Panel VRBPAC (FDA) 28.06.22 ma zwolnić nowe wersje szczepionek na COVID z wymogu przechodzenia badań klinicznych przed dopuszczeniem do obrotu
Tegoroczna szczepionka na grypę miała 0% skuteczności. Nowe ich wersje tworzy się, zgadując prawdopodobne mutacje wirusa na kolejny sezon i wprowadza bez testów. Tak ma być ze szczepionkami na COVID.
Musimy działać i protestować przeciw planowanym zmianom legislacyjnym. Co zrobić instruuje “The Defender”. Wybór tych samych mutacji wirusa do szczepionek dla całego świata nie ma sensu. Tym sposobem nowe regulacje ukryją fakt, że pierwotne (obecne) szczepionki na COVID powodują więcej strat, niż korzyści.
Tabela poniżej pokazuje różnorodność kolejnych klas mutacji Sars-Cov-2
https://childrenshealthdefense.org/defender/fda-pfizer-moderna-skip-trials-covid-vaccines/?utm_source=salsa&eType=EmailBlastContent&eId=790cca51-9e9d-40ec-afe9-602c981e0790
Fragment artykułu
“On June 28 the VRBPAC will meet once again to discuss the “Future Framework” and it will be presented as a done deal because manufacturers want a decision on vaccine strain selection by June to deliver shots for autumn vaccination appointments.
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The FDA’s VRBPAC will meet on June 28 to vote on a “Future Framework” for evaluating so-called “next-generation” COVID-19 shots. The “Future Framework” is a plan to rig the COVID-19 vaccine regulatory process in perpetuity.
The “Future Framework” would take the “flu strain selection process” that fails every year and apply it to future (reformulated) COVID-19 shots. Federal bureaucrats, many of whom have financial conflicts of interests, would choose which SARS-CoV-2 variants to include in a yearly (or twice yearly) COVID-19 shot.
In the process, all future COVID-19 shots will be deemed automatically “safe and effective” without further clinical trials because they are considered “biologically similar” to existing COVID-19 shots.
The “Future Framework” is the most reckless idea in the history of public health. It shows that the FDA has completely abandoned science and its statutory duty to protect the public. If the Republic is to survive, we must stop the “Future Framework” before June 28.
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 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.
Who to contact:
President Joseph R. Biden
The White House
1600 Pennsylvania Ave NW
Washington, D.C. 20500
(202) 456-1111 (comment line is open 11 a.m.-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, D.C. 20500
(202) 456-1111 (11 a.m.-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.
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 am 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 Governor, State Senator and State House/Assembly Member.
We want to let them know that we are watching, understand what they are up to and that this wretched plan must be stopped.
Extra credit:
Here are the email addresses for all of the public health political appointees, FDA staff and VRBPAC members who have a say in connection with the “Future Framework”:
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
Let’s contact them as well (proposed subject line and email text below).
Subject line: The “Future Framework” is the WORST idea in the history of public health. Please vote “No.”
1. The FDA must revoke the authorizations for Moderna, Pfizer and J&J COVID-19 shots and withdraw them from the market immediately. SARS-CoV-2 was never a good candidate for a vaccine. These shots do not stop infection, transmission, hospitalization or death. They appear to have negative efficacy and are driving the evolution of variants that evade vaccines. The pandemic will never stop as long as the FDA and CDC are promoting shots that lack sterilizing immunity.
2. The FDA and CDC must pivot to therapeutics. This was always the answer. About twenty off-the-shelf treatments are more effective than vaccines (if used for prophylaxis or early intervention). Get these safe and effective medicines to people who need them and let doctors be doctors again and treat patients based on their own best clinical judgment.
3. 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 before 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; and
Proper monitoring for carcinogenesis, mutagenesis and impairment of fertility.
Originally published by Toby Rogers on his Substack page, uTobian.
The views and opinions expressed in this article are those of the authors and do not necessarily reflect the views of Children's Health Defense.”