August 23, 2021, the U.S. Food and Drug Administration granted full approval1 to the COVID-19 mRNA injection developed by Pfizer/BioNTech, sold under the brand name Comirnaty, for use in people aged 16 and older. It’s the fastest approval in history,2 granted less than four months after Pfizer filed for licensing May 7, 2021.3 It’s also based on just six months’ worth of data from 44,047 people aged 16 and older. Half of them got the shots and half initially received a placebo. However, in the second week of December 2020, Pfizer unblinded the control group and 93% of controls opted to get the real injection4 rather than remain in the control group for the remainder of the trial, which is slated to continue for another two years. Pfizer CEO Albert Bourla commented on the FDA’s approval, saying it “affirms the efficacy and safety profile of our vaccine,” and that he’s “hopeful this approval will help increase confidence in our vaccine …”5 According to STAT News,6 public health officials hope the approval “will persuade some people who remain hesitant about the vaccine to get the shot,” and will “make it easier for some public and private organizations to require vaccination.” FDA Ditches Public Hearing, Circumventing Established NormsNormally, the FDA will hold a formal hearing and allow for public and expert input before a drug is moved from emergency use authorization to full approval, but nothing is normal when it comes to COVID. In this instance, no such hearing was held, and an FDA spokesperson called it unnecessary, because the public had been allowed to comment on all three COVID-19 jabs — Pfizer’s, Moderna’s and Johnson & Johnson’s — during a December 20, 2020, Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting. According to many, that isn’t good enough.7 As reported by The BMJ:8
Media Are Lying About Pfizer’s FDA ApprovalBefore we go any further, let’s clear up what the FDA actually approved, because they did not approve the Pfizer shot currently given. In the interview above, Dr. Robert Malone, the inventor of the mRNA vaccine platform, explains how we are being misled, yet again. The injection that got the FDA approval is a Pfizer/BioNTech collaboration, to be sold under the brand name Comirnaty, and this injection is not currently available. Malone explains:
What this means is, if you want to get the licensed COVID shot, you have to wait. This also means that if employers demand that employees get vaccinated because there’s now a licensed COVID injection, employees should then demand to actually receive the FDA licensed Comirnaty,9 not the emergency use only10 Pfizer product that is currently being given. FDA ‘Tricking Us Into Giving Up Our Right to Refuse’Now, while the two products are not necessarily identical, the FDA in its infinite wisdom has decreed that the two can be used interchangeably, but their legal statuses, however, are not interchangeable. As explained by Robert F. Kennedy Jr. and Dr. Meryl Nass in a recent article:11
Approval by Captured Agency Hardly Affirms SafetyWhile 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
Risk of Heart Inflammation AcknowledgedThe 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
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 insert19 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 webpage20 that addresses those effects in adolescents and young adults. Heart Inflammation Study Won’t End Until 2025In 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:
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 1222 — 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. 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
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 ImmunityRapidly 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%. 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.
There’s NO Control Group in This Mass ExperimentMaking 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
With the approval of Comirnaty, a formal package insert30 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
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 COVIDAs 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+ protocols33 and nebulized hydrogen peroxide, as detailed in Dr. David Brownstein’s case paper34 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. from http://articles.mercola.com/sites/articles/archive/2021/08/31/pfizers-covid-shot-granted-full-approval.aspx
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