June 30, 2022
FLASH Update - Future Framework to Proceed
In our last of edition of RHF, we alerted you to a June 28 meeting of the FDA’s Vaccine and Related Biological Products Committee (VRBPAC). The meeting was to consider approving a framework for modifying COVID-19 vaccines to address emerging variants which has become known as the Future Framework.
The Future Framework will irreversibly degrade the vaccine authorization and approval process.
How will it do so?
FDA telegraphed the punch on page 13 of the VRBPAC’s briefing document, which states that simple antibody response studies can be used instead of clinical trials to gain approval for future COVID-19 vaccines:
“The evaluation of modified vaccines for the purpose of vaccine strain composition decisions will need to rely mainly on comparative immunogenicity data [antibody studies] due to the time constraints involved in vaccine manufacturing and clinical efficacy evaluation.”
In other words, we will rely on lab tests of antibody responses (even in non-human test animals) to any particular COVID-19 vaccine formulation when deciding to approve a vaccine rather than using the Gold Standard of Randomized Controlled Trials.
FDA equates antibody responses (immunogenicity) to vaccines as equivalent to vaccine efficacy, but VRBPAC admitted on April 6 that there is no known linkage between antibodies and effectiveness.
Hey, there’s no time for clinical trials; we’ve got vaccines to push out the door!
That’s right, there will no longer be any pre-approval vaccine clinical trials, safety studies or toxicity or tissue distribution studies, no vaccine adverse drug / other vaccine interaction trials. There will only be post-immunization tracking of effectiveness and adverse events. A misinformed public and their children down to 6 months of age will actually comprise the trial.
So much for informed consent.
Moderna, Pfizer and Novavax are all developing reformulated COVID-19 vaccines. But they know that the FDA is not going to look at health outcomes under the Future Framework, so they are going to great lengths to jack up the antibody responses.
And lest you think they will rely on VAERS for tracking of adverse events, that has been determined to be a little too messy for the COVID Cartel of Big Pharma, FDA, NIH and CDC. VAERS, that has shown 29,031 reports of death following Covid-19 shots, is felt by the Cartel to be full of “unreliable” and inconvenient bad news that the Cartel would just as soon avoid.
“Unreliable” even though over 80% of VAERS reports come from health care professionals taking care of vaccine injured, and who have no incentive to mislead when filling out a document - under penalty of perjury - which takes nearly an hour of time to complete!
FDA will rely instead on a heretofore completely obscure (at least to most researchers and clinicians) Sentinel BEST Initiative. Sentinel will probe selected data sets to find “signals” of vaccine adverse events.
The Cartel is not going to leave adverse event discovery to the very clinicians who are providing care to the vaccine injured. What do they know anyway? They will use their hand-selected data mining system to report what they decide they want to have reported.
But not to worry, FDA vaccine head Peter Marks said that he was “comfortable” that the Sentinel BEST Initiative would catch any safety signals (meaning adverse events) after the shots are introduced into the market.
Now that’s reassuring.
Time is big money for the COVID Cartel after all.
The day after VRBPAC authorized a new mRNA vaccine approval process, the Biden administration announced it will buy 105 million mRNA injections in a no-bid contract at a 56% premium over previous costs. You’ve gotta admire the Biden team’s negotiating skills.
Not only that, but the government also has an option to purchase another 200 million doses, representing over $9 billion for Pfizer. This on top of record-breaking First Quarter, 2022 sales of $26 billion.
What to do?
Again, we recommend that you contact your congressional representatives and voice your opposition to the COVID-19 vaccine Future Framework approval and purchase process.
Be prepared for the onslaught this fall of next generation SARS-CoV-2 variants as hyped by the government, and the attendant non-stop promotions for the newest crop of vaccines.
Don’t be a trial subject. We have the same expectation of coming COVID-19 vaccines we had of those authorized up until now: Unsafe and ineffective.
