Frozen SARS-CoV-2 injections broke decades-old pharmaceutical law

...and they are still getting away with it...

I wrote to the European Medicines Agency (EMA) at the time

On December 21 2020, I wrote the following to the European Medicines Agency (EMA):

Subject of your enquiry: GMDP in relation to COVID-19 vaccines that are delivered to vaccination centres bypassing the wholesaler networks

”Dear EMA,

I am an experienced consultant in biopharmaceutical supply- chains. I wish to enquire how the inspectorate with assure GMDP [Good Manufacturing and Distribution Practice] and appropriate quality systems will be maintained with regard to patient safety for the frozen and ultra cold vaccines being assessed for emergency approval? It appears to me that these vaccines are being despatched from manufactures part-finished ie not in the final dosage form for patient administration and there represents a potential risk if untrained personnel, working outside the bounds of a quality system, are employed in ordering, processing and inventory management of the vaccines, also, what is the status in regard to the falsified medicines directive, 2011, in regard to traceability in the case of a serious adverse event of other reason for product recall.

Your, Hedley Rees”

Two months later (after a chaser email), this is the reply I received: