Pfizer’s
COVID Shot Granted Full Approval
Part 3
Do Data Justify Full Approval of
Pfizer’s COVID Jab?
Analysis by Dr. Joseph Mercola
August 31, 2021 (1)
This is Part 3 of a document in three parts: Part 1 | Part 2
| Part 3
Do Data Justify Full Approval of
Pfizer’s COVID Jab?
In the morning of August 23, 2021, mere hours before the FDA announced
its approval of the Pfizer shot, Doshi published a BMJ blog questioning
whether available data could really support full approval. He wrote: (#25)
“On
28 July 2021, Pfizer and BioNTech posted updated results for their
ongoing phase 3 covid-19 vaccine trial. The preprint came almost a year
to the day after the historical trial commenced, and nearly four months
since the companies announced vaccine efficacy estimates ‘up to six
months.’
But you won’t find 10 month follow-up
data here. While the preprint is new, the results it contains aren’t
particularly up to date. In fact, the paper is based on the same data
cut-off date (13 March 2021) as the 1 April press release, and its
topline efficacy result is identical: 91.3% … vaccine efficacy against
symptomatic covid-19 through ‘up to six months of follow-up.’
The 20 page preprint matters because
it represents the most detailed public account of the pivotal trial
data Pfizer submitted in pursuit of the world’s first ‘full approval’
of a coronavirus vaccine from the Food and Drug Administration. It
deserves careful scrutiny.”
Doshi points out that while Pfizer has touted a 95% efficacy rate, and
even higher against severe disease, this refers to relative risk
reduction, not absolute risk reduction, which is actually an
insignificant 0.7% (#26)
to 0.84%. (#27)
Moreover, “measuring vaccine efficacy two months after dosing says
little about just how long vaccine-induced immunity will last,” Doshi
says.
6-Month Preprint Showed Evidence
of Waning Immunity
Rapidly waning immunity is the proverbial elephant in the room,
according to Doshi, who points to Israeli data showing Pfizer’s shot
went from a 95% effectiveness at the outset, to 64% in early July 2021
and 39% by late July, when the Delta strain became predominant. “This
is very low,” Doshi says, pointing out that the FDA’s expectation for
any vaccine is an efficacy rate of at least 50%.
Waning efficacy has the potential to be far more than a minor
inconvenience; it can dramatically change the risk-benefit calculus. ~
Peter Doshi
The FDA cannot claim it doesn’t know the protection offered is
pathetically short, as Pfizer’s preprint, which contained six months’
worth of data, showed evidence of rapidly waning immunity as early as
March 13, 2021.
By the fourth month into the trial, efficacy had dropped from 96% to
90%, and one month after that, it was down to 84%. Curiously, while
Pfizer had this data in April 2021, they didn’t publish it until the
end of July 2021. Still, that’s what the FDA is basing its decision on.
What’s more, this rapid drop in effectiveness could hardly be due to
the emergence of the Delta variant, Doshi adds, because 77% of trial
participants were in the U.S., where the Delta variant didn’t become
established until months after the data cut-off date.
“Waning
efficacy has the potential to be far more than a minor inconvenience;
it can dramatically change the risk-benefit calculus,” Doshi writes. (#28) “And whatever its cause — intrinsic
properties of the vaccine, the circulation of new variants, some
combination of the two, or something else — the bottom line is that
vaccines need to be effective.
Until new clinical trials demonstrate
that boosters increase efficacy above 50%, without increasing serious
adverse events, it is unclear whether the 2-dose series would even meet
the FDA’s approval standard at six or nine months.”
There’s NO Control Group in This
Mass Experiment
Making matters even worse, Pfizer, like all other COVID jab developers,
went ahead and eliminated their control groups at the end of 2020. So,
we’re figuratively flying blind, having nothing to compare the
vaccinated treatment group against.
This is a recipe for disaster, as it effectively hides side effects. If
large numbers of people suddenly start developing a health problem, it
can simply be written off as a new normal and/or can be blamed on some
other environmental factor. Doshi comments on how this decision impacts
our ability to evaluate any data coming out of these trials: (#29)
“Despite
the reference to ‘six month safety and efficacy’ in the preprint’s
title, the paper only reports on vaccine efficacy ‘up to six months,’
but not from six months.
This is not semantics, as it turns
out only 7% of trial participants actually reached six months of
blinded follow-up (‘8% of BNT162b2 recipients and 6% of placebo
recipients had ?6 months follow-up post-dose 2.’) …
This all happened because starting
last December, Pfizer allowed all trial participants to be formally
unblinded, and placebo recipients to get vaccinated. By 13 March 2021
(data cut-off), 93% of trial participants (41,128 of 44,060 …) were
unblinded, officially entering ‘open-label followup’ …
So despite this preprint appearing a
year after the trial began, it provides no data on vaccine efficacy
past six months, which is the period Israel says vaccine efficacy has
dropped to 39%.
It is hard to imagine that the
<10% of trial participants who remained blinded at six months (which
presumably further dwindled after 13 March 2021) could constitute a
reliable or valid sample to produce further findings.”
With the approval of Comirnaty, a formal package insert (#30) has been released, and
in section 6.1, they clearly state they’ve not had placebo participants
since December 2020, not even among teenagers: (#31)
“Section
6.1 — Upon issuance of the Emergency Use Authorization (December 11,
2020) for COMIRNATY, participants were unblinded to offer placebo
participants COMIRNATY. Participants were unblinded in a phased manner
over a period of months to offer placebo participants COMIRNATY.”
While a formal package insert now exists for Pfizer’s mRNA shot, the
Centers for Disease Control and Prevention will not issue Vaccine
Information Statements (VIS) for it, but will continue to use online
fact sheets. (The use of online fact sheets is why all package inserts
for the COVID shots have been completely blank.)
If You’re ‘Vaccinated’ You May Be
High-Risk for COVID
As discussed in yesterday’s lead article (August 30, 2021), data are
now mounting showing people over the age of 50 who are “fully
vaccinated” actually make up the bulk of COVID-19 related
hospitalizations and deaths in that age group. One possible explanation
for this is that antibody dependent enhancement is afoot, which makes
people more prone to serious illness rather than less.
To be on the safe side, I recommend considering yourself “high-risk”
for severe COVID if you’ve received one or more shots, and implement
known effective treatment at the first sign of a respiratory infection.
Options include the Zelenko protocol, (#32) the MATH+ protocols (#33) and nebulized hydrogen
peroxide, as detailed in Dr. David Brownstein’s case paper (#34) and Dr. Thomas Levy’s
free e-book, “Rapid Virus Recovery.”
Whichever treatment protocol you use, make sure you begin treatment as
soon as possible, ideally at first onset of symptoms.
Previous Part of this
Document
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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