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Thread: FDA seems to approve Pfizer Covid shot (but perhaps it hasn't)

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    United States Avalon Member mojo's Avatar
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    Default FDA seems to approve Pfizer Covid shot (but perhaps it hasn't)

    Another sad day for our institutions. Myself and others have lost trust in them. I'm not sure what the real statistics would show us about the harmful effects of the vax, but I do know the insert on the Covid vax does not list ingredients. How will FDA approve the shot without this knowledge?


    Quote The Food and Drug Administration (FDA) on Monday granted full approval to Pfizer's COVID-19 vaccine for individuals 16 years and older.

    "The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic," Acting FDA Commissioner Janet Woodcock said in a statement issued Monday. "While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product."

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    Default Re: FDA seems to approve Pfizer Covid shot (but perhaps it hasn't)

    This will help with the imminent mandates.

    Rigorous scientific testing doesn't instil the confidence in people as it once used to. So many institutions feel and come across as compromised.
    To the mind that is still, the whole universe surrenders. -Lao Tzu

    I must not fear. Fear is the mind-killer.

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    Default Re: FDA seems to approve Pfizer Covid shot (but perhaps it hasn't)

    Im beginning to really feel its over. They have put alot of time and planning into this operation for many years. they have checked off all the variable on the list and have accounted for everything.
    And with the VAERS numbers they still push this through? Really?
    They will be able to force this on everyone now. Its a lawless country now, no one to turn to, no authority I can believe in. This is very very dangerous

    Im pulling for the Australian Truckers who will be creating a blockaid on I believe the 31st. To take thier country back from these criminals.

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    Default Re: FDA seems to approve Pfizer Covid shot (but perhaps it hasn't)

    Quote Posted by mojo (here)
    I do know the insert on the Covid vax does not list ingredients. How will FDA approve the shot without this knowledge?
    1. If I understand this right (can anyone confirm?), if it's approved then they have to list the ingredients.
    2. Let the lawsuits begin.

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    Default Re: FDA seems to approve Pfizer Covid shot (but perhaps it hasn't)

    FDA warns against ivermectin as COVID treatment

    Quote People should never take drugs formulated for animals, the FDA warned
    I'm about to blow a gasket... They are complaining people are taking animal medicine. It's not that we went about trying to hurt our bodies, FDA has done absolutely nothing to provide access to therapeutics.

    Quote The Food and Drug Administration (FDA) reiterated a warning against the use of ivermectin as a COVID-19 treatment amid growing reports of individuals taking the drug often used to treat parasitic worms in animals.

    Mississippi state health officials issued a recent alert prompted by increasing calls of people with potential ivermectin exposure taken to prevent or treat COVID-19 infection. While the drug has FDA-approval for certain uses in animals and humans, over 70% of the recent calls involved livestock formulations, officials said.

    The FDA previously issued concerns over self-medication with ivermectin intended for animals, noting some people might mistakenly believe the drug can substitute for ivermectin intended for humans.

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    Default Re: FDA seems to approve Pfizer Covid shot (but perhaps it hasn't)


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    Default Re: FDA seems to approve Pfizer Covid shot (but perhaps it hasn't)

    Quote Posted by mojo (here)
    Another sad day for our institutions. Myself and others have lost trust in them. I'm not sure what the real statistics would show us about the harmful effects of the vax, but I do know the insert on the Covid vax does not list ingredients. How will FDA approve the shot without this knowledge?


    Quote The Food and Drug Administration (FDA) on Monday granted full approval to Pfizer's COVID-19 vaccine for individuals 16 years and older.

    "The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic," Acting FDA Commissioner Janet Woodcock said in a statement issued Monday. "While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product."

    That woman... Janet Woodcock... is either living in cloud cuckoo land or she is a shameless (and dangerous) liar...

    But we should expect no less now as people in key positions of authority around the world throw us to the wolves and literally don't give a damn about having any personal integrity or speaking the truth about anything -

    Just mind boggling how treacherous they are...

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    Default Re: FDA seems to approve Pfizer Covid shot (but perhaps it hasn't)

    Quote Posted by mojo (here)
    FDA warns against ivermectin as COVID treatment

    Quote People should never take drugs formulated for animals, the FDA warned
    I'm about to blow a gasket... They are complaining people are taking animal medicine. It's not that we went about trying to hurt our bodies, FDA has done absolutely nothing to provide access to therapeutics.

    Quote The Food and Drug Administration (FDA) reiterated a warning against the use of ivermectin as a COVID-19 treatment amid growing reports of individuals taking the drug often used to treat parasitic worms in animals.

    Mississippi state health officials issued a recent alert prompted by increasing calls of people with potential ivermectin exposure taken to prevent or treat COVID-19 infection. While the drug has FDA-approval for certain uses in animals and humans, over 70% of the recent calls involved livestock formulations, officials said.

