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This is what you can do regarding future mandates



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ChossidMom




 
 
    
 

Post Tue, Jun 21 2022, 2:25 pm
AS OF 7PM PACIFIC TIME, JUNE 20, 2022, NO DOCUMENTS HAVE BEEN MADE AVAILABLE BY THE FDA.
I am absolutely opposed the the idea of allowing pharmaceutical companies to alter the mRNA sequences in their injectable products without full placebo-controlled clinical studies to determine whether such newly formulated injections are safe and effective.

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.

The FDA’s Vaccine and Biological Products Advisory Committee (VRBPAC) will be meeting on Tuesday, June 28, 2022 to discuss this issue, which Toby Rogers referred to as “THE WORST IDEA IN THE HISTORY OF PUBLIC HEALTH.”

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.

- Toby Rogers

HURRY - THE DEADLINE IS SOON!!
GIVE THE FDA YOUR OPINION ASAP:
ORAL PRESENTATIONS: Those individuals interested in making formal oral presentations should notify the contact person on or before 3 pm Pacific Time (6pm Eastern) on June 21, 2022.

Send an email to: CBERVRBPAC@fda.hhs.gov and submit

A brief statement of the general nature of the evidence or arguments you wish to present

Your name

Your email address

Your phone number

An indication of the approximate time requested to make your presentation (3 minutes)

CONTACT PERSON: Prabhakara Atreya or Sussan Paydar, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 1226, Silver Spring, MD 20993-0002, 240-506-4946, CBERVRBPAC@fda.hhs.gov

WRITTEN SUBMISSIONS (TO VRBPAC): All electronic and written submissions submitted on or before June 22, 2022, will be provided to the committee. The deadline for written public comment to be provided to the committee is 9pm Pacific time, (midnight Eastern) on Monday, June 27, 2022. CLICK HERE

WRITTEN SUBMISSIONS (TO FDA): Comments received after June 22, 2022, and by June 27, 2022, will be taken into consideration by FDA. The deadline for written public comment is 9pm Pacific time, (midnight Eastern) on Monday, June 27, 2022. CLICK HERE

CLICK HERE (OR BELOW) TO SUBMIT YOUR FORMAL PUBLIC COMMENT TO THE FDA
If the warning message below pops up, just ignore it. This is just another way that they try to mess with us.


The form has a pulldown menu that asks a question that appears to be purposefully misleading. The most appropriate choice is “individual consumer.”



After you submit your public comment to the FDA (above) send the email below to your 2 Senators and your Congressional Representative and every mainstream and alternative media group you possibly can.
SEND IT 10+ TIMES A DAY UNTIL YOU GET A SATISFACTORY RESPONSE.
https://www.congress.gov/membe.....ember

CLICK HERE TO CALL EVERY MEMBER OF THE HOUSE OF REPRESENTATIVES.

SUBJECT:
STOP THE FDA BEFORE IT IS TOO LATE

SAMPLE EMAIL:
I am absolutely opposed the the idea of allowing pharmaceutical companies to alter the mRNA sequences in their injectable products without full placebo-controlled clinical studies to determine whether such injections are safe and effective.

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.

Any reformulated COVID-19 shots MUST go through proper clinical trials and FDA review. That means:

Large (50,000+ person) double-blind randomized controlled trials with inert saline placebos conducted by an independent third party.

Safety and efficacy studies for two years prior to any application; the treatment and control groups must be followed for 20 years to monitor adverse events and all-cause mortality (no more wiping out the control group after 6 months to hide bad outcomes).

Greater than 90% efficacy with less than 1% Grade 3 Adverse Events.

Proper monitoring for carcinogenesis, mutagenesis, and impairment of fertility.

I DEMAND that you speak out publicly against this outrageous proposal PRIOR to the FDA meeting on Tuesday, June 28, 2022.


Send emails to the following people:
sean.mccluskie@hhs.gov, commissioner@fda.hhs.gov, ashish.jha@whitehouse.gov, Aux7@cdc.gov, Peter.Marks@fda.hhs.gov, Hong.Yang@fda.hhs.gov, Richard.Forshee@fda.hhs.gov, Huilee.Wong@fda.hhs.gov, Leslie.Ball@fda.hhs.gov, Doran.Fink@fda.hhs.gov, hanae@bcm.edu, paula.annunziato@merck.com, adam.berger@nih.gov, hbernstein@northwell.edu, acohn@cdc.gov, anc0@cdc.gov, hjanes@fredhutch.org, hgans@stanford.edu, david.kim@hhs.gov, asmonto@umich.edu, offit@chop.edu, spergam@fredhutch.org, Jportnoy@cmh.edu, erubin@hsph.harvard.edu, erubin@nejm.org, ashane@emory.edu, swamy002@mc.duke.edu, fullerao@umich.edu, RandyHawkins@cdrewu.edu, officeofthepresident@mmc.edu, JYLee@uams.edu, ofer.levy@childrens.harvard.edu, wayne_marasco@dfci.harvard.edu, cmeissner@tuftsmedicalcenter.org, mrn8d@virginia.edu, stanley-perlman@uiowa.edu, mhsawyer@ucsd.edu, mew2@cdc.gov


MEETING DETAILS
WATCH THE MEETING ON TUESDAY JUNE 28, 2022:
The Docket Number is FDA-2022-N-0905

SUBMIT A PUBLIC COMMENT:
https://www.federalregister.go.....mment

FEDERAL REGISTER:
https://www.federalregister.go.....mment

ANNOUNCEMENT PAGE:
https://www.fda.gov/advisory-c.....ement


PROCEDURE: On June 28, 2022, from 8:30 a.m. to 5 p.m. ET, the meeting is open to the public. Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. All electronic and written submissions submitted to the Docket (see ADDRESSES) on or before June 22, 2022, will be provided to the committee. Comments received after June 22, 2022, and by June 27, 2022, will be taken into consideration by FDA.

ORAL PRESENTATIONS: Oral presentations from the public will be scheduled between approximately 1:30 p.m. and 2:30 p.m. ET. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and email addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before 6 p.m. ET on June 21, 2022. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by June 23, 2022.

For press inquiries, please contact the Office of Media Affairs at fdaoma@fda.hhs.gov or 301-796-4540.


by James Roguski

The old system is crumbling, and we must build its replacement quickly.

If you are fed up with the government, hospital, medical, pharmaceutical, media, industrial complex and would like to help build a holistic alternative to the WHO, then feel free to contact me directly anytime.

JamesRoguski.substack.com/about

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