Here it is folks, in black letters, from the FDA itself.
It is important to note that FDA’s authorization and licensure standards for vaccines do not require demonstration of the prevention of infection or transmission. A vaccine can meet the licensure standard if the vaccine’s benefits of protecting against disease outweigh the vaccine’s risks for the licensed use. There is no requirement that the vaccine also prevents infection with the pathogen that can cause the disease or transmission of that pathogen to others.48
Please note that a saline injection meets this standard. That is, it has no side effects and thus no risks, therefore that it is ineffective is irrelevant and it can be licensed as the risks do not outweigh the rewards (both are nil.)
Likewise, the FDA now states that a “vaccine” that is entirely safe but only prevents 1% of deaths that would otherwise occur is licensable. It could in fact prevent 0.0001% of deaths and be licensable provided it is entirely safe. Note this very carefully — absolutely no evidence is required that any vaccine, in the position of the FDA, actually works in any meaningful percentage of the population so long as it doesn’t harm people.
Oh by the way that’s not what the standard was either — not when I was a kid, not when my daughter was a kid, nope. If it didn’t prevent infection it wasn’t a vaccine. Indeed until a few years ago the dictionary so-stated.
Similarly, a vaccine can meet the EUA standard without any evidence that the vaccine prevents infection or transmission. To that end, there is no requirement that the clinical trials supporting a vaccine’s licensure or authorization be designed to determine whether the vaccine prevents infection of a pathogen or transmission of that pathogen to others.
This goes even further; under an EUA a “vaccine” can be called that without any evidence whatsoever that it prevents infection or transmission and no trials are required, nor any results required for either an EUA or license, that demonstrate any degree of protection against infection and giving the pathogen to other people. In other words zero evidence is required that any protection to the community at large is conferred by your taking that shot.
Yet that’s not what you were told and sold as well, was it?
Indeed, not only was it not what you were sold its not the indication either — let me quote again, from the FDA’s own words:
On August 23, 2021, the Agency approved the Biologics License Application (BLA) for Comirnaty (COVID-19 Vaccine, mRNA), and the approval was granted to BioNTech Manufacturing GmbH.1213 Comirnaty is indicated for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older. On January 31, 2022, the Agency approved the BLA for Spikevax (COVID-19 Vaccine, mRNA), and the approval was granted to Moderna. 14 Spikevax is indicated for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and
older.
The drug is indicated for active immunization (that word immunize means to prevent infection) and then in the next few words they say it out loud: TO PREVENT COVID-19.
Yet no such evidence was or is required from said trials and thus the marketing of same is fraud as there is no evidence and approval does not indicate that the alleged claim is true.
Think about how stupid it is that we have allowed this to occur: A drug does not have to actually demonstrate evidence that it works as the “indication” in the prescribing information and label claims it does in order be “approved” or “authorized” and sold, and if we discover it doesn’t actually work as the label indication states that discovery does not immediately void said approval nor does it expose the maker to damages, including punitive damages, for selling something they had no evidence actually worked as claimed.
Biden, the CDC, your doctor, every single spouting Karen everywhere, mayors, governors, Donald Trump and more all said you wouldn’t get Covid if you took the jabs with at least a reasonable degree of certainty.
No evidence whatsoever was required to make that statement.
They mark the complete destruction of an agency that once meant something. An agency where one intrepid woman prevented the Thalidomide disaster from coming here to the United States. It ravaged Europe — but with a couple of exceptions spared the US, and all because the FDA stopped it.
But that was then — and this is now. That which was no longer is, and therefore “approved” by the FDA no longer means anything as they have proven they can, and will change the rules whenever they want, without notice and for those who lie about what something means when they approved that thing they not only will let that happen they consider it perfectly fine.
The FDA has categorically stated that no evidence is required and in fact an alleged “vaccine” need not prevent anything.
Therefore all such mandates are void for want of consideration; the premise of such a mandate is that it protects not just you but prevents transmission and thus protect others. This has now been categorically disavowed and thus all such mandates are void and attempts to enforce them are felony assaults. They are active, ongoing frauds perpetrated by your physician, health department, governor, mayor, school superintendent and more.
This is not limited to Covid. It is their position on all so-called “vaccines” and is wildly different than what you were sold, and what was the case years ago. Indeed the FDA just approved a second drug that failed its trials (this one for ALS) so effectiveness is, it would appear, no longer required at all for any drug, device, vaccine or otherwise the FDA allegedly “approves.”