Clinical trials are no longer needed
At least that is what Pfizer, Moderna (and soon the FDA) say
The FDA advisory panel that oversees vaccine development and distribution, VRBPAC (Vaccines and Related Biological Products Advisory Committee) will vote at its June 28 meeting about whether to adopt the ‘flu vaccine model’ (what some are calling the “Future Framework”).
OK, so what is the “Influenza Strain Selection Process”?
You can watch it be discussed at the last VRBPAC meeting on March 6, 2022. (You really don’t want to watch this boring….uh, stuff… but here is the link starting at 6:26:00 if you choose to go down the rabbit hole.)
I (try to) save your sanity by simply showing a couple of screenshots of that presentation.
This ‘Future Framework” has a couple of simple aspects.
1 - You try to make your best guess about which strains will be most effective in a vaccine and put several (usually four versions) into a single shot (aka - multivalent vaccines).
In this slide, you can see the process for selecting what goes into each year’s flu vaccine.
Can you pick out what is missing (after manufacturers submit a new request and before they start distribution???
You got it: No clinical trials.
The “Influenza Vaccine Strain Selection Process” specifically excludes
any new clinical trials.
Vaccine makers simply dream up a new batch of antigens, put it in a vial, and put it into billions of people. No tracking of side effects. No knowledge of how well (or poorly) the drug prevents infections or illness or death.
Just in case you were wondering… the FDA is well aware of this limitation.
Note from the slide above….
So far, FDA has required clinical data for its COVID vaccines (supposedly).
So far, FDA has only approved monovalent c19 vaccines (one type of mRNA per vax) - but are proposing to go ahead and try vials with several types of mRNA… without clinical trials.
And finally,
They specifically suggest that, instead of clinical trials (with their annoying metrics like “lives saved” and “protection from infection”), they will exclusively use the presence of antibodies to mean the vaccine ‘works’.
Don’t worry. They are already finding ways to overcome this obstacle:
(just a few slides later…)
Clinical trials are no longer needed
Given the fact pattern surrounding the COVID vaccines, this was always the inevitable next step. If they can get away with openly fraudulent clinical trials while courts deny any ability to file suit against the FDA and CDC due to "lack of standing", then there is nothing to prevent progression to more flagrant efforts to approve medications without any evidence of safety or efficacy. This proves what students of Austrian economics have known for decades, namely, that government institutions have no incentive to meaningfully protect consumers. If there were ever any individuals in these bureaucracies with good intentions, they have all long ago been replaced in accordance with Pournelle's Iron Law. What we need is for institutions like HHS to have safeguards against the obvious ethical issues with conflicts of interest that have arisen... PSYCH! They already have this bullshit, and Anthony Fauci's wife is one of the top ethicists at NIH. Can we please just use this as an opportunity to recognize that government regulation of industry is bankrupt of purpose and function and call for the abolition of these institutions that serve as nothing more than apologists for corporate malfeasance?
They already conducted a clinical trial with five billion people and the trial failed.