Pfizer’s
COVID Shot Granted Full Approval
Part 2
Approval by Captured Agency
Hardly Affirms Safety
Analysis by Dr. Joseph Mercola
August 31, 2021 (1)
This is Part 2 of a
document in three parts: Part 1 | Part 2
| Part 3
Approval by Captured Agency
Hardly Affirms Safety
While the notion of full approval might sway some fence-sitters,
especially if they don’t understand that the licensed product is not
what you get if you get a Pfizer shot right now, it’s unlikely to
influence those who have kept an eye on the skyrocketing number of
adverse event reports logged into the U.S. Vaccine Adverse Events
Reporting System (VAERS).
As of August 13, 2021, VAERS had logged 595,620 adverse events
following COVID injection, including 54,142 hospitalizations and 13,608
deaths. (#12)
While these numbers are completely unheard of — with reported deaths
from COVID-19 shots exceeding the reported death rate of more than 70
vaccines combined over the past 30 years — they may still be just the
tip of the iceberg.
Previous investigations have shown VAERS reports account for a mere 1% (#13,14) to 10% (#15) of all vaccine-related
injuries, which means the death toll from these jabs may be in the
six-digits already.
The notion that a “vaccine” that has killed more people in nine months
than all other vaccines combined in three decades is considered safe
really stretches the bounds of credulity. It’s simply not believable,
and to many simply reaffirms the suspicion that the FDA is a captured
agency working for the benefit of Big Pharma rather than safeguarding
the public from dangerous drugs.
As noted by a commenter on BMJ associate editor Peter Doshi’s article
“Does the FDA Think These Data Justify the First Full Approval of a
COVID-19 Vaccine?” republished by The Defender: (#16)
“The
Fraud and Death Administration has really outdone itself this time.
Owned by pharma, serving pharma, to the extreme detriment to humanity.
They deserve to be shuttered permanently, they are an organization of
criminals.”
Risk of Heart Inflammation
Acknowledged
The FDA didn’t go so far as to give the Pfizer shot a completely clean
bill of health, however. As reported by STAT News: (#17)
“The
FDA’s prescribing information for the vaccine includes its associated
risk of myocarditis and pericarditis, two types of heart inflammation
that have appeared rarely among people who’ve received the mRNA
vaccines, mostly within seven days after the second shot, health
officials said. Men under 40 appear to be at higher risk than women and
older men, with the highest observed risk in boys age 12 to 17.”
According to the Centers for Disease Control and Prevention, As of
August 18, 2021, VAERS had received 1,339 reports of myocarditis or
pericarditis in people under the age of 30 following COVID injection,
with a majority of these cases being associated with the Pfizer shot. (#18)
Pfizer’s new Comirnaty package insert (#19) also clearly states at
the top of its first page under “Warnings and Precautions” that
“postmarketing data demonstrate increased risk of myocarditis and
pericarditis, particularly within seven days of the second dose.”
Then, under Section 5.2 of the insert, Pfizer has added an entire
section explaining the details of those adverse effects, and directing
readers to a CDC webpage (#20)
that addresses those effects in adolescents and young adults.
Heart Inflammation Study Won’t
End Until 2025
In its approval letter for Comirnaty, (#21) the FDA orders
Pfizer/BioNTech to conduct research to investigate the risk of
inflammation in and around the heart, as voluntary reporting mechanisms
are insufficient:
“We
have determined that an analysis of spontaneous postmarketing adverse
events reported under section 505(k)(1) of the FDCA will not be
sufficient to assess known serious risks of myocarditis and
pericarditis and identify an unexpected serious risk of subclinical
myocarditis.
Furthermore, the pharmacovigilance
system that FDA is required to maintain under section 505(k)(3) of the
FDCA is not sufficient to assess these serious risks.
