Vincent van Gogh The red tree house 1890
The FDA. the U.S. Food and Drug Administration, announced on Monday that it gave full approval to a vaccine. But it didn’t. Or rather, it did, but the approval is for a vaccine that doesn’t exist. Or rather, it exists, but it’s not being produced. Or rather, it’s being produced, but under different names and with different legal statuses.
The FDA is playing a game with Americans, in order to get them to submit to being vaccinated. And this has to stop. No more. The role of the FDA is to protect people, not cajole them into politically desired but illegal actions. Below are 3 -bullet points of- articles about the (non-) approval. One from Peter Doshi, senior editor at The BMJ, and a powerful foe to the FDA, one from Robert Kennedy jr, and one from Jill Malone, wife of Dr. Robert Malone.
But first, yet another lie -BIG, not noble- from Anthony Fauci, as told to Anderson Cooper. There is no approval for “the Pfizer product”, and Fauci knows that very well. Or rather, there is approval for a Pfizer product that is not available to anyone. And that should never have been approved the way it was in the first place, but that’s another story. Still, Fauci said it.
In theory, if he were called on it (but of course he won’t be by any reporter he talks to), he could say that the products are the same anyway. But he won’t say that, because he realizes full well that they have different legal statuses; they are “legally distinct” in the words of the FDA. So Fauci can’t say they are the same. Even if it’s just a matter of a different label on a vial.
Yes, it sounds crazy, but that’s the legal labyrinth the FDA and Pfizer have negotiated themselves into. Why? Kennedy says it best: Pfizer is unlikely to allow any American to take a Comirnaty vaccine until it can somehow arrange immunity for this product..
And: “If it says “Comirnaty,” it’s a licensed product. If it says “Pfizer-BioNTech,” it’s an experimental product, and under 21 U.S. Code 360bbb, you have the right to refuse. If it comes from Moderna or Johnson & Johnson (marketed as Janssen), you have the right to refuse. [..] If it doesn’t say Comirnaty, you have not been offered an approved vaccine.”
Jill Malone: The vaccine that is likely to be supplied for some time, WILL BE THE Pfizer – EUA vaccine. So any mandates based on full approval are meaningless.
Fauci Dismisses “Freedom” In Call For Vaccine Mandates: “The Time Has Come. Enough Is Enough.”
“There was some poll that showed about 30% of people who are not anti-vax, they were just waiting to get what they felt was the real final stamp of approval, which we just got today with the Pfizer product.” He continued, “And those 30% are saying when that occurs, they will feel very, very comfortable about getting vaccinated. So right away, you’re talking about 30%. I hope they come through with what the survey said.”
[..] “They’re going to give a lot of incentive and backing for a lot of institutions and organizations and places of employment to mandate, and that could be colleges, university, the military, organizations that employ a lot of people, some of the big corporations are going to say if you want to work for us in person, you’ve got to be there and get vaccinated.”
[..] “I know I respect people’s freedom, but when you’re talking about a public health crisis that we’ve been going through for well over a year and a half, the time has come. Enough is enough. We’ve just got to get people vaccinated.” “If we keep lingering without getting those people vaccinated that should be vaccinated, this thing could linger on, leading to the development of another variant which could complicate things.”
Here’s Peter Doshi, senior editor at The BMJ.
Does The FDA Think These Data Justify The First Full Approval Of A Covid-19 Vaccine?
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% (95% CI 89.0 to 93.2) vaccine efficacy against symptomatic covid-19 through “up to six months of follow-up.”
[..] the recent reports from Israel’s Ministry of Health caught my eye. In early July, they reported that efficacy against infection and symptomatic disease “fell to 64%.” By late July it had fallen to 39% where Delta is the dominant strain. This is very low. For context, the FDA’s expectation is of “at least 50%” efficacy for any approvable vaccine.
[..] evidence of waning immunity was already visible in the data by the 13 March 2021 data cut-off… And it’s hard to imagine how the Delta variant could play a real role here, for 77% of trial participants were from the United States, where Delta was not established until months after data cut-off.
[..] 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.”) 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%.
—a total of three covid-19 related deaths (one on vaccine, two on placebo). There were 29 total deaths during blinded follow-up (15 in the vaccine arm; 14 in placebo). The crucial question, however, is whether the waning efficacy seen in the primary endpoint data also applies to the vaccine’s efficacy against severe disease.
[..] here we are, with FDA reportedly on the verge of granting a marketing license 13 months into the still ongoing, two year pivotal trial, with no reported data past 13 March 2021, unclear efficacy after six months due to unblinding, evidence of waning protection irrespective of the Delta variant, and limited reporting of safety data.
