“The FDA did NOT grant full approval to the Pfizer shots”

 

image:  Disney's Pinnochio

I continue to post updates on the COVID crisis because it is threatening our basic freedoms.  While some states have banned vaccine mandates, such as Texas, Ohio has not yet voted. And now we are being told that the FDA has given its full approval to the Pfizer vaccine.  I’ve already asked how long-term effects can be studied when there has not been a long-term testing period.  So below is an extract from Carl Schwitzer’s “The FDA did NOT grant full approval to the Pfizer shots” at AmericanThinker:

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 [my emphasis], 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 [my emphasis].

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.

. . .

The rest of the column is here. Becker News has another report on the same subject.  I am linking here, as the analyses are a bit difficult to follow, and a second report may help to clarify.  One thing is clear: we are being lied to again.

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