Therefore, based on appropriate
scientific data, we have determined that you are required to conduct
the following studies: 4. Study C4591009, entitled ‘A
Non-Interventional Post-Approval Safety Study of the Pfizer-BioNTech
COVID-19 mRNA Vaccine in the United States,’ to evaluate the occurrence
of myocarditis and pericarditis following administration of COMIRNATY.”
The FDA accepted Pfizer’s suggested timetable for the post-approval
study to evaluate incidence of heart and heart sack inflammation, which
includes the submission of an interim report at the end of October
2023, a study completion date of June 30, 2025, and submission of a
final report October 31, 2025.
Modern-Day Child Sacrifice?
The notion that the current Pfizer shot or the BioNTech product,
Comirnaty, are “safe” is rather ludicrous in light of all this, and the
idea that the FDA is even considering approving the shot for children
as young as 12 (#22)
— and are running trials on babies — is completely incomprehensible.
Even worse, Fauci is pushing for infant approval by the end of the
year. (#23)
The myocarditis study for Comirnaty (which may or may not be as
dangerous as the current Pfizer shot) won’t be completed until four
years from now, yet they see it fit to give this experimental injection
to every last child in the United States? What are they thinking? Is it
really wise to trade the risk of flu-like illness for heart damage?
From the start of this pandemic, children have proven very resistant to
SARS-CoV-2 infection and rarely ever suffer any significantly ill
effects.
As reported by NPR, (#24)
Pfizer’s youth trial, which includes children between the ages of 6
months and 11 years, doesn’t even test “to see whether the vaccine
actually prevents children from getting sick.” Instead of assessing
actual symptoms, the trial “will look at their blood to see if they are
making the kinds of antibodies that have been shown to prevent disease.”
In other words, all they’re looking for is the antibody against the
synthetic spike protein your body produces. But that antibody is not
the best way to assess protection, as the protection is very narrow.
Actual viruses contain several different proteins against which your
body produces both antibodies and memory T cells when you’re infected
naturally.
This is why natural immunity is far more robust and long-lasting, and
why the claim that vaccine-induced protection is superior to natural
immunity is false. In my view, experimenting on children and not even
doing a comprehensive job of it is simply unconscionable.
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Source
and Notes
(1) This document is
part of an article
by Dr. Mercola, 31-Aug-2021, "Pfizer’s
COVID Shot Granted Full Approval" (only
available in the original
site for
48
hours after publication date)
(2) Sources and references as
quoted in the
original site:
# 1, 21 FDA.gov BLA Approval
Pfizer/BioNTech August 23, 2021
# 2, 7 The
Defender August 23, 2021
# 3 Pfizer
May 7, 2021
# 4, 25, 28, 29 The
BMJ Opinion August 23, 2021
# 5, 6, 17 STAT
News August 23, 2021
# 8 The BMJ 2021;
374:n2086
# 9 FDA BLA
Comirnaty Approval August 23, 2021
# 10 FDA
EUA August 23, 2021
# 11 The
Defender August 24, 2021
# 12 OpenVAERS.com Through August
13, 2021
# 13 AHRQ
December 7, 2007
# 14 The
Vaccine Reaction January 9, 2020
# 15 BMJ
2005;330:433
# 16 The
Defender August 24, 2021, Comment by Nick Quinlan
# 18 CDC
COVID-19 Reported Adverse Events August 23, 2021
# 19 Pfizer
Comirnaty Package Insert
# 20 CDC
August 23, 2021
# 22, 24 NPR
August 18, 2021
# 23 Politico
August 24, 2021
# 26 Medicina
2021; 57: 199
# 27 The
Lancet Microbe July 1, 2021; 2(7): E279-E280
# 30, 31 FDA.gov
Comirnaty Package Insert
# 32 Zelenko
protocol
# 33 Covid19criticalcare.com
# 34 Science,
Public Health Policy and The Law July 2020; 1: 4-22 (PDF)
© Copyright by Dr. Joseph Mercola.
However, since August 2021 he declared: "Again
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In this way I hope to continue my mission to help you take control of
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