The FDA's proposed "Future Framework" is the worst idea in the history of public health
If approved on June 28, all reformulated Covid-19 shots will skip clinical trials
31 May 2022

I. Pfizer and Moderna’s Dilemma

Pfizer and Moderna have a problem — their Covid-19 shots do NOT work. Everyone knows this. The shots do not stop infection, transmission, hospitalization, nor death. Over half a billion doses of this product have been injected into Americans in the past 17 months and these shots have made NO discernible impact on the course of the pandemic. Far more Americans have died of coronavirus since the introduction of the shots than before they were introduced.

Pfizer and Moderna are making $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” and it will be voted on by the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on June 28.

II. Doubling down on a failed strategy

Viruses vary by region. At any given time, the influenza strain circulating in England is different than it is in South Africa which is different than in southeast Asia. However, pharmaceutical companies prefer to create one-size-fits-all vaccines in order to decrease manufacturing costs and thereby increase profits. So the W.H.O. and public health agencies around the world (including FDA and CDC) have created a vast “influenza surveillance network” that identifies the different influenza strains in circulation. Then they engage in an elaborate theatrical performance called the “flu strain selection process” where they select four influenza strains that will go into the one-size-fits-all flu vaccine used throughout the world that year.

This carefully choreographed process is a complete and total failure. This is not a surprise — using a one-vaccine-fits-all approach to prevent a rapidly evolving virus that varies by region is never going to work. Lisa Grohskopf from the CDC’s Influenza Division reports that last year the flu shot was somewhere between 8% and 14% effective (based on data from seven sites that participate in the U.S. Flu Vaccine Effectiveness Network).