QED
And BTW, the FDA did NOT grant full approval to the Pfizer Vaxx jab.
They only granted "approval" to extend the EUA to use for 12-16 yr olds, and to grant Pfizer the naming rights of their version of the Vaxx jab.
Kudos to American Thinker for pointing this out. The utterly abysmal English comprehension skills of the Enemedia at ABCNNBCBS, coupled with a deliberately mendacious press release by the FDA, combined to put out a completely fraudulent narrative on Monday.
People who can read, let alone think, should not be fooled.
None of the shots are "approved", and ALL of them continue to be used solely under an Emergency Use Authorization.
Period. Full stop.
Comirnaty is approved, but there's none of it in the US, and anyone harmed by it can sue.
The Pfizer vaxx jab that is available in the US is still only authorized under the EUA, and may be legally refused, as can the JandJ and Moderna brands of experimental poison.
And they have the nerve to criticize us for calling out "FAKE NEWS!!"
ReplyDeleteThe "news" stories regarding the FDA approval is so distorted from 99% of the media outlets, that many people will now foolishly run out to get the jab believing it to be suddenly "safe."
"The EUA for the Pfizer-BioNTech COVID-19 Vaccine for individuals 16 years of age and older was based on safety and effectiveness data from a randomized, controlled, blinded ongoing clinical trial in approximately 18,000 individuals who received the vaccine and approximately 18,000 who received a placebo. The vaccine was 95% effective in preventing COVID-19 disease among these clinical trial participants with eight COVID-19 cases in the vaccine group and 162 in the placebo group. The duration of safety follow-up for the vaccinated and placebo participants was a median of two months after receiving the second dose."
ReplyDeleteI don't see how this is evidence of any effectiveness or of anything, because it doesn't even make any sense. What's the logic supposed to be here? Because only 8 in the vaccine group out of 162 in the placebo group contracted the disease, they assume the vaccine made the difference? There's a million different factors involved in an individual contracting the disease, and they're disregarding every single one of them and simply assuming that both samples ought to have contracted the disease at the same rate because yes. What do you want to bet that this can't be reproduced even if you tried a hundred times? What do you want to bet that every single time the amount of people contracting the disease whether vaccinated or not would vary?
In the first place, how did they diagnose them? PCRs? The tool that isn't designed for diagnosis, is prone to false positives and the FDA themselves are removing as a valid test by the end of this year? It's a shame that the FDA doesn't provide a link to such clinical trial to find out the methodology, and very suspicious too all things considered.
Does this make any sense to anyone reading this comment?
Sorry, a BLA is the approval. BLA's are used for vaccines, not IND (Investigational New Drug) or NDA (New Drug Application). Read the regs and statutes.
ReplyDeleteNow, it doesn't look like they followed the rules in granting this approval, so it's possible it could be voided, but it is approved.
ReplyDeleteOf course it doesn't make sense.
BTW, those "18,000 individuals"?
All over 18. By law.
@Anon 1:31P,
ReplyDeleteNope. They re-issued the EUA. The BLA isn't "unlimited use approval". Read the second letter linked at the AmThinker site:
https://www.fda.gov/media/150386/download
They even reference the BLA in the renewed EUA.
This is smoke and mirrors to bamboozle and confuzle.
Apparently not, I found more info in the FDA website:
ReplyDeletehttps://www.fda.gov/media/151707/download
Page 16 you have efficacy against COVID-19, you can see this statement:
"16 through 17 years of age began enrollment from September 16, 2020, and 12 through
15 years of age began enrollment from October 15, 2020."
I knew it:
"Note: Confirmed cases were determined by Reverse Transcription-Polymerase Chain Reaction (RT-PCR) and at least 1 symptom
consistent with COVID-19 (symptoms included: fever; new or increased cough; new or increased shortness of breath; chills; new or
increased muscle pain; new loss of taste or smell; sore throat; diarrhea; vomiting)."
Of course they used PCR, like that old study at the beginning in a plane claiming 91% of people were asymptomatic based on PCRs that has been debunked a million times by now.
"Subgroup analyses of vaccine efficacy (although limited by small numbers of cases in some subgroups) did not
suggest meaningful differences in efficacy across genders, ethnic groups, geographies, or for participants with
obesity or medical comorbidities associated with high risk of severe COVID-19."
Nonetheless they don't show the data so we can't judge by ourselves, we know nothing about the medical history of the participant, or their nutrition, no blood samples, we don't know their lifestyle either. So it's all conjecture, with some controversial data which gives some indication of the possibility.
