FDA is trying to legalize its illegal approvals of COVID vaccines without human trials. Now one animal trial will do the trick to "prove" efficacy?
FDA is trying to legalize its illegal approvals of COVID vaccines without human trials. Now one animal trial will do the trick to "prove" efficacy?
HUGE thanks to ICAN, Del Bigtree and Aaron Siri for exposing this piece of work
You can’t prove efficacy with an animal trial. You can’t prove safety with an animal trial. The anthrax vaccine studies PROVED that even when a vaccine seemed to work in animals, it was unclear what the right dose was and equally unclear how antibody levels related to protection, because they didn’t. Maybe because no one knew which antibody to measure?
Surrogate markers for approval of vaccines (or anything else) became a total joke when FDA began ignoring the requirement that “correlates of protection” were a essential before you could use antibodies, T cells, animals or anything besides humans to assess a vaccine. This means that you have to prove the surrogate marker or animal model actually duplicates the human response, since usually they don’t.
FDA officials ditched this absolutely necessary standard (imho illegally) and now want to a) cover their tracks, and b) foist more untested and possibly deadly injections on us going forward.
Who needs them? They are simply a Potemkin Village of a regulatory agency at this point. Thank God ICAN is watching.
With public faith in FDA continuing to decline, the agency published draft guidance stating that a single animal study could be sufficient to demonstrate a vaccine’s effectiveness. ICAN’s attorneys submitted a comment in opposition to this draft guidance which comes shortly after FDA approved a COVID-19 booster based on trials performed solely in mice.
Back in 2007, an FDA advisory committee met to re-review the safety, effectiveness, and dosing of phenylephrine (Sudafed PE), a drug which has been on the market for nearly 50 years. At the 2007 meeting, the committee considered its efficacy data “borderline” but nonetheless voted 11-1 in favor of its efficacy, although it did vote in favor of additional studies being done.
On September 12, 2023, the same FDA committee, possibly attempting to bolster its image as a tough regulatory watchdog, voted unanimouslyto label phenylephrine “ineffective” as a nasal decongestant. The committee noted “significant methodological and statistical issues with the design and conduct of the original studies submitted to and evaluated by the Panel…. All but one evaluated extremely small sample sizes, none adequately controlled for bias … and none performed appropriate sample size calculations,” and observed, “After a thorough review of all the available evidence, it is also possible that there may have been bias and/or data integrity issues at [at] least one study center … where five of the seven positive oral PE studies were conducted.”
If FDA follows the panel’s advice, the drug will be pulled from the market, despite the long-standing indications of its inefficacy, most of which were known in 2007. It’s too bad the committee didn’t perform this “thorough review” at any point prior to the last 50 years, before Americans wasted billions of dollars on an ineffective treatment (nearly $2 billion in 2022 alone) that apparently only exposed them to potential harm without benefit.
Ironically, on September 11, 2023, just one day before the committee met to clamp down on this “ineffective drug” with shoddy clinical trials, FDA issued draft guidance stating that, under certain circumstances, a manufacturer can show evidence of effectiveness for a biological product with a single clinical investigation conducted in animals, giving the exampleof “[w]hen the product is a preventive vaccine, and there is a well-established model of infection for a relevant infectious disease, and use of the vaccine in the animal model demonstrates prevention of disease.” Notably, this occurred shortly after FDA authorized the newest Pfizer COVID-19 vaccines, which are as Dr. Paul Offit notes, “new product[s],” even though Pfizer tested this brand-new shot only in mice — not humans.
Thus, on December 18, 2023, ICAN, through its attorneys, filed a formal comment in opposition to the draft guidance. In it, ICAN points out that, despite urging by ICAN in its November 2020 petition, FDA refused to amend the Phase III trials of the COVID-19 vaccines to ensure they met the required standard of “substantial evidence” of effectiveness. As a result, we now have generations of new vaccines being approved based on those original ineffective products.
Now, FDA is doubling down on its malfeasance by authorizing COVID-19 vaccines without human trials while simultaneously creating guidance to excuse its lack of oversight. As ICAN’s comment notes:
[I]t is apparent that FDA is tailoring guidance based on the vaccine manufacturers’ clinical trials instead of requiring that these trials comply with what any reasonable licensing agency should and would require. FDA has seemingly forgotten that its function is to regulate the pharmaceutical industry, not rubber stamp it. The Draft Guidance does not provide oversight, and even worse lends illegitimacy to the FDA when there is clearly insufficient evidence to support authorization or licensure. This is especially troubling for products that will be injected into healthy humans including babies, children, and pregnant women.
Rest assured that ICAN’s legal team will continue to serve as a watchdog for FDA and ensure it is held accountable for improperly wielding its regulatory authority and fulfilling its responsibilities.
To support future legal action like this, click here to donate!
You can read more about ICAN’s work serving as watchdog for our federal health agencies at the links below:
What we need to bring to the fore... to the public.... is the FDA is no longer the FDA... THe FDA is an arm of Big Pharma now... they are completely captured, they do what Big Pharma wants... they have been doing this for years because 70% of their budget comes from Big Pharma and you don't bite the hand that feeds you.
Why do we still pretend there are a regulatory agency?
We are living in a horror show