Anonymous ID: 3ca085 Aug. 29, 2021, 5:04 p.m. No.14488501   🗄️.is 🔗kun

Sorry in advance for long post.

 

Anons, I consider myself to have good judgement and common sense which makes up for my inability to navigate cleverly worded documents such as the exchange between FDA and Pfizer. Simply trusting my gut and what I see as not only a major failure of those elected to execute the will of we the people but an active attempt to overthrow our free will, is not exactly a defense id like to present to my employer in hopes of keeping my hard earned job. I will not submit to vax mandate and will force my employers hand! I will not rest easy if I have failed to exhaust every avenue I can in the event my employer is not bluffing.

 

I am trying to work the angle of the EUA and the claims of some that the approval is a complete fraud. I firmly believe the FDA approval has been taken completely out of context but I cannot find a smoking gun per se’ to use in my defense.

 

In my readings it clearly states (from 8-23-21) the Pfizer BLA (Biologics License Application) has been approved but in the same breadth the FDA also sts it has extended the EUA from a letter posted 8-12-21. The EUA has been amended to include the use of COMIRNATY in ages 12-15 for a two dose series and to provide a third dose for age 12 and older in cases where it is determined the patient is immunocompromised; whereas they go into detail giving an example of a solid organ transplant patient. It sts, Comirnaty is an FDA-approved Covid-19 vaccine made by Pfizer for biontech that is approved as two dose series for prevention of Covid-19 in individuals age 16 and older. That leads one to believe it has full FDA approval. However towards the end of the fact sheet it sts;

 

“This EUA for the Pfizer-BioNTech COVID-19 Vaccine and COMIRNATY will end when the Secretary of HHS determines that the circumstances justifying the EUA no longer exist or when there is a change in the approval status of the product such that an EUA is no longer needed.”

 

Which can be found here:

http://labeling.pfizer.com/ShowLabeling.aspx?id=14471&format=pdf

 

I believe they have executed a play on words which is being pushed by the DS media platforms to create an echo chamber to inject a blatant lie which emboldens employers, county/state elected officials, school district leaders etc. to implement vax mandates.

 

I have two theories I will present in hopes of extreme criticism to keep me on the right path:

 

1st - FDA approved a rebranding of the Pfizer Covid vax, new labeling, package inserts etc but still falls under EUA. The presumption of full approval will embolden those in power to initiate mandatory vax policies.

 

2nd - The approval was back-doored with the BPCI Act of 2009 where it amends the PHS act and other statutes to create an abbreviated licensure pathway in which case the approval is legit but may not be in full effect currently.

PHS act and BPCI act information in following links:

 

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/reference-product-exclusivity-biological-products-filed-under-section-351a-phs-act

 

Quote from above link: “The BPCI Act amends the PHS Act and other statutes to create an abbreviated licensure pathway for biological products shown to be biosimilar to, or interchangeable with, an FDA-licensed biological reference product.”

 

https://www.fda.gov/drugs/guidance-compliance-regulatory-information/deemed-be-license-provision-bpci-act

 

Quote from above link: On March 23, 2020, the BPCI Act requires that an approved marketing application for a “biological product” under section 505 of the FD&C Act shall be deemed to be a license for the biological product (i.e., an approved BLA) under section 351 of the PHS Act.

 

I tried to find Pfizers BLA application in hopes to discover exactly what was applied for, any ideas on how to obtain that?

 

Any word experts that can decipher this for all would be well appreciated.

 

God bless and God speed anons