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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