    The FDA previously issued concerns over self-medication with ivermectin intended for animals, noting some people might mistakenly believe the drug can substitute for ivermectin intended for humans.
    I like the way they tilt the media to acknowledge that Ivermectin is used to treat worms in livestock, as if they want the public to believe it has no human uses.... but they do not make note that the human version of Ivermectin is working, when it comes to being used prior to hospitalization in studies in human form. As well as speeding up the recovery of those in critical care units. My husband went from critical condition to going home in 3 days after demanding Ivermectin in the ICU..

    They neglect to tell people that ivermectin works, and instead try to paint those who are aware of it, and treating themselves any way they can, as fools... As the medical establishment does not want to lose the $3,000 per course of treatment for Remdesivir for a treatment of Ivermectin that keeps them out of the hospital, AND costs less than a dollar a dose.

    The stores in my area now are requiring that you provide all kinds of personal identification if you buy livestock ivermectin. Including your address and drivers license. I bet those "Calls" the FDA are receiving, are calls asking how to adjust the doses making it ok for human consumption, as the patients cannot get their Dr.s to prescribe it... . Those taking the calls should see this as an outcry AGAINST the status quo, and be alarmed that they're "wealth care" system, is fully known at this point, and well being is the last thing they care about. If they continue to keep ivermectin from the public I think I will really begin to question anything any Dr. prescribes.

    It's shameful and criminal, that the FDA and those treating this pandemic, are keeping the real medications that work, out of the hands of those that desperately need it.
    Last edited by Denise/Dizi; 23rd August 2021 at 16:53.

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    Default Re: FDA seems to approve Pfizer Covid shot (but perhaps it hasn't)

    Mike Adams takes a close look at this, very much in his own style, in his new Situation Update for today.

    https://www.brighteon.com/4614e124-3...0-409c2dd12dd8

    Source: https://www.brighteon.com/embed/4614e124-31d4-4299-a3d0-409c2dd12dd8

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    Default Re: FDA seems to approve Pfizer Covid shot (but perhaps it hasn't)

    https://www.thegatewaypundit.com/202...andates-video/

    Biden’s Surgeon General Vivek Murthy on Sunday said the FDA’s approval of the Pfizer vaccine will likely lead to more vaccine mandates.

    According to reports, the FDA is expected to approve Pfizer’s Covid vaccine on Monday.
    Up until now the FDA has been able to distribute the Covid vaccines under “emergency use authorization.”

    Vivek Murthy told CNN’s Brianna Keilar on Sunday that businesses and universities will likely be able to impose more mandates with the FDA’s vaccine approval.
    There are universities and businesses that have been considering putting in vaccine requirements in order to create a safer — a workplace, a learning environment,” Murthy said.

    “I think this announcement from the FDA would likely encourage them and make them feel more comfortable in putting some requirements in place,” he added.

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    Default Re: FDA seems to approve Pfizer Covid shot (but perhaps it hasn't)

    Quote Posted by mojo (here)
    FDA warns against ivermectin as COVID treatment

    Quote People should never take drugs formulated for animals, the FDA warned
    I'm about to blow a gasket... They are complaining people are taking animal medicine. It's not that we went about trying to hurt our bodies, FDA has done absolutely nothing to provide access to therapeutics.

    Quote The Food and Drug Administration (FDA) reiterated a warning against the use of ivermectin as a COVID-19 treatment amid growing reports of individuals taking the drug often used to treat parasitic worms in animals.

    Mississippi state health officials issued a recent alert prompted by increasing calls of people with potential ivermectin exposure taken to prevent or treat COVID-19 infection. While the drug has FDA-approval for certain uses in animals and humans, over 70% of the recent calls involved livestock formulations, officials said.

    The FDA previously issued concerns over self-medication with ivermectin intended for animals, noting some people might mistakenly believe the drug can substitute for ivermectin intended for humans.
    I doubt that there is much difference between human and animal meds. The issue with the paste I bought is DOSAGE. It is for horses and we need a miniscule amount compared to the measured dosage of the syringe. I have heard but it is not verified that human pills have had a formulation change. NEVER give the horse Ivermectin to a dog as it is a higher concentration than a dog can tolerate and very hard to measure (for heart worm treatment).

    The issue IMO is the concentration with Ivermectin. If I could not get human brands, I would use animal meds.

    Quote FDA Requirements
    Many drugs sold or dispensed by veterinarians for the treatment of illness in small domestic animals are generic equivalents of human drugs. For example, a pet can have an inflammatory condition and take prednisone for this condition—the same medication humans can get with a physician’s prescription.2

    However, medications produced for livestock and intended to be mixed with feed may not undergo the same level of manufacturing scrutiny by the U.S. Food and Drug Administration (FDA) as human drugs do.3 These products may have more impurities that don't represent a health concern for the animals but could be a risk for people.
    I cannot describe the feeling I am having over this FDA approval of the jab. Now at least we MUST know what is in it and maybe we can sue.
    Last edited by Delight; 23rd August 2021 at 17:56.

