FDA’s “Future Framework” for Covid vaccines a reckless plan | Eastern NC Now

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. Over half a billion doses 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 about $50 billion a year on these shots and they want that to continue. So they need to reformulate. Maybe target a new variant, maybe change some of the ingredients — who knows, these shots have disappointed 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 already, 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.

https://brownstone.org/articles/the-fdas-future-framework-for-covid-vaccines-is-reckless-plan/