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….