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    Default Re: FDA seems to approve Pfizer Covid shot (but perhaps it hasn't)

    Dr. Roger Hodkinson calls out the Covid hoax.

    Wow logical thinking ... the video is 4 minutes long

    https://t.me/HATSTRUTH/1486

    https://brighteon.com/2cb95f1a-0e44-...6-d59e5d5c8fbd

    Source: https://www.brighteon.com/embed/2cb95f1a-0e44-41ce-9cc6-d59e5d5c8fbd
    Last edited by Bill Ryan; 23rd August 2021 at 18:27. Reason: embedded the video

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    Default Re: FDA seems to approve Pfizer Covid shot (but perhaps it hasn't)

    Biden just gave a live speech about it:


    Watch and Weep

    **edit to add that I am enjoying watching the down-votes tally up.
    Last edited by Sue (Ayt); 24th August 2021 at 15:20.
    "We're all bozos on this bus"

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    Default Re: FDA seems to approve Pfizer Covid shot (but perhaps it hasn't)

    Quote Posted by Denise/Dizi (here)
    I bet those "Calls" the FDA are receiving, are calls asking how to adjust the doses making it ok for human consumption, as the patients cannot get their Dr.s to prescribe it... Those taking the calls should see this as an outcry AGAINST the status quo, and be alarmed that they're "wealth care" system, is fully known at this point, and well being is the last thing they care about. If they continue to keep ivermectin from the public I think I will really begin to question anything any Dr. prescribes.

    It's shameful and criminal, that the FDA and those treating this pandemic, are keeping the real medications that work, out of the hands of those that desperately need it.
    I think we ALL must start BOYCOTTING the medical industrial complex. We also MUST turn to a spiritual level of connection. The reason is that the material world has apparently been fully taken over by the (I DON"T KNOW WHAT IT IS). Lets call "IT" out as all antithetical to LIFE.

    "IT" has run rough shod over the individual people in the ALL systems because we developed wide enough coordination globally to effect change simultaneously. NOW "IT" is ramping up to implode the whole DELIBERATELY. Individuals are targeted by the same screws we always succombed to like OUR fear of pain, death, poverty, illness, suffering. The individuals add up to a collective "mind". That is why we must overcome ourselves. It may not save the world but we will go down as humans and not tools.

    The PLAN is to destroy EVERYTHING. The word "rubber stamped" means that the end aim will automatically approve the steps because the DEPARTMENTS of civilization managing our life systems are all controlled now. THE PRONGS IN THE PITCHFORK ARE POKING US.

    Only a spiritual door will carry us out of the harm. The harm is much greater than death. If we knew this FOR SURE, we would be brave hearts and blithe spirits and we'd have a chance. However, we believe the LIE that IF YOU "cooperate, be a nice person, believe the story, and all will be OK"

    NO IT WON"T.

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  29. Link to Post #15
    United States Avalon Member Denise/Dizi's Avatar
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    Default Re: FDA seems to approve Pfizer Covid shot (but perhaps it hasn't)

    Quote Posted by Delight (here)
    Quote Posted by mojo (here)
    FDA warns against ivermectin as COVID treatment

    Quote People should never take drugs formulated for animals, the FDA warned
    I'm about to blow a gasket... They are complaining people are taking animal medicine. It's not that we went about trying to hurt our bodies, FDA has done absolutely nothing to provide access to therapeutics.

    Quote The Food and Drug Administration (FDA) reiterated a warning against the use of ivermectin as a COVID-19 treatment amid growing reports of individuals taking the drug often used to treat parasitic worms in animals.

    Mississippi state health officials issued a recent alert prompted by increasing calls of people with potential ivermectin exposure taken to prevent or treat COVID-19 infection. While the drug has FDA-approval for certain uses in animals and humans, over 70% of the recent calls involved livestock formulations, officials said.

    The FDA previously issued concerns over self-medication with ivermectin intended for animals, noting some people might mistakenly believe the drug can substitute for ivermectin intended for humans.
    I doubt that there is much difference between human and animal meds. The issue with the paste I bought is DOSAGE. It is for horses and we need a miniscule amount compared to the measured dosage of the syringe. I have heard but it is not verified that human pills have had a formulation change. NEVER give the horse Ivermectin to a dog as it is a higher concentration than a dog can tolerate and very hard to measure (for heart worm treatment).

    The issue IMO is the concentration with Ivermectin. If I could not get human brands, I would use animal meds.



    I cannot describe the feeling I am having over this FDA approval of the jab. Now at least we MUST know what is in it and maybe we can sue.
    They have a monthly heartworm medication for dogs, 12 doses per package, given once a month, and it is ivermectin. Easy to get from a vet for heart health... I have two packages of it for my shih tzus in the medicine cabinet. It is given by weight as well, in chewable tablets.

