Monday, November 16, 2020

vaccine - day seven


so we have a new vaccine in the market place and now they are talking about a vaccine available by December. When I say they, from the mouth of Dr Anthony Fauci, no less. Discussion of emergency measures to implement the vaccine.

so please, can we have another or further discussion? Using the gold standard, like the rules of evidence in law. Any mention of this seems to have floated off into the ether. Peer review and documentation. Actual publishing of findings including side effects. Then even after that once one or a number of vaccines have been implemented, what protections are available should anything go wrong?

look, we have had so much lazy news during the election. Why confront us with more?

so there are a few organizations I would like some detail from in regards to the vaccine approval process

the World Health Organization

the Center for Disease Control

the Food and Drug Administration and their Center for Biologics Evaluation and Research 

including such details as the multi-step approval process, which typically includes

the Investigational New Drug application

Pre-licensure vaccine clinical trials

A Biologics License Application (BLA)

Inspection of the manufacturing facility

Presentation of findings to FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC)

Usability testing of product labeling

if you go to the CDC website, these are just a few steps in regard to the vaccine approval process. A little more detailed than Dr Fauci on the television stating,

"Well, everything should be fine by December." 



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