Pfizer’s COVID Shot Granted Full Approval
Part 3
Do Data Justify Full Approval of Pfizer’s COVID Jab?
Part 3
Do Data Justify Full Approval of Pfizer’s COVID Jab?
Analysis by Dr. Joseph Mercola
August 31, 2021 (1)
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.”
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.”
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.”
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.
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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)
# 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 I will still be writing my daily articles that I started 25 years ago BUT they will only be available for 48 hours before they are removed. In this way I hope to continue my mission to help you take control of your health – but it's up to you to download, share and repost this content. I will not be enforcing my copyright on this information so that you may freely share it."