

    P.S. Pfizer made $33 billion so far this year on its mRNA vaccine."

    _____


    https://anthraxvaccine.blogspot.com/2021/08/fda-covid-vaccine-approval-dr-robert.html

    August 24, 2021

    FDA Covid Vaccine "Approval"--Dr. Robert Malone has compiled a laundry list of concerns from multiple sources regarding the validity of the so-called approval

    [longer article; I'm excerpting some things I didn't expect after reading the first article]

    "...The prescribing info says: "There is a pregnancy exposure registry for COMIRNATY. Encourage individuals exposed to COMIRNATY around the time of conception or during pregnancy to register by visiting https://mothertobaby.org/ongoingstudy/covid19-vaccines/ ." WHY ARE THEY DOING A PREGNANCY STUDY?..."

    [emphasis in next paragraph mine]
    "The BLA [biologics license approval] acknowledges LONG term myocardial issues with a 5 year follow up consistent with the lower range for Long term follow-up (LTFU) for Gene Therapy Products. Is FDA tacitly acknowledging the Gene Therapy classification? These products [COMIRNATY?] have been classified by FDA and by their manufacturers in SEC filings as Gene Therapy Products, which require up to 15 years long term follow up in studies. This was acknowledged by Moderna in their 2Q 2020 filing. Will FDA collect other long term data on autoimmune disease, cancer and other disorders as contemplated in their Gene Therapy Guidance document? "

    "Regarding the Pediatric Indication Requirements applied to the BioNTech license, Postmarketing requirements include multiple “deferred” studies

    o Deferred pediatric Study C4591001 to evaluate the safety and effectiveness of COMIRNATY in children 12 years through 15 years of age.

    o Deferred pediatric Study C4591007 to evaluate the safety and effectiveness of COMIRNATY in infants and children 6 months to <12 years of age.

    o Deferred pediatric Study C4591023 to evaluate the safety and effectiveness of COMIRNATY in infants <6 months of age."

    _____


    https://anthraxvaccine.blogspot.com/2021/08/the-fdas-approval-of-pfizers-comirnaty.html

    August 24, 2021

    The FDA's "approval" of Pfizer's Comirnaty vaccine is a Bait and Switch that makes mandates illegal

    written with Robert F. Kennedy, Jr.

    https://childrenshealthdefense.org/defender/mainstream-media-fda-approval-pfizer-vaccine/

    [emphasis mine]
    "At least for the moment, the Pfizer Comirnaty vaccine has no liability shield. Vials of the branded product, which say “Comirnaty” on the label, are subject to the same product liability laws as other U.S. products.

    When the Centers for Disease Control and Prevention’s (CDC) Advisory Committee for Immunization Practices places a vaccine on the mandatory schedule, a childhood vaccine benefits from an generous retinue of liability protections.

    But licensed adult vaccines, including the new Comirnaty, do not enjoy any liability shield. Just as with Ford’s exploding Pinto, or Monsanto’s herbicide Roundup, people injured by the Comirnaty vaccine could potentially sue for damages.

    And because adults injured by the vaccine will be able to show that the manufacturer knew of the problems with the product, jury awards could be astronomical.

    Pfizer is therefore unlikely to allow any American to take a Comirnaty vaccine until it can somehow arrange immunity for this product.

    Given this background, the FDA’s acknowledgement in its approval letter that there are insufficient stocks of the licensed Comirnaty, but an abundant supply of the EUA Pfizer BioNTech jab, exposes the “approval” as a cynical scheme to encourage businesses and schools to impose illegal jab mandates.

    The FDA’s clear motivation is to enable Pfizer to quickly unload inventories of a vaccine that science and the Vaccine Adverse Events Reporting System have exposed as unreasonably dangerous, and that the Delta variant has rendered obsolete.

    Americans, told that the Pfizer COVID vaccine is now licensed, will understandably assume that COVID vaccine mandates are lawful. But only EUA-authorized vaccines, for which no one has any real liability, will be available during the next few weeks when many school mandate deadlines occur.

    The FDA appears to be purposefully tricking American citizens into giving up their right to refuse an experimental product.

    While the media has trumpeted that the FDA has approved COVID vaccines, the FDA has not approved the Pfizer BioNTech vaccines, nor any COVID vaccines for the 12- to 15-year age group, nor any booster doses for anyone.

    And FDA has not licensed any Moderna vaccine, nor any vaccine from Johnson & Johnson — so the vast majority of vaccines available in the US, if not all, remain unlicensed EUA products.

