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Did the FDA Really Approve Pfizer’s COVID ‘vaccine’?
Well, Not Exactly
Media Conflates Two Different FDA Letters to Create the Illusion the current Pfizer ‘vaccine’ has been approved, when it hasn’t
By: David Deschesne
Fort Fairfield Journal, September 8, 2021
With the current fanfare over the U.S. Food & Drug Administration’s supposed “approval” of the Pfizer COVID-19 gene therapy ‘vaccine’ it has been lost in nearly all media reports that the FDA did not actually approve the current Pfizer drug in circulation now, but rather, a proposed gene therapy drug called COMIRNATY - a gene therapy similar to the current batch of Pfizer drugs in circulation, but not yet in production. The FDA also is withholding approval for pediatric use, is requiring the gene therapy to continue to be studied in the population and orders the manufacturer to report all adverse events to the FDA.
Meanwhile, a second letter from the FDA, on the same day as the previously mentioned letter, discusses the current batch of Pfizer gene therapy ‘vaccines’ for COVID-19 and simply restates the Emergency Use Authorization—which is not “Approval” in any sense of the word when it comes to FDA nomenclature.
The establishment media then began hyping the pre-scripted narrative that the Pfizer COVID-19 ‘vaccine’ had been approved in order to create the illusion within the minds of unsophisticated Americans that they were referring to the current so-called ‘vaccine’ now in stock everywhere when in reality, the approval was for a similar gene therapy that is yet to be produced in the future. But that approval was fraught with inconsistencies, omissions and deviations from FDA protocol at levels of disinformation and obfuscation never before seen in the history of the agency.
This kind of sloppy, disingenuous reporting of narratives rather than facts by the establishment media over the past year has caused thousands of unnecessary deaths from the alleged vaccines since the start of the year as people made uninformed health decisions based on narratives rather than facts.
Dr. Robert Malone, the inventor of mRNA vaccines, stated in an interview with Steve Bannon that the establishment media is lying about the Pfizer vaccine receiving FDA approval. He said the FDA issued two separate and distinct letters showing that the Pfizer shot is still under an emergency-use authorization and that the full FDA approval was given to a BioNtech product, ‘Comirnaty’, that is similar to the Pfizer gene therapy vaccine. This new shot, Comirnaty, has yet to be manufactured and won’t be available for several years because several cardio-toxicity studies have yet to be completed.
The first letter from the FDA, dated August 23, 2021 and addressed to Ms. Elisa Harkins at Pfizer, Inc. in Collegeville, Pennsylvania simply discusses the reasoning for the Emergency Use Authorization and adds a few more caveats; there is no talk of “approval” in that letter.1
The second letter—the so-called “approval” letter is addressed to Mr. Amit Patel at BioNTech Manufacturing GmbH, which is a subsidiary of Pfizer. It talks about approval of the newly named “Comirnaty” gene therapy and lays out several stipulations and restrictions on the drug once it is released to the public.2
Dr. Malone explained the difference between the two letters on the Steve Bannon Show recently.3 “So, the little trick that they’ve done here is they have 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...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 the liability waiver will no longer apply to.”
The FDA bypassed/disregarded the normal advisory committee and public comment process for the approval of the Comirnaty license. As a developer of vaccines, Dr. Malone said he had never before seen in his entire career a drug or vaccine receive full approval from the FDA without first going through an advisory committee and public comment period. “I humbly submit that there is a ton of controversy going on around these vaccines here, in Europe, in Australia, etc. and this is another bold face lie that there are no concerns or controversial issues; not the least of which in controversial issues is cardio-toxicity for which there are many, many studies now required. So, what they’ve done here, I think, is jam through something to enable the government and commercial entities and states to mandate vaccines.”
He also said the approval is based on outdated data from the Alpha and Beta strains and does not take into account the current Delta strain.
Notes:
1. https://www.fda.gov/media/150386/download
2. https://www.fda.gov/media/151710/download
3. https://rumble.com/vlmd4g-pfizer-seeking-full-indemnification.html
4. https://rumble.com/vlmce2-dr.-malone-sounds-alarm-on-liability-coverage-of-pfizer-vax.html