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. 

———————- 

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.





Similar Posts

Denmark suspends national Covid-19 vaccination programme till fall, and then what? / The Local

A Danish health worker prepares a Covid-19 vaccination in Aalborg in January 2021. The country suspended its general Covid vaccination programme on April 26th 2022. Photo: Henning Bagger/Ritzau Scanpix Noting that the epidemic was under control and that vaccination levels were high, the Danish Health Authority said the country was in a “good position.” “Therefore…

FDA plans (dated June 26, 2009) for safety evaluation of Swine Flu Vaccines

Here is an FDA briefing document for the Vaccines and Related Biological Products Advisory Committee meeting of July 23, 2009. It lays out the plan that has been followed since then. The plan involved very limited safety data collection before starting vaccinations, and a detailed plan for obtaining data on adverse reactions after vaccinations have…

Gardasil trial stopped in India after 4 girls aged 10-14 die/ dnaIndia

According to DNAIndia, … The programme was marred by controversy after four deaths and complications among 120 girls were reported after vaccination. The girls complained of stomach disorders, epilepsy, headaches and early menarche… More from The Hindu: Dr. Katoch said a memorandum was signed with PATH-International in February 2007 for a project allotted to it…

Now you know Boris Johnson is certifiably insane AND you can see where the elites are trying to take “nature”/ Daily Mail

https://www.dailymail.co.uk/news/article-10128185/Boris-Johnson-jokes-horrified-children-feeding-humans-animals-climate-change-event.html  Boris Johnson jokes about ‘feeding humans to animals’ to ‘redress the sad imbalance’ on the planet to baffled children as he hosts bizarre ‘Kids Lobby’ briefing in Downing Street The PM was taking questions with WWF UK’s Tanya Steele in No9 Downing Street when they faced a question about the balance of nature on Earth…

Hospitalization rates for Covid dropped steadily in USA over past month, Deaths have been flat

Deaths and hospitalization rates are the two measures available to the US public to best assess Covid extent and severity. Hospitalization rates are definitely down; see CDC’s graph below.  Mortality rates have held steady at 1000/day for the whole of the past month. I have no data on how treatment patterns have changed over time…

Legal immunity set for swine flu vaccine makers: What are the implications?

AP Medical Writer Mike Stobbe got a swine flu vaccine scoop–yet the news is four weeks old. It turns out that DHHS Secretary Sibelius has not only given immunity to the makers of Tamiflu and Relenza for injuries stemming from their use against swine flu. She also granted immunity to future swine flu vaccines and…

2 Comments

  1. It seems like the most effective lawsuit so far has been the one to force the FDA to turn over their clinical trial data for the Pfizer shot.

    Would it be better to do more like that one, such as with Moderna? I haven't seen good outcomes with lawsuits aimed at getting the FDA to follow the law or do its job.

  2. COVID-19 Vaccine Massacre:
    68,000% Increase in Strokes,
    44,000% Increase in Heart Disease,
    6,800% Increase in Deaths Over Non-COVID Vaccines

    The corporate media is now controlled by the interests of Big Pharma which has spent over $1 BILLION in promoting COVID-19 vaccines. See:

    Local, National Media Paid $MILLIONS To Push COVID-19 Vaccines

    Even last night’s Oscar’s show was sponsored by Pfizer and BioNTech.

    So when this corporate media now switches their focus to trying to convince the American public that Russia and Putin are a threat to our national security, that’s an indication to look around and see what they are trying to cover up and hide.

    And one does not have to look very far to see the damaging effects of their COVID-19 vaccines. The government’s own database of Vaccine Adverse Events Reporting System (VAERS) through March 18, 2022 shows that there are unprecedented increases in recorded deaths and injuries following COVID-19 vaccines for the past 15 months since they were issued emergency use authorizations (EUAs), as compared to recorded deaths and injuries reported following all FDA-approved vaccines for the previous 30 years.

    These government statistics show there is no greater danger to the lives of Americans today than our own government which is sitting on data that show the following increases of reports in VAERS following COVID-19 vaccines:

    68,000% increase in strokes
    44,000% increase in heart disease
    6,800% increase in deaths
    5,700% increase in permanent disabilities
    5,000% increase in life threatening injuries
    4,400% increase in hospitalizations
    This is mass murder and genocide.

    If the corporate media switched from covering the war in Ukraine and published this data directly from the government’s own database, there would be riots all across the U.S. right now, if not a Civil War.

    But the largely brain-dead American consumer is content to watch their corporate news and blame all the world’s problems on Russia right now instead, as we face huge labor shortages and supply chain bottlenecks due to all these deaths and injuries from the COVID-19 vaccines that will now be blamed on Russia.

    A false flag attack on American soil that will be blamed on Russia seems imminent now.

    Here is a summary of the raw data in VAERS for the past 15 months following COVID-19 vaccines. (Source.)

    https://davidicke.com/2022/04/01/covid-19-vaccine-massacre-68000-increase-in-strokes-44000-increase-in-heart-disease-6800-increase-in-deaths-over-non-covid-vaccines/

    Vaccinereaction.com

Comments are closed.