Robert F. Kennedy, Jr. and Meryl Nass, M.D. at childrenshealthdefense.org.
2 Things Mainstream Media Didn’t Tell You About FDA’s Approval of Pfizer Vaccine
Monday, the U.S. Food and Drug Administration (FDA) approved a biologics license application for the Pfizer Comirnaty vaccine. The press reported that vaccine mandates are now legal for military, healthcare workers, college students and employees in many industries. New York City Mayor Bill de Blasio has now required the vaccine for all teachers and school staff. The Pentagon is proceeding with its mandate for all military service members.
[..] First, the FDA acknowledges that while Pfizer has “insufficient stocks” of the newly licensed Comirnaty vaccine available, there is “a significant amount” of the Pfizer-BioNTech COVID vaccine — produced under Emergency Use Authorization (EUA) — still available for use. The FDA decrees that the Pfizer-BioNTech vaccine under the EUA should remain unlicensed but can be used “interchangeably” (page 2, footnote 8) with the newly licensed Comirnaty product. Second, the FDA pointed out that the licensed Pfizer Comirnaty vaccine and the existing, EUA Pfizer vaccine are “legally distinct,” but proclaims that their differences do not “impact safety or effectiveness.”
[..] EUA products are experimental under U.S. law. Both the Nuremberg Code and federal regulations provide that no one can force a human being to participate in this experiment. Under 21 U.S. Code Sec.360bbb-3(e)(1)(A)(ii)(III), “authorization for medical products for use in emergencies,” it is unlawful to deny someone a job or an education because they refuse to be an experimental subject. Instead, potential recipients have an absolute right to refuse EUA vaccines.
U.S. laws, however, permit employers and schools to require students and workers to take licensed vaccines. EUA-approved COVID vaccines have an extraordinary liability shield under the 2005 Public Readiness and Preparedness Act. [..] At least for the moment, the Pfizer Comirnaty vaccine has no liability shield. Vials of the branded product, which say “Comirnaty” on the label, are subject to the same product liability laws as other U.S. products.
When the Centers for Disease Control and Prevention’s (CDC) Advisory Committee for Immunization Practices places a vaccine on the mandatory schedule, a childhood vaccine benefits from a generous retinue of liability protections. But licensed adult vaccines, including the new Comirnaty, do not enjoy any liability shield. Just as with Ford’s exploding Pinto, or Monsanto’s herbicide Roundup, people injured by the Comirnaty vaccine could potentially sue for damages. And because adults injured by the vaccine will be able to show that the manufacturer knew of the problems with the product, jury awards could be astronomical.
Pfizer is therefore unlikely to allow any American to take a Comirnaty vaccine until it can somehow arrange immunity for this product.
[..] the FDA’s acknowledgement in its approval letter that there are insufficient stocks of the licensed Comirnaty, but an abundant supply of the EUA Pfizer BioNTech jab, exposes the “approval” as a cynical scheme to encourage businesses and schools to impose illegal jab mandates. The FDA’s clear motivation is to enable Pfizer to quickly unload inventories of a vaccine that science and the Vaccine Adverse Events Reporting System have exposed as unreasonably dangerous, and that the Delta variant has rendered obsolete.
Americans, told that the Pfizer COVID vaccine is now licensed, will understandably assume COVID vaccine mandates are lawful. But only EUA-authorized vaccines, for which no one has any real liability, will be available during the next few weeks when many school mandate deadlines occur. [..] While the media has trumpeted that the FDA has approved COVID vaccines, the FDA has not approved the Pfizer BioNTech vaccines, nor any COVID vaccines for the 12- to 15-year age group, nor any booster doses for anyone.
And the FDA has not licensed any Moderna vaccine, nor any vaccine from Johnson & Johnson — so the vast majority, if not all, of vaccines available in the U.S. remain unlicensed EUA products.
Here’s what you need to know when somebody orders you to get the vaccine: Ask to see the vial. If it says “Comirnaty,” it’s a licensed product. If it says “Pfizer-BioNTech,” it’s an experimental product, and under 21 U.S. Code 360bbb, you have the right to refuse. If it comes from Moderna or Johnson & Johnson (marketed as Janssen), you have the right to refuse. The FDA is playing bait and switch with the American public — but we don’t have to play along. If it doesn’t say Comirnaty, you have not been offered an approved vaccine..
And Jill Malone.
FDA Pfizer Authorization (Comirnaty): Key Points To Consider And Discuss
FDA Pfizer authorization (Comirnaty): Key points to consider and discuss.
These points are an aggregate of many minds, including Dr. Robert Malone. 23 Aug 2021
General talking points
• Why mandates if herd immunity isn’t possible?
• What happens 8 months after boosters?
