https://www.youtube.com/watch?v=joD5fG4kS3o"Vaccine ‘shedding’ concerns not scientifically plausible"
https://en.wikipedia.org/wiki/Biologics_license_applicationA 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
[ + ] mememeyou
[ - ] mememeyou [op] 1 point 3 yearsApr 30, 2021 23:24:58 ago (+1/-0)*
Official narrative: https://www.nebraskamed.com/COVID/the-covid-19-vaccines-irregular-periods-and-spike-protein-shedding
"Shedding can’t happen without a live vaccine. The mRNA vaccines – Pfizer and Moderna – are not live vaccines and do not replicate. The Johnson & Johnson and AstraZeneca vaccines are considered live vaccines because they both contain adenovirus. (Again, they do NOT contain the coronavirus.) But the adenovirus in both the Johnson & Johnson and AstraZeneca vaccines can’t replicate, so there’s no way they can shed."
"Why Does Pfizer's COVID-19 Vaccine Need To Be Kept Colder Than Antarctica?"
https://www.npr.org/sections/health-shots/2020/11/17/935563377/why-does-pfizers-covid-19-vaccine-need-to-be-kept-colder-than-antarctica
[LIVING CREATURES WITH SELF-MOVING 'THINGS' IN THE PFIZER VACCINE
](https://www.bitchute.com/video/AigyLkKud77X/)
[ + ] YamaMaya
[ - ] YamaMaya 2 points 3 yearsMay 1, 2021 03:09:53 ago (+2/-0)*