by Dr. Joseph Mercola, ©2022

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(Jul. 8, 2022) — In a rather shocking turn of events, the U.S. Food and Drug Administration sneaked in a “Future Framework”1 scheme that will allow Pfizer and Moderna to reformulate and release updated COVID shots without conducting any additional human clinical trials, other than what’s already been done.2,3,4

FDA Rewrites the Rules on the Fly

A vote on the Framework was scheduled to be taken June 28, 2022, by the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC), but while the VRBPAC approved (19-2) a bivalent COVID shot for fall 2022,5 the expected voting on the Framework, specifically, didn’t seem to take place — only it DID.

As it turns out, we’ve been bamboozled yet again by an agency that keeps rewriting the rules on the fly. Toby Rogers, Ph.D. — a political economist whose research focus is on regulatory capture and Big Pharma corruption6 — explains how they sneaked this one by us:7

“Yesterday [June 28], the FDA’s Vaccines and Related Biological Products Advisory Committee approved a bivalent COVID-19 shot with the Wuhan strain and the Omicron variant …

At the meeting, the manufacturers (Moderna, Pfizer, and Novavax) were asked what their production timelines are… and they said out loud, ‘So long as we don’t have to provide any clinical data, we’ll have them ready by fall.’ No one had a problem with that …

Wait, hold up, I thought the FDA was voting on the Future Framework yesterday? The policy question was whether reformulated COVID-19 shots would be treated as new molecular entities (which they are) in which case they should be subject to formal review or whether reformulated shots would be treated as ‘biologically similar’ to existing Covid-19 shots and be allowed to skip clinical trials altogether.

Apparently the FDA did not have the votes to just pass this as a policy question. If you ask anyone whether reformulated mRNA represents a new molecular entity, well of course it is, so that would require formal regulatory review.

What the FDA did instead was to smuggle the policy question in disguised as a vote about reformulated ‘boosters’ for the fall.

In essence, the FDA just started doing the Future Framework (picking variants willy nilly, skipping clinical trials) and essentially dared the committee members to turn down a booster dose — knowing that all of the VRBPAC members are hand-picked because they’ve never met a vaccine they did not like.

So of course only two people on the committee had the courage to turn down a booster dose — even though it was based on this preposterous process (that was never formally adopted) where there was literally no data at all … By stealth, the FDA replaced a system based on evidence with a system based entirely on belief.”

Worst Idea in the History of Public Health

A decision to release reformulated mRNA shots without additional clinical trials is the worst development yet, by far, and has the power to radically change medical science moving forward.

Not only will completely untested COVID injections be churned out, but this “framework” may also, over time, be widened to include other vaccines and drugs that drug makers may want to tinker with. Heck, it could even lower standards for drug trials in general, which historically have required at least 10 years of multi-phase testing.8

In a May 31, 2022, Substack article, Rogers explained the origin and purpose of this incredibly dangerous proposal:9

“Pfizer and Moderna have a problem — their mRNA COVID-19 shots do not stop infection, transmission, hospitalization, nor death from the SARS-CoV-2 virus. Everyone knows this … Pfizer and Moderna are making about $50 billion a year on these 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 review by the 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’ … The purpose of the ‘Future Framework’ is to rig the COVID-19 vaccine regulatory process in perpetuity in favor of the pharmaceutical industry.

If this ‘Future Framework’ is approved all future COVID-19 shots, regardless of the formulation, will automatically be deemed ‘safe and effective’ without additional clinical trials because they are considered ‘biologically similar’ to existing shots.

This is literally the worst idea in the history of public health. If you change a single molecule of mRNA in these shots it will change health outcomes in ways that no one can anticipate. That necessarily requires new clinical trials — which is what the FDA is proposing to skip …

The FDA authorized COVID-19 shots for kids on June 14 and 15. So if the FDA approves the ‘Future Framework’ on June 28th, the shots that will be given to kids (and Americans of all ages) in the fall will be the reformulated shots that skipped clinical trials.”

SARS-CoV-2 Is a Horrible Vaccine Candidate, and They Know It

Before we continue, let’s review one important factor that tends to get lost. As explained by Rogers,10 “Viruses that evolve rapidly are bad candidates for a vaccine,” for the simple reason that they mutate faster than vaccine development can keep up with.

This is why we don’t have a vaccine against the common cold. It’s’ also why all previous attempts to develop a coronavirus vaccine failed. Those studies never made it past animal trials. The vaccines caused antibody-dependent enhancement, making the animals sicker than normal when exposed to the virus.

Most people are unaware that SARS-CoV-2 mutates at a rate that is two to 10 times faster than the influenza virus,11,12 and these mutations can considerably reduce vaccine effectiveness. Indeed, we’ve seen this both with the seasonal flu vaccine and the COVID shots. When you vaccinate against a rapidly mutating virus you also run the risk of pressuring it into a more virulent and/or vaccine-resistant form. As noted by Rogers:

“The FDA’s ‘expert advisory committee’ (VRBPAC) met on April 6, 2022 to discuss the ‘Future Framework’ for the first time. All of the committee members agreed that COVID-19 shots are not working, that boosting multiple times a year was not feasible, and that the shots need to be reformulated.

They also unanimously agreed that there are no ‘correlates of protection’ that one can use to predict what antibody levels would be sufficient to prevent SARS-CoV-2 infection.”

By now, the VRBPAC must know that the only way forward, really, is to withdraw the COVID shots and focus on therapeutics. But they’re not doing that. Instead, they’re doubling down on a failed strategy. On top of that, they’re making the situation even worse by foregoing clinical trials. There’s no doubt in my mind that this will pose grave risks to public health. I agree with Rogers, who said:13

“Think about it. The more mRNA you put into a shot, the higher the adverse event rate (as the genetically modified mRNA hijacks the cell and starts cranking out spike proteins). So if Pfizer and Moderna put more mRNA into these shots (in order to cover multiple variants) adverse event rates will skyrocket.

But if Pfizer and Moderna put less mRNA per variant into a shot (in order to keep the total amount of mRNA at 100 mcg for Moderna and 30 mcg for Pfizer) then the effectiveness against any one particular variant will be reduced. The Future Framework is 100% guaranteed to fail.”


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In a May 31, 2022, Substack article, Rogers explained the origin and purpose of this incredibly dangerous proposal:9

A vote on the Framework was scheduled to be taken June 28, 2022, by the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC), but while the VRBPAC approved (19-2) a bivalent COVID shot for fall 2022,5 the expected voting on the Framework, specifically, didn’t seem to take place — only it DID.

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