• What’s the plan for the next variant?
• Why we’re messing with vaccine injury liability if the vaccines are safe and effective?
There are now TWO LEGALLY distinct (Pfizer vs. BionTech), but otherwise identical products, based on two FDA letters, as well as a press release. The analysis of these FDA products below is preliminary and subject to change.
Letter to Pfizer
• DOES NOT GIVE FULL APPROVAL
• Extends EUA to allow supply of current Pfizer under EUA because limited supply of BioNTech version.
• “The products are legally distinct with certain differences that do not impact safety or effectiveness. (page 2, Pfizer letter) [..] here FDA quietly admits that the licensed Pfizer vaccine and the authorized Pfizer vaccine are identical with regard to safety/efficacy, but they are “legally distinct.” That’s code for one has manufacturer liability, while the other doesn’t. It is also code for “we don’t want to impose a mandate on the EUA product cause it is illegal, but we can probably get away with a mandate on the licensed product.”
[..] yes, we licensed the vaccine, but…there is a lot of the old vaccine out there, actually “a significant amount” and this amount will be considered an EUA and will continue to be used. Now, why would they do that? Why specify that identical versions of the product will be legally different? Because they need the license to impose the mandates. But they need the EUA to evade liability.
Along with the license comes liability for the manufacturer. (While all EUA products were given a liability shield.) the feds want us to THINK the vaccine we are receiving is licensed, which will make people submit because they think it can now be mandated , but instead we are almost certain to receive the EUA vials instead, to save Pfizer’s behind.
“On August 23, 2021, FDA approved the biologics license application (BLA) submitted by BioNTech Manufacturing GmbH for COMIRNATY (COVID-19 Vaccine, mRNA) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 16 years of age and older.” The efficacy claims are based on outdated data. The press release indicates that the basis of the efficacy claims was as quoted below. However, those data are outdated, and captured with strains of virus (Alpha, Beta) that are no longer predominant. The efficacy claims are therefore invalid – it is quite clear that the vaccine is much less effective in preventing infection by the currently circulating strain (Delta)
In its letter to BioNTech, the FDA states “” 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.” The first sentence says that VAERS will be incapable of assessing known serious risk The second sentence says that the other pharmacovigilance systems that by law FDA employs (supposedly about 20 different databases when they were bragging about them last October) are similarly incapable of assessing known serious risk.
• The risks in pregnancy remain unknown. “although not FDA requirements, the company has committed to additional post-marketing safety studies, including conducting a pregnancy registry study to evaluate pregnancy and infant outcomes after receipt of Comirnaty during pregnancy.” The prescribing info says: “There is a pregnancy exposure registry for COMIRNATY. Encourage individuals exposed to COMIRNATY around the time of conception or during pregnancy to register by visiting https://mothertobaby.org/ongoingstudy/covid19-vaccines/ .” WHY ARE THEY DOING A PREGNANCY STUDY?
FDA has licensed the BioNTech vaccine for 16 and up
• All of the authorized vaccine on shelves and in freezers will remain only authorized, until the new product with Cominaty labelling arrives.
• 3d or booster doses and vaccine for 12-15 year olds remains under EUA
• Why not also approve the Pfizer version? Why leave it under EUA?
• When the press says the “Pfizer vaccine is fully approved.” It is not. The vaccine that is likely to be supplied for some time, WILL BE THE Pfizer – EUA vaccine. So any mandates based on full approval are meaningless.
THE BLA acknowledges LONG term myocardial issues with a 5 year follow up consistent with the lower range for LTFU for Gene Therapy Products. Is FDA quietly acknowledging the Gene Therapy classification? These products have been classified by FDA as Gene Therapy Products which require UP to 15 years long term follow up in studies. This was acknowledged by Moderna in their 2Q 2020 filing.
Using superior CDC published methods, normalizing for people vaccinated, Children’s Health Defense estimates 176x reports of VAERS deaths associated with C19 vaccines compared with flu vaccines. 35x the number for H1N1 (where stimulated reporting is speculated) Using CDC published methods we estimate under-reporting of VAERS deaths to be 5- 15x. for a total of 30,000-90,000 deaths, mostly non-C19. Underreporting for lifethreatening events may be 24-64x. IN ADDITION – (Israel MOH, combined with Dagan study), we have estimated between 35-86,000 EXCESS USA deaths due to Covid in those vaccinated (>=1 dose)
We try to run the Automatic Earth on donations. Since ad revenue has collapsed, you are now not just a reader, but an integral part of the process that builds this site. Thank you for your support.
Support the Automatic Earth in virustime. Click at the top of the sidebars to donate with Paypal and Patreon.
Home › Forums › The Lies Must Stop