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发帖数: 73 | 1 Pfizer vaccine is formally coded as "state of the art US weapon system"
Check the definition of the redaction codes used
https://www.archives.gov/declassification/iscap/redaction-codes.html
https://www.acus.gov/recommendation/exemption-b4-freedom-information-act
3.3 (b) (4) Reveal information that would impair the application of state-of
-the-art technology within a U.S. weapon system
https://www.fda.gov/media/151733/download
On page 6 of 30, redaction code (b) (4) refers to a weapon technology
3. Chemistry, Manufacturing and Controls (CMC)
a. Product Quality
COMIRNATY Manufacturing Overview
COMIRNATY contains a nucleoside-modified messenger RNA (mRNA) encoding the
viral spike glycoprotein (S) of SARS-CoV-2 that is formulated in lipids
including ((4-
hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2- hexyldecanoate), 2-(
polyethylene
glycol 2000)-N,N-ditetradecylacetamide, 1,2-distearoyl-sn-glycero-3-
phosphocholine,
and cholesterol. COMIRNATY is supplied as a frozen suspension to be diluted
with a
diluent, 0.9% Sodium Chloride Injection, USP, that is supplied separately or
can be
acquired elsewhere, if necessary. Manufacture of the mRNA drug substance
will take
place in Andover, MA, USA. The final formulated drug product will be
manufactured,
filled, finished, labeled and packaged in Puurs, Belgium or in Kalamazoo, MI
, USA. The
0.9% Sodium Chloride Injection, USP diluent will be manufactured by
Fresenius-Kabi
USA, LLC (b) (4) ) and Hospira, Inc. (b) (4)
The mRNA in COMIRNATY is a single-stranded, 5’-capped mRNA encoding the
full-
length SARS-CoV-2 spike glycoprotein derived from the Wuhan-Hu-1 isolate (
GenBank
MN908947.3 and GenBank QHD43416.1). The antigen-coding RNA sequence is codon-
optimized and contains two proline mutations ( (b) (4)), which ensures an
antigenically optimal trimerized pre-fusion confirmation (S-2P). The RNA
also contains
common structural elements, including 5’-cap, 5’-UTR, 3’-UTR, and poly(A)
tail, all of
which are designed for mediating high RNA stability and translation
efficiency. During
RNA transcription, (b) (4) is replaced with the (b) (4) . This nucleoside
substitution has been
demonstrated to enhance translation of in vitro transcribed mRNA while
reducing its reactogenicity. |
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