More on the Later Expectations FDA laid out for COVID vaccine EUAs on December 10, 2020.

I have some more of FDA's power points for you.  

https://www.fda.gov/media/144329/download

Three days ago, I laid out FDA's criteria for issuing an EUA here, and showed that (at a minimum for the pediatric age groups), the Pfizer vaccine failed to meet at least 5 of those criteria.  How could the vaccine have gotten EUAs?  Good question.

But FDA's pre-authorization requirements weren't all that FDA's Doran Fink, MD, PhD was there to talk about.  He also presented information on the expectations FDA had after issuing an EUA, given that not a lot of data were required initially.

Below is what FDA said would be needed for its ongoing assessment.  This makes sense.  Did FDA take the required information into consideration?  What information has it relied on??  Or has it, perhaps, relied on fake information, such as that generated by the Centers for Propaganda in Atlanta?  Can we demand to see what FDA has relied on for its continuing assessments regarding the benefits of COVID vaccines?

* There needs to be ongoing evaluation of the risk vs. benefit for the vaccine.  

* There must be continued safety followup using real world data.  

* You can't guess at the degree of effectiveness:  more precise and robust assessments of vaccine effectiveness will be required.  

* You will need to see how long protection lasts.  

* You have to keep looking for ADE aka VED. What else?

* Both active and passive monitoring for adverse effects for continue.  

* The double-blinded, placebo controlled studies should be continued for as long as is feasible.  

* FDA says  just because we gave you an EUA, that does not mean you have to unblind the subjects or offer vaccine to those who received placebo.  OTOH, trial participants may choose to leave a trial for every reason.

I think FDA was being disingenuous with this last statement, both to its advisors and to the public.  Because practically as soon as the vaccine was authorized, FDA gave Pfizer the go-ahead to unblind the trial and vaccinate everybody, despite its advisers recommending against doing so.

* EUAs can be revoked, if the circumstances justifying them no longer exist, or if the issuing criteria are no longer met.  

* If there are issues with safety or efficacy, manufacturing quality or the way the disease spreads in the population has changed, the EUA can be revoked.

We know very well that the issuing criteria have no longer been met:  the efficacy is awful after the first few months, safety is a disaster, and manufacturing quality, with various extraneous and uncharacterized particles and nanoparticles in the vaccines should all have resulted in the revocation of the EUAs. 

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Children's Health Defense has asked for a revocation in court; our case is pending.  It was specifically filed because the EUA should not be extant after a license is issued:

FEDERAL

Against FDA to Revoke COVID Vaccine EUAs & Refrain from Licensure

Children’s Health Defense v. FDA

Status: Motion to stay filed; Anticipating a hearing date
Lead Attorney: Ray Flores
CHD Attorney: Mary Holland

Summary

On August 31, 2021, CHD filed suit in Federal Court in the Eastern District of Tennessee against the FDA and Acting Commissioner, Janet Woodruff seeking vacatur of the August 23, 2021 Licensure of Pfizer’s currently unavailable Comirnaty vaccine.

This suit is the natural follow up to the Citizen Petition submitted by Dr. Meryl Nass and Robert F. Kennedy, Jr., on May 16, 2021 which received over 30,000 public comments (thank you!). The FDA’s August 23, 2021 denial cleared the way for attorneys Robert F. Barnes and Derek Jordan of Barnes Law along with RFK, Jr., to file suit on CHD’s behalf. The Complaint alleges one sole count, “Failure to Abide by Federal Law as Abuse of Discretion — APA 5 USC 706(2)(A)”

“Defendants’ arbitrary and capricious authorization of the Comirnaty vaccine gives the misleading impression to the public that the currently available Pfizer vaccine is fully approved, when in fact it is not. What is available, according to the FDA’s own admission is actually the EUA, liability-free product.