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Vaccine Shedding: "A Full Report on shedding must be included" in every application to introduce a new biologic product into interstate commerce...which 'emergency use' Covid vaxes have avoided.

submitted by mememeyou to science 3.0 yearsApr 30, 2021 22:53:13 ago (+20/-0)     (files.catbox.moe)

https://files.catbox.moe/g6q9ng.JPG

https://www.youtube.com/watch?v=joD5fG4kS3o
"Vaccine ‘shedding’ concerns not scientifically plausible"

https://en.wikipedia.org/wiki/Biologics_license_application
A biologics license application (BLA) is defined by the U.S. Food and Drug Administration (FDA) as follows:

The biologics license application is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce (21 CFR 601.2). The BLA is regulated under 21 CFR 600 – 680. A BLA is submitted by any legal person or entity who is engaged in manufacture or an applicant for a license who takes responsibility for compliance with product and establishment standards. Form 356h specifies the requirements for a BLA. This includes:

Applicant information
Product/manufacturing information
Pre-clinical studies
Clinical studies
Labeling[1]
Some biological products are regulated by the Center for Drug Evaluation and Research (CDER) while others are regulated by Center for Biologics Evaluation and Research (CBER).[2]

A BLA is submitted after an investigational new drug has been approved. If the Form 356h is missing information, the FDA will reply within 74 days.[3] A BLA asserts that the product is "safe, pure, and potent", the manufacturing facilities are inspectable, and each package of the product bears the license number.

After approval, annual reports, reports on adverse events, manufacturing changes, and labeling changes must be submitted.

https://www.contagionlive.com/view/pfizer-biontech-covid-19-vaccine-91-percent-effective-6-months


2 comments block

YamaMaya 2 points 3.0 years ago

Anything using a live virus can shed. Regardless if its "attenuated" it can mutate and continue to replicate. Theres rumors of unvaxed women getting the same period symptoms out of nowhere after exposed to a vaxed person would make sense if they were using something live whoch could shed.