    But as far as the horse ivermectin? The dose IS important, and there are veternarians, and vet techs, that are helping to get the adjustment properly for humans. I cannot name names for obvious reasons. Most people that raise or board horses in my area, use the ivermectin all the time, and have it stocked in their homes... . And they're telling those that are unaware that they do this and the proper dosages..

    People need to be aware that the horse ivermectin has different solutions, some 1.87%, some less, and this also must be taken into account when seeking the proper dose for self care. I won't recommend it, but I will say I took a course of treatment, and it sure worked for me. And when my husband demanded it at the hospital, he recovered very quickly. Once he signed papers releasing the Dr. of copability for changing his treatment protocol, the Dr. went on to tell him that indeed hospitals in Sacramento, California... (Our state capital), was using ivermecrin with great success...

    He went from 65 liters of forced oxygen, to 2 liters of "blow by" oxygen in 3 days and was sent home to recover after only 3 doses of ivermectin. Granted he had been there 6 days prior, but not really getting better up to that point.

    If Dr.s are afraid of blowback by prescribing it, people have no options really. Other than to seek out alternative versions of it.

    As far as the FDA approving the "Jab"... (I won't call it a vaccine, because it isn't a true vaccine when defined)... My body is off limits. I choose what I put into it. I would fight to avoid anyone sticking something in my body that I do not approve of. Just because the FDA approved it's use, does not give them my permission to use it on me.. And I feel if they try to force the issue, it will get ugly

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  31. Link to Post #16
    Avalon Member Delight's Avatar
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    Default Re: FDA seems to approve Pfizer Covid shot (but perhaps it hasn't)

    Quote Posted by Denise/Dizi (here)
    They have a monthly heartworm medication for dogs, 12 doses per package, given once a month, and it is ivermectin. Easy to get from a vet for heart health... I have two packages of it for my shih tzus in the medicine cabinet. It is given by weight as well, in chewable tablets.

    But as far as the horse ivermectin? The dose IS important, and there are veternarians, and vet techs, that are helping to get the adjustment properly for humans. I cannot name names for obvious reasons. Most people that raise or board horses in my area, use the ivermectin all the time, and have it stocked in their homes... . And they're telling those that are unaware that they do this and the proper dosages..

    People need to be aware that the horse ivermectin has different solutions, some 1.87%, some less, and this also must be taken into account when seeking the proper dose for self care.
    There is a 1% Ivermectin solution for cow shots that can be titrated safely for dogs by mouth. People can tolerate the horse paste. Of course we cannot recommend it.

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    United States Avalon Member onawah's Avatar
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    Default Re: FDA seems to approve Pfizer Covid shot (but perhaps it hasn't)

    Breaking: FDA gives full approval to COVID vaccines; no public hearing; no transparency; no open review of vaccine data t
    It all happened behind closed doors

    by Jon Rappoport
    August 23, 2021

    https://blog.nomorefakenews.com/2021...-transparency/

    "The fix is in.

    We raced from “emergency use authorization” of experimental vaccines to “full approval.” Boom.

    Despite the promise of “transparency” prior to giving full approval to the COVID vaccines, the FDA gave its final green light today. Slam-dunk.
    https://www.fda.gov/news-events/pres...vid-19-vaccine

    And there was NO public hearing.

    “Full approval” means the vaccine marketing/intimidation/mandate campaigns will ramp up much higher. “Well, now there is NO reason for anyone to refuse the shot. The FDA states it is completely safe and effective.”

    Obviously, the FDA didn’t want to allow even mainstream “experts” to speak in a public hearing before approval; the agency is running a very tight ship. No slip-ups. No defections.

    An 8/20 article in the BMJ https://www.bmj.com/content/374/bmj.n2086
    ...(“Covid-19: FDA set to grant full approval to Pfizer vaccine without public discussion of data”) quotes a few of these dissenting mainstream pros. For example:

    “Kim Witczak, a drug safety advocate who serves as a consumer representative on the FDA’s Psychopharmacologic Drugs Advisory Committee, said the decision removed an important mechanism for scrutinising the data.”

    “’These [FDA] public meetings are imperative in building trust and confidence especially when the vaccines came to market at lightning speed under emergency use authorisation,’ she said. ‘The public deserves a transparent process, especially as the call for boosters and mandates are rapidly increasing. These meetings offer a platform where questions can be raised, problems tackled, and data scrutinised in advance of an approval’.”

    “Witczak is one of the more than 30 signatories of a citizen petition calling on the FDA to refrain from fully approving any covid-19 vaccine this year to gather more data. She warned that without a [public FDA] meeting ‘we have no idea what the data looks like’.”

    “’It is already concerning that full approval is being based on 6 months’ worth of data despite the clinical trials designed for two years,’ she said. ‘There is no control group after Pfizer offered the product to placebo participants before the trials were completed’.”

