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FDA to determine if it should allow Pfizer and Moderna to skip clinical Trials for future COVID vaccines, or any vaccine, for that matter. In other words, they can reformulate a vaccine and redistribute that new product without any oversight because it is simply a reformulation of the original shot. Sound familiar? This same tactic was used to declare genetically engineered crops substantially equivalent to conventional and organic crops.
The term substantial equivalence was first mentioned in connection with food safety in a report of the OECD Group of National Experts on Safety in Biotechnology (OECD, 1993). The members of the group agreed that the most practical approach to determining the safety of foods derived by modern biotechnology is to consider whether they represent a substantial equivalent to analogous traditional products. The term substantial equivalence and the underlying approach were “borrowed from the US Food and Drug Administration’s (FDA) definition of a class of new medical devices that do not differ materially from their predecessors and thus, do not raise new regulatory concerns”
“FDA has a historic- decision to make on June 28 2022 – one that could affect everyone’s lives. If approved, all reformulated future mRNA Covid shots will skip clinical trials… just in time for the kids…
If the FDA authorizes Covid-19 shots for kids on June 14 and 15 and then approves the “Future Framework” on June 28th, the shots that will be given to kids in the future will be the reformulated shots that skipped clinical trials.
How you know the world is run by evil reason — what number are we up to now? Unbelievable – the FDA could skip clinical trials in future to save the mRNA industry from the utter failures – where are the good guys… where is the sanity… where are the people protecting the children and humanity from this pharma-takeover, this mass-democide, WHERE?”
(https://pennybutler.com/fda-future-framework-decision/)
Pfizer and Moderna’s dilemma
Pfizer and Moderna are making $50 billion a year on these (COVID) shots and they want that to continue. So they need to reformulate the shots. Maybe target a new variant, maybe change some of the ingredients — who knows, these shots don’t work so it’s not clear what it will take to get them to work.
This is a problem because reformulated shots mean new clinical trials and new regulatory reviews by the U.S. Food and Drug Administration (FDA). There is a decent chance that any reformulated shot might fail a new clinical trial and the public is deeply skeptical of these shots so the scrutiny would be intense.
So Pfizer and Moderna have figured out a way to use regulatory capture to get their reformulated COVID-19 shots approved WITHOUT further clinical trials. Their scheme is called the “Future Framework” and it will be voted on by the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on June 28.
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Tags: covid, democide, eua, FDA, future framework, moderna, pfizer