Notice that they didn't deny anything about subgroups by ages! Why the percentage falls off 5% when they are younger than 65, what if they are younger than 50? 40? 30? 20? Does it keep falling off until it's a cliff? I'm going to guess yes, and that's why they don't deny it like they do with gender, race, geographies or obesity and they don't show it.
My own perusal of the FDA announcement appears to herald 16-and-up full approval, unless (a) I'm reading it wrong, and/or the press release is crosswise from the actual report.
ReplyDeleteLink, please? Thank you, sir.
Aesop, reading the Letter and the Product Insert are revealing. They clearly say it does not prevent The Plague and even though they clearly say there is no information concerning impacts on pregnancies and pregnant women, they recommend they get it anyway.
ReplyDeleteAnd 10 additional studies to cover the conditions and long term impacts - that we know about.
This is what passes for "thoroughly and rigorously reviewed" now?
"This is smoke and mirrors to bamboozle and confuzle."
ReplyDeleteWell, then… MISSION ACCOMPLISHED.
I've never been much good at interpreting bureaucratize, and I'm damned if I can figure out what is approved and what is merely an extension of the EUA. What's the truth here?
On the other hand, does it even matter? In a world ruled by an oligarchy, does truth have any role at all?
If they tested this on actual minors, they violated a fundamental tenet of law and medicine: you cannot test something on someone who cannot give consent, and a minor cannot give consent, while a parent can only give consent to authorized treatments.
ReplyDeleteOne is not allowed to "volunteer" their minor children for harmful or potentially injurious ANYTHING. Not vaccine trials, not motion picture stunt work, not working in coal mines or garment sweat shops.
"Paging Dr. Mengele..."
"One is not allowed to "volunteer" their minor children for harmful or potentially injurious ANYTHING. Not vaccine trials, not motion picture stunt work, not working in coal mines or garment sweat shops."
ReplyDelete..Not for the naked correct of Nevermind...
You know, I read that damn letter 3 times the other day, and kept thinking I was reading it wrong because all it did was extend the EUA. At least now I know I didn't read it wrong....
ReplyDeleteThat's fine, my regular doctor is prepared to give me a medical exemption if needed anyway. I've spent the last 2 years having screwed up reactions to drugs that I previously tolerated, AND to what appears to be a LONG list of preservatives/stabilizers in foods (or maybe its a short list of families of preservatives, but we can't narrow it down further). So damned if I'm taking a shot of something that I can't tell if I'm going to react to it or not.
It seems that what they've done is fully authorize something you can't get in the U.S., while continuing to allow what you can get under the EUA, which makes mandating it a violation of federal and international law, and continues to both the DotGov and Pfizer et al from any criminal or civil claims for damages suffered as a result of getting it.
ReplyDeleteIOW, business as usual for this anarchic "government".
@Aesop,
ReplyDeleteI'd like your thought son this please. Get back to me through Teh Blog if you would.
https://scitechdaily.com/inescapable-covid-19-antibody-discovery-neutralizes-all-known-sars-cov-2-strains/
"Even in an emergency, when there is a rapidly spreading contagious disease and an effective vaccine, the state is not permitted to forcibly vaccinate or medicate anyone. The constitutional alternative is to segregate infected and exposed people separately to prevent them from transmitting the disease to others. Here again, modern constitutional law demands a high level of justification. The Supreme Court has long recognized that “involuntary confinement of an individual for any reason, is a deprivation of liberty which the State cannot accomplish without due process of law,”[98] and some justices have called freedom from such confinement fundamental in nature.[83] While it has not decided a case that involved isolation or quarantine for disease, it has held that civil commitment for mental illness is unconstitutional unless a judge determines the person is dangerous by reason of a mental illness.[83,98] Assuming, as most scholars do, that the law governing commitment to a mental institution also applies to involuntary confinement for contagious diseases, the government would have the burden of proving, by “clear and convincing evidence,” that the individual actually has, or has been exposed to, a contagious disease and is likely to transmit the disease to others if not confined.[129,130]" https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1449224/
ReplyDeleteOver and above that, bodily autonomy is a natural right, preceding any government, including the present one. So is armed defense to attempted invasion of that right, if the State prefers to ignore the rule of law.
@Phil,
ReplyDeleteIt sounds promising, but so did the press releases for the current crop of poisons.
And no word on where it stands in the list of things to be tried, beyond investigational.