    “’Full approval of covid-19 vaccines must be done in an open public forum for all to see. It could set a precedent of lowered standards for future vaccine approvals’.”

    Understand—this devastating criticism of the FDA is coming from a person who operates WITHIN the public-health establishment.

    Amidst a tsunami of reports of vaccine injuries and deaths from around the world, the FDA is proving it is an agency that will certify maiming and killing without hesitation."

    Also posted here: https://projectavalon.net/forum4/sho...=1#post1447873
    Each breath a gift...
    _____________

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  35. Link to Post #18
    United States Avalon Member Victoria's Avatar
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    Default Re: FDA seems to approve Pfizer Covid shot (but perhaps it hasn't)

    https://www.fda.gov/media/151710/download



    Our STN: BL 125742/0 BLA APPROVAL

    BioNTech Manufacturing GmbH August 23, 2021
    Attention: Amit Patel
    Pfizer Inc.
    235 East 42nd Street
    New York, NY 10017

    Dear Mr. Patel:

    Please refer to your Biologics License Application (BLA) submitted and received on
    May 18, 2021, under section 351(a) of the Public Health Service Act (PHS Act) for
    COVID-19 Vaccine, mRNA.

    LICENSING

    U.S. Food & Drug Administration
    10903 New Hampshire Avenue
    Silver Spring, MD 20993
    w w w.fda.gov
    We are issuing Department of Health and Human Services U.S. License No. 2229 to
    BioNTech Manufacturing GmbH, Mainz, Germany, under the provisions of section
    351(a) of the PHS Act controlling the manufacture and sale of biological products. The
    license authorizes you to introduce or deliver for introduction into interstate commerce,
    those products for which your company has demonstrated compliance with
    establishment and product standards. Under this license, you are authorized to manufacture the product, COVID-19 Vaccine,
    mRNA, which is indicated for active immunization to prevent coronavirus disease 2019
    (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
    in individuals 16 years of age and older. The review of this product was associated with the following National Clinical Trial
    (NCT) numbers: NCT04368728 and NCT04380701.

    MANUFACTURING LOCATIONS
    Under this license, you are approved to manufacture COVID-19 Vaccine, mRNA drug
    substance at The final formulated product will be manufactured, filled,
    labeled and packaged at Pfizer

    . The diluent, 0.9% Sodium Chloride Injection, USP, will be manufactured at

    (b) (4)(b) (4)(b) (4)
    Page 2 – STN BL 125742/0 – Elisa Harkins

    You may label your product with the proprietary name, COMIRNATY, and market it in
    2.0 mL glass vials, in packages of 25 and 195 vials. We did not refer your application to the Vaccines and Related Biological Products
    Advisory Committee because our review of information submitted in your BLA, including
    the clinical study design and trial results, did not raise concerns or controversial issues
    that would have benefited from an advisory committee discussion.
    DATING PERIOD
    The dating period for COVID-19 Vaccine, mRNA shall be 9 months from the date of
    manufacture when stored between -90ºC to -60ºC (-130ºF to -76ºF). The date of
    manufacture shall be no later than the date of final sterile filtration of the formulated
    drug product (at , the date
    of manufacture is defined as the date of sterile filtration for the final drug product; at
    Pfizer , it is defined as the date of the

    Following the final sterile filtration,
    , no
    reprocessing/reworking is allowed without prior approval from the Agency. The dating
    period for your drug substance shall be when stored at We have
    approved the stability protocols in your license application for the purpose of extending
    the expiration dating period of your drug substance and drug product under 21 CFR
    601.12.
    FDA LOT RELEASE
    Please submit final container samples of the product in final containers together with
    protocols showing results of all applicable tests. You may not distribute any lots of
    product until you receive a notification of release from the Director, Center for Biologics
    Evaluation and Research (CBER).
    BIOLOGICAL PRODUCT DEVIATIONS
    You must submit reports of biological product deviations under 21 CFR 600.14. You
    should identify and investigate all manufacturing deviations promptly, including those
    associated with processing, testing, packaging, labeling, storage, holding and
    distribution. If the deviation involves a distributed product, may affect the safety, purity,
    or potency of the product, and meets the other criteria in the regulation, you must
    submit a report on Form FDA 3486 to the Director, Office of Compliance and Biologics
    Quality, electronically through the eBPDR web application or at the address below.
    Links for the instructions on completing the electronic form (eBPDR) may be found on
    CBER's web site at https://www.fda.gov/vaccines-blood-b...roblem-center-
    biologics-evaluation-research/biological-product-deviations: Food and Drug Administration Center for Biologics Evaluation and Research Document Control Center (b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)
    Page 3 – STN BL 125742/0 – Elisa Harkins
    10903 New Hampshire Ave.
    WO71-G112
    Silver Spring, MD 20993-0002

    MANUFACTURING CHANGES

    You must submit information to your BLA for our review and written approval under 21
    CFR 601.12 for any changes in, including but not limited to, the manufacturing, testing,
    packaging or labeling of COVID-19 Vaccine, mRNA, or in the manufacturing facilities.


