Not So Fast

Go to page 12 of this document and read what it actually says, notice it has today’s date.

https://www.fda.gov/media/150386/download

Page 12 – Pfizer Inc.
• This product has not been approved or licensed by FDA, but has been
authorized for emergency use by FDA, under an EUA to prevent Coronavirus
Disease 2019 (COVID-19) for use in individuals 12 years of age and older; and
• The emergency use of this product is only authorized for the duration of the
declaration that circumstances exist justifying the authorization of emergency
use of the medical product under Section 564(b)(1) of the FD&C Act unless the
declaration is terminated or authorization revoked sooner.

Go back up to the bottom of page 7 and the top of page 8 and you will see this,

The emergency use of Pfizer-BioNTech COVID‑19 Vaccine under this EUA must be consistent
with, and may not exceed, the terms of the Authorization, including the Scope of Authorization
(Section II) and the Conditions of Authorization (Section III). Subject to the terms of this EUA and
Page 8 – Pfizer Inc.
under the circumstances set forth in the Secretary of HHS’s determination under Section
564(b)(1)(C) described above and the Secretary of HHS’s corresponding declaration under Section
564(b)(1), Pfizer-BioNTech COVID‑19 Vaccine is authorized to prevent COVID-19 in individuals
12 years of age and older as described in the Scope of Authorization (Section II) under this EUA,

despite the fact that it does not meet certain requirements otherwise required by applicable federal
law.

My bold.

Emergency Use Authorization.

Period.

From here to the day I croak, if you come at me with that Frankenjenction I will do my absolute best to Fold, Spindle and Mutilate you all the way to death, with my bare hands if necessary.

40 thoughts on “Not So Fast

  1. It a mind fuck ! no one reads he fine print here in the fucking us of a anymore.
    make no mistake, these fuckers will use this bullshit paper to try and force everyone to get
    the jab. so much for my body, my choice crap.
    look for more assholes to try and force people to be jabbed by ONLY SHOWING THE MAIN PART, AND LYING ABOUT THE OTHER PAGES SHOWED ABOVE.
    fuck them. my dad always said the fuckers print only what helps them and not you.
    he was talking about the “news” back in the 1960’s -1970’s after that he never watched the “news” other to check sports and weather. and he didn’t trust the weather man that often either.

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  2. IANAL (or MD) but if I look further down on page 12, paragraph AA, I see the following. They seem to be drawing a distinction (with or without a difference) between the EUA vaccine and the brand name COMIRNATY vaccine. “Licensed” seems to be full approval, not EUA. Any vaccine made before this approval continues to be under the EUA and can be used under the EUA.

    Conditions With Respect to Use of Licensed Product
    AA. COMIRNATY (COVID-19 Vaccine, mRNA) is now licensed for individuals 16 years of age and older. There remains, however, a significant amount of Pfizer-BioNTech COVID-19 vaccine that was manufactured and labeled in accordance with this emergency use authorization. This authorization thus remains in place with respect to that product for the previously-authorized indication and uses (i.e., for use to prevent COVID-19 in individuals 12 years of age and older with a two-dose regimen, and to provide a third dose to individuals 12 years of age or older who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise).
    BB. This authorization also covers the use of the licensed COMIRNATY (COVID-19 Vaccine, mRNA) product when used to provide a two-dose regimen for individuals aged 12 through 15 years, or to provide a third dose to individuals 12 years of age or older who have undergone solid organ transplantation or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise. Conditions A through W in this letter apply when COMIRNATY (COVID-19 Vaccine, mRNA) is provided for the uses described in this subsection III.BB, except that product manufactured and labeled in accordance with the approved BLA is deemed to satisfy the manufacturing, labeling, and distribution requirements of this authorization.

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    • I obviously missed this. So they are renaming the Pfizer jab and approving it in spite of the known deaths and side effects. Allow me to repeat myself, I will use everything in reach and inflict maximum physical damage on anyone getting with league darts reach of me with any of them.

      Liked by 1 person

      • Glad you have thought about it and come to a decision that is right for you. I don’t disagree with you even though I decided to get the shot. Your concerns are definitely valid and I share them. If I never hear the term “follow the science” again, it will definitely improve my gag reflex. I think the FDA release could hardly have been more confusing, one more reason why people don’t trust them or anyone else in government, and I definitely am against any mandatory vaccine rules.

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  3. It may be “authorized to prevent COVID-19 in individuals” but the data I have seen tells me it does not prevent COVID-19 in individuals.

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  4. Looks like they are using the EUA to continue to indemnify the company producing the agent? A BLA license looks like the company would be liable. Without the EUA.

    Also, the new, funny name of the agent is probably the name under which it will be marketed?

    I am not an attorney, but sometimes play one on the internet.

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  5. You come at me with that, and you either get The Holy Hot Sauce in your face (IF I’m feeling mellow/unthreatened) or Mister .357 Head/body ache. Your call.

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  6. That’s Jack Elam in that meme. I apologize for going off topic (I tend to go on about Westerns) but I just want to say his sequence in the beginning of “Once Upon A Time In The West” showed that Sergio Leone could tell a story no matter how long it took. You would never get away with a scene timed like that in today’s instant gratification Hollyweird. It was brilliant. Lack of that kind of film making is part of the reason the movie industry is going through a well deserved collapse and maybe it does loop back around and speak to the mindless herd mentality that thinks we could or should force vaccinations. I’ve said before that I got the Pfizer shot and have no issues but that was between me and my doctors based on my special risk factors and has no bearing on anyone else’s medical decisions. The idea of ANY medical decision being forced is wildly wrong.

