The first big lie
This article: The story of mRNA: How a once-dismissed idea became a leading technology in the Covid vaccine race was published Nov. 10, 2020. The headline picture is of giant ultra-low temperature freezers, ready to store finished vials containing mRNA vaccines for injection.
The article begins:
ANDOVER, Mass. — The liquid that many hope could help end the Covid-19 pandemic is stored in a nondescript metal tank in a manufacturing complex owned by Pfizer.
Most working in the industry will know that Pfizer owns none of the physical assets required to develop, manufacture, transport and store the mRNA vaccines—it is all carried out by third-party organisations.
The next big lie
As it turned out, the ‘finished vials’ were not finished—they contained 5 patient doses, frozen down to -70°C, requiring the addition of a measured quantity of saline diluent (supplied separately) to each vial, with a subsequent mixing operation to be carried out.
Adding to the complexity, the vials containing the 5 doses were packed in trays, each tray housing 195 vials. They had to be thawed from -70°C to room temperature, in a refrigerator (+2 to +8°C). This is a tricky business, as molecular structure could alter during thawing. Studies have to be run to prove the thawing can take place safely.
The full details can be found towards the bottom of this document on the MHRA website: Conditions of Authorisation for COVID-19 Vaccine Pfizer/BioNTech (Regulation 174), updated 5 May 2022.
Pharmaceutical law requires a licensed facility to carry out the conversion
Under pharmaceutical law (in any country) the conversion of the -70°C vials must be carried out in a facility licensed to manufacture pharmaceutical products. To achieve a license, the facility owner needs to prove every operation is carried out to Current Good Manufacturing Practice (CGMP). The definition of manufacturing below should help with understanding the scope of what comes under that umbrella:
Pharmaceutical manufacturer means any entity which is engaged in the production, preparation, propagation, compounding, conversion, or processing of prescription drugs, whether directly or indirectly by extraction from substances of natural origin, independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis, or any entity engaged in the packaging, repackaging, labeling, relabeling, or distribution of prescription drugs.
Is that clear enough for you?!
The hurriedly constructed vaccination centres had no such licenses and given none of the people working in them had any kind of skills or experience in manufacture, they would not be capable of getting one.
These licenses are not ‘nice to haves’, they are essential to ensure the proper checks and balances are in place to avoid potentially dangerous errors.
This lie led to gross non-compliances with pharmaceutical law, under the responsibility of FDA/EMA/MHRA etc.
Normally, this would call for a halt to all activities carried out in the vaccination centres, period. Why is it not happening?
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