    LABELING
    We hereby approve the draft content of labeling including Package Insert, submitted
    under amendment 74, dated August 21, 2021, and the draft carton and container labels
    submitted under amendment 63, dated August 19, 2021.
    CONTENT OF LABELING
    As soon as possible, but no later than 14 days from the date of this letter, please submit
    the final content of labeling (21 CFR 601.14) in Structured Product Labeling (SPL)
    format via the FDA automated drug registration and listing system, (eLIST) as described
    at http://www.fda.gov/ForIndustry/DataS...oductLabeling/
    default.htm. Content of labeling must be identical to the Package Insert submitted on
    August 21, 2021. Information on submitting SPL files using eLIST may be found in the
    guidance for industry SPL Standard for Content of Labeling Technical Qs and As at http://www.fda.gov/downloads/Drugs/G...ormation/Guida
    nces/UCM072392.pdf. The SPL will be accessible via publicly available labeling repositories.
    CARTON AND CONTAINER LABELS
    Please electronically submit final printed carton and container labels identical to the
    carton and container labels submitted on August 19, 2021, according to the guidance
    for industry Providing Regulatory Submissions in Electronic Format — Certain Human
    Pharmaceutical Product Applications and Related Submissions Using the eCTD
    Specifications at https://www.fda.gov/regulatory-infor...-fda-guidance-
    documents/providing-regulatory-submissions-electronic-format-certain-human-
    pharmaceutical-product-applications. All final labeling should be submitted as Product Correspondence to this BLA STN BL
    125742 at the time of use and include implementation information on Form FDA 356h.
    ADVERTISING AND PROMOTIONAL LABELING

    Page 4 – STN BL 125742/0 – Elisa Harkins

    You may submit two draft copies of the proposed introductory advertising and
    promotional labeling with Form FDA 2253 to the Advertising and Promotional Labeling
    Branch at the following address: Food and Drug Administration Center for Biologics Evaluation and Research Document Control Center 10903 New Hampshire Ave. WO71-G112 Silver Spring, MD 20993-0002 You must submit copies of your final advertising and promotional labeling at the time of
    initial dissemination or publication, accompanied by Form FDA 2253 (21 CFR
    601.12(f)(4)). All promotional claims must be consistent with and not contrary to approved labeling.
    You should not make a comparative promotional claim or claim of superiority over other
    products unless you have substantial evidence or substantial clinical experience to
    support such claims (21 CFR 202.1(e)(6)).
    ADVERSE EVENT REPORTING
    You must submit adverse experience reports in accordance with the adverse
    experience reporting requirements for licensed biological products (21 CFR 600.80),
    and you must submit distribution reports at monthly intervals as described in 21 CFR
    600.81. For information on adverse experience reporting, please refer to the guidance
    for industry Providing Submissions in Electronic Format —Postmarketing Safety
    Reports for Vaccines at https://www.fda.gov/regulatory-information/search-fda-
    guidance-documents/providing-submissions-electronic-format-postmarketing-safety-
    reports-vaccines. For information on distribution reporting, please refer to the guidance
    for industry Electronic Submission of Lot Distribution Reports at http://www.fda.gov/BiologicsBloodVac...oryInformation
    /Post-MarketActivities/LotReleases/ucm061966.htm.
    PEDIATRIC REQUIREMENTS

    Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for
    new active ingredients, new indications, new dosage forms, new dosing regimens, or
    new routes of administration are required to contain an assessment of the safety and
    effectiveness of the product for the claimed indication in pediatric patients unless this
    requirement is waived, deferred, or inapplicable. We are deferring submission of your pediatric studies for ages younger than 16 years
    for this application because this product is ready for approval for use in individuals 16
    years of age and older, and the pediatric studies for younger ages have not been
    completed.
    Page 5 – STN BL 125742/0 – Elisa Harkins

    Your deferred pediatric studies required under section 505B(a) of the Federal Food,
    Drug, and Cosmetic Act (FDCA) are required postmarketing studies. The status of
    these postmarketing studies must be reported according to 21 CFR 601.28 and section
    505B(a)(4)(C) of the FDCA. In addition, section 506B of the FDCA and 21 CFR 601.70
    require you to report annually on the status of any postmarketing commitments or
    required studies or clinical trials.
    Label your annual report as an “Annual Status Report of Postmarketing Study
    Requirement/Commitments” and submit it to the FDA each year within 60 calendar
    days of the anniversary date of this letter until all Requirements and Commitments
    subject to the reporting requirements under section 506B of the FDCA are released or
    fulfilled. These required studies are listed below:

