Covax a WIN in President’s Eyes

Citizen Petition and a Petition for a Stay of Action

B5EB5444-CA7D-4AFD-A9B2-9AB26C6E26D7On November 6, 2020, ICAN filed a Citizen Petition and a Petition for a Stay of Action demanding that the FDA require valid endpoints for determining efficacy in the COVID-19 vaccine trials currently being run by Pfizer, Moderna, AstraZeneca, and Johnson & Johnson.  ICAN’s demands include that the vaccine be shown to prevent serious cases of COVID-19 (not just mild cases) and that it can stop transmission of COVID-19.

As explained in our previous legal updates, ICAN’s legal team has been hammering away at the safety requirements for the clinical trials of COVID-19 vaccines, including demanding they be placebo-controlled, long-term, and have other safeguards.  Many of those demands were subsequently met and we are not done fighting on that front.  But there is now another battle we are fighting. 

ICAN’s legal team, led by Aaron Siri, has now also focused its efforts on the basis the FDA will rely upon to determine whether any of the COVID-19 vaccine frontrunners are effective.  Many Americans have been led to believe that the vaccines currently in trials are the answer to all pandemic-related problems.  Many believe this is because a vaccine, when available, will prevent individuals from having a serious case of COVID-19 and will stop people from spreading it to others.  However, the clinical trials for Pfizer, Moderna, AstraZeneca, and Johnson & Johnson’s products are not designed to determine either of these! 

Instead, each of the four trials’ primary goals for determining whether the vaccine is effective merely requires determination of whether it can reduce symptoms of mild cases of COVID-19.   The trials will also not demonstrate whether or not a vaccine recipient can still transmit COVID-19 to others.  This means that, under the current rules, a COVID-19 vaccine can be licensed without demonstrating it can prevent severe COVID-19, hospitalization, or deaths, nor stop the spread of COVID-19.

Also concerning is that “cases” of COVID-19 for trial purposes are being demonstrated by positive PCR tests.  The scientific literature has shown that such PCR tests can be highly unreliable, frequently giving false positives.  Consistent with this literature, we demanded that only positive PCR results meeting certain criteria be relied upon.  ICAN also demanded that all participants be tested before and after vaccination for T-cell immunity to SARS-CoV-2, which is not currently part of the protocols.  If a person has pre-existing immunity to SARS-CoV-2 (either from being exposed to COVID-19 or otherwise) their presence in the study could affect the result by showing fewer people getting sick than would actually occur in the “wild.”

These alarming deficiencies in the studies were what led ICAN to direct its attorneys to file a petition demanding that all four Phase III COVID-19 vaccine trials amend their efficacy endpoints.  ICAN demanded, among other things, that the trials test and determine (1) whether these vaccines will prevent severe cases of COVID-19; and (2) whether they will stop the spread of the virus.  ICAN further demanded improvements in the PCR testing protocol and T-cell testing pre-and-post vaccination.

Recognizing the critical importance that these changes be made in a timely manner, on November 11, 2020, ICAN’s attorneys filed a Petition for a Stay of Action with the FDA which asks that the agency stay, or pause, any action related to the trials until the requested actions in the efficacy petition are implemented.

ICAN’s attorneys separately sent a letter to Dr. Peter Marks, the Director of the Center for Biologics Evaluation and Research at the FDA, bringing these very concerns to his attention.  You can read that letter hereDr. Marks has referred to himself as “the FDA point person on COVID-19 vaccines” and has assured Americans that the FDA “will make sure they’re safe and effective.”  ICAN will closely review any response from Dr. Marks given his promise that he and the FDA “uphold globally respected standards for product quality, safety, and efficacy” and his statement that he would resign if “something that was unsafe or ineffective [] was being put through.”

There are numerous other legal and non-legal efforts ICAN is engaged in with regard to COVID-19 vaccines that are not yet ready to be discussed here but will be featured in future updates. 

If you would like to provide the FDA a comment regarding the efficacy petition we have filed regarding COVID-19 vaccines, you can do so here.


Gary Ogden

Good information here on worrisome components of the Moderna/NIH vaccine, such as PEG (polyethylene glycol). As a woodworker I have used PEG as a moisture-inhibiting stabilizer in applications where minimizing expansion and contraction of the wood was essential. It is a waxy substance I certainly don't want injected into anyone.

Loraine fishel

Thank you for doing this important work trying to save all of us.

False Scientists

@bob Moffit, I hope it comes crashing down, but it will be too late for many. My elderly parents were scared into getting flu vaccination this year and will accept a Covid vaccine.


Bob, I think Professor Sucharit Bhakdi would agree with you.

Angus Files

They can track every person with COVID but cant tell us a truthfull number of autism cases below another example of how easy it is to track and trace what suitss them.

"Tasks" tracking software ,tracking between FB ,Twitter and Google Zukerberg under oath slippery as an eel..

BREAKING: Josh Hawley Uncovers SECRET Facebook Content Monitoring...

Pharma For Prison


Aaron Siri; God is with him, so who can be against him. Brilliant mind that comes off as just a humble man, a kind man, and a patient man. He sure lead Plotkin gently down the road to truth.

Pretty good, does it cause you from ending up in the hospital or dead, and will it stop the spread.

Bob Moffit

"Also concerning is that “cases” of COVID-19 for trial purposes are being demonstrated by positive PCR tests. The scientific literature has shown that such PCR tests can be highly unreliable, frequently giving false positives."

In my humble opinion . NOTHING about Covid pandemic can be trusted .. NOTHING .. such as the actual numbers of those who died from Covid .. as well as … the number of "positive cases" we are inundated daily with by mainstream media .. or … the efficiency of well known long used drugs like HCQ suddenly being declared UNSAFE .. on and on.

Through out it all … Fauci remains a revered "expert" that has never addressed the obvious questions as I just raised … indeed .. he has instead been the major spokesman we are supposed to TRUST …

I will not be surprised should the day arrive when all the COVID SCAREMONGERING comes crashing down .. just as it did after Y2K .. Zika .. WMD … a whole host of similar hoaxes throughout history.

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