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Robert Malone, MD on the Availability of Comirnaty

green leaves
[Comirnaty] is absolutely not available. So the little trick that they have done here, is [the U.S. Food and Drug Administration] issued two separate letters for two separate vaccines. The Pfizer vaccine, which is what currently available is still under Emergency Use Authorization…

The product that’s licensed [by the FDA] 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.

— Robert Malone, MD, inventor of the mRNA technology used in the Pfizer/BioNTech and Moderna/NIAID COVID biologics

Click here to view References:

Bannons War Room. Pfizer Seeking Full Indemnification. Rumble Aug. 24, 2021.


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16 Responses

  1. I’m not a vaxx supporter, but this should be clarified. Dr Malone walked back that comment soon after making it. He recognized that the FDA said that since the Comirnaty vaxx and the Pfizer vaxx are the same, the Pfizer vaxx effectively received FDA approval and can be given as FDA approved; the new vaxx bottles will be renamed Comirnaty.

    1. If this is true, why were separate letters issued? Why not just license all Pfizer-Biontech vaccines? If the vial isn’t labeled Comirnaty, is it still licensed as opposed to”approved” or “fully approved?”

  2. To be fair, Malone walked back this comment, as reported in the Washington Post:

    Malone quickly conceded his statement on the Bannon show was wrong. “When one is doing rapid analysis on the fly, one does not always get everything right,” he told The Fact Checker. “On this particular legal liability issue I did not hunt down the details myself, and relied on comments from a third party lawyer which were not fully correct.” He said the statements we received from Pfizer and HHS “are consistent with my current understanding.”

    https://www.washingtonpost.com/politics/2021/08/30/false-claim-that-fully-approved-pfizer-vaccine-lacks-liability-protection/

  3. Listen to the commercials on radio and TV, they only state “Good News!! A (Not THE PFIZER) Covid 19 Vaccine has been approved!” If the Pfizer was approved they would be bragging like hell! Also go to the Pfizer website, Pfizer Vaccine is not FDA approved. Comirnaty is FDA approved, same formula with ***distinct differences** in the footnotes. Comirnaty is not available.

  4. I didn’t finish my comment, sorry ….They are tricking us into thinking Pfizer is approved and it is ok for the Government and Business’ to mandate it. Legally, the Pfizer-Biontech Covid -19 Vaccine (BNT162B20) is NOT FDA approved! Don’t fall for it!

  5. “which is substantially similar but not necessarily identical.”
    My understanding is that the formulations are the same, however as Comirnaty has not yet been packaged or labeled, changes may still be made. Of course if changes are made, then FDA review should be required.

    But still, the Comirnaty approval includes requirements for additional studies, AND, the vaccines are legally different. And, imho, it’s perfectly reasonable to consider Pfizer’s willingness to accept liability for adverse reactions when deciding whether or not to get the vaccine.

  6. The revised sept 22, 2021 version Pfizer’s vax info fact sheet about Comirnaty and the Biontech vax by Pfizer says that either is “being offered” and “can be used interchangeably to provide COVID-19 vax series”. The footnote states that “the licensed vaccination has the same formulation as the emergency use 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.”

    If in fact the Comirnaty vax is unavailable to the US populace, I find this extremely misleading.

    Pg 4 goes onto acknowledge that the protection of this vax is currently unknown. The lists of risks is significant.

  7. The footnote that says “Legally Distinct” is where they admit you can’t be mandated to take the Pfizer vaccine, only the Corminaty. They don’t spell it out for you, but yeah, if the Corminaty isn’t available to you, you can’t be required to get vaccinated.

  8. The PREP Act shields all the pharmaceutical companies for Covid19 vaccines and other drugs because of the pandemic. Interestingly …while the FDA and CDC are proclaiming the vaccines are all safe none of the safety studies have been completed and will not be completed until 2026. The FDA Approval of Comirnaty is a conditional approval pending completion of those studies, in spite of claiming it’s OK for 16 years old+ no safety study is available at present. Pfizer states on their website and Fact Sheet safety is unknown – which is the truth. Completely unknown because they are all in fact experimental until all studies are completed. So truth is the Government is lying to everyone.

  9. The FDA states IN THEIR OWN RE-ISSUED EUA LETTER that the Emergency Use Authorization for the Pfizer-BioNTech vaccine was renewed *because there isn’t enough of the APPROVED vaccine to go around*:

    “Although COMIRNATY (COVID-19 Vaccine, mRNA) is approved to prevent COVID-19 in individuals 16 years of age and older, there is not sufficient approved vaccine available for distribution to this population in its entirety at the time of reissuance of this EUA. Additionally, there are no COVID-19 vaccines that are approved to provide:
    COVID-19 vaccination in individuals age 12 through 15; a third primary series dose to certain immunocompromised populations described in this EUA; a homologous booster dose to the authorized population described in this EUA; or a heterologous booster dose following completion of primary vaccination with another authorized COVID-19 vaccine.”

    The Pfizer-BioNTech vaccine is still on an EUA, and it is NOT the same as Comirnaty, which is not available (hence the re-issue of the Pfizer-BioNTech EUA). That’s per FDA’s letter. If you think the Pfizer-BioNTech EUA vaxx is “the same as Comirnaty” and “FDA approved” then your argument is with the FDA, not me ¯\_(ツ)_/¯

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

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