Event 2021 – Part 5 (Clinical Trials, C19 EUA, & Swine Flu scam)

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1.) Phases of Clinical Trials
2.) Emergency Use Authorization for Vaccines to Prevent COVID-19 (FDA)
3.) If we don’t learn from history, we are destined to repeat it
4.) Swine Flu Extras

Part 5

Phases of Clinical Trials

Phases of Clinical Trials

Phase one: Is it Safe?
Phase two: Is it Effective?
Phase three: Is it Better?
(Typically 10 years)

  • Phase I – Determine Safety.
  • Phase II (aka Exploratory Trials) – If a Safe Dose is Found – Does the Drug Work?

  • Phase III – How does the drug compare with that already used for the problem? (This phase of research occurs when there is compelling evidence of efficacy & safety).

    Demonstrate the drug is Effective & Safe in a larger number of patients in the target group (the people the drug is intended to treat). Monitor side effects & risks. Test different doses and different ways of giving the drug. Can the drug be used at different stages of the disease being treated – early, late .…Provide sufficient information about the drug for marketing approval -> FDA.

  • Phase IV – Post Marketing Surveillance Studies (The long-term effect of the drug or treatment & other impact or use of the drug.)

Emergency Use Authorization for Vaccines to Prevent COVID-19 (FDA)

Emergency Use Authorization for Vaccines to Prevent COVID-19 (FDA)

The Emergency Use Authorization document. Issued in Oct 2020. Non-binding recommendation. Doesn’t place the FDA or the public under any obligation.

These are the Emergency Use Authorization requirements:

Based on this declaration and determination, FDA may issue an EUA after FDA has determined that the following statutory requirements are met (section 564 of the FD&C Act (21 U.S.C. 360bbb-3)) (Ref. 3): (01)

  1. The chemical, biological, radiological, or nuclear (CBRN) agent referred to in the March 27, 2020 EUA declaration by the Secretary of HHS (SARS-CoV-2) can cause a serious or life-threatening disease or condition.
  2. Based on the totality of scientific evidence available, including data from adequate and well-controlled trials, if available, it is reasonable to believe that the product may be effective to prevent, diagnose, or treat such serious or life-threatening disease or condition that can be caused by SARS-CoV-2.
  3. The known and potential benefits of the product, when used to diagnose, prevent, or treat the identified serious or life-threatening disease or condition, outweigh the known and potential risks of the product.
  4. There is no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating the disease or condition.

These are critical. If any of these 4 get knocked-out, EUA (Emergency Use Authorization) dies.

The problem is, there ARE adequate treatments.

By “definition”, the EUA doesn’t exist.
The PCR-Tests – Gone.
The Emergency-Vaccines – Gone.

If we don't learn from history, we are destined to repeat it (Swine Flu)

If we don’t learn from history, we are destined to repeat it.

Plays an old (1979) segment from CBS ’60 Minutes’ on the swine flu (also known as H1N1) & the vaccine that was developed to stop the pandemic.

Swine Flu Extra's

Not in presentation, but also found these nuggets:

And already had a post Déjà Vu… Swine Flu which contains the Swine Flu panic from 10 years ago:

And this is recent short <3 min video from Mr. Hall – Senate Committee:

December 2020 – April 2021: 3,362 deaths from COVID Vaccines (30 people a day dying). Estimated as being less than 1% of what actually happens. There has been more COVID-19 vaccine deaths than all the vaccine deaths for the 15 year period between 1997 and 2013. Plus almost a thousand heart attacks and over 8000 hospitalizations.

In 1976, there were 45 million people vaccinated for the Swine Flu, 53 people died and the program was immediately halted because it was considered too risky.

A law passed in 1986, which created a compensation programme, which shields vaccine manufacturers & the medical personnel who administer the vaccines from liability.

“These vaccines have not been formally approved by the FDA, and that means noone can be required to take the vaccine.”

Penny (PennyButler.com)
Penny (PennyButler.com)

Truth-seeker, ever-questioning, ever-learning, ever-researching, ever delving further and deeper, ever trying to 'figure it out'. This site is a legacy of sorts, a place to collect thoughts, notes, book summaries, & random points of interests.