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

Source: The FDA’s proposed “Future Framework” is the worst idea in the history of public health

I. Pfizer and Moderna’s Dilemma

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

More @ Source.

VII. Call to action

We have very little time and an enormous challenge in knocking this proposal down before the VRBPAC meets on June 28. So I am asking to you to contact your elected officials to tell them to reject this dangerous proposal.

Below are talking points that you can paste into an email, a script that you can use on the phone, and a tool for looking up your elected officials. I am only asking you to contact 8 officials — the President and Vice President; your two Senators and U.S. Representative; and your Governor, state House/Assembly member, and state Senator. Please be respectful but make it clear that this plan must be stopped.

Talking points (to paste into an email, letter, or fax)

Subject line: NO “flu framework” for future Covid-19 shots

The FDA and CDC are developing a “Future Framework” to authorize future Covid-19 shots without requiring additional clinical trials. This would be a public health disaster. I am asking you to contact the FDA to tell them to stop all work on this “Future Framework” immediately. If the FDA proceeds with this “Future Framework” I am asking you to eliminate all funding for the FDA in this year’s budget.

Phone script

Hi, my name is ____________. I live at __________________[address]. I’m calling because the FDA is proposing a “Future Framework” to authorize future Covid-19 shots without requiring additional clinical trials. This would be a public health disaster. I am asking you to contact the FDA to tell them to stop all work on this “Future Framework”. If the FDA proceeds with this “Future Framework”, I am asking you to eliminate all funding for the FDA in this year’s budget.

Whom to contact: 8 phones calls, letters, emails, or faxes:

President Joseph R. Biden
The White House
1600 Pennsylvania Ave NW
Washington, DC 20500
(202) 456-1111 (The White House comment line is open between the hours of 11 to 3 p.m. EST Tues.-Thurs.)
https://www.whitehouse.gov/contact/
https://twitter.com/POTUS

Vice President Kamala Harris
The White House
1600 Pennsylvania Ave NW
Washington, DC 20500
(202) 456-1111 (between the hours of 11 to 3 p.m. EST Tues.-Thurs.)
https://www.whitehouse.gov/contact/
https://twitter.com/VP

You can look up contact info for your two U.S. Senators and U.S. Representative here:

https://www.govtrack.us/congress/members/map

The message for State elected officials is slightly different:

Hi, my name is ____________. I live at __________________[address]. I’m calling because the FDA is proposing a “Future Framework” to authorize future Covid-19 shots without requiring additional clinical trials. This would be a public health disaster. If the FDA proceeds with this “Future Framework” I are asking you to nullify the actions of the FDA and reject any Covid-19 shots that have not gone through proper clinical trials.

This is a great tool to look up contact info for your Governorstate Senator, and state House/Assembly member:

https://myreps.datamade.us/

That’s it, just 8 people. We want to let them know that we are watching, that we understand what they are up to, and that this wretched plan must be stopped.

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