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SARS-Co-V2 / COVID treatment options are under an Emergency Use Authorization (EUA) Phase 3 Studies i some cases are still underway. Yet these products have been unleashed to mass population of the world before a BLA for any of them has been approved by the FDA.
Vaccine manufacturer Biologics Licensing Application (BLA) paperwork/studies to be fully FDA approved is still abt 1.5 years out. We are NOT following same processes of the past this go round for COVID. Let me explain below.
If all previous efficacy historical scientific timeline measures were adhered to accordingly in this case ( as in the past), for a vaccine to become fully approved, the process would be 5-10 years in the making! Yes you heard that right!
We have 3 said treatment products for the SARS-Co-V2 / COVID virus circulating despite not having full FDA approval. All of them have had less than 1 year in and out of clinical trials with their specific ingredients and being placed into human being arms. You will see that below.
Part of the BLA application process requires that "sufficient" data to be submitted to ensure the quality and consistency of the vaccine product. And even then, any EUA product could be pulled off the market and/or be revoked for various reasons. My question is as it always has been - what is deemed "sufficient" for them to be ok right now.
When you are talking about Billions of people around the world and potentially making these products mandatory before they complete all their trial studies. Just like Mr. Monkey at right...I am pondering the complete evidence at this passing and numbers of population controlled studies that would validate the unknown risk to myself and my family if I say yes.....
With the SARS-Co-V2 treatments for COVID-19, this is the first time clinical trials have only extended 4-6 MONTHS in human study before giving the thumbs up to distribute to the worlds population. Don't you feel the need to question that speed? I know I do.
Its important to note: The mRNA shots in particular of the 3 on the EUA market are the very first mRNA vaccines to be rolled out to the general public.
Here's a footnote I found on studies with animals whom were subjected in trial phase to a Coronavirus in the past that did not fair well. All the ferrets in the end died.
These vaccines are experimental compounds that use “synthetic messenger RNA (mRNA)” housed in fat cells. In 2005 an animal study was done with SARS-CoV-1 mRNA vaccines on ferrets. Two doses were administered in the same manner as the SARS-CoV-2, aka, COVID-19 mRNA Vaccines.
The ferrets showed no adverse reaction and seemed to be completely healthy. After some time, the ferrets were exposed to the SARS-CoV-1 coronavirus in the wild. The ferrets died.
The mRNA Vaccine had caused a cytokine storm, a fatal cascade of exaggerated immune responses. The SARS-CoV-1 vaccines was not further developed."
In fact - in both Pfizer and Moderna - their most recent SARS-CoV-2 products available for your use - the animal experimental studies did not have a lengthy years process prior to human study.
“They overlapped preclinical studies with the early phases of the trials,” said Dr. William Moss, executive director for the International Vaccine Access Center at Johns Hopkins University.
This is all why YOUR informed consent throughout the process to be a recipient of an SARS-Co-V-2 EUA product or not is YOUR right to accept or refuse. Read 21 U.S. Code § 360bbb–3 & for EUA products. You need to know what that means. Read also about informed consent law HERE.
Your "choice" is paramount. No one even to the top of the chain in our country (as in below) should place continued, (perhaps unhealthy long-range restrictions), on any human being. In this case - the controversial mask mandate. Especially saying these things with, what appears to be, intimidation tactics ("or else" in other words...). Especially regarding drugs that are still in investigational study to become a fully licensed medical product!
Everyone who receives these SARS-Co-V2 / COVID treatment options (to include your children if you so desire) are part of final on-going clinical phase trial studies.
You will be able to go to the Clinical Trials pages below to verify that information .
As a whole, these vaccines are in development less than a year from beginning to at present at this time. This is in lieu of years in the making historically for vaccines. See that article here for 5-10 years process - It is enlightening: (https://coronavirus.jhu.edu/vaccines/timeline)
I attached all SARS-CoV2 vaccine links/product names through the Clinical Trials Government website below. This way you can go to these sites to see the applications for each of the SARS-Co-V2 products out for distribution and into your arms!
Please review this information prior to making your informed consent decision to be a recipient. That is is your human right.
See below please for yourself! And remember the "choice" in this is YOURS. Stand strong on your convictions but please be informed! Thank you.
Queen V / Teri V
signing out ---------------
ModernaTX, Inc./ Biomedical Advanced Research and Development Authority / (NIAID) Drug name: mRNA-1273 Completion of Study: October 27, 2022 https://clinicaltrials.gov/ct2/show/study/NCT04470427
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J & J / Janssen Vaccines & Prevention B.V. - Drug Name: Ad26.COV2.S / JNJ-78436735 Completion: Jan. 2 2023 https://www.clinicaltrials.gov/ct2/show/NCT04505722...
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Pfizer/BioNTECH SE - Drug name: BNT162b1 / BNT162b2 / BNT162b2SA Completion of Study: April 6, 2023 https://clinicaltrials.gov/ct2/show/study/NCT04368728
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