slightly condensed for short attention span
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.
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?