HEY EVERYBODY… Let’s authorize endless gene therapy experiments to be conducted on the general population without long term safety studies or placebo control groups. What could go wrong?
CLICK HERE (OR BELOW) TO SUBMIT YOUR FORMAL PUBLIC COMMENT TO THE FDA
AS OF 10PM PACIFIC TIME, JUNE 22, 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
The discussion of this issue began at at 6 hours, 25 minutes and 51 seconds into the April 6, 2022 VRBPAC meeting.
Proposed Framework For Addressing Future Covid 19 Vaccine Strain Composition
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April 6 2022 Vrbpac Meeting Discussion Summary
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A summary of the discussion from the April 6, 2022 VRBPAC meeting:
1. What considerations should inform strain composition decisions to ensure that available COVID-19 vaccines continue to meet public health needs, e.g.:
- Role of VRBPAC and FDA in coordinating strain composition decisions
- Timelines needed to implement strain composition updates
- Harmonization of strain composition across available vaccines
2. How often should the adequacy of strain composition for available vaccines be assessed?
3. What conditions would indicate a need for updated COVID-19 vaccine strain composition, and what data would be needed to support a decision on a strain composition update?
4. What considerations should guide the timing and populations for use of additional COVID-19 vaccine booster doses?
There was general agreement among committee members that given the complexities of changing COVID-19 vaccine strain composition, decisions on this should be undertaken as a coordinated process led by FDA, with input from VRBPAC, and also considering any recommendations that WHO might provide.
Several committee members opined that strain change decisions should be data-driven and based on compelling evidence that current vaccine strain composition is not adequately effective against severe disease caused by circulating variants but also compelling evidence that a specific modified vaccine composition will improve upon vaccine effectiveness.
While a modified vaccine would ideally be assessed in efficacy studies, or based on an immune correlate of protection, given the current imperfect understanding of COVID vaccine immunology and time constraints involved, evaluation of modified vaccines will need to rely mainly on neutralizing antibody data.
Committee members expressed that ideally, a single recommendation for strain composition apply to all available vaccines, and ideally vaccines based on a modified strain composition could be used as both primary series and booster doses.
The committee found it challenging to make more specific recommendations without a concrete proposal and data from studies; FDA acknowledges this challenge and conveyed the intent to further discuss data from studies of modified vaccines and a more concrete proposal for strain composition recommendation at an upcoming VRBPAC meeting once such data are available.
Committee members expressed that recommendations on the use of additional doses as part of a fall vaccination campaign should be aligned with the goals of public health vaccination programs, which at this time and considering characteristics of currently available vaccines is prevention of severe disease, hospitalization, and death.
Committee members agreed that frequent use of booster doses is neither practical or sustainable, especially considering the incremental benefit against severe disease and transient benefit against infection and more mild disease suggested by available data for second booster doses of mRNA vaccines.
Some committee members opined that annual vaccination campaigns similar to the seasonal influenza vaccine model might be considered, but other committee
members felt that additional time and experience with COVID vaccines was needed to determine whether this would be a practical, sustainable, or necessary approach.
There was consensus among committee members that continued monitoring of vaccine effectiveness will be critical for making decisions about the need for additional doses.
HURRY – THE DEADLINE IS SOON!!
GIVE THE FDA YOUR OPINION ASAP:
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.
CLICK HERE TO CALL EVERY MEMBER OF THE HOUSE OF REPRESENTATIVES.
STOP THE FDA BEFORE IT IS TOO LATE
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:
email@example.com, firstname.lastname@example.org, email@example.com, 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, firstname.lastname@example.org, email@example.com, firstname.lastname@example.org, email@example.com, firstname.lastname@example.org, email@example.com, firstname.lastname@example.org, email@example.com, firstname.lastname@example.org, email@example.com, firstname.lastname@example.org, email@example.com, Jportnoy@cmh.edu, firstname.lastname@example.org, email@example.com, firstname.lastname@example.org, email@example.com, firstname.lastname@example.org, RandyHawkins@cdrewu.edu, email@example.com, JYLee@uams.edu, firstname.lastname@example.org, email@example.com, firstname.lastname@example.org, email@example.com, firstname.lastname@example.org, email@example.com, firstname.lastname@example.org
WATCH THE MEETING ON TUESDAY JUNE 28, 2022:
The Docket Number is FDA-2022-N-0905
SUBMIT A PUBLIC COMMENT:
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 email@example.com 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.
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