DIY FROZEN JABS BROKE PHARMACEUTICAL LAW
Why aren't the authorities taking action?
JUST IMAGINE THIS…
…you get a shiny new car delivered straight from the manufacturer. You are told to contact your local hardware shop, where they will connect up the brakes following instructions on the internet.
When you ask if the hardware shop has ever done it before, the answer is NO…
…but the instructions are clear, sir or madam.
How would you feel about that? The brakes are your last line of defence in keeping you safe, and they are connected by amateurs (albeit willing and enthusiastic), following instructions on the internet.
Well, that’s the equivalent of what happened with the Frozen SARS-CoV-2 injections.
It was illegal under EU and UK pharmaceutical law, detailed in Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2017 (The Orange Guide).
WHAT WERE THE INSTRUCTIONS?
Taking the Pfizer/BioNTech example, here is the MHRA website link to the instructions:
Frozen vials should be transferred to 2 °C to 8 °C to thaw; a 195 vial pack may take 3 hours to thaw (see section 6.4). Alternatively, frozen vials may also be thawed for 30 minutes at temperatures up to 25 °C for immediate use. Once thawed, the undiluted vaccine can be stored for up to 5 days at 2 °C to 8 °C, and up to 2 hours.at temperatures up to 25 °C
Allow the thawed vial to come to room temperature and gently invert 10 times prior to dilution. Do not shake. Prior to dilution the vaccine should present as an off-white solution with no particulates visible. Discard the vaccine if particulates or discolouration are present.
The thawed vaccine must be diluted in its original vial with 1.8 mL sodium chloride 9 mg/mL (0.9%) solution for injection, using a 21 gauge or narrower needle and aseptic techniques. Warning: Unpreserved sodium chloride 9 mg/mL (0.9%) solution for injection is the only diluent that should be used. This diluent is not provided in the vaccine carton.
Equalise vial pressure before removing the needle from the vial by withdrawing 1.8 mL air into the empty diluent syringe
Gently invert the diluted solution 10 times. Do not shake.
The diluted vaccine should present as an off-white solution with no particulates visible. Discard the diluted vaccine if particulates or discolouration are present. The diluted vials should be marked with the new discard date and time and stored between 2 °C to 25 °C. Use immediately, and within 6 hours after dilution. After dilution, the vial contains 5 doses of 0.3 mL. Withdraw the required 0.3 mL dose of diluted vaccine using a sterile needle and syringe and discard any unused vaccine within 6 hours after dilution.
All of the above is classed, under the Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2017 (The Orange Guide), as PRODUCTION OPERATIONS. That means they come under Good Manufacturing Practice (GMP) Regulations to ensure Quality is maintained.
Chapter 5 of the Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2017 (The Orange Guide) relates to PRODUCTION.
Let’s see what is says
WHAT IS THE LEGAL REQUIREMENT?
This is the start of Chapter 5: PRODUCTION
Production operations must follow clearly defined procedures; they must comply with Good Manufacturing Practice (GMP) in order to obtain products of the requisite quality and be in accordance with the relevant manufacturing and marketing authorisations.
5.1 Production should be performed and supervised by competent people.
5.2 All handling of materials and products, such as receipt and quarantine, sampling, storage, labeling, dispensing, processing, packaging and distribution should be done in accordance with written procedures or instructions and where necessary, recorded.
5.3 to 5.16 describes the various obligations that must be observed during production, such as inventory control, production of labels etc etc.
WHY HAS THERE BEEN NO ACTION FROM REGULATORY AUTHORITIES?
As to why there has been no regulatory enforcement to stop this going on, your guess is as good as mine.
These are laws and they have been broken. Restaurants that ignore the rules of good food hygiene are closed down and the owners prosecuted, very often.
Think about it…