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      • I’m not a smoker (I’m also not an anti smoking Nazi) but I find the documented fact that smokers aren’t getting COVID to be hilarious. Wife and I have a nice place rented on the beach week after next after and it might be time for a good cigar and glass of brandy out on the terrace overlooking the beach and listening to the night surf. I’ll be raising a glass to all freedom lovers!

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    • Obviously you haven’t seen the studies showing smokers 80% less likely to get the coof. I’m not linking it, do yer own damn homework. Beavis.

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      • You can’t link a study that shows 80% because none do. Smokers are slightly less likely to catch covid but much more likely to be hospitalized if they do become infected.
        There are a number of possible explanations, none conclusive.

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    • Nicotine has been proven to prevent the white blood cells from going nuts, not dying after they surround the virus, and attacking your healthy cells.

      That said, smokers like Phil tend to check out sooner and faster than most, saving those benefits for the rest of us.

      That was told to me by my sister, a critical care nurse when I said what you said about smoking.

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  7. Well isn’t that special! Our bodies, our choice, right beavis? I’ve had 80 year old patients who smoked their whole lives who never had smoking related health problems.

    Are you using herbicides or pesticides bitch? Cause that’s what caused my dad’s cancer that killed him.

    Bless your little heart, beavis.

    Phil I quit using an e-cig so I didn’t choke every mother fucker that came within arms reach.

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    • Your body your choice as long as it doesn’t negatively impact anyone else, sweetie. You have no right to exhale smoke or the covid virus in anyone’s face.
      Sitting at home drunk? Fine. Driving drunk? Nope.
      Your anecdotes aren’t proof of anything. If you ever had any scientific training you either learned nothing or you’re are so old you forgot everything.
      Patients? If you are a health care provider, that is worrisome. Notice I didn’t say ‘professional’ because if you really mean what you wrote then you have no business being near patients and are certainly no professional. A professional would understand the difference between data and an anecdote.
      Consider a career change to bouncer at a lesbian bar, roller derby, or putting shot for the Russians.

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      • I also knew someone who, at 96, refused to let herself be put into a nursing home because she knew they wouldn’t let her keep up her 3-packs/day Malrboro habit.

        Anecdote or not, how old was George Burns when he died?

        I’ve been smoking non-filters for 37 years and still don’t care…

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        • Good for you. 2 of 3 smokers will die prematurely because of smoking. 1 of 3 won’t. Hope you are in the 1/3 group.
          My grandfather smoked and drank until the day he died at 93. What does that prove? Absolutely nothing!
          Smoking isn’t safe no matter how many anecdotal exceptions we come up with. A health care professional would never imply that it is.

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      • My point beaver (aka pussy) is that there are multiple environmental and life choices that contribute to the development of cancer (addressing your statement of carcinogens in cigarettes). Husband currently has a list of potential health problems/cancers he can develop because of contaminated water while stationed at Camp Lejeune. Did you serve your country bitch?

        You choose to focus on smoking just to pick at Phil. 2 out of 3 smokers die prematurely? Show your research. Sister has worked for NIH as a research microbiologist for many years and says research is often skewed to support the results the PTB require. The government is not above reproach.

        As a health care provider, I educate my patients on the pros and cons of health care treatment, side affects and adverse effects of any drug or treatment prescribed as I was trained to do. Patients have the right to autonomy and the right to choose what’s right for them. I educate. I DON’T FORCE TREATMENT ON ANYONE! Patients rights you know.

        And with all the smoking related laws, when was the last time someone blew smoke in your face?

        Stop being a fucking lemming!

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      • Here’s a summary of the study that published the 2/3 number.
        https://www.saxinstitute.org.au/our-work/45-up-study/

        Here is a link to the ACTUAL DATA from that study
        https://www.saxinstitute.org.au/our-work/45-up-study/data-book/

        Here’s a link to some CDC stats on smoking and mortality.
        https://www.cdc.gov/tobacco/data_statistics/fact_sheets/health_effects/tobacco_related_mortality/inind.htm

        The evidence against cigarettes is so overwhelming that even tobacco companies now admit cigarettes kill. Yet many smokers are screaming about a vaccine that has relatively few life threatening side effects and will save millions of lives. America is dying by drowning in ignorance.

        I’m curious Sandy, are you transitioning? It appears you identify as female but I work with a really butch dyke who is more feminine. I hope you find happiness with your chosen gender, whichever that is.

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  8. The FDA has conveniently given these poisons the official rubber stamp of approval. No NEW EVIDENCE presented as to their safety…..just a defacto change from experimental to approved.
    The FDA……PROOF that you can buy scientists just as easily as politicians.

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  9. I’d take the jab, so long as I could get the same saline injectable that politicians are photographed getting. BTW, Phil, QANTAS is being used as an incentive to get the jab, with flight discounts, lotteries for free flights and holidays. Remember that shit next time you’re booking a flight, maybe let the airline (and their subsidiary Jetstar) know that you won’t play with them no more.

    Like

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