A sample of Dr. Joseph Mercola's News Reports and Analysis

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 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."