FROZEN SARS-CoV-2 INJECTIONS BROKE THE LAW
Why didn't FDA/MHRA/EMA notice?
Consolidation of posts on Frozen vaccines
The mRNA frozen injections were an instant red flag for me when they appeared on the scene. In January 2022, I posted on frozen jabs, exposing them for the nonesense they were. You can read it here, and I will follow up with more on the topic.
FROZEN SARS-CoV-2 INJECTIONS WERE NOT FINISHED
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:
“Dear Mr. Rees,_
_Thank you for contacting the EMA._
_We would first like to clarify that the EMA rigorous evaluation of Covid-19 vaccines ensures that these medicines meet the necessary quality standards, and this also includes verifying compliance with Good Manufacturing Practice (GMP)._
_In accordance with the requirements of Directive 2001/83/EC, all active substance and finished product manufacturers for Covid-19 vaccines are required to comply with the requirements of EU GMP for medicinal products for human use. Furthermore, Article 80(g) of Directive 2001/83/EC provides that distributors must comply with the principles of and guidelines for Good Distribution Practice (GDP). Having appropriate quality systems to ensure the quality of the product and safety of the patient is a fundamental requirement of both GMP and GDP. Compliance with GDP ensures that medicines in the supply chain are stored in the right conditions at all times, including during transportation._
_Furthermore, as per the requirements of Article 111 of Directive 2001/83/EC manufacturers, located in the Union or in third countries, and wholesale distributors of medicinal products shall be subject to repeated inspections as means of supervision._
_After the product release and distribution, these vaccines are prepared for administration and administered by appropriately trained healthcare professionals using aseptic techniques_ _in line with the detailed handling instructions described in the SmPC (i.e. section 6.6)__. For further details into the arrangements for administration of these medicines, you will need to liaise with the EU National Competent Authority that oversee these operations._
_Lastly, as per requirements concerning biological medicinal products, the name and the batch number of the administered product for each patient is recorded. This allows traceability at batch/lot level should this be required in case or recalls or for pharmacovigilance purposes._
_For further details regarding the authorisation details for the 2 vaccines with require very low transportation temperatures, please see the following links:_
_[https://www.ema.europa.eu/en/medicines/human/EPAR/comirnaty#product-information-section]_
_[https://www.ema.europa.eu/en/medicines/human/EPAR/covid-19-vaccine-moderna#assessment-history-section]_
_Kind regards,_
European Medicines Agency”
IMPORTANT QUESTIONS DESERVE CONSIDERED ANSWERS
The questions I asked were important, as they referred directly to the safety of patients.
The answers from EMA were worryingly complacent.
It was then that I realised no serious consideration was going to be given to anyone sounding an alarm bell over potential issues in the SARS-CoV-2 injections supply-chain.