    Here’s what you need to know when somebody orders you to get the vaccine: Ask to see the vial. If it says “Comirnaty,” it’s a licensed product. If it says “Pfizer-BioNTech,” it’s an experimental product, and under 21 U.S. Code 360bbb, you have the right to refuse.

    If it comes from Moderna or Johnson & Johnson (marketed as Janssen), you have the right to refuse.
    "
     
    Last edited: Aug 30, 2021
    Richard Watson likes this.
  5. Penny

    Penny New Member

    Last edited: Aug 25, 2021
  6. Dan2

    Dan2 New Member

    Last edited: Oct 24, 2021 at 12:42 AM
  7. Dan2

    Dan2 New Member

    Newer blog post by Meryl Nass

    https://anthraxvaccine.blogspot.com/2021/08/big-news-you-cannot-be-forced-to-get.html

    Thursday, August 26, 2021

    BIG NEWS!!! You cannot be forced to get the Covid vaccine. Here is the way out.
    By Meryl Nass MD

    [emphasis by Meryl Nass]

    Let me show you how FDA, Pfizer and BioNTech colluded to fool everyone about the EUA status of the vaccine Americans will be offered. But close reading of their document gives you an escape route. The "Fact Sheet for Recipients", [https://www.fda.gov/media/144414/download] dated August 23, 2021, is approved by FDA and is on FDA's website, and is signed by BioNTech and Pfizer.

    Direct quotes from this easy to read 8 page document [https://www.fda.gov/media/144414/download] are below, and I suggest you print the document out, as it will help you avoid a vaccine mandate. Pay close attention. I added numbers to the most interesting excerpts.

    After stating that you might receive the licensed vaccine or a vaccine under EUA in item 2, item 6 indicates that both the licensed vaccine AND the EUA vaccine are both under EUA. (This may be the way chosen to shield the licensed vaccine from liability.) Item 5 says that while under EUA, it is your choice whether or not to receive the vaccine.

    Show this document to your college, your hospital, your boss. They cannot force you to receive either of these vaccines!

    -----------------

    1. The FDA-approved COMIRNATY (COVID-19 Vaccine, mRNA) and the FDA-authorized Pfizer-BioNTech COVID-19 Vaccine under Emergency Use Authorization (EUA) have the same formulation and can be used interchangeably to provide the COVID-19 vaccination series.[1]

    2. You are being offered either COMIRNATY (COVID-19 Vaccine, mRNA) or the Pfizer-BioNTech COVID-19 Vaccine to prevent Coronavirus Disease 2019 (COVID-19) caused by SARS-CoV-2.

    3. 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.

    4. WHAT IF I DECIDE NOT TO GET COMIRNATY (COVID-19 VACCINE, mRNA) OR THE PFIZER-BIONTECH COVID-19 VACCINE?

    5. Under the EUA, it is your choice to receive or not receive the vaccine. Should you decide not to receive it, it will not change your standard medical care.


    6. 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.

    Manufactured by Pfizer Inc., New York, NY 10017

    Manufactured for BioNTech Manufacturing GmbH An der Goldgrube 12 55131 Mainz, Germany LAB-1451-7.2 Revised: 23 August 2021
     
    John Schumacher, ND Hauf and DebraGM like this.
  8. Dan2

    Dan2 New Member

    To the people who viewed the compilation PDF today, I edited it tonight to make it more professional looking, more presentable than the first version I posted earlier today.

    edit: new PDF, post #12
     
    Last edited: Oct 24, 2021 at 3:38 AM
  9. Dan2

    Dan2 New Member

    Edited it again to take out the quotes from Robert Malone's interview with Steve Bannon on August 24 (post # 3 in this thread) because some of what he said wasn't accurate.
     
    Last edited: Aug 31, 2021
    ND Hauf likes this.
  10. Jacks

    Jacks Gold

    Awesome thread - thanks everyone for figuring out the details of this. I'm not so worried now as I was!
     
    Dan2 likes this.
  11. Jack Kruse

    Jack Kruse Administrator

    You need to worry about how to build a life around them
     
  12. Dan2

    Dan2 New Member

    I decided Zelenko needs to be censored sometimes. I can't believe I included his doomsday language and "you have no legal recourse" tweet. For his next tweet he should quote the Born to Run lyrics. New and improved most presentable, starting the compilation with RFK Jr.'s website name instead of the first thing at the top of the first page being anthraxvaccine.blogspot.com hahaha, then Senator Ron Johnson's letter to the FDA, then Meryl Nass, and none of my emphasis-bolding: attachment


    P.S. This one's for you, Zelenko



    This too
     
    Last edited: Oct 24, 2021 at 6:13 AM

Share This Page