Heard this a couple days ago. They are LYING! Why would they LIE! They are Mincing words. They want to force this on you. Who is making Millions??
You may have heard that the Pfizer-BioNTech COVID-19 shot received FDA approval this past Monday. Politicians, national health officials, and journalists are breathless with excitement about how this approval will finally induce the remaining "vaccine-hesitant" into stepping forward to receive their jab. The FDA even has a press release on its website about it.
There's just one problem.
If you read the actual letters that the FDA sent to Pfizer on August 23, 2021, you'll see that the FDA did no such thing. In the sense that the term "FDA approval" is generally understood, this drug is not approved by the FDA. It is still under EUA (Emergency Use Authorization). It is still an experimental drug.
The FDA sent two letters. The first one was a letter of BLA (Biologics License Application) approval, and the second was a letter of EUA extension to COMIRNATY.
The BLA approval letter approves Pfizer's application for a license to label its COVID-19 drug with the brand name COMIRNATY. This letter also spells out the terms and requirements for nine additional clinical trials over five years, and yearly status reports, to study the acknowledged occurrences of myocarditis and pericarditis that have followed the administering of the Pfizer shots. This license to label and manufacture is not a full approval of the drug, which clearly is still subject to many years of clinical trials.
The EUA extension letter extends the term of the EUA for the current drug and authorizes (licenses) the experimental use of the brand-name drug COMIRNATY. In the first paragraph on page 2, this letter references the license approval letter. In the second paragraph on page 2, the August 12 EUA is re-issued to include the name-branded drug in the emergency use authorization, and to add "language regarding warnings and precautions related to myocarditis and pericarditis." In the last paragraph on page 4, the EUA nature of the drugs is re-iterated, and COMIRNATY is additionally authorized for use for individuals aged 12 through 15 years.
The mRNA gene therapy shots are still experimental. Mandating them is still wrong — by a wide variety of ethical standards.
Dr. Meryl Nass, M.D. found the truths that the FDA buried in the blather of these letters and offers a theory about why it was done this way. The drug-manufacturers were granted immunity from liability for the drugs produced under the EUAs. The granting of the license re-applies the customary liability for injury and death caused by the product. Pfizer, the health officials, and the politicians get to take a fictitious victory lap for the "approval," while Pfizer-BioNTech continues to stealthily enjoy immunity from product liability because there are many millions of the unlicensed doses on the shelves and in the manufacturing pipeline that will be administered first. The licensed version will not arrive on shelves or be jabbed into arms for many months to come.
Of great concern, considering the factual content of the FDA EUA letters to Pfizer, is the breezy way the press release on the FDA website repeatedly uses the words "approve" and "approval" in reference to the Pfizer drug. If only there were a word for intentionally saying things to the public that do not match reality...
COMIRNATY seems like an unusual name for anything, much less a cutting-edge-technology gene therapy. Out of idle curiosity, I ran the name through an anagram solver. For a result, it gave TIROMANCY, which is divination or prophecy by examining how curds form during the coagulation of cheese. How apropos. That's something I'm willing to try for forecasting the results of the next election!
https://www.americanthinker.com/blog/2021/08/the_fda_did_not_grant_full_approval_to_the_pfizer_shots.html#ixzz74hDkUPbA
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DeSantis strikes back at AP over COVID treatment
Most people have heard by now that the FDA approved the Pfizer vaccine. However, a different but equally important FDA medication approval for COVID-19 got little or no media coverage. It was the FDA's emergency use authorization for primary care physicians to administer REGEN-COV (casirivimab and imdevimab), manufactured by Regeneron Pharmaceuticals, Inc. The FDA fact sheet provides the details. It is intended for immediate use on high-risk patients testing positive for COVID-19. It works largely by calming the immune system to keep it from overreacting. It is the internal inflammation from this overreaction that causes the severe symptoms that can lead to hospitalization or death.
The lack of media coverage in this case was likely because REGEN-COV could make people think twice about getting vaccinated. Many people are concerned about the known, although rare serious side-effects caused by the vaccines. In addition, people are not being told that the vaccines have proven less effective for the new delta variant. Until REGEN-COV was approved, the only option primary care physicians had after a positive test was to recommend quarantine, wait until symptoms improve, or report to emergency care if they worsen. For many, that short delay is too late.
Since the beginning of the pandemic, the left has launched a war on hydroxychloroquine and ivermectin as early treatment options and the NIH continues to prohibit their off-label use as an early treatment of COVID-19. The NIH decision was made despite evidence that both these inexpensive drugs have been shown to be highly effective when used in the earliest stages of COVID-19 in India and many other non-Western countries. Yet both these inexpensive medications remain off-limits in virtually all western countries.
The latest example of this war came Monday during a Richmond NBC local evening news segment. It basically warned that ivermectin was for deworming animals (how yucky), so it should be avoided. However, a much more egregious example was the attack by the Associated Press on Gov. Ron DeSantis (a major contender to run for president in 2024) for advocating the use of newly FDA-approved REGEN-COV.
Florida Gov. Ron DeSantis on Monday sent a blistering letter to Associated Press CEO Daisy Veerasingham accusing the news outlet of publishing a "partisan smear" against him and possibly discouraging COVID-19 positive Floridians from seeking "life-saving treatment."
The governor sent the letter in response to a complaint he received from the AP about his press secretary Christina Pushaw's criticisms of a reporter who wrote a story linking DeSantis' advocacy for a COVID antibody drug to one of his top donors who is heavily invested in the company that makes the drug.
The Democrats' obsession since day one to block proven early COVID-19 treatment options and place all bets on the vaccinations never seemed quite right and resulted in many thousands of easily avoidable deaths. I say this even though the delta variant has hit many people I know personally in my small rural corner of Virginia. About half were fully vaccinated; thankfully, no one died.
It is clear that the continuation of the pandemic hysteria works to the Dems' political advantage — especially considering the upcoming November elections. Many states are using it to justify maintaining weakened voting safeguards (e.g., no photo ID, extreme early voting, mail-in ballots, ballot-harvesting, etc.). However, this same obsession is present in most wealthy Western countries as well. Is there a larger globalist agenda behind it? Inquiring minds want to know.
https://www.americanthinker.com/blog/2021/08/desantis_strikes_back_at_ap_over_covid_treatment.html
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