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

    Final Protocol Submission: October 7, 2020

    Study Completion: May 31, 2023

    Final Report Submission: October 31, 2023

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

    Final Protocol Submission: February 8, 2021

    Study Completion: November 30, 2023

    Final Report Submission: May 31, 2024

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

    Final Protocol Submission: January 31, 2022

    Study Completion: July 31, 2024 Final Report Submission: October 31, 2024 Submit the protocols to your IND 19736, with a cross-reference letter to this BLA STN
    BL 125742 explaining that these protocols were submitted to the IND. Please refer to
    the PMR sequential number for each study/clinical trial and the submission number as
    shown in this letter. Submit final study reports to this BLA STN BL 125742. In order for your PREA PMRs to
    be considered fulfilled, you must submit and receive approval of an efficacy or a labeling
    Page 6 – STN BL 125742/0 – Elisa Harkins
    supplement. For administrative purposes, all submissions related to these required
    pediatric postmarketing studies must be clearly designated as:

    • Required Pediatric Assessment(s)

    We note that you have fulfilled the pediatric study requirement for ages 16 through 17
    years for this application.

    POSTMARKETING REQUIREMENTS UNDER SECTION 505(o)

    Section 505(o) of the Federal Food, Drug, and Cosmetic Act (FDCA) authorizes FDA to
    require holders of approved drug and biological product applications to conduct
    postmarketing studies and clinical trials for certain purposes, if FDA makes certain
    findings required by the statute (section 505(o)(3)(A), 21 U.S.C. 355(o)(3)(A)).

    We have determined that an analysis of spontaneous postmarketing adverse events
    reported under section 505(k)(1) of the FDCA will not be sufficient to assess known
    serious risks of myocarditis and pericarditis and identify an unexpected serious risk of
    subclinical myocarditis. Furthermore, the pharmacovigilance system that FDA is required to maintain under
    section 505(k)(3) of the FDCA is not sufficient to assess these serious risks. Therefore, based on appropriate scientific data, we have determined that you are
    required to conduct the following studies: 4. Study C4591009, entitled “A Non-Interventional Post-Approval Safety Study of
    the Pfizer-BioNTech COVID-19 mRNA Vaccine in the United States,” to evaluate
    the occurrence of myocarditis and pericarditis following administration of
    COMIRNATY. We acknowledge the timetable you submitted on August 21, 2021, which states
    that you will conduct this study according to the following schedule: Final Protocol Submission: August 31, 2021 Monitoring Report Submission: October 31, 2022 Interim Report Submission: October 31, 2023 Study Completion: June 30, 2025 Final Report Submission: October 31, 2025 5. Study C4591021, entitled “Post Conditional Approval Active Surveillance Study
    Among Individuals in Europe Receiving the Pfizer-BioNTech Coronavirus
    Page 7 – STN BL 125742/0 – Elisa Harkins

    Disease 2019 (COVID-19) Vaccine,” to evaluate the occurrence of myocarditis
    and pericarditis following administration of COMIRNATY.

    We acknowledge the timetable you submitted on August 21, 2021, which states
    that you will conduct this study according to the following schedule:

    Final Protocol Submission: August 11, 2021

    Progress Report Submission: September 30, 2021

    Interim Report 1 Submission: March 31, 2022

    Interim Report 2 Submission: September 30, 2022

    Interim Report 3 Submission: March 31, 2023

    Interim Report 4 Submission: September 30, 2023

    Interim Report 5 Submission: March 31, 2024

    Study Completion: March 31, 2024

    Final Report Submission: September 30, 2024

    6. Study C4591021 substudy to describe the natural history of myocarditis and
    pericarditis following administration of COMIRNATY.
    We acknowledge the timetable you submitted on August 21, 2021, which states
    that you will conduct this study according to the following schedule: Final Protocol Submission: January 31, 2022 Study Completion: March 31, 2024 Final Report Submission: September 30, 2024 7. Study C4591036, a prospective cohort study with at least 5 years of follow-up for
    potential long-term sequelae of myocarditis after vaccination (in collaboration
    with Pediatric Heart Network). We acknowledge the timetable you submitted on August 21, 2021, which states
    that you will conduct this study according to the following schedule: Final Protocol Submission: November 30, 2021 Study Completion: December 31, 2026
    Page 8 – STN BL 125742/0 – Elisa Harkins

    Final Report Submission: May 31, 2027

    8. Study C4591007 substudy to prospectively assess the incidence of subclinical
    myocarditis following administration of the second dose of COMIRNATY in a
    subset of participants 5 through 15 years of age.

    We acknowledge the timetable you submitted on August 21, 2021, which states
    that you will conduct this assessment according to the following schedule:

    Final Protocol Submission: September 30, 2021

    Study Completion: November 30, 2023

    Final Report Submission: May 31, 2024 9. Study C4591031 substudy to prospectively assess the incidence of subclinical
    myocarditis following administration of a third dose of COMIRNATY in a subset of
    participants 16 to 30 years of age. We acknowledge the timetable you submitted on August 21, 2021, which states
    that you will conduct this study according to the following schedule: Final Protocol Submission: November 30, 2021 Study Completion: June 30, 2022 Final Report Submission: December 31, 2022 Please submit the protocols to your IND 19736, with a cross-reference letter to this BLA
    STN BL 125742 explaining that these protocols were submitted to the IND. Please refer to the PMR sequential number for each study/clinical trial and the submission number
    as shown in this letter.

    Please submit final study reports to the BLA. If the information in the final study report
    supports a change in the label, the final study report must be submitted as a
    supplement to this BLA STN BL 125742. For administrative purposes, all submissions
    related to these postmarketing studies required under section 505(o) must be submitted
    to this BLA and be clearly designated as:

    • Required Postmarketing Correspondence under Section 505(o)
    • Required Postmarketing Final Report under Section 505(o)
    • Supplement contains Required Postmarketing Final Report under Section
    505(o)

    Section 505(o)(3)(E)(ii) of the FDCA requires you to report periodically on the status of
    any study or clinical trial required under this section. This section also requires you to
    periodically report to FDA on the status of any study or clinical trial otherwise

    Last edited by Bill Ryan; 23rd August 2021 at 18:51. Reason: embedded the PDF

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  37. Link to Post #19
    United States Avalon Member Denise/Dizi's Avatar
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    Default Re: FDA seems to approve Pfizer Covid shot (but perhaps it hasn't)

    Quote Posted by Delight (here)
    Quote Posted by Denise/Dizi (here)
    They have a monthly heartworm medication for dogs, 12 doses per package, given once a month, and it is ivermectin. Easy to get from a vet for heart health... I have two packages of it for my shih tzus in the medicine cabinet. It is given by weight as well, in chewable tablets.

    But as far as the horse ivermectin? The dose IS important, and there are veternarians, and vet techs, that are helping to get the adjustment properly for humans. I cannot name names for obvious reasons. Most people that raise or board horses in my area, use the ivermectin all the time, and have it stocked in their homes... . And they're telling those that are unaware that they do this and the proper dosages..

    People need to be aware that the horse ivermectin has different solutions, some 1.87%, some less, and this also must be taken into account when seeking the proper dose for self care.
    There is a 1% Ivermectin solution for cow shots that can be titrated safely for dogs by mouth. People can tolerate the horse paste. Of course we cannot recommend it.
    I was going to suggest that as well...just for informational purposes. Most online sites such as Amazon are either quickly running out of the injectable liquid, or charging a fortune for it...For example it went from $39.95 to $109.95 a bottle.... And I was only able to find one person selling it on Amazon as of this morning...

    I found it on this site for $39.95 ... plus $3.99 shipping... These have a stopper at the top that will require a needle to pierce it, and draw out the proper dose... and keep it safe for reuse later, but you can then just unscrew the needle tip and use the tube as the dispenser for your canine.

    https://vic.pharmacy/

    The stores are now requiring personal information for tracking purposes of those buying the paste. (I took apple flavored IverCare, as it didn't taste as bad as the others, and was 1.87%, without all of the other unnecessary medications added to it. )

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    United States Avalon Member Denise/Dizi's Avatar
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    Default Re: FDA seems to approve Pfizer Covid shot (but perhaps it hasn't)

    How can they approve this "immunization" when it is already proven so ineffective that even "Vaccinated" people are still getting CoVid, spreading it, AND requiring additional "Booster Vaccines"? Which by the way, do not stop people from getting, spreading or suffering the virus, but "Might" limit the amount of damage the virus does. Keeping them a small bit safer from the ICU, but no guarantees.

    The insanity of it all is just astonishing. There seems to be no effort to treat or stop the virus from damaging the population other than "vaccinating", when they do have methods that can diminsh the damage caused by the virus, and in many cases, keep people out of the hospitals almost entirely... Prophylactic treatments seem to be deliberately overlooked in this situation. People are not being told that there are things that can be given that may help them both survive the virus, but also to limit the amount of illness being suffered, as it kills the virus sooner, so it doesn't spread as far... without having to get the shots.

    What is troublesome, is the whole vaccine passport id program. Those who do not get it, will be choked out of work, out of traveling, out of schools. Those wanting to work, will be forced to take the jab if those employers are regulated to provide proof their employees are vaccinated. As it is, they're already suggesting that they will have concerts again, so long as the attendees all have proof they were vaccinated. It's ridiculous. As they will still be spreading it among themselves and bringing it back to their communities.

    I just cannot believe that the FDA approved the "vaccine" at all, with all of the deaths and side effects. While everyone was worried about being "Chipped" they just rolled this out and easily frightened the populations into phone tracking, taking shots that harm the population , etc.. The fact that so many are really just shaming their neighbors for not getting the vaccine? Is an indicator that this is heading in an ugly direction.

    I will be following this thread intently.

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